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 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• Enforcement of the guidance• A draft guidance does not confer rights or impose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

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:

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

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

Congress is watching

Regulatory Compliance

Agency Activity

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

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

cwelch@npainfo.org

(202) 204-4726