[Senate Hearing 111-651]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 111-651
 
             DIETARY SUPPLEMENTS: WHAT SENIORS NEED TO KNOW

=======================================================================

                                HEARING

                               before the

                       SPECIAL COMMITTEE ON AGING
                          UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                             WASHINGTON, DC

                               __________

                              MAY 26, 2010

                               __________

                           Serial No. 111-18

         Printed for the use of the Special Committee on Aging



  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html



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                       SPECIAL COMMITTEE ON AGING

                     HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon                    BOB CORKER, Tennessee
BLANCHE L. LINCOLN, Arkansas         RICHARD SHELBY, Alabama
EVAN BAYH, Indiana                   SUSAN COLLINS, Maine
BILL NELSON, Florida                 GEORGE LeMIEUX, FLORIDA
ROBERT P. CASEY, Jr., Pennsylvania   ORRIN HATCH, Utah
CLAIRE McCASKILL, Missouri           SAM BROWNBACK, Kansas
SHELDON WHITEHOUSE, Rhode Island     LINDSEY GRAHAM, South Carolina
MARK UDALL, Colorado                 SAXBY CHAMBLISS, Georgia
KIRSTEN GILLIBRAND, New York
MICHAEL BENNET, Colorado
ARLEN SPECTER, Pennsylvania
AL FRANKEN, Minnesota
                 Debra Whitman, Majority Staff Director
             Michael Bassett, Ranking Member Staff Director

                                  (ii)

  
?

                            C O N T E N T S

                              ----------                              
                                                                   Page
Opening Statement of Senator Herb Kohl...........................     1
Opening Statement of Senator Bob Corker..........................     3
Opening Statement of Senator Al Franken..........................     3
Opening Statement of Senator Orrin Hatch.........................     3

                                Panel I

Statement of Greg Kutz, Forensic Audits and Special 
  Investigations, Government Accountability Office, Washington, 
  DC.............................................................     6
Statement of Tod Cooperman, President, Consumerlab.com, White 
  Plains, NY.....................................................    36
Statement of Charles Bell, Program Director, Consumers Union, 
  Yonkers, NY....................................................    43
Statement of Steven Mister, President and CEO, Council for 
  Responsible Nutrition, Washington, DC..........................    61

                                Panel II

Joshua Sharfstein, Deputy Commissioner, Food and Drug 
  Administration, Silver Spring, MD..............................    98

                                APPENDIX

Prepared Statement of Senator Al Franken.........................   127
Mr. Mister's Response to Senator Al Franken's Question...........   127
Testimony submitted by The Coalition for Dietary Supplements, 
  Washington, DC.................................................   128

                                 (iii)

  


       HEARING ON DIETARY SUPPLEMENTS: WHAT SENIORS NEED TO KNOW

                              ----------                              --



                        WEDNESDAY, MAY 26, 2010

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:05 p.m. in room 
SD-562, Dirksen Senate Office Building, Hon. Herb Kohl 
(chairman of the committee) presiding.
    Present: Senators Kohl [presiding], Franken, Corker, and 
Hatch.

        OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN

    The Chairman. Good afternoon. We'd like to thank our 
witnesses for participating in today's hearings on dietary 
supplements.
    The use of dietary supplements, which can take the form of 
vitamins, minerals, fiber, or other nutritional products, has 
grown substantially over the past few decades. Recent surveys 
indicate that at least 40 percent of American adults consume 
these products, many of which can serve as a valuable addition 
to daily diets.
    Today, we'll address concerns that have arisen over whether 
the marketing and manufacturing of these products meet the 
standards that American consumers deserve.
    Dietary supplements have become a multibillion-dollar 
industry. In 2006, Americans reportedly spent $23 billion on 
herbal and specialty supplements, which is almost half the 
amount that they spent on prescription drugs. However, several 
consumer safety issues arise with these products. Because 
dietary supplements are available over the counter, consumers 
sometimes take them in addition to, or even as a replacement 
for, other prescription medication or drugs, without consulting 
their doctors or receiving notification of potentially harmful 
interactions. In fact, the accurate information is not always 
easily accessible to the average consumer.
    The number of scientific studies conducted on the safety or 
efficacy of herbal supplements is limited, and unlike 
pharmaceutical drugs, these supplements are not subject to FDA 
approval before being marketed and sold. In addition, claims 
about these products and advertisements are subject to only 
limited regulation.
    In 2007, the FDA released Good Manufacturing Practices, or 
GMPs, that began to address some of these concerns. Though it 
took 13 years to complete them, these guidelines are intended 
to improve the safety and production of dietary supplements.
    The industry itself has stepped up oversight efforts and 
has taken on an active role in monitoring its own practices and 
helping both the FDA and the Federal Trade Commission identify 
and effectively deal with misleading ads and unfair marketing. 
Despite these positive developments, we'll hear today that 
legitimate concerns remain about the industry.
    A Government Accountability Office investigation uncovered 
both improper advertising and marketing of dietary supplements, 
as well as the existence of contaminants, such as mercury, 
lead, and pesticides, in certain products.
    While the levels of contaminants have not set off alarms 
with Federal regulatory officials or scientists, some exceed 
allowable limits. As part of their investigation, GAO referred 
marketing and contaminant samples to FDA and FTC for further 
review and possible action. Given these findings, it's obvious 
that more must be done.
    We look forward to working with colleagues in the Senate, 
including Senators Harkin and Hatch, and Senators McCain and 
Dorgan, who have long taken an interest in dietary supplement 
issues, in order to ensure that meaningful provisions 
addressing these issues are included in the Food Safety Act, 
soon to come about.
    We need to be sure companies are properly registered, 
including their product lists, so that FDA has the ability to 
identify and act on safety concerns. Since two-thirds of 
consumers believe the government requires supplement labels to 
contain warnings about potential side effects or dangers, we 
must ensure consumers receive comprehensive information about 
the safety of these products, by requiring warning labels on 
products that contain ingredients known to have adverse effects 
or harmful interactions with prescription drugs. We should also 
encourage vigorous oversight to reduce and eliminate dangerous 
contaminants even in small amounts. We need to ensure that FDA 
has the authority to recall products that are found to harm 
those who take them.
    Finally, as FDA authority expands, we need to continue to 
provide them with the resources to do these things. Last year, 
we were successful in securing a $152-million increase for 
FDA's food safety oversight, and we'll continue to advocate for 
additional funding in the future.
    Now, let's be clear, no one is suggesting that consumers 
should not be able to take vitamins or other dietary 
supplements. Our concern is that be able--that they be able to 
do so safely. American consumers should have access to 
comprehensive, accurate information about these products so 
that they are empowered to make the best decisions about their 
own health.
    We thank you once again for being here, one and all.
    We turn, now, to the ranking member, Senator Corker, for 
his comments.

    OPENING STATEMENT OF SENATOR BOB CORKER, RANKING MEMBER

    Senator Corker. Mr. Chairman, thank you. I thank you for 
having this hearing, and certainly welcome the witnesses.
    I wake up every morning, drink a cup of coffee, and take 
some dietary supplements. Certainly I care about the safety of 
those. I know today we going to hear about some of the 
practices of vendors and others relating to dietary 
supplements.
    I do want to point out that, back in 1994, we passed a law, 
DSHEA, that in implementation, would have overseen the safety 
of many of these dietary supplements. Sixteen years later, we 
still haven't fully implemented a portion of that law, which is 
Good Manufacturing Practices.
    I think one of the things that we should do here in 
Congress, before we look at passing new laws, is try to make 
sure the laws that are on the books are actually implemented 
appropriately.
    So, today I look forward to hearing from our witnesses. As 
I've said, I thank you for coming, and certainly look forward 
to being educated, in the process.
    Thank you very much.
    The Chairman. Thanks, Senator Corker.
    Senator Franken.

            OPENING STATEMENT OF SENATOR AL FRANKEN

    Senator Franken. I really have no opening comments.
    I'm eager to hear the witnesses and thank them for coming.
    Thank you, Mr. Chairman, for having this hearing.
    The Chairman. Thank you, Senator Franken.
    Senator Hatch.

            OPENING STATEMENT OF SENATOR ORRIN HATCH

    Senator Hatch. Well, thank you, Mr. Chairman.
    As the author, along with Senator Harkin, of the DSHEA--of 
the Dietary Supplemental Health and Education Act--if you don't 
mind, I would like to make a formal statement.
    The Chairman. Sure.
    Senator Hatch. I appreciate you, Mr. Chairman, for allowing 
me to.
    This issue before the committee today is extremely 
important to my home State of Utah, and my fellow Utahans, and, 
I think, every citizen in America. I want all Americans, 
including senior citizens, to have the best and most accurate 
information about the dietary supplements that they use.
    False health claims about these products, on the Internet 
and newspaper ads or on product labels, are illegal today. So 
is selling contaminated dietary supplements. Companies engaging 
in these types of activities are breaking the law, and 
therefore, should be taken off the market immediately. That 
power is granted through current law. So, amending that law is 
not necessary. What is necessary is providing the Food and Drug 
Administration the funding it needs to properly enforce and 
implement current law.
    As an original author of the 1994 Dietary Supplement Health 
Education--Health and Education Act, and the Nonprescription 
Drug Consumer Protection Act of 2006, it is important for 
committee members to understand the history behind these laws.
    Senator Tom Harkin and I were the lead sponsors of both 
bills, which enjoyed strong bipartisan support. In fact, DSHEA 
passed the Senate twice, by unanimous consent; in the House of 
Representatives, once, by unanimous consent. DSHEA established 
a statutory framework for the FDA so that dietary supplements 
are regulated as foods. The law grandfathered U.S. dietary 
supplements already on the market at the time of its enactment, 
because these products had a history of safe use. DSHEA also 
includes a strong safety standard so that potentially harmful 
products could be removed from the market.
    Through DSHEA, the FDA has an imminent hazard authority it 
may use to immediately remove any unsafe product from the 
market. The law also requires manufacturers to submit marketing 
safety information to the FDA about any new agreements not 
previously marketed. This information must be submitted to the 
FDA 75 days prior to putting a product on the market.
    Another key provision authorized issuance of Good 
Manufacturing Practice, or GMP, standards so that FDA 
inspectors could ensure products are being manufactured in 
compliance with the law. One of my biggest frustrations was 
that, once the DSHEA was signed into law, it took the FDA many 
years to implement any GMP standards. Today, these GMP 
standards apply to large- and medium-sized manufacturers, and, 
in a few weeks, will apply to small manufacturers.
    Finally, DSHEA required that all ingredients on dietary 
supplements be listed on the label, and that any claims made 
must be truthful and not misleading. Misleading claims or 
labels are a violation of the law, and the FDA should take 
products with misleading claims and labels off the market, 
period.
    Some have argued that dietary supplements should be subject 
to premarket approval. But, let me explain why this is not 
done. Most dietary supplements have been used safely for years 
and raised no concerns warranting the time and resources 
necessary for premarket approval, or even review. The entire 
time Senator Harkin and I were writing this legislation, not 
one Member of Congress raised any concerns about the 
Grandfather Clause.
    In addition, the FDA has not been able to find the 
necessary resources to even enforce the current law. As 
chairman of the Appropriations Subcommittee which funds the 
FDA--you are aware of this issue. Therefore, it is clear to me 
that FDA has much higher priorities than dietary supplements. 
Moreover, the FDA has not asked for additional funding for 
supplement enforcement, which I believe is an indicator these 
products are not the safety concerns some would argue from the 
cases highlighted at this hearing.
    The Dietary Supplement and Nonprescription Drug Consumer 
Protection Act of 2006 mandated a system to provide the 
government with information about serious adverse events 
associated with the use of the two FDA-regulated products: 
dietary supplements and over-the-counter drugs. This law 
requires manufacturers, packers, or distributors of these 
products to provide to the FDA, within 15 business days, any 
reports of serious AERs. It also is important to note that 
previous FDA commissioners--Dr. Jane Henney, Dr. Mark 
McClellan, Dr. Lester Crawford, and Dr. Andy von Eshenbach--
have all stated, in Senate hearings and in meetings--in my 
meetings with them--that through DSHEA they had the power 
necessary to regulate dietary supplements. Moreover, current 
FDA commissioner, Dr. Margaret Hamburger--Hamburg, excuse me--
has assured me that she will work with me to ensure that these 
laws are enforced.
    To ensure that these laws are properly enforced, Senator 
Harkin and I introduced a Dietary Supplement Full 
Implementation and Enforcement Act of 2010. This legislation 
requires the Secretary of Health and Human Services to submit 
annual reports to Congress regarding HHS activities on dietary 
supplements. It directs the FDA to issue its ``new dietary 
ingredient,'' or NDI, guidance, as recommended by the General 
Accountability Office, within 180 days, and requires the FDA to 
notify the Drug Enforcement Agency if it finds that a new 
dietary ingredient being evaluated contains an anabolic 
steroid. Now, I'm also the author of the Anabolic Steroid law, 
along with now-Vice President Biden. We've worked hard to make 
sure that the consumers are protected.
    This bill, S. 3414, is supported by the Major League 
Baseball Players Association, the NFL Players Association, the 
Natural Products Association, the United Natural Products 
Alliance Council for Responsible Nutrition, American Herbal 
Products Association, and the Consumer Healthcare Products 
Association. So, I urge the members of the committee to 
seriously consider supporting our bill.
    Now, Mr. Chairman, before I close, I want to emphasize that 
a vast majority of the dietary supplement industry are 
providing consumers not only with safe products, but also 
accurate information about their use. They, too, want bad-actor 
companies--and certainly I do, as well--off the market.
    So, as chairman of the Agricultural Appropriations 
Subcommittee, please work with me, Mr. Chairman, to ensure that 
the FDA has the money to enforce existing laws. That should be 
this committee's first goal. We should not be talking about 
changing current law; and, instead, focus on enforcing current 
law. Hopefully, today's hearing will begin such discussions.
    Thank you, Mr. Chairman, sorry it took so long.
    The Chairman. Thank you very much, Senator Hatch, for your 
statement.
    We'll now introduce the first panel.
    The first witness today will be Greg Kutz. Mr. Kutz is the 
Managing Director of the Government Accountability's Office of 
Forensic Audits and Special Investigations Unit. The unit is 
charged with providing Congress with the results of these 
forensic audits and investigations.
    Our second witness today will be Tod Cooperman. Dr. 
Cooperman is the President and Founder of ConsumerLab.com and 
PharmacyChecker.com, which publish consumer reports and 
independent evaluations of popular products and online 
pharmacies. He's a graduate of Boston University's School of 
Medicine.
    Third today will be Charles Bell. Mr. Bell is a Programs 
Director for Consumers Union, the nonprofit publisher of 
Consumer Reports Magazine. He oversees grant-funded projects 
that provide comparative information on health insurance and 
other consumer healthcare issues.
    Next, we'll be hearing from Steve Mister. Mr. Mister is the 
President and CEO of the Council for Responsible Nutrition, a 
trade association that represents product manufacturers and raw 
ingredient suppliers of dietary supplements. Mr. Mister is 
speaking here today on behalf of the five major trade 
organizations. He's a former Vice President and Associate 
General Counsel for the Consumer Healthcare Products 
Association.
    We welcome you all here today, and we're looking forward to 
your statements, hopefully at about 5 minutes.
    Mr. Kutz.

