[Congressional Record Volume 156, Number 80 (Tuesday, May 25, 2010)]
[Senate]
[Pages S4214-S4218]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. HARKIN (for himself and Mr. Hatch):
  S. 3414. A bill to ensure that the Dietary Supplement Health and 
Education Act of 1994 and other requirements for dietary supplements 
under the jurisdiction of the Food and Drug Administration are fully 
implemented and enforced, and for other purposes; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. HARKIN. Mr. President, today I am joining with the distinguished 
senior Senator from Utah, Senator Hatch, to introduce the Dietary 
Supplement Full Implementation and Enforcement Act of 2010. Forty 
percent of Americans regularly take supplements--and I am one of them. 
We are taking charge of our own health. We are developing healthier 
habits. We are waking up to the fact that we don't live to eat, we eat 
to live--and we need to be mindful of what we put into our bodies.
  Countless people have told me how they have been helped by dietary 
supplements. Consumers want alternatives. They want less invasive, less 
expensive options. They don't want to just cure disease, they want to 
prevent disease. They want to feel good--and to look good.
  As you know, I have long championed the cause of health prevention, 
and I strongly believe that safe, properly labeled dietary supplements 
can be an important part of a healthy lifestyle. In 1994, I introduced 
the Dietary Supplement Health and Education Act--DSHEA--along with my 
good friend Senator Hatch, and we revolutionized the way that 
supplements are regulated and sold in the United States.
  DSHEA struck an important balance. On the one hand, it recognized the 
importance of enhancing consumer access to vitamins, minerals, and 
other dietary supplements, and it recognized the virtues of scientific 
research and education on the benefits and risk of supplements. On the 
other hand, it recognized the need for important regulatory safeguards 
to protect consumer health, including new safety standards, penalties 
for mislabeling or adulterating dietary supplements, and rules to 
ensure the scientific substantiation of claims regarding dietary 
supplements. As a result, over the last 15 years, Americans have 
enjoyed unprecedented access to a range of safe products that help 
improve their health.
  In 2006, Congress identified a need for additional regulatory 
safeguards, and we passed a law that requires manufacturers, packers, 
and distributors of dietary supplements to report to FDA serious 
adverse events associated with the use of supplements. Dietary 
supplement manufacturers are also now required to register their 
businesses with FDA under the BioTerrorism law we passed in 2002. S. 
510, the food safety legislation approved by the Senate HELP Committee 
last year, which I hope will soon be considered on the Senate floor, 
contains additional provisions that apply to dietary supplements. The 
legislation gives FDA the authority to revoke the registration of a 
dietary supplement facility in certain instances, and it authorizes FDA 
to initiate a mandatory recall of any food, including a dietary 
supplement, that will cause serious adverse health consequences or 
death.
  In short, Congress has been active in passing laws that promote 
access to dietary supplements, but also ensure those products are safe 
for their intended uses. I am proud of our record on this issue, and I 
believe we have established a regulatory framework that is in the best 
interest of the American people and their long term health.
  I am concerned, however, that not enough is being done to fully 
implement and enforce these dietary supplement laws. I am very pleased 
that FDA recently issued final regulations on current Good 
Manufacturing Practice for dietary supplements, but it took them nearly 
15 years to get those rules on the books. In the fall of 2004, FDA 
opened a docket and held a public meeting on new dietary ingredients, 
but it has still not produced guidance on that issue. Perhaps most 
alarming, there are still scores of illegal products being sold in this 
country that masquerade as dietary supplements. Some bad actors simply 
slap a dietary supplement label on illegal products in the hopes that 
the supplement label will help those products evade notice by FDA or 
the label will help promote sales. These products are clearly not 
dietary supplements and both consumers and the legitimate dietary 
supplement industry have a right to be upset about their sale. I am 
encouraged that President Obama's FDA has been sending Warning Letters 
on some of these illegal products, but more needs to be done. Part of 
the problem is that FDA's dietary supplement program has been under-
resourced. But part of the problem is that enforcement of DSHEA has not 
been made a priority.
  That is why I am proud to introduce the Dietary Supplement Full 
Implementation and Enforcement Act of 2010. This is an updated version 
of a bill that Senator Hatch and I introduced in

