text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Dietary Supplement Full 
  Implementation and Enforcement Act of 2010''.
  
  SEC. 2. FINDINGS.
  
      Congress finds the following:
              (1) Each year, more than 150,000,000 Americans regularly 
          consume dietary supplements to maintain and improve their 
          health.
              (2) Consumer expenditures on dietary supplements exceeded 
          $25,000,000,000 in 2008.
              (3) Given the growing awareness of the importance of 
          prevention and wellness in the health care system of the United 
          States, it is vital that laws governing the safety of, and 
          education about, dietary supplements be fully implemented and 
          enforced.
              (4) In 1994, Congress approved, and the President signed 
          into law, the Dietary Supplement Health and Education Act of 
          1994 (Public Law 103-417) (referred to in this Act as 
          ``DSHEA''). DSHEA balanced the importance of continuing 
          consumer access to vitamins, minerals, and other dietary 
          supplements, promoting scientific research on the benefits and 
          risks of dietary supplements, and fostering public education on 
          the benefits and risks of supplement use with the need for 
          regulatory safeguards to protect consumer health, including a 
          new standard for safety, penalties for mislabeled or 
          adulterated dietary supplements, rules to ensure scientific 
          substantiation of the claims made regarding dietary 
          supplements, and a notification requirement to the Food and 
          Drug Administration before dietary supplements that contain 
          certain new dietary ingredients may be marketed.
              (5) DSHEA requires that claims made on dietary supplement 
          labels, packaging, and accompanying material be truthful, non-
          misleading, and substantiated. Manufacturers are prohibited 
          from making claims that products are intended to diagnose, 
          treat, mitigate, cure, or prevent a disease.
              (6) DSHEA requires that dietary supplements comply with 
          good manufacturing practice (referred to in this section as 
          ``GMP'') requirements, and authorizes the Food and Drug 
          Administration to establish such requirements.
              (7) In 2007, after many years of delay, the Food and Drug 
          Administration published regulations detailing the GMP 
          requirements for dietary supplements, including requirements 
          for identity, purity, strength, sanitary conditions, and 
          recordkeeping. The Food and Drug Administration began to 
          enforce those requirements in 2008.
              (8) DSHEA requires that, before marketing a dietary 
          supplement containing certain new dietary ingredients, the 
          manufacturer or distributor must submit notice to the Food and 
          Drug Administration that includes information showing that the 
          dietary supplement will reasonably be expected to be safe. 
          According to the Food and Drug Administration, the Food and 
          Drug Administration has raised objections to more than 70 
          percent of all new dietary ingredient notifications submitted 
          to the agency.
              (9) The Food and Drug Administration has successfully used 
          the adulteration provisions of DSHEA to remove from the 
          marketplace dietary supplements that present an unreasonable 
          risk of injury or illness.
              (10) In 2002, Congress passed the Public Health Security 
          and Bioterrorism Preparedness and Response Act (Public Law 107-
          188). This law requires any facility engaged in manufacturing, 
          processing, packing, or holding food for consumption in the 
          United States, including dietary supplements, to be registered 
          with the Food and Drug Administration.
              (11) In 2006, Congress supplemented DSHEA by approving the 
          Dietary Supplement and Nonprescription Drug Consumer Protection 
          Act (Public Law 109-462). This law requires dietary supplement 
          manufacturers, packers, and distributors to report promptly to 
          the Food and Drug Administration any reports the manufacturer 
          or other responsible person receives of serious adverse events 
          associated with the use of the products of such manufacturer or 
          other responsible person. Information the Food and Drug 
          Administration receives under this reporting requirement may 
          help the agency detect possible safety problems related to 
          dietary supplement products or ingredients.
              (12) DSHEA created the Office of Dietary Supplements within 
          the National Institutes of Health to expand research and 
          consumer information about the health effects of dietary 
          supplements. The Office of Dietary Supplements has greatly 
          expanded the number of scientific studies of dietary 
          supplements and the availability of reliable information to 
          consumers.
              (13) While the Food and Drug Administration has taken some 
          important steps to implement and enforce DSHEA and the other 
          laws governing the regulation of dietary supplements, the 
          agency has not fully implemented and enforced DSHEA and the 
          other laws governing the regulation of dietary supplements.
              (14) Both the public and regulated industry would benefit 
          from more guidance from the Food and Drug Administration on the 
          procedures and definitions concerning the regulation of new 
          dietary ingredients under section 413 of the Federal Food, 
          Drug, and Cosmetic Act (21 U.S.C. 350b).
              (15) If the Food and Drug Administration determines that a 
          product labeled as a dietary supplement includes an anabolic 
          steroid or an analogue of an anabolic steroid, the Food and 
          Drug Administration does not systematically notify the Drug 
          Enforcement Administration of that determination.
              (16) The Food and Drug Administration needs adequate 
          resources to implement and enforce DSHEA and other laws 
          governing the regulation of dietary supplements appropriately. 
          Congress has appropriated additional funds over the last 
          several years to implement and enforce DSHEA, reaching more 
          than $14,000,000 for fiscal year 2009.
              (17) According to the Food and Drug Administration, full 
          implementation of DSHEA and the other laws governing the 
          regulation of dietary supplements would require substantial 
          additional resources. In 2002, the Food and Drug Administration 
          reported to Congress in writing that the agency would need 
          between $24,000,000 and $65,000,000 per year to fully implement 
          DSHEA.
  