      STATEMENT OF GREG KUTZ, FORENSIC AUDITS AND SPECIAL 
 INVESTIGATIONS, GOVERNMENT ACCOUNTABILITY OFFICE, WASHINGTON, 
                               DC

    Mr. Kutz. Mr. Chairman and members of the committee, thank 
you for the opportunity to discuss dietary supplements.
    Today's testimony highlights the results of our 
investigation into allegations of deceptive marketing 
practices. My testimony has two parts. First, I will discuss 
the marketing of supplements; and second, I will discuss our 
testing of supplements for harmful substances.
    First, posing as fictitious elderly consumers, we tested 
the marketing practices of numerous storefront and mail-order 
retailers. This included telephone calls across the country and 
in-store visits here in the Washington, D.C., area and in 
Florida. We also evaluated claims made on Web sites and in 
other written materials. What we found was deceptive marketing 
practices related to supplements frequently used by the 
elderly.
    Perhaps more alarming was the dangerous medical advice 
provided to our fictitious consumers. Key claims made include: 
first, supplements can prevent and cure serious disease; 
second, supplements can replace prescription medications; and, 
third, supplements can safely be combined with aspirin or other 
medications.
    I have in my hand a bottle of garlic capsules that cost us 
about $11 for a 30-day supply. Mr. Chairman, you'll be amazed 
to know that this product, according to its marketing 
materials, ``prevents and cures cancer.'' As an added bonus, it 
``prevents the common cold, obesity, and diabetes.'' If these 
claims were true, imagine how this product could reduce 
healthcare costs in this country.
    Next, I have in my hand a bottle of ginseng capsules that 
cost us about $10 for a 50-day supply. In another amazing 
claim, this product ``reduces brain damage from a stroke.'' As 
an added bonus, it's supposed to ``treat Lou Gehrig's disease, 
and improve digestion, endurance, and sexual performance.'' 
There are numerous supplements claiming to treat and cure 
things like cancer and Alzheimer's disease. You can see these 
products for sale on eBay, Amazon.com, and craigslist.
    So, what's the problem with this? These products should not 
be marketed as a treatment or cure for specific disease without 
FDA approval as a drug. None of these products has that FDA 
approval.
    In addition to these deceptive claims, we found other 
dangerous information provided to our fictitious consumers. For 
example, we were told that we could stop taking our 
prescription medication for high blood pressure, and instead, 
take garlic. In another case, we were told that we could take 
ginkgo with our daily prescription of aspirin. According to 
FDA, combining ginkgo with aspirin can increase the risk of 
bleeding. As the Chairman mentioned, we have referred several 
of these cases to FDA and FTC for further investigation. In a 
moment, I will play for you excerpts from some of our 
undercover visits and phone calls to sellers of supplements.
    Moving on to my second point, we found trace amounts of 
harmful substances in 37 of the 40 herbal supplements that we 
tested. All 37 had trace amounts of lead, while others had 
trace amounts of items such as mercury, arsenic, and 
pesticides. However, FDA and EPA do not consider these trace 
amounts to be an immediate health risk.
    In conclusion, the deceptive marketing and dangerous advice 
identified pose a risk to the health of the elderly and perhaps 
other consumers. Aggressive marketers are providing consumers 
with unsubstantiated claims that their products can treat 
incurable disease. My advice to consumers across the country is 
to consult with your doctor before taking any dietary 
supplements.
    I will now play the audio excerpts I mentioned, Mr. 
Chairman, of our marketing tests. You will see the 
transcription of the conversations on the monitors as you 
listen.
    [Video presentation.]
    Mr. Kutz. Mr. Chairman, I applaud you and the other members 
of the committee for your efforts today to protect elderly and 
other consumers from the deceptive marketing of dietary 
supplements.
    That ends my statement, and I look forward to your 
questions.
    [The prepared statement of Mr. Kutz follows:]

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    The Chairman. Thank you very much, Mr. Kutz.
    Dr. Cooperman.

 STATEMENT OF TOD COOPERMAN, PRESIDENT, CONSUMERLAB.COM, WHITE 
                           PLAINS, NY

    Dr. Cooperman. OK. Senators Kohl, Senator Corker----
    Can you hear me? OK.
    Senators Kohl and Corker, members of the committee, I'm Dr. 
Tod Cooperman, President of ConsumerLab.com, a company that I 
founded 11 years ago to help consumers better identify high-
quality health and nutrition products based on independent 
testing.
    I'm accompanied by Dr. William Obermeyer, our Vice 
President for research, who spent 9 years at the FDA, testing 
foods and dietary supplements within the Center for Food Safety 
and Applied Nutrition.
    We appreciate this opportunity to present findings that are 
particularly relevant to the aging population.
    ConsumerLab's testing is funded by over 40,000 individual 
and institutional subscriptions to our Web site. We also 
provide a voluntary certification program, and test products 
for clinical researchers, particularly those funded by the NIH. 
Our recent survey of people who receive our free e-newsletter 
revealed that, among those aged 65 and older, 32 percent use 10 
or more supplements daily.
    A senior citizen in a vitamin store is a bit like a kid in 
a candy store. However, while the FDA recommends a strict limit 
on lead contamination in candy, it has not set a limit in 
supplements. Our tests show that this policy has created a 
buyer-beware situation. Based on tests of over 2,000 dietary 
supplements, representing over 300 different brands, we find 
that one out of four has a quality problem. Problems have been 
found in products from every-size manufacturer and are most 
common in herbal supplements, multivitamins, and products with 
ingredients that are newer to the market.
    The most common problem is a lack of ingredient or 
substandard ingredient. Our most recent tests of herbal 
supplements show that 46 percent contained less than their 
expected amounts of key compounds. For example, an extra-
strength ginseng product provided less than 10 percent of the 
claimed amount of expected ginsenoside compounds. We reported a 
similar problem with the same product 3 years earlier.
    A major cause of these problems is the reliance by some 
manufacturers on cheap, nonspecific tests which overstate the 
amount of actual ingredient in raw materials and supplements. 
More specific tests show the actual amounts to be lower.
    The next most common problem is contamination with lead and 
other heavy metals. The FDA professes a policy of reducing lead 
levels to the lowest amount that can be practicably obtained in 
manufacturing, yet the FDA has neither set, nor suggested, 
limits on heavy metals in supplements.
    The only limit for lead in supplements in the United States 
is in the State of California. That limit, which is half of a 
microgram per daily serving, typically works out to be just 
slightly higher than the FDA candy limit. But, it is still very 
conservative and meaningful. Products sold in California 
exceeding this limit must carry a warning label. ConsumerLab 
has found that 11 percent of herbal supplements exceed the 
California limit for lead.
    Cadmium, a toxin and carcinogen, also occurs in certain 
herbal supplements, but the FDA has not set a limit on cadmium 
in supplements. ConsumerLab has found that 40 percent of St. 
John's wort supplements and 14 percent of valerian supplements 
exceed World Health Organization guidelines for cadmium 
contamination.
    While individual products with elevated levels of lead and 
cadmium are generally not toxic in themselves, they 
unnecessarily expose Americans to toxins, and the effects are 
cumulative. As noted earlier, many seniors take 10 or more 
supplements daily, and additional exposure comes from foods, 
beverages, and the environment. It would be dangerous to 
suggest that a single supplement needs to contain a toxic 
amount of heavy metal to be a threat to health. However, a 2007 
report by the FDA on lead contamination in multivitamins made 
this faulty assumption, and has been criticized for doing so.
    Unfortunately, the USP may soon adopt an industry proposal 
permitting 10 micrograms of lead per daily serving of a 
supplement, 20 times higher than the California limit. We think 
such a lax standard would be a terrible mistake, permitting an 
individual supplement to exceed the total amount of lead that a 
child can tolerate, and just a few supplements to surpass the 
daily threshold for adults.
    Will Good Manufacturing Practices help? These practices, as 
mentioned, are now required of most supplement manufacturers to 
help ensure batch-to-batch uniformity. However, bad products 
can be made under Good Manufacturing Practices, because the 
GMPs do not include standards for purity and ingredient 
identity. These standards, and the selection of tests used to 
measure against them, are left to each manufacturer to 
determine for itself.
    In conclusion, nearly 11 years of product reviews by 
ConsumerLab.com have shown consistent problems with a 
significant percentage of dietary supplements, particularly 
herbal supplements. However, in nearly every supplement 
category that we do test, we do find products that meet high 
quality standards, showing that this is achievable. If we want 
our supplements to be the best and safest in the world, we will 
need to have better guidance from the government, establishing 
rigorous standards and test methods, greater enforcement of 
current regulations, and more self-regulation from the 
industry.
    In my written testimony, you'll find additional statistics, 
information, and references. Thank you for your time.
    [The prepared statement of Dr. Cooperman follows:]

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    The Chairman. Thank you very much, Dr. Cooperman.
    Mr. Bell.

 STATEMENT OF CHARLES BELL, PROGRAM DIRECTOR, CONSUMERS UNION, 
                          YONKERS, NY

    Mr. Bell. Chairman Kohl, Ranking Member Corker, members of 
the committee, I'm Charles Bell. I work for Consumers Union, 
the nonprofit publisher of Consumer Reports, based in Yonkers, 
NY.
    I just wanted to point out, at the outset, that even though 
Dr. Cooperman and I both come from New York, we have no 
official relationship with ConsumerLab.com. We're separate 
organizations. We certainly appreciate the research work that 
they are doing.
    If--I would--I submitted a rather long written statement. I 
would just summarize some of the highlights.
    In terms of senior use of dietary supplements, findings 
from several sources indicate that dietary supplement use 
generally increases with age. According to a survey published 
in the Journal of American Medicine, 49 percent of Americans 
aged 57 to 85 use a dietary supplement and 52 percent of 
seniors reported using supplements concurrently with 
prescription drugs.
    Many dietary supplements, including most vitamins and 
minerals, taken within recommended limits are generally safe 
and can have important benefits for consumers. However, 
Consumers Union is concerned that there's a significant and 
growing number of highly questionable products that are 
entering the market that would probably fail rigorous safety 
testing.
    We would note that, since the passage of DSHEA in 1994, the 
marketplace has grown. This is quite a large and dynamic 
marketplace today, with industry sources estimating there could 
be between 30- to 75,000 dietary supplement products on the 
market, with another 1,000 new products or so entering every 
year. So, that's a lot of products for the FDA and other health 
authorities to keep an eye on. We think, at the same time, that 
consumers and seniors really do need to be aware that there are 
significant unresolved safety problems with dietary 
supplements.
    We publish, in Consumer Reports over the last 20 years or 
so, several articles with lists of unsafe supplements that we 
think consumers should avoid. For example, in 1995 we published 
an article calling out five herbal supplements, including 
ephedra. But, the other four that were on that list--chaparral, 
comfrey, lobelia, and yohimbe--continue to be sold in the 
market today. We updated our list in 2004 and 2008.
    Generally when Consumer Reports warns about product 
hazards, we're used to seeing some type of swift response from 
the marketplace, either of the product being corrected or fixed 
by manufacturers, or withdrawn by the governments. We are 
concerned that we see a lot of products that we think consumers 
should not be running into staying on store shelves that could 
be a dangerous surprise for a senior or a consumer.
    But, we also have advised consumers not to use weight-loss 
supplements, generally speaking. We are concerned about multi-
ingredient herbal supplements, often with concentrated herbal 
extracts spiked with stimulants, like bitter orange or high 
levels of caffeine. We've also been concerned about supplements 
marketed for sexual enhancement purposes that also have high 
levels of stimulants and multiple ingredients, and sometimes 
also turn out to be contaminated with prescription drugs.
    We are concerned that FDA does not have a program of 
manufacturer registration. When the HHS inspector general 
visited FDA in 2001, they found that the agency was unable to 
provide information for many, many products that it should 
supposedly be overseeing.
    We cite, in our testimony, information about the increasing 
amount of imported ingredients that are used in supplement 
manufacturing. China now provides about one-third of global 
vitamin manufacturing, and many herbal and other botanical and 
dietary supplement products are sourced there, as well. We are 
concerned about whether the FDA really has sufficient resources 
to police the imports of products from China, or any other 
country, because there are many other countries that are 
potentially involved.
    We have also expressed concern about new supplements that 
contain nanoparticles. There is a report that was done by the 
Project Emerging--on Emerging Nanotechnologies, here in DC., 
that there's more than 44 dietary supplements with 
nanoparticles that have already entered the marketplace. We 
don't--we're not sure the FDA has looked at the safety profile 
for any of these, and we do not think that they should be 
permitted to be sold until they are subject to premarket safety 
testing.
    We believe that seniors really do need to be aware of 
interactions between--potential interactions between 
prescription drugs and dietary supplements. As noted, 52 
percent of seniors are also taking prescription drugs. There 
are many, many different warnings for different types of 
supplements. For example, ginkgo biloba can interfere with 
blood clotting, and physicians generally advise consumers to 
cease from using herbal medicine 2 weeks prior to having 
surgery. In other cases, the supplement can lower the 
effectiveness of the prescription drugs that consumers are 
taking, or actually intensify it.
    So, we support the Dietary Supplement Safety Act of 2010 
that would strengthen public oversight of dietary supplements. 
It would include provisions for manufacturer registration, 
mandatory recall authority, and reporting of nonserious adverse 
events.
    We thank you very much for your interest in these issues, 
and look forward to working with the committee, and with the 
industry, to address the problems that are being discussed here 
today.
    [The prepared statement of Mr. Bell follows:]

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    The Chairman. Thank you, Mr. Bell.
    Now we'll hear from Mr. Mister.