[[Page S4216]]

the 108th Congress. I am grateful that the Senator from Utah joins me 
again today in introducing this important legislation. Its basic goal 
is to give FDA the resources it needs to fully implement and enforce 
our dietary supplement laws, but also to hold FDA accountable for what 
it does with those resources.
  According to FDA, full implementation of the laws governing the 
regulation of dietary supplement will require substantial additional 
resources. My bill authorizes FDA to receive the necessary sums to 
implement and enforce the law. It also authorizes the Office of Dietary 
Supplements at NIH to receive additional sums to expand research and 
development of consumer information on dietary supplements.
  On the implementation front, the bill requires FDA to issue guidance 
that clarifies for consumers and industry FDA's expectations with 
regard to its new dietary ingredient premarket notification program.
  On the enforcement front, the bill directs FDA to inspect facilities 
to ensure compliance with the new dietary supplement good manufacturing 
practice regulations; to use the authority under DSHEA to protect the 
public from unsafe dietary supplements; and to ensure that claims made 
for dietary supplements are truthful, non-misleading and substantiated. 
It also requires FDA to notify the Drug Enforcement Administration if 
FDA objects to a new dietary ingredient notification because the 
product may contain an anabolic steroid or an analogue of an anabolic 
steroid.
  On the accountability front, the bill requires the Secretary of the 
Health and Human Services to submit an annual report to Congress that 
lists, among other things, how many people at FDA worked on supplement-
related issues in the prior years; the number of times FDA inspected 
dietary supplement facilities; the number of times FDA issued a warning 
letter or initiated an enforcement action because a manufacturer was 
not in compliance; the number of times FDA objected to the marketing of 
a new dietary ingredient; and the number of dietary supplement claims 
the FDA determined to be false, misleading, or not substantiated.
  The bottom line is that dietary supplements offer tremendous health 
benefits to Americans, but it is not fair to consumers, the FDA, or the 
people who make supplements if we don't take action to clarify our 
current regulatory requirements, to better inform everyone about the 
benefits and risk of these products, and to clear the market of the 
clearly illegal or spiked products that masquerade as supplements. The 
bill that Senator Hatch and I have developed is an important and 
measured response to these challenges. I am heartened that a number of 
organizations that are deeply concerned about these issues have 
endorsed our bill, including, among others, the United Natural Products 
Alliance, the Natural Products Association, the Council for Responsible 
Nutrition, the Consumer Healthcare Products Association, the American 
Herbal Products Association, the Major League Baseball Players 
Association, and the NFL Players Association. The bill recognizes the 
need to implement and enforce current law in this area rather than 
simply discard the important balance we struck in 1994. And it is 
grounded in the firm belief that safe, properly labeled dietary 
supplements remain a vital part of our collective effort to help all 
Americans improve their health.
  Mr. HATCH. Mr. President, today Senator Tom Harkin, Chairman of the 
Senate Health, Education, Labor and Pensions Committee and I are 
introducing the Dietary Supplement Full Implementation and Enforcement 
Act of 2010, which is similar to the legislation we introduced in the 
108th Congress.
  Our goal in introducing this commonsense bill is to ensure that the 
