Dietary Supplements: What Every Retailer Needs To Know

1. Dietary Supplements: What Every Retailer Needs To Know Cara Welch, Ph.D. Vice President, Scientific & Regulatory Affairs NPA Marketplace June 15, 2012

2. What Every Retailer Needs To Know • Regulatory compliance • NDI • GMP • AER • EMA • Agency Activity • FDA • FTC • GAO • State Activity

3. Regulatory Compliance – NDI • Where it stands: • FDA issued guidance as a draft in July 2011 • Industry comments filed December 4th • No official action from FDA since then • Enforcement of the guidance • A draft guidance does not confer rights or impose requirements – it is simply the agency’s interpretation and articulation of how it will enforce the law

4. Regulatory Compliance – NDI • A congressional response • Nothing formally introduced to date • Possible legislation would: • Re-set the grandfathered date to 2007 • Expressly state that synthetic, bio-identical versions of botanical constituents can be dietary ingredients • Define “chemically altered” in a narrow manner • allowing expansive reading of “not chemically altered” in DSHEA

5. Regulatory Compliance – GMP • FDA GMP Rule for Dietary Supplements • 21 CFR 111 • Published June 25, 2007 • In effect for all manufacturers June 25, 2010 • FDA increasing inspections under the Rule • Compliance rate poor • >25% of inspections have led to notices of significant violations

6. Regulatory Compliance – GMP • Typical violations include: • Failure to qualify suppliers • Failure to conduct identity testing incoming ingredients • Failure to set master manufacturing specifications • Failure to keep batch records • Failure to test finished products • Failure with the basic systems of GMPs

7. Regulatory Compliance – GMP • Enforcement actions coming fast and furious • Warning letters • Injuctions • Product seizure • How does this affect me?

8. Regulatory Compliance – AER • The Dietary Supplement and Non-Prescription Drug Consumer Protection Act • AKA, the SAER Law • Industry supported this law • Now struggling to comply? • Misunderstanding of requirement? • How does this affect me?

9. Regulatory Compliance – EMA • EMA = FDA’s Tainted Products Initiative • Products marketed as dietary supplements that are deliberately contaminated with undisclosed ingredients. • weight loss  60 recalled products • sexual enhancement  70 recalled products • bodybuilding  90 recalled products

10. Regulatory Compliance – EMA • FDA Resources • Searchable database of tainted products at: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=tainted_supplements_cder • RSS feed of known tainted products: http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/TDS/rss.xml • Ongoing investigations and testing of products • Criminal actions are ongoing

11. Regulatory Compliance – EMA • How do we support this? • Conduct thorough analyses of incoming products, especially if in the suspect categories • Report suspected tainted products to FDA – don’t return them to the supplier: • Report via email: TaintedProducts@fda.hhs.gov • Report Suspected Criminal Activity: www.fda.gov/oci • Report Unlawful Sales of Medical Products on the Internet: http://www.fda.gov/Safety/ReportaProblem/ucm059315.htm • Report Health Fraud Scams: www.fda.gov/healthfraud

12. Regulatory Compliance • Congress is watching

13. Agency Activity

14. Agency Activity – FDA • FDA Budget • Years of underfunding before FY 2010 • FY2012 - $50m increase; $39m for food safety • FY 2013 – President’s budget = no increase • FY 2014 automatic cuts to kick in • Impact • pressure for user fees, registration fees, inspection fees • If no enforcement funding, open to criticism that industry is not regulated

15. Agency Activity – FDA • FDA – Revisions to the Daily Values • Proposed Rulemaking to Revise the Daily Values • Would replace RDIs with EARs as the basis of the %DV on the label. • Estimated Average Requirements only cover half the population; RDIs assure >90% of people get adequate nutrition. • The same amount of a nutrient would appear to satisfy a higher % of particular nutrients

16. Agency Activity – FTC • FTC – New Consent Orders • Settling defendants must sign consent order agreeing that claims for health benefits will be: • Substantiated by at least two adequate and well-controlled, human clinical studies, • Conducted by different researchers independently of each other, • Conform to acceptable designs and protocols, and • Considered in light of entire body of relevant and reliable scientific evidence. • Claims to treat or prevent disease must be approved by FDA through drug approval or OTC monograph • POM Wonderful case: final decision a win for both?

17. Agency Activity – GAO • GAO Report • Requested by Sen Durbin and Cong Waxman • Follow up report regarding FDA’s regulation of dietary supplements • AER reporting system • Addressing concerns re: safety of supplements • Assure “consumers have useful information about the safety and efficacy of supplements” • Expected this fall

18. State Activity • California Right to Know Act • Ballot initiative to require labeling of products containing genetically engineered ingredients • Calls for private enforcement: • Bounty hunters can sue • No harm/damages required • Recovery = retail price of products sold • Attorneys recover their fees and expenses

19. State Activity • The Safe Drinking Water and Toxic Enforcement Act of 1986 • Prop 65 • How does this affect me? • California retailer • Other 49 state retailer • Solutions?

20. Thank You • Cara Welch, Ph.D. • VP, Scientific & Regulatory Affairs • Natural Products Association • cwelch@npainfo.org • (202) 204-4726