  STATEMENT OF STEVEN MISTER, PRESIDENT AND CEO, COUNCIL FOR 
             RESPONSIBLE NUTRITION, WASHINGTON, DC

    Mr. Mister. Good afternoon. My name is Steve Mister. I'm 
the President of the Council for Responsible Nutrition.
    More than 150 million Americans take dietary supplements 
each year, including many who are extremely passionate about 
their rights to purchase supplements and to have access to 
information about their health choices.
    The dietary supplement industry is committed to 
manufacturing and marketing high quality, safe, and beneficial 
products that have a valuable role in a wellness regimen. This 
industry is likewise committed to ensuring that consumers 
receive truthful, accurate, and nonmisleading information on 
dietary supplements.
    We also share the committee's concerns about bad actors in 
the industry, whether they are unaware of the extensive 
regulatory framework governing dietary supplements or they are 
willfully breaking the law. We condemn adulterated or 
misbranded products, and we denounce false, misleading, or 
deceptive marketing practices, activities that are engaged in 
by a very small minority, who damage the reputation of the 
responsible industry.
    The supplement industry, as a whole, has a demonstrated 
track record of providing high quality products to its 
consumers, as well as a reputation on Capitol Hill for active 
lobbying for stronger enforcement of the law under which our 
industry operates. Our industry has gone even further; through 
its five industry associations, we have developed a variety of 
voluntary self-regulatory programs that address the issues that 
have the potential to tarnish our industry and hurt our 
consumers.
    So, let's put some perspective on the committee's concerns:
    First, the notion that supplement users will forsake 
conventional medicine or other healthy behaviors is a myth. To 
the contrary, supplement users are more likely than nonusers to 
engage in other healthy habits, such as eating a healthy diet, 
exercising regularly, and visiting their doctors.
    Second, among our passionate supplement users are a high 
percentage of healthcare professionals--doctors, nurse 
practitioners, pharmacists, and registered dietitians.
    Third, there are literally millions of dietary supplements 
sold in this country each year, and very, very few serious 
adverse events. The strong safety profile for the overwhelming 
majority of these products defies the examples that were raised 
before the committee.
    Let's also be clear here that the FDA and the FTC have 
ample authority under existing law to address the concerns that 
are being raised. The Dietary Supplement Health and Education 
Act authorized FDA to prescribe comprehensive regulations for 
the manufacturing of supplements, called ``Good Manufacturing 
Practices.'' When it comes to the safety of ingredients, DSHEA 
provides the agency with the ability to remove products from 
the market if they present an unreasonable or significant risk 
of injury or illness to consumers. It likewise requires 
companies to notify FDA before they bring a new dietary 
ingredient to the market, and to provide evidence that 
demonstrates a reasonable expectation of the safety of the 
ingredient. The law prohibits labeling claims that purport to 
treat or cure a disease, and it demands that all label claims 
be truthful, not misleading, and substantiated with adequate 
evidence.
    Separately, the FTC Act gives the Federal Trade Commission 
similar authority over supplement advertising and marketing 
claims, whether made by manufacturers or retailers.
    The problem is that FDA has suffered from a lack of 
funding, resources, and, until recently, perhaps the political 
will, to consistently and aggressively enforce and implement 
this law. The industry calls on Congress today to provide 
sufficient resources to FDA to fully implement the provisions 
of DSHEA that were enacted 16 years ago. The Dietary Supplement 
Full Implementation and Enforcement Act of 2010, introduced 
recently by Senators Harkin and Hatch, will go a long way 
toward providing adequate funding and accountability for FDA.
    The industry recognizes that it, too, must foster a climate 
of compliance, and all five industry associations have 
ambitious programs to do just that. Individual companies also 
maintain their own rigorous programs. For instance, all three 
major vitamin supplement retail chains require initial training 
for all of their entry-level employees, and ongoing continuing 
education for their retail staffs, to remind their employees 
over and over about the limits on what they can and cannot say 
to consumers.
    However, based on the testimony and the video today, the 
industry associations recognize that we need to do more. So, 
today the five associations pledge to the committee to increase 
our efforts to educate retailers and their clerks who sell 
dietary supplements about what is permitted under the law.
    We are confident in the role that dietary supplements can 
play in the health and wellness of this Nation, particularly 
senior citizens. Dietary supplements help to preserve good 
health and independence for our senior citizens, and they can 
help to reduce the risk of certain chronic diseases. Vitamins 
fill in nutritional gaps, especially when seniors fail to get a 
nutritious diet, or when aging itself reduces their bodies' 
natural ability to absorb nutrients from conventional food.
    I'm confident this industry and robust government agencies, 
working together, can address the concerns raised today under 
the existing law. We look forward to working with Congress, the 
FDA, and the FTC to provide senior citizens, as well as all 
consumers, with even more confidence in the safety, quality, 
and benefits of dietary supplements.
    Thank you.
    [The prepared statement of Mr. Mister follows:]