Food and Drug Administration properly implements and enforces existing 
dietary supplement laws--namely the 1994 Dietary Supplement Health 
Education Act, DSHEA, and the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act of 2006. This is important to protect the 
150,000,000 Americans who regularly take dietary supplements and to 
remove ``bad actor'' companies from the marketplace.
  This issue is extremely important because the laws already on the 
books are sufficient if the FDA has the resources and the will to fully 
enforce them. Indeed, previous FDA commissioners--Dr. Jane Henney, Dr. 
Mark McClellan, Dr. Lester Crawford and Dr. Andy von Eschenbach--have 
all stated as much in Senate hearings and in my meetings with them. 
Moreover, current FDA Commissioner Dr. Margaret Hamburg has assured me 
that she will work with me to ensure these laws are enforced.
  Bottom line: the FDA already has the regulatory authority it needs 
under current law.
  That is why I will not support any changes to existing dietary 
supplement laws until the legislation we are introducing today has been 
approved by both the House and the Senate and signed into law by the 
President. We also need to ensure this legislation is fully funded by 
this Congress and enforced by the FDA with the full backing of this 
Administration. It is important to give FDA the resources it needs to 
accomplish both tasks. The legislation that we are introducing today 
will do just that.
  Senator Harkin and I have asked our colleagues on the Senate 
Appropriations Committee to provide the FDA with the funds it needs to 
fully implement DSHEA. We will continue to work diligently to help them 
succeed in that task.
  As you know, DSHEA clarified the FDA's regulatory authority over 
dietary supplements while ensuring that Americans will continue to have 
access to safe dietary supplements and helpful information about these 
products. It passed the Senate twice by unanimous consent. The 
legislation we are introducing today includes a Sense of the Congress 
and outlines the methods the FDA should use to better implement and 
enforce laws related to dietary supplements. It further requires the 
dietary supplement industry to redouble its efforts to comply with the 
law and cooperate with the FDA.
  To provide the FDA with the resources necessary to regulate 
compliance with dietary supplement laws, this bill directs the agency 
to use part of its 2010 Fiscal Year Budget for that purpose. It also 
authorizes the National Institutes of Health's Office of Dietary 
Supplements to expand research and develop more consumer information on 
dietary supplements.
  Furthermore, the legislation requires the Secretary of Health and 
Human Services (HHS) to submit an annual report to Congress, starting 
no later than January 31, 2011, regarding HHS activities on dietary 
supplements. Finally, it directs the FDA to issue its New Dietary 
Ingredient (NDI) guidance, as recommended by the General Accountability 
Office, within 180 days and requires the FDA to share any information 
on tainted NDI with the Drug Enforcement Agency.
  It is my sincere hope that all my colleagues will support this effort 
to ensure that dietary supplement consumers and manufacturers are 
protected and properly regulated. Our constituents deserve no less.
  This legislation is supported by the Major League Baseball and NFL 
players associations, the Natural Products Association, the United 
Natural Products Alliance, Council for Responsible Nutrition, American 
Herbal Products Association and the Consumer Health Care Products 
Association.
  I hope that each of you will see the wisdom in supporting this 
measure.
  Mr. President, I ask unanimous consent that letters of support be 
printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                      NFL Players Association,

