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

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

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in July 2011 Industry comments filed December 4 th No official action from FDA since then Enforcement of the guidance A draft guidance does not confer rights or impose requirements – it is simply the agency’s interpretation and articulation of how it will enforce the law

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

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

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

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

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?

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

Regulatory Compliance – EMA FDA Resources Searchable database of tainted products at: ion.cfm?sd=tainted_supplements_cder RSS feed of known tainted products: med/RSSFeeds/TDS/rss.xml Ongoing investigations and testing of products Criminal actions are ongoing

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 Report Suspected Criminal Activity: Report Unlawful Sales of Medical Products on the Internet: Report Health Fraud Scams:

Congress is watching Regulatory Compliance

Agency Activity

Agency Activity – FDA FDA Budget Years of underfunding before FY 2010 FY $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

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

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?

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

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

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?

Thank You Cara Welch, Ph.D. VP, Scientific & Regulatory Affairs Natural Products Association (202)