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    The Chairman. Thank you very much, Mr. Mister.
    As I said, and as you've indicated, you're speaking for 
virtually the entire dietary supplement industry. You were 
quoted by the New York Times as saying that you've seen late-
night commercials for dietary supplement products that, ``made 
your blood boil,''. So, what more should you and your industry 
be seeing--be doing about this to ensure that your ``blood 
doesn't boil'' and you don't have to take excessive dietary 
supplements?
    Mr. Mister. Senator, I don't know if we have a product for 
``blood boiling.''
    You know, actually, the industry does have a very 
aggressive approach to these kinds of ads. We were very 
troubled about this several years ago, and it led to the 
formation of a program, with the Council for the Better 
Business Bureaus, called the National Advertising Division. 
Under that program, over the past 3 years, we have provided 
unrestricted grants of almost half a million dollars, and over 
the next 5 years, we will increase that to a total of 1 and a 
half million. It allows the National Advertising Division to 
look at supplement ads, so the ones like I saw on late-night 
television can be referred to the NAD, they can review those 
ads for the veracity of the claims, decide whether they're well 
substantiated, and issue a decision. If they recommend a change 
to the ad and the advertiser chooses to ignore that 
recommendation, then it can be referred to the Federal Trade 
Commission. The history is that, when those cases go there, the 
FTC takes high priority on those cases.
    The Chairman. Well, that's well and good, but you've heard 
Mr. Kutz, today, talk--I mean, he has in his hand dietary 
supplements that make representations that are flatout not 
true. Now, don't you think your industry should be able to 
police that? Without--I mean, we understand the FDA and its 
importance. My committee oversees the FDA, and we've worked 
hard to get additional monies for enforcement; so we're not 
indifferent to that need, by any means. But, shouldn't your 
industry be able to see to it that claims that are made, like 
the ones Mr. Kutz has just--has right in his hand, are off the 
market?
    Mr. Mister. Well, I think to expect any industry 
association to achieve 100-percent compliance against all its 
actors is a little unrealistic, Senator. But, first thing I 
would do would be to encourage Mr. Kutz to refer those ads to 
the NAD--I'd be happy to talk to him about how you follow one 
of those challenges--and to turn over the products to the FDA, 
before Dr. Sharfstein leaves today, so that FDA can 
appropriately prosecute those companies for violating the law.
    The Chairman. You refer to training employees who sell 
these products, very carefully and completely. Yet, as Mr. Kutz 
indicated here on his video, there are employees in your 
industry who are making sales representations that are, again, 
flatout untrue. When I ask you whether or not your industry can 
do better, of course you say, and you should say--and I'm sure 
you mean--that ``we can do a lot better,'' because I understand 
that very carefully and clearly. But, do you think your 
industry needs to step up its efforts to see to it that 
products are not misrepresented, either in the manufacturer or 
in the sale?
    Mr. Mister. Senator, as I indicated in my testimony, we 
recognize that we can do more. In fact, one of the other 
associations, the Natural Products Association, already 
announced, this morning, a new retail toolkit that it will get 
out to its members, who are the retailers who sell these 
products. The other industry associations are also evaluating 
options.
    So, yes, there is more that we can do to make sure that 
retailers, and their clerks, understand what the limits are 
under the law.
    The Chairman. Mr. Kutz, in your testimony you outlined 
several examples of what appear to be misleading marketing and 
advertising claims. Have you reported this information to the 
FDA or the FTC? What do you hope or expect is going to be the 
outcome?
    Mr. Kutz. We did--we've met with both organizations and 
sent a written referral of the more egregious cases to both 
organizations. So, that's what we've done.
    The Chairman. Have they indicated that they're going to 
sufficiently take additional look at these reports that you've 
submitted to them?
    Mr. Kutz. I can't speak with any--certainly they were 
concerned, and I think that they indicated some action, but 
time will tell whether they actually take strict action with 
this.
    The Chairman. OK.
    Senator Corker.
    Senator Corker. Thank you, Mr. Chairman. Again, thank you 
for having the hearing.
    I appreciate all of you, as witnesses.
    Mr. Mister, the retail salesperson out in the field--I've 
been in a lot of these stores, as I'm sure most people in this 
room have, and sometimes there's a school of thought about a 
product. I mean, some people think garlic does certain things, 
how would you go about, on a realistic basis, with retailers 
across the country and clerks who come in to work in these 
various units--how would the industry go about ensuring that 
each of these clerks in each of these situations with--some of 
these products are sort of built around a belief system that 
exists about what certain things do. There are different 
beliefs around what they do. How would you, in fact, adequately 
police units like this? Should that even part of what your 
responsibility is, as an entity?
    Mr. Mister. Well, Senator, there is a lot of emerging 
evidence, very good scientific evidence, about the benefits of 
supplements, that goes beyond just general health and 
maintenance. So, there are research studies now looking at the 
ability of these products to actually prevent diseases and 
treat diseases. However, unlike the belief system, the law is 
very clear. We're not allowed to make those kinds of claims in 
our labeling and our advertising.
    So, I think it would be very easy for the industry to 
develop programs that train their employees, just as some of 
these major retail chains already have, that make it clear 
that, when you're talking to a consumer, you can talk about 
basic nutritional information, you can talk about those things 
that are already on the label that deal with the structure and 
function of the body, but you can't take a product--no matter 
what you personally believe, you can't take a product off the 
shelf and recommend it to a consumer to treat or cure a 
disease. We can make that message fairly clear to retail 
clerks.
    Senator Corker. The retail clerk--I expect that I could 
probably go get a job at one of these units pretty easily, even 
with my lack of experience, and would my advocating on behalf 
of that be based on what's on the label? I mean, is that how 
these are actually marketed?
    Mr. Mister. Well, as I indicated, I've had the opportunity 
to talk to all three major retail chains, in the last week. 
Their programs differ from one company to another. But, all of 
them have programs that start with all entry-level employees, 
and talk to them about what they can say about individual 
products. Then they have these continuing programs that go 
beyond just the basics of what you can and cannot say, and will 
get into particular lines of products. So, these are the things 
that they could say about weight loss, these are the things you 
can say about general nutrition information, these are things 
you can say about men's specialty supplements, or women's 
specialty supplements. The longer the employee is there, the 
more training they get.
    Senator Corker. The laboratory that you use to test these 
units--y'all don't actually do testing yourself. Y'all get 
others to do the testing and accumulate the information, is 
that right?
    Mr. Kutz. We use the lab that FDA had recommended----
    Senator Corker. Yeah.
    Mr. Kutz [continuing]. To us, yes.
    Senator Corker. So, when you talked about these trace 
amounts that you found, and they were not damaging enough to--
the trace amounts that you found in most--in all of these 
products, were not enough to actually damage anybody, is that 
correct?
    Mr. Kutz. According to FDA and EPA. We do not have the in-
house expertise to make that type of a conclusion, so we 
consulted----
    Senator Corker. Yet----
    Mr. Kutz [continuing]. With the government experts on that, 
yes.
    Senator Corker. So, look--each of us probably, from time to 
time, take prescriptions also, in addition to the dietary 
supplements that some of us may take daily, and many Americans 
do. What--do you have any idea how that would compare to trace 
elements that might be found in actual prescription drugs?
    Mr. Kutz. I wouldn't have that information, no.
    Senator Corker. Would that be helpful to know?
    Mr. Kutz. Perhaps other experts here might know. I just 
don't know that, sir.
    Senator Corker. When you test a particular product for 
someone, are they paying you to do that? How does that come 
about? Are you paid to test products, by the people that are 
getting ready to market them?
    Mr. Kutz. We did it on behalf of the committee, actually. 
We went--we paid to have these products tested, on behalf of 
Senator Kohl, to test for things like arsenic, pesticides, and 
things like that. So, that's what we did.
    Senator Corker. Yeah.
    Mr. Kutz. I think other people actually----
    Senator Corker. But, I assume you have a business model. 
You certainly don't rely upon this committee, hopefully, to 
survive. So, what do you do, on a daily basis?
    Mr. Kutz. I'm not sure what you mean. What do we do----
    Senator Corker. So, tell me what the company does, outside 
of work here at the committee.
    Mr. Kutz. I'm with GAO, so----
    Senator Corker. Oh, I'm----
    Mr. Kutz. Sorry.
    Senator Corker [continuing]. I apologize. I apologize. 
[Laughter.]
    Senator Corker. I apologize.
    Mr. Kutz. We don't typically test supplements.
    Senator Corker. I'm getting my witnesses confused. I 
apologize.
    Mr. Kutz. That's OK.
    Senator Corker. So, I'm actually thinking about Mr. 
Cooperman, here. I apologize.
    Would you have any ideas as to how these would compare to 
other prescription drugs?
    Dr. Cooperman. No, we also don't regularly test 
prescription drugs----
    I'm sorry.
    We do not regularly test prescription drugs. We are focused 
primarily on the dietary supplements.
    Senator Corker. When someone pays you to test--I assume 
that's what you do, before they want to market. Is that 
correct?
    Dr. Cooperman. Actually, there are two things that we do, 
as I mention in my testimony. We were set up to help consumers 
identify better-quality health and nutrition products. So, what 
we do is go out, select, on our own, a group of products, such 
as the ones that you may use, and test them against standards 
that we can find--because again, as I mentioned, the FDA has 
not set standards, so we use standards from California, World 
Health Organization, Europe--and test these products against 
those standards to see how they compare, and then publish all 
results for all those products that we've selected for testing.
    We also have a voluntary certification program so that any 
manufacturer can come to us and have a product tested. If it's 
certified--it passes all the same tests that we use for the 
products we select--it will be--also be noted, on our Web site, 
as having met that standard.
    Senator Corker. So, when somebody fails a test, do y'all 
ever follow back up with that? I mean, what happens when a 
product comes through your lab and actually fails?
    Dr. Cooperman. Right. It's a good question. The products 
that we select for testing, if a product fails, it's reported 
publicly as--to our subscribers--we have about 40,000 
subscribers--what happened with that product. Any manufacturer 
is welcome to contact us, and, within 48 hours, we'll give them 
the full results for that product, the--where it was purchased, 
the lot number--to help them try to figure out, you know, what 
the problem is so they can correct that problem.
    Senator Corker. Thank you, Mr. Chairman.
    The Chairman. Thank you very much.
    Senator Franken.
    Senator Franken. Thank you, gentlemen.
    I just want to get something clear, Mr. Kutz. These claims 
that--these deceptive marketing practices--were these all just 
oral, or were they written on the packaging?
    Mr. Kutz. Both.
    Senator Franken. Both.
    Mr. Kutz. Both, yes.
    Senator Franken. OK. So, Mr. Mister talked about voluntary 
self-regulatory regimens. If these are marketed--if these are 
on the packaging, I'm not quite sure how robust this voluntary 
self-regulatory regimen really could be. I mean, this is--was--
on the garlic packaging, for example, did it have the claims 
of--that you'd mentioned?
    Mr. Kutz. I think it was on the Web site, in that 
particular case. Again, on the packaging piece, I would say 
that the ones on the ``prevention, cure, treat disease,'' those 
were mostly small companies; that was not your major, national 
chains.
    Senator Franken. OK, I see.
    Mr. Kutz. The oral is where the national chains were 
actually giving--four of the seven you saw on the----
    Senator Franken. I agree with----
    Mr. Kutz [continuing]. Were national chains.
    Senator Franken [continuing]. Senator Corker, that--I'll 
bet you Senator Corker could get a job---- [Laughter.]
    Senator Franken [continuing]. Selling. I'll bet you he'd be 
a manager within months. [Laughter.]
    Senator Franken. So, I mean, I could see how there might be 
some turnover and that kind of thing. So, I can't hold the 
industry responsible for every person working there.
    Mr. Bell, how does a Minnesota senior know that the 
supplement that he or she is taking works, and works--and does 
what it claims to do?
    Mr. Bell. Well, it's--you know, if the person had an 
advanced medical degree, it would be--probably help. It's quite 
challenging for consumers, on their own, to sort out the 
efficacy and safety of dietary supplements. We believe that 
there's a significant----
    Senator Franken. Well, you can go to your doctor.
    Mr. Bell. Sure. There's a variety of methods that we 
advocate for people to get information. One, you know, there 
are good sources available through the Federal Government, 
through the National Institutes of Health. Office of Dietary 
Supplements has a very good Web site, with authoritative 
information. We think the standard should be, you know, what is 
in the comparative medical evidence. Is there comparative 
reviews of clinical studies----
    Senator Franken. What percentage of these supplements would 
you say live up to their claims on their labeling?
    Mr. Bell. I would be hard-pressed to answer. I think it's 
very hard to characterize a marketplace, where you have so many 
different products. I think there's a large mass of products 
that are generally fine, and have, you know, good--vitamins, 
for example; you know, most vitamin products state what they 
contain; they're relatively straightforward products. Many 
minerals, and even some herbal products, have relatively 
standardized preparations. People can consult labels for--the 
U.S. Pharmacopeia-verified label is another thing people can 
look for. But, I absolutely agree that consumers should discuss 
the use of supplements with their physician or----
    Senator Franken. Especially because----
    Mr. Bell [continuing]. Medical provider----
    Senator Franken. I don't mean to interrupt you, but you 
testified to the interaction between prescription drugs and 
supplements, that, for example, I know I--if you eat 
grapefruit, that it acts bad on statins, right?
    Mr. Bell. Uh-huh. There is really a lot that people need to 
know. In some of the journal articles I cited in my testimony, 
there are lists of as many as, you know, 20 to 30 different 
supplements that could affect cardiovascular health. They can 
affect it in multiple ways--you know, they can intensify the 
effect of medications people are taking; they can weaken it; 
they can interfere with clotting and other factors, so 
they're--people who could be at risk in surgery. So, we 
provide, you know, through our Web site, information for our 
subscribers. I know the General Accounting Office has 
recommended the FDA do more to inform and educate consumers. 
But, I would just say, it's--it is a very large task, because 
these are very complicated decisions. I think that the medical 
provider and the physician has to be a gateway, because someone 
needs to take a look at the medications and the particular 
supplements that the consumer is taking, and make sure that the 
harmful interactions will not be present.
    In some cases, physicians have also found patients are 
taking supplements that are contaminated, and then they need to 
send that----
    Senator Franken. Well, as Mr. Cooperman talked about----
    Mr. Bell [continuing]. Preparation out to an outside lab--
yes--send it out to an outside lab to see if prescription drugs 
might be present in that product.
    So, I would urge seniors to do their homework. We try to 
provide straightforward information about supplements that we 
think are beneficial. But, I would say there's relatively few 
products that we recommend. We think there is scant evidence 
for many, many products, and that--so consumers may be putting 
their money at risk----
    Senator Franken. Mr. Mister seemed to have a different 
opinion, for some reason.
    Mr. Cooperman--and I'm running out of time here, and I'm 
sorry--you were talking about the contamination. I was picking 
up on Mr. Bell, there. What do you think can be done to 
improve--just--so that seniors are getting at least what they 
want, that it's at the level of what they want of the stuff 
that either does or doesn't do what it's supposed to do, and 
that they don't get the bad stuff that they don't want?
    Dr. Cooperman. Yeah----
    Senator Franken. What can be done, do you think? You know, 
is the new law, that Senator Hatch has crafted with Senator 
Harkin--is that sufficient? Or is there something that you 
think needs to be done on a policy?
    Dr. Cooperman. It's an excellent question. As we see it, 
one of the biggest problems here, as I said repeatedly in my 
testimony, is that there are no quality standards built into 
the law, neither into the GMPs or into the wider DSHEA law. 
That is left to the--each manufacturer, to pick their own 
standard. Then, within that, they're each allowed to determine 