                                     Washington, DC, May 24, 2010.
     Hon. Tom Harkin, Chairman,
     Hon. Orrin G. Hatch,
     Committee on Health, Education, Labor & Pensions, Washington, 
         DC.
       Dear Chairman Harkin and Senator Hatch: The issue of the 
     public disclosure--and regulation--of dietary supplements 
     remains a critically important concern to the NFLPA. As for 
     all professional athletes, professional football players rely 
     on supplement label information to educate themselves on the 
     nature of the ingredients contained therein. Without complete 
     and precise label disclosure of all ingredients contained in 
     a particular supplement, players can face sanctions--and even 
     career-ending sanctions--if unlisted ingredients would 
     violate League-Player drug-testing regimes.
       Thus, the Association welcomes the introduction of the 
     Dietary Supplement full implementation and enforcement act of 
     2010,

[[Page S4217]]

     which focuses on providing the FDA with sufficient resources 
     to play its role in overseeing the supplement marketplace.
       We endorse your legislation, salute your leadership, and 
     will work with you to realize enactment of this important 
     measure.
           Sincerely,
                                               DeMaurice F. Smith,
     Executive Director.
                                  ____

                                             Major League Baseball


                                          Players Association,

                                       New York, NY, May 24, 2010.
     Hon. Tom Harkin, Chairman,
     Hon. Orrin Hatch,
     Committee on Health, Education, Labor and Pensions, U.S. 
         Senate, 428 Dirksen Senate Office Building, Washington, 
         DC.
       Dear Chairman Harkin and Senator Hatch: Over the last 
     several years, the Major League Baseball Players Association 
     has shared with you our concerns about the federal 
     government's regulation of dietary supplements. There are 
     still far too many supplements available in the United States 
     that contain pharmaceuticals, steroids and other dangerous 
     ingredients. And, too often, what is actually inside the 
     bottle is not listed on the label. This unfortunate reality 
     is especially problematic for professional athletes. Players 
     have been suspended, their careers jeopardized, for doing 
     nothing more than taking a supplement purchased at a national 
     nutrition store, only to learn later that the product 
     contained an ingredient not listed on the label that violated 
     drug testing protocols.
       The Dietary Supplement Full Implementation and Enforcement 
     Act of 2010 will address one of the biggest obstacles to 
     improved safety--an overall lack of enforcement. We 
     understand your concern that imposing new obligations and 
     requirements on legitimate supplement companies alone will 
     not rid the marketplace of adulterated products. By providing 
     the FDA with both additional resources and increased 
     accountability, your legislation should help make possible a 
     goal we all share--a reliable supplement marketplace.
       The Association endorses the bill, and we look forward to 
     working with you throughout the legislative process on 
     additional measures to improve enforcement and ensure product 
     safety and label accuracy. Users of dietary supplements, be 
     they professional athletes or not, deserve the same promise 
     made to those who consume traditional food--the assurance 
     that the products they take, that are sold without 
     restriction to adults and children throughout the country, 
     are safe and the products' labels can be trusted.
           Sincerely,
     Michael S. Weiner.
                                  ____



                    Natural Products AssociationTM,

                                     Washington, DC, May 25, 2010.
     Hon. Tom Harkin,
     U.S. Senate,
     Washington, DC.
     Hon. Orrin G. Hatch,
     U.S. Senate,
     Washington, DC.
       Dear Senators Harkin and Hatch: On behalf of the Natural 
     Products Association (NPA), I commend your leadership and 
     bipartisan efforts to craft sensible legislation that will 
     strengthen the Food and Drug Administration's (FDA) ability 
     to fully enforce the current laws governing the regulation of 
     dietary supplements. Founded in 1936, NPA is the nation's 
     largest and oldest trade association dedicated to the natural 
     products industry, representing more than 10,000 retail, 
     manufacturing, wholesaler, and distribution outlets of 
     natural products, including dietary supplements, foods, and 
     health/beauty aids.
       NPA supports the Dietary Supplement Full Implementation and 
     Enforcement Act of 2010 as it appropriately recognizes that 
     the Dietary Supplement Health and Education Act (DSHEA) of 
     1994 grants the FDA more than adequate statutory authority to 
     regulate supplements. While some have called for new 
     regulations on supplements, you understand that the real need 
     to fully enforce the statutes already on the books.
       Historically, concurrent with the passage of DSHEA, the FDA 
     experienced budget cuts, and lacked the resources to 
     effectively regulate all the industries under its watch. To 
     ensure that the FDA is able to carry out the law as Congress 
     intended, this legislation authorizes an increase in funding 
     for FDA to implement DSHEA. The Dietary Supplement Full 
     Implementation and Enforcement Act of 2010 strengthens FDA's 
     ability to enforce DSHEA, tightens product-specific 
     enforcement, requires the release of the long-awaited New 
     Dietary Ingredient (NDI) guidance, and holds the FDA 
     accountable for filing annual reports to Congress about how 
     they are regulating dietary supplements.
       Additionally we are supportive of the doubling of funding 
     given to the Office of Dietary Supplements (ODS) to expand 
     research and consumer information about dietary supplements. 
     An increase in funding for ODS is especially important 
     because dietary supplements come from natural ingredients and 
     cannot be patented. While this ensures that these products 
     are readily and affordably available, it takes away the 
     ability of manufacturers to recoup research costs.
       Again, we applaud your introduction of the Dietary 
     Supplement Full Implementation and Enforcement Act of 2010, 
     and look forward to working with you in enacting this 
     important piece of legislation.
           Sincerely,

