Transcript Regulatory Compliance

Dietary Supplements:
What Every Retailer Needs To
Know
Cara Welch, Ph.D.
Vice President, Scientific & Regulatory Affairs
NPA Marketplace
June 15, 2012
What Every Retailer Needs To Know
• Regulatory compliance
•
•
•
•
NDI
GMP
AER
EMA
• Agency Activity
• FDA
• FTC
• GAO
• State Activity
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• A draft guidance does not confer rights or impose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 NonPrescription 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/sdNavigat
ion.cfm?sd=tainted_supplements_cder
• RSS feed of known tainted products:
http://www.fda.gov/AboutFDA/ContactFDA/StayInfor
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 email: [email protected]
• 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
Regulatory Compliance
Congress is watching
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
[email protected]
(202) 204-4726