their own way of testing against that standard; and there are 
good tests and there are very lenient tests.
    So, a first step, really, would be to set some standards, 
you know, rather than just having States go off, like 
California, and set their standards. Perhaps have some type of 
guidance, if not law, you know, from the Government, in terms 
of standards. I think----
    Senator Franken. I'm sorry, but we've--my time----
    Dr. Cooperman. OK.
    Senator Franken [continuing]. Is up, and I've indulged the 
panel enough. Maybe Senator Hatch would either want to pick up 
on that or ask what he likes---- [Laughter.]
    Senator Franken [continuing]. Whatever he wants to ask.
    The Chairman. Thank you, Senator Franken.
    Senator Franken. Thank you.
    The Chairman. Senator Hatch?
    Senator Hatch. Well, thank you, Mr. Chairman. I'm grateful 
to my colleague for recognizing that.
    Have any of you ever used dietary supplements? Everybody is 
shaking their head.
    [Witnesses indicating yes.]
    Senator Hatch. You use them today?
    Mr. Bell. Yes.
    Dr. Cooperman. Sure.
    Senator Hatch. How about you?
    Mr. Bell. I take a multivitamin.
    Senator Hatch. Multivitamin. I presume you do.
    Mr. Mister. Took a handful this morning, Senator.
    Senator Hatch. OK.
    It's Kutz?
    Mr. Kutz. ``Kootz,'' yes.
    Senator Hatch. ``Kootz. Kootz.'' Mr. Kutz. Yes.
    Senator Hatch. ``Kootz,'' sorry. I wanted to thank you for 
your testimony. I want to ask you for yes/no answers on some 
questions, just to be clear for the record.
    Based on your testimony, you stated that the FDA statutes 
and regulations do not permit sellers to make claims that their 
products can treat, prevent, or cure specific diseases. Is that 
correct?
    Mr. Kutz. Yes.
    Senator Hatch. OK. When you and your staff shared these 
drug-type claims with the FDA and the Federal Trade Commission, 
both agencies agreed that these, ``drug-type,'' claims were 
improper, and were in likely violation of the current statutes 
and regulations.
    Is that correct?
    Mr. Kutz. Yes.
    Senator Hatch. OK. Finally, from the samples tested, the 
levels of heavy metals found did not exceed any FDA or 
Environmental Protection Agency, or EPA, regulations governing 
dietary supplements or their raw ingredients. In fact, the FDA 
and the EPA officials did not express concern regarding any 
immediate negative health consequences from consuming those 40 
supplements. Am I correct on that?
    Mr. Kutz. Can I say yes, with a footnote?
    Senator Hatch. Yes.
    Mr. Kutz. There were 16 that they did not have a tolerance 
level for, although they did say, Senator, that they were very 
low, based on----
    Senator Hatch. OK. Nobody's more interested in making sure 
that this industry works properly in the best interests of our 
people than I am. The trouble is, FDA doesn't have the money to 
really do what it should do.
    Mr. Cooperman, could you please explain a little bit how 
ConsumerLab works? Do organizations hire you to conduct tests 
on their products?
    Dr. Cooperman. Right. I believe that Senator Corker just 
asked the same question.
    We have two programs. We go out and do reviews, where we 
select products, test them, and report all the results. We also 
have a voluntary certification program, where companies can 
come to us voluntarily, just as the USP does and NSF does, and 
if that product passes that certification testing, we will note 
that on our Web site, as well.
    Senator Hatch. What do you do with those that don't pass 
that certification testing?
    Dr. Cooperman. The ones that don't pass, that information 
is given to the manufacturer; hopefully, they'll correct that.
    Senator Hatch. But, you don't make that public at all.
    Dr. Cooperman. The USP does not, as part of that 
certification program; that's a separate thing from the reviews 
we conduct where all the result are published.
    Senator Hatch. Am I correct that ConsumerLab is a for-
profit organization?
    Dr. Cooperman. That's right.
    Senator Hatch. If that is the case, what happens when one 
of your clients doesn't like the results of your tests, and 
those results show that a product may potentially pose a public 
health risk? What do you do?
    Dr. Cooperman. Sure. Yeah, I mean, it's a very good 
question.
    Senator Hatch. Are these results still made available to 
the public, for instance?
    Dr. Cooperman. Yes, as I just said, in our product 
reviews--and there are many examples from those in the 
testimony I gave--all those results are published. So, there's 
no pulling back on any information. What a manufacturer can do 
is fix it later. As I said, we have a published protocol, where 
any manufacturer can come to us and, for free, not only get the 
results, but we would even send out their sample to another 
laboratory, of our mutual choosing, if they wish to challenge 
those results.
    Senator Hatch. Are your lab tests and your findings peer-
reviewed by scientific experts outside of your organization?
    Dr. Cooperman. Our Web site is not a peer-reviewed Web 
site. Dr. William Obermeyer, who is from the FDA, chooses these 
laboratories. There all accredited laboratories. In fact, going 
even beyond what the GAO is able to do, any product that fails 
our tests is sent to a second independent laboratory for 
confirmation before we would even publish those results.
    Senator Hatch. OK. Do you have an auditing program for all 
the labs that you use, to ensure the accuracy and reliability 
of the results you're giving?
    Dr. Cooperman. Right. I can have Dr. Obermeyer speak more 
toward that. It would be helpful, perhaps, if the FDA actually 
regulated the laboratories--they do not--in terms of the 
dietary supplements.
    Senator Hatch. Well, they have the authority to. But, 
again, we--we're responsible, too, for not providing the money 
so that they can do a better job.
    Mr. Mister, I just--I'm----
    Mr. Bell, I'm not trying to ignore you, I may get to you.
    But, Mr. Mister, let me ask you this. In Mr. Cooperman's 
testimony, he said that Current Good Manufacturing Practices--
or GMPs, we call them--CGMPs--can still allow bad products on 
the market, because the CGMPs do not include standards for 
purity and ingredient identity. Is this a loophole that allows 
unsafe products on the market? Can you give the committee some 
reassurances, here?
    Mr. Mister. Well, it's certainly not a loophole, Senator. 
The GMP regulations do give individual companies some 
flexibility, when FDA comes to inspect, to demonstrate how 
their product identity matches to a standard, to prove that it 
is what it says it is.
    Senator Hatch. Yeah.
    Mr. Mister. But, it does leave some flexibility to the 
company. However, that's not to say that the company can just 
pick any standard they want, the standard must be 
scientifically defensible to FDA during that inspection. Just 
saying, ``We looked at the product and it looked like Vitamin D 
to us,'' is certainly not going to pass muster.
    So, companies have to develop standards and use testing 
that FDA would agree to.
    Senator Hatch. OK.
    Mr. Bell, are you familiar with the Bioterrorism Act of 
2002, and that it requires mandatory registration of all food 
facilities, including dietary supplement facilities?
    Mr. Bell. Yes, I am aware that law has been passed. 
However, we are concerned that it does not provide the same 
detail and amount of information that could be available 
through expanded manufacturer registration requirements.
    Senator Hatch. Have you ever completed this registration 
and seen that you can click a box to identify oneself as a 
dietary supplement manufacturer?
    Mr. Bell. I have--I--Senator, I have not seen that 
registration form itself. But, my--our concerns were based on 
the HHS inspector general report that found that FDA often--you 
know, 30 percent of the time--did not have information on how 
to contact manufacturers who had submitted adverse event 
reports, and they, 60 percent of the time, did not have 
ingredients of products that they were investigating. I 
certainly hope that situation has improved. But, we would 
support strengthening manufacturer registration to the same 
level for monograph drugs.
    Senator Hatch. Mr. Chairman, could I ask one more question? 
I notice----
    The Chairman. Sure, go right ahead, Senator Hatch.
    Senator Hatch. I'll finish with this last----
    I noted, in--Mr. Bell, in your testimony, that Consumers 
Union supports S. 3002, the Dietary Supplement Safety Act of 
2010. As you may know, consumers of dietary supplements let 
Senator McCain know that they had serious concerns with this 
bill, because it could jeopardize the availability and 
affordability of dietary supplements.
    Senators Harkin, Enzi, and I worked with Senator McCain and 
Senator Dorgan to incorporate four concepts from this bill into 
S. 510, the Food Safety Modernization Act. Now, these concepts 
include mandatory registration of facilities, mandatory recall 
of dietary supplements, publication of new dietary ingredients, 
or NDIs, guidance in mandating the FDA to notify the DEA when a 
``new dietary ingredient'' application is rejected because the 
product contains an anabolic steroid.
    Now, the last two concepts were introduced in the 
legislation that Senator Harkin and I introduced yesterday. So, 
I would hope you--that would please you.
    Now, could I ask you one thing? Does the Consumer Union--
does it put out a list of pharmaceuticals that--with a cross-
list--what dietary supplements may be harmful or may have----
    Mr. Bell. Yes, sir, we do. I actually have it with--here 
with me, if you'd like----
    Senator Hatch. Well, I'd love to have that, if you'd be----
    Mr. Bell. Sure. Sure.
    Senator Hatch [continuing]. Could get that to my office.
    Mr. Bell. Absolutely. I----
    Senator Hatch. I'd love to look that over as part of, you 
know, our total desire, here, to get this industry doing 
everything it can to be right. By and large, the vast majority 
of them, as you've indicated, put out pretty good products, 
that work, and--you know. But, we have some bad actors, too, 
and we've got to get those, and get them out of this business, 
because nobody--Mr. Mister, you don't want any bad products in 
this industry. It hurts everybody.
    Mr. Mister. Absolutely.
    Senator Hatch. So, we need everybody working on it; but, 
more importantly, I'll hope you'll all advocate that we, in 
Congress, do our job by giving enough money to FDA to really 
look into these matters and do the job that DSHEA and these 
other bills that we have passed direct them to do. For example, 
it took well over 10 years to get GMPs, and they're still not 
done. So, Good Manufacturing Practices are still not done. 
We've been beating up the FDA for years to get that done. Part 
of the problem is money, and part of the problem is our fault, 
up here on Capitol Hill.
    We're all concerned about the aged and those who rely on 
dietary supplements. Most of the aged I know do, and they feel 
much better because they do. So, we want to make sure that 
they're good-quality products and that they will continue to 
help people who are aging, with the problems they might have.
    Thank you, Mr. Chairman. Sorry I took so long.
    The Chairman. Thank you very much, Senator Hatch.
    Mr. Mister, I'm sure that you represent an industry that 
wants, in every possible way, to be clean and above board and 
beyond reproach. I believe that's your goal. So, we--the GAO 
has done some investigation and uncovered products that may 
very well be misleading, in terms of what they claim. They've 
given their information to the FTC and the FDA.
    In the event that the FTC and the FDA conclude that what 
GAO uncovered is basically true, I would think, then, that you, 
your trade organization, and your industry would want those who 
transgressed to be made public, and for everybody to understand 
and know, not only for the public's sake, but also as a lesson 
to those who would do wrong and, in the process, harm your 
industry.
    Mr. Mister. We've been a strong advocate for transparency 
in the enforcement actions, and also for increasement in the 
enforcement actions.
    The Chairman. Good.
    Mr. Mister. So, we would absolutely support FDA and FTC 
investigating any of the claims that have been made today, 
because the vast majority of the industry, who are doing things 
right, they want a level playing field. They are 
disadvantaged----
    The Chairman. That's good----
    Mr. Mister [continuing]. If there are rogue players out 
there on the fringes doing something wrong and misleading 
consumers.
    The Chairman. That's--no, that's very good.
    Mr. Mister. Our goal is to increase----
    The Chairman. I just want to ask Mr. Kutz--again, those two 
bottles that you have in--at the desk, tell us again what they 
claim, very clearly, the one and the other?
    Mr. Kutz. The garlic ``prevents and cures cancer,'' and the 
other----
    The Chairman. It what? Say it again, loud.
    Mr. Kutz. ``Prevents and cures cancer.''
    The Chairman. Wow.
    Mr. Mister.
    What does the other one say?
    Mr. Kutz. This ``reverses the effects of a stroke.''
    The Chairman. Mr. Mister. Mr. Mister. [Laughter.]
    Now, I know--I know how hard it is. I've been in business 
all my life, and I understand how it's hard to be 100 percent. 
So, this is not personal or wanting to be overly critical. But, 
at least on the basis of what he says there, believing he's 
representing what's on the labels, that's pretty shocking, 
isn't it?
    Mr. Mister. It's very disturbing, Senator. Those claims are 
illegal and most likely untrue.
    The Chairman. Now, doesn't your trade association have a 
way of seeing to it that those things don't occur?
    Mr. Mister. Well, I can say with relative certainty, 
Senator, that the manufacturers of those products are not our 
members. We're a trade association, we're not a police 
organization. So, we can't police the industry for companies 
that are not our members.
    The Chairman. I see.
    Mr. Mister. But, certainly, we use our trade association, 
and the other four associations in the industry, likewise, use 
theirs, as a soapbox to preach what companies should do, and 
then to urge companies to do the right thing, to recognize 
companies that do, with certifications programs, and then to 
hold up those who don't, through programs like our NAD program, 
to public scrutiny. So, we do as much as we can as a trade 
association. At some point, we have to rely on the enforcement 
agencies, like FDA and FTC to do their jobs, too.
    The Chairman. Very well said.
    Senator Corker.
    Senator Corker. Mr. Mister, what kind of process would a 
company go through at the FDA to make sure the claims that my 
product was making were actually valid?
    Mr. Mister. Well, the first thing you would have to do is 
register your facility, wherever you are making the product or 
storing it, under the Bioterrorism Act. They are already 
required to have a onetime registration. The Food Safety 
legislation would increase that to an annual registration, and 
the industry is on record supporting that.
    The second thing you would do is, you would have to notify 
FDA of the claims you are making. Depending on the kind of 
claims they were, there are different levels of scrutiny. If it 
is what's called a ``structure function claim,'' which means 
you're simply saying that this has some affect on the normal 
function of the body, like maintaining a healthy immune system, 
then you'd have to notify them within 30 days of marketing the 
product. If you're going to make a claim that you help to 
reduce the risk of a disease, then you're a ``health claim,'' 
and you actually have to submit evidence to the agency, and 
they have to give you approval to make that claim. Then the 
third thing you do is on the ingredients. Regardless of the 
claims you make, if you're bringing a new dietary ingredient to 
market that was not on the market prior to 1994, you also have 
to give FDA a notification 75 days before when you want to 
bring the product to market. You have to submit evidence to the 
agency that there is a reasonable basis for the expectation of 
safety of the ingredient.
    Senator Corker. So, the claims that one would make on a 
label would be claims that, assuming everything worked 
properly, the FDA would have had to validate that product 
actually does that. Is that correct?
    Mr. Mister. If the law were working properly, those claims 
would have been submitted to FDA, and FDA would know that they 
were out there.
    Senator Corker. So, in essence, the fact that these two 
products were sold--and, while that hurts your industry and 
y'all are self-policing and not really charged with making sure 
that these things occur--the fact is, the FDA and the FTC 
should have caught that. Is that correct?
    Mr. Mister. We would like to see those cases prosecuted. I 
mean, as----
    Senator Corker. But, should----
    Mr. Mister. We put an awful lot of attention on garlic and 
ginseng and ginkgo today----
    Senator Corker. But, are these----
    Mr. Mister [continuing]. Which disturbs consumers.
    Senator Corker [continuing]. Are these issues that those 
two organizations should have caught? I mean, who polices that?
    Somebody behind you is shaking their head, ``No, no, no.'' 
So, who--I don't know which one of you is right, but who, in 
fact, is supposed to----
    Mr. Mister. Well, the question is, you know, How many 
resources does the agency have to police everything that's on 
the Internet? You know, some of the----
    Senator Corker. Well, no, no. No----
    Mr. Mister [continuing]. Some of the products----
    Senator Corker [continuing]. No, no. No, that's not the 
question. The resource issue is one I know that Senator Hatch 
has mentioned earlier, but under whose jurisdiction is it to 
actually ensure that somebody's not out there selling products 
that are making claims that are not warranted?
    Mr. Mister. Well, it depends, Senator, on whether the claim 
is made in the form of advertising or made in the form of 
labeling. FDA has jurisdiction over the labeling. FTC has 
jurisdiction over the advertising. The interesting thing 
about----
    Senator Corker. So, in these cases, these were labels, and 
so, that would have been the FDA's responsibility. So, they're 
not carrying out their responsibilities in that regard. Is that 
correct?
    Mr. Mister. Yes, sir.