                                                     John Gay,

                                            Executive Director and
     Chief Executive Officer.
                                  ____

                                           United Natural Products


                                                     Alliance,

                                 Salt Lake City, UT, May 24, 2010.
     Hon. Tom Harkin,
     Chairman, Committee on Health, Education, Labor, and 
         Pensions, U.S. Senate, Washington, DC.
     Hon. Orrin G. Hatch,
     Member, Committee on Health, Education, Labor, and Pensions, 
         U.S. Senate, Washington, DC.
       Dear Chairman Harkin and Senator Hatch: The United Natural 
     Products Alliance (UNPA), an association of dietary 
     supplement and functional food companies that share a 
     commitment to providing consumers with natural health 
     products of superior quality, benefit, and reliability, 
     wishes to express its appreciation to you for your work to 
     develop the Dietary Supplement Full Implementation and 
     Enforcement Act of 2010. We are very supportive of this 
     legislation and of your continued hard work to ensure that 
     consumers have access to safe, high-quality dietary 
     supplements and information about those products.
       In 1994, you both led the effort to enact legislation that 
     would establish in law a rational and transparent framework 
     for the regulation of dietary supplements. As documented by 
     the Committee on Labor and Human Resources in the report 
     accompanying your bill, the Dietary Supplement Health and 
     Education Act (DSHEA) (S. 784), the Food and Drug 
     Administration had shown an animosity toward supplement 
     products through a series of divergent regulatory actions and 
     unpublished policies that consumers rightly concluded 
     threatened their access to supplement products. The 
     tremendous citizen reaction to those policies supported your 
     conclusion that the Federal Food, Drug and Cosmetic Act 
     needed to be amended.
       DSHEA was passed, not once, but twice, by the Senate, and 
     once by the House of Representatives, all by unanimous 
     consent--testimony to the significance of this legislation. 
     In fact, when President Clinton signed DSHEA into law in 
     1994, he noted that ``In an era of greater consciousness 
     among people about the impact of what they eat on how they 
     live, indeed, how long they live, it is appropriate that we 
     have finally reformed the way government treats consumers and 
     these supplements in a way that encourages good health.''
       DSHEA had several important components, a few of which I 
     will mention in the context of your new legislation. First, 
     it established the simple principle that all dietary 
     supplements on the market in the United States at the time of 
     enactment would be presumed to be dietary supplements in the 
     future, unless there were violations of other parts of the 
     law. For new ingredients sold after that date, a manufacturer 
     was required to submit a ``New Dietary Ingredient'' (NDI) 
     notification to the FDA in advance of marketing. Second, as 
     part of DSHEA's numerous provisions to ensure the safety of 
     supplement products, the law authorized issuance of current 
     Good Manufacturing Practice (cGMPs) regulations specific to 
     supplements. The law established the requirements for 
     labeling, product claims and supporting substantiation. And, 
     it established at the National Institutes of Health an Office 
     of Dietary Supplements (ODS) to conduct research, provide 
     consumer information on supplements and act as an advisor to 
     other federal agencies.
       In the years following enactment of DSHEA, by any objective 
     measure, FDA was slow to implement the law. Very few warning 
     letters were issued. Very few enforcement actions were 
     taken--despite the fact that for many years you worked 
     together to provide FDA with additional resources to act 
     against products that were clearly violations of the law. The 
     cGMPs were not issued for 13 years--resulting in unwarranted 
     criticism that dietary supplements are ``not regulated''. 
     Likewise, uncertainty arose whether some products contained 
     old or new ingredients under the law, and guidance on New 
     Dietary Ingredients has not been forthcoming from FDA. This 
     must change.
       It has become clear that there has been a lack of 
     enforcement against clear violations of the law and that this 
     is largely due to two factors: a lack of focus by the agency; 
     and a competition for resources that has drained funding into 
     other areas. Your bill would rectify that situation and 
     return needed attention to appropriate implementation of 
     DSHEA and successor laws such as the 2006 Dietary Supplement 
     and Non-Prescription Drug Consumer Protection Act. 
     Specifically, we find beneficial the provisions that would 
     provide Congress with a professional judgment estimate of the 
     costs to implement the laws addressing dietary supplement 
     regulation. This will allow Congress, and specifically the 
     Appropriations Committees, the ability to evaluate the 
     adequacy of the agency's funding and that of the Office of 
     Dietary Supplements. We also highlight the need for 
     provisions urging increased FDA efforts to conduct 
     inspections under the new cGMPs, evaluate claims 
     (prioritizing with those that are clear violations of the 
     law), promptly issuing guidance on NDIs, and notifying the 
     Drug Enforcement Administration if NDI notification suggests 
     that the substance may contain anabolic steroids or their 
     analogues which by definition are not dietary supplements. In 
     addition, the Annual Accountability Report on the Regulation 
     of Dietary