  SEC. 3. SENSE OF CONGRESS.
  
      It is the sense of Congress that:
              (1) The Food and Drug Administration should increase 
          efforts to implement DSHEA more fully and effectively, by--
                      (A) providing Congress with a professional judgment 
                  estimate of the annual costs during the 5-year period 
                  beginning on the date of enactment of this Act to fully 
                  implement and enforce DSHEA and other dietary 
                  supplement laws and regulations under the jurisdiction 
                  of the Food and Drug Administration;
                      (B) conducting inspections, using appropriately 
                  trained inspection personnel, of all facilities in 
                  which a dietary supplement is manufactured, processed, 
                  packed, or held to ensure compliance with the new 
                  dietary supplement good manufacturing practices 
                  regulations;
                      (C) using the authority under DSHEA to protect the 
                  public from unsafe dietary supplement products and 
                  ingredients and to ensure that claims made are 
                  truthful, non-misleading, and substantiated, with 
                  highest regulatory priority given to cases of clear 
                  violations of the law (including the intentional 
                  adulteration and spiking of products);
                      (D) implementing the recommendations contained in 
                  the January 2009 report of the Government 
                  Accountability Office, entitled, ``Dietary Supplements: 
                  FDA Should Take Further Actions To Improve Oversight 
                  and Consumer Understanding'', (GAO 09-250) that the 
                  Food and Drug Administration--
                              (i) require all dietary supplement 
                          manufacturers, packers, and distributors to 
                          identify themselves specifically as such under 
                          existing registration requirements and to 
                          update such information annually;
                              (ii) promptly issue guidance to clarify 
                          when a dietary supplement ingredient is a new 
                          dietary ingredient, the evidence needed to 
                          document the safety of new dietary ingredients, 
                          and appropriate methods for establishing the 
                          identity of a new dietary ingredient; and
                              (iii) coordinate with stakeholder groups 
                          involved in consumer outreach to identify, 
                          implement, and evaluate the effectiveness of 
                          additional mechanisms for educating consumers 
                          about the safety, efficacy, and labeling of 
                          dietary supplements; and
                      (E) notifying the Drug Enforcement Administration 
                  if the Food and Drug Administration determines that the 
                  information in a new dietary ingredient notification 
                  submitted under section 413 of the Federal Food, Drug, 
                  and Cosmetic Act (21 U.S.C. 350b) is inadequate to 
                  establish that the new dietary ingredient will 
                  reasonably be expected to be safe, because the dietary 
                  supplement may contain an anabolic steroid or an 
                  analogue of an anabolic steroid.
              (2) The manufacturers, packers, retailers, and distributors 
          of dietary supplements and dietary supplement ingredients 
          should increase efforts to--
                      (A) comply fully with all requirements of DSHEA and 
                  the Dietary Supplement and Nonprescription Drug 
                  Consumer Protection Act;
                      (B) cooperate fully and appropriately with the Food 
                  and Drug Administration in implementation and 
                  enforcement of Federal laws and regulations; and
                      (C) provide the Food and Drug Administration with 
                  appropriate input on known and suspected violations of 
                  such laws and regulations.
  