    Senator Corker. So, it's--but--and again, I'm not trying to 
shift blame--it's not really your responsibility. Y'all do that 
because you want your industry to be healthy. A lot of 
industries set up organizations like yours to ensure that's the 
case. But, it's really FDA's responsibility, ultimately, to do 
the real policing. Is that correct?
    Mr. Mister. Yes, sir. They have--they're the ones that have 
the regulatory authority.
    Senator Corker. Mr. Bell, Senator Hatch asked you the 
question about his legislation and the four points that were 
added in trying to accommodate, I guess, and to get to a place 
where there's a lot of support. He asked you if you, in fact, 
supported his legislation, in its form, or whether you thought 
other actions were necessary. You didn't really respond. I 
think he was trying to lobby for your support, and you didn't 
answer. So, I'm asking.
    Mr. Bell. Well, thank you, Senator. You know, we've just 
had a chance to look at the bill that came out. On the four 
points that you mentioned, those are points that we support, 
and we're pleased to see that there is emerging agreement 
around those four points.
    I guess we had also been concerned that we would like to 
see expanded reporting of the nonserious adverse events for the 
mild and moderate events that are required to be reported for 
prescription drugs and over-the-counter drugs.
    We think that those should be reported for dietary 
supplements, as well, because it would give FDA a much fuller 
record to warn the public about emerging safety problems.
    In the recent Hydroxycut recall, where--or the removal from 
the marketplace--the public never got any information, even 
though the FDA had received about 72 serious, you know, 
adverse-event reports about that product. So, we would like to 
see more transparency and realtime information flowing to 
consumers, because we think consumers are put at risk when that 
information is not there.
    The FDA estimates that there's about 50,000 adverse events 
taking place related to dietary supplements each year, but GAO 
said, under the expanded reporting of serious events, we only 
got about 900 reports to FDA last year. So, there's a lot more 
information out there that could potentially be helpful for--to 
consumers, in our opinion.
    Senator Corker. So, to educate a layman and others who may 
be tuning in, give me an example of one of those types of 
events that you would like for consumers to know about.
    Mr. Bell. Well, it could be things like headache or 
temporary nausea. The standard for the serious event is really 
something that puts consumer in a hospital, that maybe causes 
organ damage or a stroke. You know, it's a pretty high level of 
medical events that require some sort of detailed intervention. 
But, there's a lot of other types of events that consumers may 
experience and complain to manufacturers about that would be 
useful for FDA to know.
    Senator Corker. So, Senator Hatch may respond to this 
himself, but, these are the types of things, I guess--when we 
all see advertising with pharmaceuticals; they're always 
talking about the disclaimers and the minor things that may 
occur if you take this, that are sort of side-effects. Would 
that be something that would be difficult for the industry, if 
it was added in to the legislation he's talking about, that 
component?
    Mr. Bell. You know, I think that's--given that the 
prescription drug companies are able to deal with it, it is a 
reasonable requirement. The reporting requirement is actually 
just an annual requirement; it's not the 15-day requirement. 
So, it's--and they maintain records in their offices. So, we 
think this would strengthen the safety profile, because we're 
mostly catching problems after the fact with these products, 
given that there wasn't a lot of premarket safety testing for 
them. We think having a fuller information base would really be 
helpful both for the agency and for physicians around the 
country.
    Senator Corker. So, Mr.--I hate to call you this. I'm going 
to call you Steve Mister. The other sounds so odd. What is your 
response to that? I mean, is that a burden on the industry, for 
that additional portion that Mr. Bell is referring to, to be 
added in?
    Mr. Mister. Well, first of all, I want to correct something 
that was said earlier. Over-the-counter drugs are subject to 
the same adverse-event reporting requirement as dietary 
supplements. So, they only report their serious adverse events, 
as well. Both of those categories were in the same----
    Senator Corker. Say that one more time.
    Mr. Mister. Over-the-counter drugs only report their 
serious adverse events. I think Mr. Bell said that they have to 
report their mild and their moderate. Senator Hatch introduced 
this legislation several years ago, on the Adverse Event 
Reporting Law, and it holds dietary supplements to the same 
standards as over-the-counter drugs when it comes to reporting 
your adverse events.
    But, second, when the GAO----
    Senator Corker. Hold on--let me--so, just to close this 
loop--Mr. Bell, so----
    Mr. Bell. Yeah. No, he's correct, I did misspeak. So----
    Senator Corker. So--just out of curiosity--why would you 
want the dietary portion to have a higher standard than over-
the-counter?
    Mr. Bell. Well, we are concerned about the--I think the 
drug interaction issues is another huge component of this, 
that--it's----
    Senator Corker. Well, would that same----
    Mr. Bell [continuing]. Largely----
    Senator Corker [continuing]. Be true, though, with over-
the- counter?
    Mr. Bell. Over-the-counter has additional premarket safety 
requirements that they need to make, so there are--we think 
there are fewer hazards of the type that we see in the dietary 
supplement world. Again, you know, the difference between 900 
reports and 50,000 reports is a pretty big gap, in our opinion.
    Senator Corker. Yeah.
    Mr. Bell. So, we would like to see a larger base of 
information collected. We don't think it's an inordinate burden 
on the industry, which doesn't spend a lot on safety testing 
for these products.
    Senator Hatch. Would you yield----
    Senator Corker. Yup.
    Senator Hatch [continuing]. For just one comment, Senator--
--
    Senator Corker. Yes, sir.
    Senator Hatch [continuing]. On this issue?
    It is true that--I think Mr. Mister could help us to 
understand--it is true that, even though you report the serious 
adverse events, you have to keep track of all of the adverse 
events that come in.
    Mr. Mister. That's correct. We have to keep----
    Senator Hatch. That's similar----
    Mr. Mister [continuing]. Them for 6 years.
    Senator Hatch [continuing]. To the pharmaceutical industry, 
as well.
    Mr. Mister. Yes, sir.
    Senator Hatch. OK. I mean, that's something I think people 
just----
    Senator Corker. But----
    Senator Hatch [continuing]. Don't realize.
    Senator Corker. But, would this additional requirement that 
Mr. Bell would like to see----
    Thank--no, thank you.
    Would that additional requirement be a large burden to the 
industry?
    Mr. Mister. It would be a burden on the industry, but, more 
than that, it would be a burden on the FDA. The interesting 
thing is that, when the GAO report came out last year making 
that recommendation, that it--we should be reporting not just 
serious adverse events, but all adverse events, FDA responded, 
at the time, saying that they don't have the resources to 
process that kind of information. It's enough for them to have 
to process the serious ones that come in from drugs and 
supplements and OTCs. To increase that to every time somebody 
called because they had a headache or thought they had a 
freckle that was----
    Senator Corker. Yeah.
    Mr. Mister [continuing]. Related to their supplement, you 
can imagine how that would----
    Senator Corker. But, let's move away from----
    Mr. Mister [continuing]. Multiply the number of events.
    Senator Corker [continuing]. The FDA, in that I think the 
issue--Senator Hatch has talked about the funding of FDA, and I 
have a sense he's gonna want to address that through 
appropriations and other efforts. Let's move that aside and 
just talk about the industry itself.
    From the standpoint of the industry, if the FDA had those 
resources, would that issue be something that, on the industry 
itself, is an undue burden?
    Mr. Mister. It would be a burden, Senator, because the way 
the standard is, is, if the adverse event is associated with 
the supplement, then the manufacturer turns it over. There's 
not a causality standard. The manufacturer does not have an 
opportunity to evaluate whether they really think it's 
connected to the supplement. If the consumer says it's 
associated, they have to turn it over.
    So, there is a large number of consumer complaints and 
calls that come in to any industry where consumers have 
questions or say, ``Well, I think maybe I got a little bit of a 
headache or something,'' or, ``It didn't taste quite right in 
my mouth as it went down.'' All those kinds of things would be 
considered mild adverse events. You can imagine, that's quite a 
burden on a industry, to say, ``You must report all of those 
within 14 days.''
    Senator Corker. This is my last question. I thank you for 
the time, Mr. Chairman, and certainly thank all of you for 
coming. As Senator Hatch has said, the industry itself is 
something that I think is important, and certainly want to make 
sure that it flourishes, but, at the same time, has proper 
checks and balances, so that consumers are protected. That's 
good for the industry, too.
    I understand the gentleman who was shaking his head 
vigorously in the background is our next witness, the FDA, or 
part of the FDA, saying that, in fact, it is not their 
responsibility, if his body language is correct, to actually 
check these labels. Before you leave the dais do you want to 
say anything else about that? Apparently he feels 180 degrees 
the opposite. I find that kind of odd.
    Mr. Mister. Well, maybe he and I are interpreting the 
question differently. Do they have a legal obligation to 
prereview that label before it gets on the market? The answer 
to that, I would agree, is no. But, if there is a product out 
there making those claims, and it's brought to the agency's 
attention, then absolutely they have authority to enforce the 
law and to prosecute that company.
    Senator Corker. So, if I want to make a product that does, 
whatever, I can make that product and make those claims and put 
it on the label, and there's no preapproval process as to 
whether that's valid, or not.
    Mr. Mister. There is no preapproval process----
    Senator Corker. It's only if somebody complains or 
somebody----
    Mr. Mister. You do that at your peril, and we hope the FDA 
would bring its resources to bear and enforce against that 
company.
    Senator Corker. I find that to be kind of odd, but I'll 
move on.
    The Chairman. Yeah--I--we want to move on, because we have 
the deputy commissioner of the FDA here.
    But, I just want to reenforce what he said. I used the word 
``odd.'' Again, I know how hard it is to be perfect. I've been 
in business all my life. But, there should be, hopefully, some 
mechanism whereby those who make false claims--even though they 
don't belong to your organization, inasmuch as you represent 
all the major players, or most of the major players--those who 
make false claims and stain the industry, there should be some 
way in which you can shame them into taking their products off 
the shelf. If nothing else, notify the FDA. I mean, there's 
some way.
    Mr. Mister. Yes, Senator, we do that. We have written to 
the FDA, on any number of occasions, when we are aware of these 
kinds of products or these claims that are being made.
    The Chairman. OK. All right, so let's move on now to the--
--
    Senator Hatch. Mr. Chairman, can I----
    The Chairman. Oh, yes, go ahead, Senator Hatch.
    Senator Hatch. There is no formal obligation for FDA to 
check before the product is made, and the--but, there is a 
tremendous liability if you represent--and tell me if I'm 
wrong, Mr. Mister--there's tremendous liability if you 
misrepresent what's on that label.
    Mr. Mister. We should never forget that the Food and Drug 
Act is, at its heart, a criminal statute. So, there are 
criminal sanctions for misbranding or mislabeling a product.
    Senator Hatch. Yes.
    Now, Dr. Cooperman, I just want to understand the service 
you provide to dietary supplement manufacturers. For those 
companies that pay ConsumerLab to test their products, if 
unsatisfactory results are found, do you still make those 
results public?
    Dr. Cooperman. We----
    Senator Hatch. For people who pay?
    Dr. Cooperman. Yeah, as I said before, we have a 
certification program, a voluntary certification program, and 
we have our product reviews. The way that the certification 
program operates is the same as the way that the USP operates 
its certification program, which is, a company comes to you 
voluntarily, pays a testing fee, you run it through all the 
rigorous tests that you see as appropriate--which are the same 
we use for the ones that we select on our own--and in that 
voluntary program, if it is certified, we will publish that. 
Those results are the property of the manufacturer, so they can 
do what they want with those results.
    Senator Hatch. But, you don't make them public, though.
    Dr. Cooperman. No, those are those results. Those are their 
results, just in the USP program.
    Senator Hatch. I just wanted to make that clear.
    Dr. Cooperman. Right.
    Senator Hatch. Mr. Mister, one last question. Would you 
just talk to us about the outreach efforts your industry has 
made to consumers so that they might have more information 
about dietary supplements? Also, what type of education could 
be provided to better educate medical professionals to prevent 
bad interactions between drugs and dietary supplements?
    Mr. Mister. I think all of the associations have various 
programs that do outreach to consumers. At CRN, we have a 
program called ``Life Supplemented.'' We have our own Web site, 
and we try to educate consumers, through the Web site, that 
dietary supplements are not a magic bullet. They are not a 
magic cure for any disease. They are part of an overall 
wellness regimen. They should be incorporated into your 
lifestyle, along with diet, exercise, seeing a doctor 
regularly, getting a good night's sleep, all of those kinds of 
healthy behaviors. So, that's one of the things that we're 
doing at CRN.
    When it comes to medical professionals, again, we have 
funding issues, just like the government does. We would like to 
see more emphasis being placed in pharmacy schools, in medical 
schools, to teach these would-be doctors and pharmacists more 
about the use of supplements, both the benefits and then the 
interactions. Supplements can also have positive interactions 
and can be used to augment drug therapy. So, we'd like to see 
that done.
    We've also done continuing education with both nurse 
practitioners and pharmacists, to educate them on some of these 
issues. Again, with more funding, we could do more of that.
    Senator Hatch. Thank you, Mr. Chairman.
    The Chairman. OK, thank you, everyone.
    Just one--Mr. Kutz, the manufacturers of those two labels, 
are they obscure manufacturers, or--what's on the label?
    Mr. Kutz. They would be--do you want me to read them to 
you?
    The Chairman. Pardon me?
    Mr. Kutz. You want me to read the labels to you?
    The Chairman. You ever heard of that name, Mr. Mister?
    Mr. Kutz. You want me to tell you, I mean?
    Senator Corker. He, yes, wants you to read it.
    Mr. Kutz. All right, the first one is American Ginseng 
capsules, and the second is 88herb.com garlic powder.
    The Chairman. You've never heard of those companies, Mr. 
Mister?
    Mr. Mister. No, sir. According to the law that Senator 
Hatch helped pass, there should be a name of a company and an 
address on the label.
    The Chairman. That's what I was--that's what I was wonder--
that's what I was asking Mr. Kutz.
    Mr. Kutz. You want to know?
    The Chairman. Yeah. [Laughter.]
    Mr. Kutz. Sure. The first one is Marathon, WI.
    The Chairman. Oh my God, that's my State. [Laughter.]
    Mr. Kutz. That's why I asked you twice. [Laughter.]
    The Chairman. Forget it. Forget the whole thing. I never 
asked anything. [Laughter.]
    Senator Hatch. Most of your players are taking them---- 
[Laughter.]
    Senator Corker. I think that's his uncle. So. [Laughter.]
    Mr. Kutz. The second one, I think it came from overseas. We 
can't tell for sure.
    The Chairman. You've not heard--I mean, that those--those 
are names that you've not heard of.
    Mr. Mister. No, sir.
    The Chairman. OK.
    Senator Corker. Can I----
    The Chairman. Go ahead.
    Senator Corker. What is a standard? You talked about the 
criminal process if somebody makes a claim. What standard is it 
that one uses in trying to establish criminality in that 
regard?
    Mr. Mister. It's a strict liability standard under the 
Food, Drug, and Cosmetic Act. So, if you say it, you're 
responsible for it.
    Senator Corker. So, based on what you're saying, these two 
companies would--based on what you're saying, these companies 
would have been liable to undergo criminal proceedings?
    Mr. Mister. Yes, sir. Not only the companies themselves, 
but the officers of those companies can be prosecuted as 
misdemeanors.
    Senator Corker. Do you know if that occurred?
    Mr. Mister. In this case? I don't.
    Senator Corker. OK.
    Senator Hatch. It's been a good----
    The Chairman. Thank you very----
    Senator Hatch [continuing]. Good panel.
    The Chairman. Go ahead.
    Senator Hatch. It's been a good panel.
    The Chairman. Thank you very much. Been a great panel. We 
appreciate your coming, and you're now excused.
    We're calling the next panel, Dr. Joshua Sharfstein, who's 
the Deputy Commissioner of the FDA.
    Are you happy you're here, Dr. Sharfstein? [Laughter.]
    [Pause.]
    The Chairman. All right, Dr. Sharfstein went to Harvard 
Medical School, and he was formerly the Commissioner of Health 
for the city of Baltimore. As I said, he's now the Deputy 
Commissioner of the FDA, second ranking individual in that very 
important commission.
    So, we're happy you're here. Please limit your comments, 
maybe to 5 minutes, so we can have enough time to dialog with 
you. Go right ahead, sir.