[[Page S4218]]

     Supplements which your bill would require will yield valuable 
     information showing the adequacy of dietary supplement 
     regulatory efforts.
       Finally, we recognize our responsibility as representatives 
     of the regulated industry to comply fully with the laws 
     regulating dietary supplements, and we pledge to continue our 
     efforts to work cooperatively with the government to develop 
     and implement rational policies that will assure American 
     consumers the safe products upon which they have come to 
     rely. As a central part of our mission, UNPA has made efforts 
     to educate ingredient suppliers, manufacturers and retailers 
     about key components of the dietary supplement laws and how 
     they should be implemented. We always strive to partner with 
     the government (including both the FDA and the Federal Trade 
     Commission) in these activities. Good examples of these 
     efforts are the numerous seminars we conduct, including five 
     focused specifically on the new cGMP regulations. We invite 
     you to review this in more detail at www.UNPA.org.
       Thank you for your leadership role on behalf of the 150 
     million Americans who regularly use dietary supplement 
     products.
           Sincerely,
                                               Loren D. Israelsen,
     Executive Director.
                                  ____



                            Council for Responsible Nutrition,

                                     Washington, DC, May 25, 2010.
     Re S. 3414--Dietary Supplement Full Implementation and 
         Enforcement Act

     Hon. Tom Harkin,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
     Hon. Orrin Hatch,
     U.S. Senate, Hart Senate Office Building, Washington, DC.
       Dear Senators Harkin and Hatch: On behalf of the Council 
     for Responsible Nutrition (CRN) and its members, I am writing 
     to express our support for S. 3414, the Dietary Supplement 
     Full Implementation and Enforcement Act of 2010 (DSFIEA). We 
     want to thank you for your commitment to legislative and 
     regulatory initiatives that would help to fully fund, 
     implement and enforce the Dietary Supplement Health and 
     Education Act (DSHEA) of 1994, and this legislation is an 
     example of your commitment to consumers and the dietary 
     supplement industry to assure access to safe and beneficial 
     supplement products. The work that you and your colleagues 
     have devoted to providing FDA with tools and resources to 
     reinforce its authority in regulating the supplement industry 
     under DSHEA is commendable and CRN stands in support of your 
     efforts.
       This legislation will help to ensure that the agency has 
     sufficient focus and resources at its disposal to implement a 
     law--DSHEA--which already provides FDA with ample authority 
     to ensure consumer safety, while still providing consumers 
     access to the products they seek. It will provide increased 
     funding for FDA, and in particular to the dietary supplement 
     programs within the Center for Food Safety & Applied 
     Nutrition (CFSAN). The legislation also directs the agency to 
     provide annual reports to Congress making itself accountable 
     for enforcing key provisions of the law, just as the industry 
     is responsible for complying with them. While some critics of 
     the dietary supplement industry have called for new laws to 
     change the way dietary supplements are regulated, this 
     legislation acknowledges that DSHEA carefully balanced 
     consumer access with consumer protection and seeks to make 
     the existing law work through real efforts to implement it. 
     Having more laws, without enforcement, only disadvantages the 
     responsible members of industry who do comply with the law 
     because it is the law and because it's the right thing to do 
     for their consumers, and gives rogue companies more laws to 
     violate. The better approach is to have a robust and 
     accountable FDA empowered and staffed to enforce the current 
     law that will level the playing field for all members of the 
     marketplace. As previous FDA Commissioners have testified to 
     Congress, DSHEA provides more than adequate authority for 
     government while still allowing consumers appropriate access 
     to the products and health information they demand.
       More than 150 million Americans use dietary supplements, 
     and these consumers demand a strong industry that is 
     appropriately regulated. We hope Congress will give this 
     legislation expedient and thoughtful consideration on its way 
     to passage. CRN stands ready to work with you and 
     Congressional leadership to deliver a strong bill to the 
     President.
       Please don't hesitate to contact me at SM[email protected] 
     or 202.204.7676 if CRN can be of any assistance in your 
     endeavors.
           Best regards,
                                                     Steve Mister,
     President and CEO.
                                  ____

