[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
U.S. GOVERNMENT PRINTING OFFICE
57-983 WASHINGTON : 2010
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202�09512�091800, or 866�09512�091800 (toll-free). E-mail, [email protected].
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:]
[GRAPHIC] [TIFF OMITTED] T7983.001
[GRAPHIC] [TIFF OMITTED] T7983.002
[GRAPHIC] [TIFF OMITTED] T7983.003
[GRAPHIC] [TIFF OMITTED] T7983.004
[GRAPHIC] [TIFF OMITTED] T7983.005
[GRAPHIC] [TIFF OMITTED] T7983.006
[GRAPHIC] [TIFF OMITTED] T7983.007
[GRAPHIC] [TIFF OMITTED] T7983.008
[GRAPHIC] [TIFF OMITTED] T7983.009
[GRAPHIC] [TIFF OMITTED] T7983.010
[GRAPHIC] [TIFF OMITTED] T7983.011
[GRAPHIC] [TIFF OMITTED] T7983.012
[GRAPHIC] [TIFF OMITTED] T7983.013
[GRAPHIC] [TIFF OMITTED] T7983.014
[GRAPHIC] [TIFF OMITTED] T7983.015
[GRAPHIC] [TIFF OMITTED] T7983.016
[GRAPHIC] [TIFF OMITTED] T7983.017
[GRAPHIC] [TIFF OMITTED] T7983.018
[GRAPHIC] [TIFF OMITTED] T7983.019
[GRAPHIC] [TIFF OMITTED] T7983.020
[GRAPHIC] [TIFF OMITTED] T7983.021
[GRAPHIC] [TIFF OMITTED] T7983.022
[GRAPHIC] [TIFF OMITTED] T7983.023
[GRAPHIC] [TIFF OMITTED] T7983.024
[GRAPHIC] [TIFF OMITTED] T7983.025
[GRAPHIC] [TIFF OMITTED] T7983.026
[GRAPHIC] [TIFF OMITTED] T7983.027
[GRAPHIC] [TIFF OMITTED] T7983.028
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:]
[GRAPHIC] [TIFF OMITTED] T7983.029
[GRAPHIC] [TIFF OMITTED] T7983.030
[GRAPHIC] [TIFF OMITTED] T7983.031
[GRAPHIC] [TIFF OMITTED] T7983.032
[GRAPHIC] [TIFF OMITTED] T7983.033
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:]
[GRAPHIC] [TIFF OMITTED] T7983.034
[GRAPHIC] [TIFF OMITTED] T7983.035
[GRAPHIC] [TIFF OMITTED] T7983.036
[GRAPHIC] [TIFF OMITTED] T7983.037
[GRAPHIC] [TIFF OMITTED] T7983.038
[GRAPHIC] [TIFF OMITTED] T7983.039
[GRAPHIC] [TIFF OMITTED] T7983.040
[GRAPHIC] [TIFF OMITTED] T7983.041
[GRAPHIC] [TIFF OMITTED] T7983.042
[GRAPHIC] [TIFF OMITTED] T7983.043
[GRAPHIC] [TIFF OMITTED] T7983.044
[GRAPHIC] [TIFF OMITTED] T7983.045
[GRAPHIC] [TIFF OMITTED] T7983.046
[GRAPHIC] [TIFF OMITTED] T7983.047
[GRAPHIC] [TIFF OMITTED] T7983.048
[GRAPHIC] [TIFF OMITTED] T7983.049
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:]
[GRAPHIC] [TIFF OMITTED] T7983.050
[GRAPHIC] [TIFF OMITTED] T7983.051
[GRAPHIC] [TIFF OMITTED] T7983.052
[GRAPHIC] [TIFF OMITTED] T7983.053
[GRAPHIC] [TIFF OMITTED] T7983.054
[GRAPHIC] [TIFF OMITTED] T7983.055
[GRAPHIC] [TIFF OMITTED] T7983.056
[GRAPHIC] [TIFF OMITTED] T7983.057
[GRAPHIC] [TIFF OMITTED] T7983.058
[GRAPHIC] [TIFF OMITTED] T7983.059
[GRAPHIC] [TIFF OMITTED] T7983.060
[GRAPHIC] [TIFF OMITTED] T7983.061
[GRAPHIC] [TIFF OMITTED] T7983.062
[GRAPHIC] [TIFF OMITTED] T7983.063
[GRAPHIC] [TIFF OMITTED] T7983.064
[GRAPHIC] [TIFF OMITTED] T7983.065
[GRAPHIC] [TIFF OMITTED] T7983.066
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:]
[GRAPHIC] [TIFF OMITTED] T7983.067
[GRAPHIC] [TIFF OMITTED] T7983.068
[GRAPHIC] [TIFF OMITTED] T7983.069
[GRAPHIC] [TIFF OMITTED] T7983.070
[GRAPHIC] [TIFF OMITTED] T7983.071
[GRAPHIC] [TIFF OMITTED] T7983.072
[GRAPHIC] [TIFF OMITTED] T7983.073
[GRAPHIC] [TIFF OMITTED] T7983.074
[GRAPHIC] [TIFF OMITTED] T7983.075
[GRAPHIC] [TIFF OMITTED] T7983.076
[GRAPHIC] [TIFF OMITTED] T7983.077
[GRAPHIC] [TIFF OMITTED] T7983.078
[GRAPHIC] [TIFF OMITTED] T7983.079
[GRAPHIC] [TIFF OMITTED] T7983.080
[GRAPHIC] [TIFF OMITTED] T7983.081
[GRAPHIC] [TIFF OMITTED] T7983.082
[GRAPHIC] [TIFF OMITTED] T7983.083
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.
[GRAPHIC] [TIFF OMITTED] T7983.084
[GRAPHIC] [TIFF OMITTED] T7983.085
[GRAPHIC] [TIFF OMITTED] T7983.086
[GRAPHIC] [TIFF OMITTED] T7983.087
[GRAPHIC] [TIFF OMITTED] T7983.088
[GRAPHIC] [TIFF OMITTED] T7983.089
[GRAPHIC] [TIFF OMITTED] T7983.090
[GRAPHIC] [TIFF OMITTED] T7983.091
[GRAPHIC] [TIFF OMITTED] T7983.092
[GRAPHIC] [TIFF OMITTED] T7983.093