 STATEMENT OF JOSHUA SHARFSTEIN, DEPUTY COMMISSIONER, FOOD AND 
             DRUG ADMINISTRATION, SILVER SPRING, MD

    Dr. Sharfstein. Great. Thank you very much, Chairman Kohl, 
Senator Corker, Senator Hatch. I very much appreciate the 
opportunity to be here with the committee.
    I am Dr. Joshua Sharfstein, the Principal Deputy 
Commissioner of the U.S. Food and Drug Administration, an 
agency of the Department of Health and Human Services.
    Thank you for the opportunity to discuss FDA's role in the 
regulation of dietary supplements, as well as the findings of 
the study on botanical dietary supplements by the GAO.
    As you've heard, modern FDA oversight of dietary 
supplements began with the 1994 enactment of the Dietary 
Supplement Health and Education Act. This regulatory system now 
includes the following key elements:
    First, prior to its marketing, the manufacturer of a 
dietary supplement is responsible for ensuring the supplement 
is safe. Manufacturers register their facilities, but not their 
products.
    Second, manufacturers are only permitted to make certain 
types of claims, and may not make false or misleading claims of 
any time--of any kind. After marketing, for most products, 
companies notify us of the claims.
    I apologize for shaking my head. Dr. Hamburg has told me I 
should not give up my day job to become a poker player. 
[Laughter.]
    But, I think you got it all sorted out, that people tell us 
about the claims after they start marketing. They don't give us 
the substantiation. There's not a review, before marketing, by 
the FDA. Under no--under only very rare circumstances are 
companies permitted to make disease-related claims.
    Third, manufacturers must abide by good manufacturing 
practices, which have--are now in effect for large- and medium-
sized firms, and shortly will be for small firms.
    Fourth, manufacturers must submit to FDA all reports of 
serious adverse events associated with the product that are 
manufactured. We--as--through our agency program performance 
initiative, called FDA Track, will be posting, monthly, how 
many reports like this we get, and from how many firms. As part 
of our transparency initiative, we have proposed making--the 
idea of making specific information about those complaints, 
along with disclaimers about the limitation of those 
information, available over the Internet. We're now taking 
public comment on that proposal.
    Fifth, a manufacturer must submit a notification to FDA 
before it markets a dietary supplement containing a new dietary 
ingredient. We do get some of those notifications now. Also, 
through FDA Track, we will be telling the public, every month, 
how many we're getting, and whether we're able to review them 
within the period of time that we need to. In addition, we're 
working on guidance that, hopefully, will make it possible for 
us to get a lot more of those notifications.
    Let me, next, turn to our enforcement priorities, because I 
think you heard very clearly wide agreement--I met extensively 
with industry and others--wide agreement that FDA's enforcement 
role is extremely important under DSHEA.
    We enforce by reviewing adverse-event reports, we obtain 
information from inspections, we review consumer and trade 
complaints, we perform laboratory analyses, and we monitor 
retail outlets, including the Internet. We also monitor product 
information. We work closely with the FTC, which is responsible 
for advertising.
    Currently, we focus on three main areas:
    First, adulteration with drug substances. Products that are 
marketed as dietary supplements, but contain active ingredients 
in FDA-approved drugs, analogs of approved drugs, and other 
compounds that do not qualify as dietary ingredients, present 
an emerging and expanding challenge, particularly in three 
areas: sexual enhancement products, weight-loss products, and 
bodybuilding products; also, I would say, in some cases, 
cholesterol products. These products are often sold with 
misleading labeling, and are frequently manufactured without 
quality controls.
    Enforcement in this area is challenging. Nonetheless, in 
the last 2 years, FDA has participated in the voluntary recall 
of many dozens of tainted supplement products, including more 
than 50 sexual enhancement products, more than 40 weight-loss 
products, and more than 80 bodybuilding supplements, by two 
distributors, alone.
    We've issued multiple consumer alerts and press 
announcements to warn consumers about hazardous products. These 
include four warnings about firms marketing sexual enhancement 
products, multiple consumer alerts about 70 tainted weight-loss 
supplements, and a public health advisory about bodybuilding 
products that are represented as containing steroids or steroid 
like substances.
    We have also participated in seizures and criminal 
prosecutions to disrupt the distribution of illegal products, 
including two civil seizures of illegal sexual enhancement 
supplements in 2009, two individuals arrested for illegally 
trafficking weight-loss supplements, and multiple search 
affidavits on firms marketing bodybuilding products that were 
represented as containing steroids or steroidlike substances, 
with one manufacturer pleading guilty.
    Second major area of our focus is illegal claims, and 
you've heard about some illegal claims from GAO today. This is 
an important area of enforcement for FDA. We are concerned that 
unsubstantiated and illegal claims that--for--such as the one 
you heard, about cancer--can encourage consumers to self-treat 
for a serious disease without the benefit of medical diagnosis. 
FDA conducts a number of enforcement activities against 
supplements that make these type of claims, and in the last 
several years, have issued, you know, hundreds of enforcement 
actions against these types of products.
    Most recently, we really focused on illegal claims around 
H1N1, because we were very concerned that people wouldn't get 
the appropriate treatment for flu. We worked jointly with other 
agencies, and wound up issuing warning letters to about 70 
supplement manufacturers for illicit claims. We even did a 
first joint FDA and FTC advisory letter.
    We appreciate the help of the GAO in this effort, the help 
of the committee by having this hearing, and the help of the 
industry by their efforts to really try to clamp down on these 
types of claims.
    The third major area of focus is unsafe ingredients. A 
dietary supplement is adulterated if it bears or contains any 
poisonous or deleterious substance that may render it injurious 
to health, if it presents a significant or unreasonable risk. 
We can ban a dietary supplement if it is an imminent hazard. We 
have taken these sorts of actions against dietary supplements 
that concern us.
    Very briefly, let me mention the GAO study, which you heard 
at length about. In general, there were a number of claims that 
they found that were illegal claims. We just got, I believe in 
the last couple days, the referral from GAO, where they 
actually named the companies, and we will, in fact, investigate 
and take action if we find those to be still in effect.
    They also analyzed, as you heard, 40 dietary supplements 
for heavy-metal contaminants. I think, given the expected 
generally small consumption of the supplements, we do not 
believe these levels represent a significant risk to health. 
For example, the cadmium levels reached to about 1.4 micrograms 
per day. This compares to FDA's tolerable daily intake level of 
60 micrograms per day.
    The lead levels reached to 1.9 micrograms per day, which is 
about a third of the FDA's tolerable daily intake. This is not 
a dangerous level, but it does represent a reasonable fraction 
of daily intake, and we believe it's possible that preventive 
standards, of the type authorized by the pending food safety 
legislation, could help FDA and supplement manufacturers keep 
the lead levels as low as feasible.
    Recently, FDA and the New York City Health Department 
identified lead in a dietary supplement at a level of 1100 
parts per million. We immediately notified the public of a 
potential risk, and the manufacturer recalled the supplement.
    You also heard about the pesticide residues. There were 41 
residues found, none of which FDA believed posed a threat to 
health. Most of them--seven of them were in--within EPA 
tolerances for dietary supplements, 31 were within tolerances 
used for fruits and vegetables, but there was no tolerance set 
for the dietary supplement. For example, there was a one that 
was found at .01 parts per million in Echinacea, but the 
residue levels are allowed at 15 parts per million for celery 
and 5 parts per million for tomatoes. So, in terms of--there 
was a legal violation, but it wasn't--it was something that was 
well within what we would see in a fruit or vegetable.
    Then, a couple others were for pesticides that are not 
permitted on any food right now in the United States, but are 
also at very low levels and within what, for example, the 
European Union permits.
    We do have a program where we routinely test supplements 
for pesticides, and we--it leads to recalls, if we find a 
problem.
    So, let me stop there, and thank you for the opportunity to 
discuss FDA's activities on dietary supplements. We look 
forward to working with you and answering your questions.
    [The prepared statement of Dr. Sharfstein follows:]