                                          American Herbal Products


                                                  Association,

                                  Silver Spring, MD, May 25, 2010.
     Senator Orrin Hatch,
     Hart Office Building,
     Washington, DC.
     Senator Tom Harkin,
     Hart Office Building,
     Washington, DC.
       Dear Senators Hatch and Harkin: This letter is to thank you 
     for introducing the Dietary Supplement Full Implementation 
     and Enforcement Act of 2010 and to express the support of the 
     American Herbal Products Association (AHPA) for this 
     important legislation.
       AHPA recognizes that this bill will protect consumer access 
     to dietary supplements by providing the Food and Drug 
     Administration (FDA) with better resources to enforce the 
     many regulations that govern this class of goods. The bill 
     will also instruct FDA to provide guidance on existing rules 
     that apply to new ingredients, and AHPA has long supported 
     full implementation of this section of the law so that 
     consumers are assured that all dietary supplements contain 
     only safe ingredients.
       Thank you again for your efforts in protecting the 
     important health care choices now enjoyed by the millions of 
     Americans who use dietary supplements.
           Sincerely,
                                                 Michael McGuffin,
     President.
                                  ____

                                      Consumer Healthcare Products


                                           Association (CHPA),

                                                     May 25, 2010.
     Hon. Tom Harkin,
     U.S. Senate,
     Washington, DC.
     Hon. Orrin G. Hatch,
     U.S. Senate,
     Washington, DC.
       Dear Senators Harkin and Hatch: On behalf of the Consumer 
     Healthcare Products Association (CHPA), representing the 
     leading manufacturers of over-the-counter medicines and 
     nutritional supplements, I am pleased to express our support 
     for the ``Dietary Supplement Full Implementation and 
     Enforcement Act of 2010.'' This bill is the most recent 
     example of your continued leadership in support of dietary 
     supplements.
       The ``Dietary Supplement Full Implementation and 
     Enforcement Act of 2010'' strengthens FDA's ability to 
     enforce the Dietary Supplement Health and Education Act 
     (DSHEA), expands research, calls for the release of the long-
     awaited New Dietary Ingredient (NDI) guidance, and requires 
     the filing of an annual report to Congress on the 
     implementation and enforcement of DSHEA.
       Critically, your bill also authorizes the funds needed for 
     the full implementation of DSHEA. In the years following 
     passage of the act, chronic budget shortfalls took a toll on 
     FDA, including funding for the Office of Dietary Supplements 
     (ODS). Authorizing these funds is an important step in making 
     sure ODS has the resources it needs.
       Again, we applaud your introduction of the Dietary 
     Supplement Full Implementation and Enforcement Act of 2010, 
     and look forward to working with you to enact this important 
     legislation.
           Sincerely,
                                                  Linda A. Suydam,
                                                        President.
                                 ______