  SEC. 4. AUTHORIZATION OF APPROPRIATIONS AND ALLOCATION OF RESOURCES.
  
      (a) Authorization of Appropriations.--There are authorized to be 
  appropriated to carry out the Dietary Supplement Health and Education 
  Act of 1994, the amendments made by such Act, and other provisions 
  under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
  that apply to dietary supplements, $30,000,000 for fiscal year 2011 and 
  such sums as may be necessary for each of fiscal years 2012 through 
  2014.
      (b) Allocation of Funds for Fiscal Year 2010.--From funds 
  appropriated to the Food and Drug Administration for fiscal year 2010 
  for the purpose of enhancing food safety, not less than $20,000,000 
  shall be expended to effectively and fully implement and enforce the 
  Dietary Supplement Health and Education Act of 1994, the amendments 
  made by such Act, and other provisions under the Federal Food, Drug, 
  and Cosmetic Act (21 U.S.C. 301 et seq.) that apply to dietary 
  supplements.
      (c) Office of Dietary Supplements.--There are authorized to be 
  appropriated for expanded research and development of consumer 
  information on dietary supplements by the Office of Dietary Supplements 
  at the National Institutes of Health--
              (1) $40,000,000 for fiscal year 2010; and
              (2) such sums as may be necessary for each of the fiscal 
          years 2011 through 2014.
  
  SEC. 5. ANNUAL ACCOUNTABILITY REPORT ON THE REGULATION OF DIETARY 
                SUPPLEMENTS.
  
      (a) In General.--Not later than January 31, 2011, and annually 
  thereafter, the Secretary of Health and Human Services shall submit a 
  report to Congress on the implementation and enforcement of the Dietary 
  Supplement Health and Education Act of 1994 and the amendments made by 
  such Act.
      (b) Contents.--The report under subsection (a) shall include the 
  following:
              (1) The total funding and number of full-time equivalent 
          personnel in the Food and Drug Administration dedicated to 
          dietary supplement regulation during the prior fiscal year.
              (2) The total funding and number of full-time equivalent 
          personnel in the Food and Drug Administration dedicated to 
          administering adverse event reporting systems, as such systems 
          relate to dietary supplement regulation, during the prior 
          fiscal year.
              (3) The total funding and number of full-time equivalent 
          personnel in the Food and Drug Administration dedicated to 
          enforcement of dietary supplement labeling and claims 
          requirements during the prior fiscal year and a brief 
          explanation of the activities of such personnel.
              (4) The total funding and number of full-time equivalent 
          personnel in the Food and Drug Administration dedicated to the 
          review and enforcement of good manufacturing practice 
          requirements with respect to dietary supplements during the 
          prior fiscal year.
              (5) The number of inspections at which the Food and Drug 
          Administration evaluated or reviewed the compliance of a 
          manufacturer with good manufacturing practices for dietary 
          supplements during the prior fiscal year, and the number of 
          times the Food and Drug Administration issued a warning letter 
          because it determined that such manufacturer was not in 
          compliance with some aspect of such requirements.
              (6) The number of new dietary ingredient notification 
          reviews that the Food and Drug Administration performed during 
          the prior fiscal year and the number of times the Food and Drug 
          Administration objected to the marketing of the dietary 
          supplement described in such notification reviews.
              (7) The number of times the Food and Drug Administration 
          issued a warning letter or initiated an enforcement action 
          against a manufacturer or distributor for failure to file a new 
          dietary ingredient notification as required under section 413 
          of the Federal Food, Drug, and Cosmetic Act.
              (8) A brief summary and explanation of all enforcement 
          actions taken by the Food and Drug Administration and the 
          Department of Health and Human Services related to dietary 
          supplements during the prior fiscal year, including the number 
          and type of actions.
              (9) The number of times the Food and Drug Administration 
          requested substantiation of dietary supplement claims from a 
          manufacturer during the prior fiscal year, the number of times 
          a manufacturer refused to provide such information, and the 
          response of the agency in such situations.
              (10) The number of dietary supplement claims determined by 
          the Food and Drug Administration during the prior fiscal year 
          to be false, misleading, or not substantiated, and a 
          description of the follow-up action taken by the agency in such 
          instances.
              (11) The research and consumer education activities 
          supported by the Office of Dietary Supplements of the National 
          Institutes of Health during the prior fiscal year.
              (12) Any recommendations for administrative or legislative 
          actions to improve the regulation of dietary supplements.
              (13) Any other information regarding the regulation of 
          dietary supplements determined appropriate by the Secretary of 
          Health and Human Services or the Commissioner of Food and 
          Drugs.
  