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    The Chairman. Dr. Sharfstein, as a former commissioner of 
health with city of Baltimore, and as a current Deputy 
Commissioner of the Food and Drug Administration, right now, 
before a prescription drug goes to market, it has to be 
authorized and OKed. That's not true of dietary supplements, as 
you know. You have a recall, but they don't have to be examined 
and authorized and OKed by the FDA or any other authority. Are 
you satisfied, at least at that point, that what we're doing is 
the right thing?
    Dr. Sharfstein. Well, I think that the framework for--that 
DSHEA puts on dietary supplements is very different than 
prescription drugs. Congress's thinking about dietary 
supplements was very different than the framework for 
prescription drugs. The way I think about DSHEA is that it 
balances access against risk. There is a very clear feeling in 
the law, like Congress and the public, that they want access to 
supplements that they--that are important to people, and many 
people in the United States, and so that people can put them on 
the market without a prereview by FDA, and particularly for the 
products that have been marketed, historically. That's not the 
case at all for drugs.
    On the other hand, there are provisions in the law that 
mitigate risk. So, you could have a situation where, you know, 
you only care about risk and it'd be very hard to have access, 
or you could say, ``We will let everything on there,'' and 
there would be no risk provisions. But, I think DSHEA tries to 
strike a balance.
    FDA needs to do a few things to maximize the risk part of 
the equation, I think, from what the law permits. That includes 
getting out the guidance on the new dietary ingredients. We 
have to do our enforcement, like you've heard. We need to fully 
implement the Good Manufacturing Principles.
    I think, as you think about that balance--the question is, 
Are we striking the right balance? I think, for the most part, 
the answer to that is yes.
    The area where I think--that gives the FDA the most concern 
with that question relates to the pharmaceutical spiking of 
dietary supplements, because we're talking about very serious 
risks and injuries that can happen to people. Often they're, 
you know, young people who don't really understand and 
they're--that they're taking what are actually prescription 
drugs or steroids through dietary supplements. There has been 
testimony by FDA, that while we are at--being as aggressive as 
we can with enforcement, we are very concerned about the state 
of the market for these products. I think that's the area that 
gives us the greatest concern.
    The Chairman. Thank you.
    Senator Corker.
    Senator Corker. It seems, also, that, in earlier testimony, 
that the disease claims--and you said so, just a minute ago--
the claims of these particular products, and their ability to 
keep a disease from occurring or getting it--is the most 
serious claim that one might make on a label. Is that correct?
    Dr. Sharfstein. Correct.
    Senator Corker. I know the distinction is food not being 
preapproved, drugs being preapproved, and that's part, I think, 
of the tension that Senator Hatch is trying to keep from 
happening, actually. Again, I'm a strong supporter of the 
dietary supplement industry, from the standpoint of being a 
consumer and just seeing so many people use these types of 
products. But, in that particular area, is there a way to--with 
the retailers, for instance--is there not some shelf 
notification or something that the FDA could do to say that, if 
a product of X claims Y, it just, should not be sold? Is there 
a way for the retailers to actually check against that without 
a preapproval process actually having to occur?
    Dr. Sharfstein. Well, I think that's a great idea. I think 
we would be happy to hear from retailers that are concerned 
about products that are being, you know, peddled to them, that 
they're concerned about a particular product, and we would then 
be able to look at it.
    But, we do take all these disease claims very seriously, 
and we would pursue enforcement action, if we could. It's 
relatively easy for us to do, because it's just the claim, 
alone, that makes that illegal. So, we see that someone's 
trying to market something for cancer, and, boom, you know, 
you're not allowed to do that.
    So, you know, I think we--FDA should be doing outreach, and 
working with the industry and the companies that are selling 
these products, to get the word out that, if they have concerns 
like that about products, that we would immediately take a look 
at them.
    Senator Corker. But, are there not guidelines that you guys 
have published, where any retailer that's serious would know 
that some claim by an entity that's producing a particular 
product that has the ingredients that it says it has in it, 
there's no way that that claim could be valid? Is there not 
some commonsense test that retailers would know a product that 
claims that absolutely could not be valid?
    Dr. Sharfstein. You know, I'm not--I think we do work with 
retailers, and we would give them that guidance. I think it's a 
very good idea, that they should--people--you know, the--
generally--typically, we don't think of the retailer as, like, 
a place to catch problems.
    But, in this case, and particularly where there are some 
major retailers, working with them would give us an opportunity 
to catch products.
    The--one of the challenges is the Internet, because, even 
though there are some major retailers, you know, anyone can set 
up a Web site and sell something. So, it gets a--it would get 
us, I think--if we had an effective relationship with the big 
retailers, we would be able to protect those areas from claims, 
perhaps, but we'd still be dealing with, probably, some 
problems through the Internet and other mechanisms.
    Senator Corker. The good manufacturing practices that we 
referred to earlier, that, have not yet been implemented--and 
I'm going to leave and go to another meeting, and I thank you 
for your testimony and certainly the early witnesses. I know, 
you know, Senator Hatch certainly has talked about the funding 
that has lacked at the FDA, but is that the only issue that has 
kept y'all, for 16 years, from implementing some of the things 
that originally were put in place in 1994? Is it simply 
funding, or is it will? What is it that has kept you from 
implementing much of that law?
    Dr. Sharfstein. Well, I think that--and I think you heard 
Mr. Mister talk about the fact that we are committed to 
implementing DSHEA, and we have made progress. We have, now, 
those GMPs in place for the small--the large and medium firms, 
and, very shortly, for the small firms. We are committed to 
getting the guidance, which is very important, on the new 
dietary ingredients out.
    You know, I've been at the agency for a year, so I can't 
speak to, you know, what happened before, but a lot of these, 
you know, things are--can be quite complicated and take much 
more time than you wish that they were going to take. I can--
I've learned that already.
    But, I think, in general, I can say that we do think it's 
important for FDA to do what it can under the law to really 
manage the risk side of the access/risk balance that I think 
DSHEA strikes.
    Senator Corker. So, we had people in, earlier, on both 
sides of the issue--that some have concerns about the industry, 
people from the industry here feeling like they are doing 
what's necessary to self-police. Senator Hatch has introduced 
legislation. That's obviously one of the reasons we're having 
this hearing today. Do you think that what he has addressed in 
his legislation seeks the balance that's appropriate for this 
industry and, if implemented, and certainly funded, would do 
those things, as responsible department head, you would think 
would be appropriate?
    Dr. Sharfstein. I think it--that that legislation--all the 
provisions of it make sense to FDA. There's also language in 
the Food Safety bill that we think would be helpful, as you 
heard, I think, also, from different people in the last panel, 
including Mr. Mister.
    I think that the one--you know, one particular area where 
we--I have met, multiple times, with industry, because I know 
they're very concerned about--relates to this issue of 
pharmaceutical spiking. I think that's an area that really 
requires the industry, the agency, and others to think through 
the kind of science, law, resources, other things we can do to 
really make a lot more progress on that. I think, even though 
we have taken a lot of enforcement there, we feel like we need 
to do better.
    Senator Corker. Does his legislation deal appropriately 
with pharmaceutical spiking?
    Dr. Sharfstein. I think that there are gaps in what--in our 
understanding of what we can do to make a difference. So, I 
think it does what it can. I think it's a good provision to 
have us, you know, kind of insist on FDA to be working with 
DEA. I think that makes sense. But, it's very challenging, 
because, particularly for certain types of claims, we can't--
like I was saying before, if there's a claim someone says cures 
cancer, than, boom, it's illegal.
    The problem with have with pharmaceutical spiking is that 
the claims are not illegal. The claim will be muscle bulking or 
sexual enhancement or weight loss, which are permit--can be 
permitted claims. So, in order for us to get to the point of 
enforcement, we often have to do very sophisticated lab 
analysis, and that can be very time consuming and challenging.
    One project I saw at FDA, they found 37 varieties of 
Viagra. You know, basically they took pharmaceutical Viagra and 
they--somebody changed little bits of it, as a chemical entity, 
and put it in, to evade detection. It took, you know, Ph.D. 
chemists quite a long time to unpack that.
    To do that kind of testing on so many different products is 
extremely challenging. That's what makes it--there was a--FDA 
testified at a hearing last fall about this, and really went 
into tremendous detail about the challenge facing the agency 
here. I don't think that we've really solved that challenge. 
I'm not sure that we had--have the answer to that, but I do 
think, in this area, that's probably our biggest concern right 
now.
    Senator Corker. Mr. Chairman, thank you.
    Thank you for your testimony and for your service.
    Thank you.
    The Chairman. Thank you for being here, Senator Corker, and 
thank you for contributing as much as you have to this hearing.
    Senator Hatch.
    Senator Hatch. Thank you, Mr. Chairman.
    Mr. Sharfstein--no, Dr. Sharfstein, first, I want to thank 
you for your testimony here today, and for acknowledging that 
DSHEA strikes the right balance. Every FDA commissioner since 
DSHEA has told me that they have enough authority under DSHEA 
to resolve the conflicts in this industry. We've tried, in 
addition, to pass additional statutes that will give you even 
more authority and would help you.
    So, there's a desire here to do what's right. Please know 
that I agree with you that enforcement of DSHEA is our top 
priority; I mean, when it comes to dietary supplements. So, I'm 
grateful for much of your testimony here today.
    Now, Dr. Sharfstein, the FDA has recently received more 
funds, and appears to be taking more--a great deal more action. 
Would you agree with that statement?
    Dr. Sharfstein. Yes. I would agree with that.
    Senator Hatch. OK. Now, that being said, is it fair to say 
that the FDA does need additional funding before we implement 
and enforce the current laws with--which regulate dietary 
supplements?
    Dr. Sharfstein. Well, I think we're on track to fully 
implement and enforce. We're going to be putting all the GMPs 
in place and we--we are on track for the new dietary guidance 
to--``new dietary ingredient'' guidance to come out, albeit a 
lot later than a lot of us would want.
    Senator Hatch. But, you still could use more money, because 
of the monumental number of companies and number of products in 
this industry.
    Dr. Sharfstein. Well, we're anticipating doing about 250 
GMP inspections in fiscal year 2010. We think there are about 
1500, roughly, companies out there. So, you know, it's a pretty 
good fraction to do, as we're learning about it. I mean, I 
think it's obvious, with more resources, we would do more, but 
I think we're on--we feel like we're on a pretty good track. 
It's been frustrating to you, members of the industry, us, and 
others, that these pieces haven't been in place. But, I think 
we are beginning to see those pieces fall into place.
    Senator Hatch. Well, I'm happy to hear that. I'm looking at 
the FDA's Total Diet Study statistics on element results for 
various food products, and in this report I see that a number 
of milk and cheese products contain arsenic, cadmium, lead, and 
other heavy metals.
    I also have a study here that are--that was published in 
the Journal of Dairy Science. The study is titled, ``A Survey 
of Selected Heavy Metal Concentrations in Wisconsin Dairy 
Feeds.'' I'm trying to help my colleague from Wisconsin to--you 
know, to--we've got to work together on these matters. It 
surveys the heavy metal content of 203 typical dairy feed 
products from 54 dairy farms in Wisconsin. It found that there 
were various levels of heavy metals throughout the dairy food 
chain. Now, am I saying that--that this poses some sort of a--
or a kind of health concern?
    Dr. Sharfstein. Well, I'll tell you how I think about these 
levels of various heavy metals. There's sort of two categories 
that I put it in.
    One category is the--you know, what most people would 
characterize as very low levels, and we want to keep them as 
low as possible----
    Senator Hatch. Right.
    Dr. Sharfstein [continuing]. Just to reduce over--you know, 
overall levels. That's pretty much how I would characterize the 
findings of the GAO report.
    Senator Hatch. Right.
    Dr. Sharfstein. Right--in that category. I think, in food, 
it's a similar type of thing. There are low levels of things, 
and we want to, generally, figure out how to keep them low, and 
lower, if possible.
    The other category are levels that actually pose a real 
threat to health, and that was--there was recently a recall of 
a dietary supplement, for 1100 parts per million of lead, which 
is more--almost twice the legal limit for lead in paint. That's 
not a safe amount, and we really had to take action there.
    I do think that, you know, it's important to distinguish 
those. I consider that a little bit of a warning that it's very 
important. I know that the industry is very serious about this, 
to--that the companies understand their supply chain, and 
really make sure the ingredients they're using are not 
contaminated with lead.
    Senator Hatch. Well, that report does confirm that 
Wisconsin dairy products are safe. I, personally, would put 
that State's dairy products at the top of the list, right under 
Utah's dairy products, of course.
    But--so, let me ask your--you this. Hasn't the FDA already 
established safe levels of heavy metals and trace elements in 
our food products? Don't those standards already allow the FDA 
to determine safe levels for dietary supplements?
    Dr. Sharfstein. I'd have to get back to you with a complete 
answer on that.
    Senator Hatch. OK.
    Dr. Sharfstein. I mean, I think our testimony here is that 
the levels that GAO found in the supplements are not of 
significant health concern. I do think that that one recent 
recall was, though.
    Senator Hatch. OK. Let me just ask one more question. In 
1994, DSHEA set forth the definition of a ``new dietary 
ingredient.'' I know the FDA has been working on a ``new 
dietary ingredient,'' or NDI, guidance document to better 
clarify when a dietary supplement is considered a ``new dietary 
ingredient.'' The evidence needed to document the safety of new 
dietary ingredients, and the appropriate methods for 
establishing the identity of a new dietary ingredient, they're 
working on.
    In addition, in a January 2009 GAO report entitled, 
``Dietary Supplements: FDA Should Take Further Actions to 
Improve Oversight and Consumer Understanding,'' one of the 
GAO's recommendations was that the FDA should promptly issue 
the NDI guidance. Now, could I ask why it's taken so long for 
the FDA to issue guidance--you know, these particular guidance 
documents? What is the current status of the NDI guidance 
document?
    Dr. Sharfstein. Sure. I think it's taken so long, in part, 
because it's a challenging topic to figure out how to define, 
how to help people think through both what qualifies as an NDI 
and what kind of information that we'd have.
    I tell people in this job, I've got, you know, two lists of 
things on my desk: one list of things that are--need to be 
moving much faster than they're actually moving forward; and 
the other list of things that are moving at about the right 
speed. There's nothing on the second list, you know. 
[Laughter.]
    So, you know, I think that everybody wants this guidance 
out. The industry wants it out, we want it out. I think that 
there--it's challenging science, in part, and law. We're 
anticipating having it out by the end of the calendar year.
    Senator Hatch. Well, as I--if I recall it correctly, it 
took since 1994 to 2007 to get GMP recommendations. That's one 
of the reasons why I think you do need some more money or you 
do need some help here. That's really important, especially in 
an industry that takes a certain amount of criticism, even 
though by and large, most all the products are good products. 
But, I'm going to help you in every way I possibly can.
    Let me just close by saying that, since you left Henry 
Waxman, we haven't been able to get together on anything. So, 
you'd better get back up here on Capitol Hill. We feel badly 
that you----
    Dr. Sharfstein. OK.
    Senator Hatch [continuing]. Betrayed us by leaving here and 
going to the FDA. But, we compliment you on being in your 
present position, and how important it is, in my eyes, and how 
important you really are to the people in America. I've really 
have appreciated your testimony here today.
    Dr. Sharfstein. OK, thank you very much.
    The Chairman. Thank you very much, Senator Hatch. With 
respect to your budget, Senator Hatch indicated that we may 
have to take another look at your budget. He's certainly right 
about that. But, I am pleased, as I'm sure you were, when the 
committee, of which I'm chairman, increased the budget for the 
FDA by $152 million last year, and much of that has gone into, 
I think, food safety examination and enforcement and oversight, 
hasn't it?
    Dr. Sharfstein. That's absolutely true. I think the--those 
increases have really revitalized the food program, and it--you 
and the committee really deserve tremendous thanks, not only by 
the agency, but all the people who rely on the agency's 
evaluation of food.
    The Chairman. No question, food safety in America is 
paramount. The results of your investigation into the 
information that you got from the GAO recently, that will be 
made public when those results are finished--when that 
examination is finished?
    Dr. Sharfstein. Sure. We'd be happy to write the committee 
and release those results.
    The Chairman. Thank you so much.
    Normally, how long does that take? Several weeks, or a 
month or two, or----
    Dr. Sharfstein. Well, it depends, in part, on the level of 
our engagement. If we decide that we're going to pursue 
enforcement action against a company, that sometimes takes a 
while, because we work with the U.S. attorneys and, you know, 
there's a whole enforcement process that has to play out. We 
can get results--we can get significant ill-gotten gains back 
for the--to people, we can--you know, there can be criminal 
prosecutions--but, those things can take time.
    So, we could, you know, probably give you an interim update 
at a certain point, but I don't want to promise a particular 
timeframe, because sometimes the--you know, the really intense 
enforcement can take a little while.
    The Chairman. Certainly.
    Well, I'd like to compliment you, Dr. Sharfstein, as well 
as Dr. Hamburg. I think you're doing a great job at the FDA. A 
very, very important part of America, in terms of ensuring the 
safety of the products that we eat and ingest. We owe you much 
appreciation for what you do, and we look forward to continuing 
our efforts with you and with your organization.
    Thank you all for being here today.
    We will now close our hearing.
    [Whereupon, at 4:08 p.m., the hearing was adjourned.]


                            A P P E N D I X

                              ----------                              


                Prepared Statement of Senator Al Franken

    Thank you, Mr. Chairman, for holding today's hearing on 
such an important topic for Minnesota seniors and all 
Americans.
    It's important to understand that the issue of dietary 
supplements is fundamentally about enabling Americans to make 
informed choices about their health. For example, several years 
ago, researchers discovered that grapefruit interacts with 
cholesterol-lowering medications. It interferes with enzymes 
that metabolize these drugs in the digestive system. So if you 
eat grapefruit while you're on a statin, you can end up with 
excessive levels of the drug in your blood, and an increased 
risk of serious side effects.
    Although this interaction is potentially harmful, it does 
not mean that we need to outlaw grapefruit! Rather, it means we 
can avoid problems by educating consumers and doctors. Research 
and education are crucial to ensuring dietary supplements are 
taken safely and effectively. This is especially true for older 
Americans, who take more supplements and more prescriptions 
than younger adults.
    I believe all Americans who want them--and especially 
seniors--should have access to safe dietary supplements. I'd 
like to thank our witnesses for being here today to share their 
expertise on this issue. I look forward to your testimony.

          Mr. Mister's Response to Senator Franken's Question

    Question. Mr. Mister, I'm a big fan of Medication Therapy 
Management, a service in which pharmacists sit down with 
seniors and other patients with chronic illness to make sure 
multiple prescriptions are taken properly and safely. Today 
we've heard about the risks of potential interactions between 
dietary supplements and prescription drugs. What role can 
pharmacists and medication therapy management play to educate 
consumers about the potential interactions of dietary 
supplements?
    Answer. Pharmacists play an instrumental, important and 
trusted role in providing information to their consumers 
utilizing multiple prescriptions. Medication therapy management 
(MTM) is another useful tool pharmacists can use to educate 
elderly consumers about the potential interactions that may 
occur with their medications and other products they may be 
ingesting. Pharmacists, in particular, are in an ideal position 
to provide key information about drug/nutrient interaction and 
drug/nutrient deficiency health advice, as well as be an 
information resource for senior citizens on the benefits of 
many health related products. Conversely, it is equally 
important that pharmacists provide information in context and 
not unnecessarily alarm senior citizens. To benefit their 
consumer, the pharmacists should not only focus on pill 
interactions, but be aware of potential issues caused by foods 
in the diet, too.

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