  SEC. 6. NEW DIETARY INGREDIENTS.
  
      (a) Guidelines for Introducing New Dietary Ingredients.--Section 
  413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b) is 
  amended--
              (1) by redesignating subsection (c) as subsection (e); and
              (2) by inserting after subsection (b) the following:
      ``(c) Guidelines.--Not later than 180 days after the date of 
  enactment of the Dietary Supplement Full Implementation and Enforcement 
  Act of 2010, the Secretary shall publish guidance that clarifies when a 
  dietary supplement ingredient is a new dietary ingredient, when the 
  manufacturer or distributor of a dietary ingredient or dietary 
  supplement should provide the Secretary with information as described 
  in subsection (a)(2), the evidence needed to document the safety of new 
  dietary ingredients, and appropriate methods for establishing the 
  identity of a new dietary ingredient.
      ``(d) Notification to DEA.--
              ``(1) In general.--If the Secretary determines that the 
          information in a new dietary ingredient notification submitted 
          under this section for an article purported to be a new dietary 
          ingredient is inadequate to establish that a dietary supplement 
          containing such article will reasonably be expected to be safe 
          because the article may be, or may contain, an anabolic steroid 
          or an analogue of an anabolic steroid, the Secretary shall 
          notify the Drug Enforcement Administration of such 
          determination. Such notification by the Secretary shall 
          include, at a minimum, the name of the product or article, the 
          name of the person or persons who marketed the product or made 
          the submission of information regarding the article to the 
          Secretary under this section, and any contact information for 
          such person or persons that the Secretary has.
              ``(2) Definitions.--For purposes of this subsection--
                      ``(A) the term `anabolic steroid' has the meaning 
                  given such term in section 102(41) of the Controlled 
                  Substances Act; and
                      ``(B) the term `analogue of an anabolic steroid' 
                  means a substance whose chemical structure is 
                  substantially similar to the chemical structure of an 
                  anabolic steroid.''.
target: Dietary Supplement Full Implementation and Enforcement Act of 2010 - Authorizes appropriations for FY2011-FY2014 to carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and other provisions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that apply to dietary supplements.
  
  Requires the allocation of funds appropriated to the Food and Drug Administration (FDA) for FY2010 for the purpose of enhancing food safety to be expended to effectively and fully implement and enforce DSHEA and other FFDCA provisions that apply to dietary supplements.
  
  Authorizes appropriations for FY2010-FY2014 for expanded research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH).
  
  Requires the Secretary of Health and Human Services (HHS) to report to Congress annually on the implementation and enforcement of DSHEA and its amendments.
  
  Amends the FFDCA to require the Secretary to publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with safety information, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identity of a new dietary ingredient.
  
  Requires the Secretary to notify the Drug Enforcement Agency (DEA) if information in a new dietary ingredient notification is inadequate to establish that a dietary supplement containing such ingredient will reasonably be expected to be safe because the ingredient may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid.
feat_title: 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.