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FDLI:Safeguarding the Functional Food and Dietary Ingredient

Supply Chain

Comments by

Daniel S. Fabricant, Ph.D.Director, Division of Dietary Supplements

ONLDS, CFSAN

daniel.fabricant@fda.hhs.gov

September 10th, 2013

Topics

• Background• Where things stand

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Dietary Supplements• In 1 year - 3rd Decade of DSHEA• Approx. 400 recalls of spiked products since

2008 • ~33% OAI on GMPs (slightly higher VAI)• only ~50 NDINs annually• Indication and Evidence of underreporting of

AERs• Increase in Claim WLs • Evident of Systemic issues• Use of our authorities (Seizures, Injunctions,

Admin. Detention)

Harm Removal Business

• What are the major non-compliance problems in the Dietary Supplement Industry?

• How does the agency address them?

Defining the problem

Invisible Harms - are those which are difficult to discern and analyze because they tend to be under-reported or unknown

Conscious Opponents - agencies are confronted with individuals or groups of individuals who are engaged in creating a harm (i.e. tainted products)

Catastrophic harms - relatively unlikely harmful events that produce enormous levels of victimization

Character of Harms – M. Sparrow

General

• General Regulatory Paradigm– Very, very limited premarket review – No Premarket approval– No formulation standards– No product registration– No approval of claims– Manufacturer responsible for ensuring safety and compliance

• Where to find Information– Statutes (15, 21 & 42 U.S.C)– Code of Federal Regulations (Title 21)– Guidances

What is a Functional Food?

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“Energy” Products• Many new products are being marketed• Issue: Whether a product is a DS or a

beverage (i.e., a conventional food)• Developing guidance to address the issue

(final guidance on distinguishing liquid dietary supplements from beverages)

9http://www.nytimes.com/2013/03/20/business/in-a-new-aisle-energy-drinks-sidestep-rules.html?pagewanted=all&_r=2&&pagewanted=print

“Represented for use as a conventional food”

• Not the same as prior definition of “simulate conventional food” (i.e., conventional food form)

• Generally, physical attributes of a food will not be primary determinant

“Represented for use as a conventional food”

• Think “how is it used” or “what is it a substitute for”– called a snack or uses another

common or usual food name– uses a standardized food name– uses label representations/pictures

that suggest conventional food uses–Packaging and serving sizes

Str/Fn Statements

• Statutory authority for dietary supplements to make Str/Fn statements

• Conventional foods aren’t authorized by statute (no guidance on substantiation)

• Deference to Nutrilab v. Schweiker– Taste– Aroma– Nutritive Value

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Disease Definition• 21 CFR 101.93(g)(1) “[D]amage to an organ, part, structure, of

system of the body such that it does not function properly…or a state of health leading to such dysfunctioning…”

http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/ucm107336.htm; January 6, 2000 Federal Register; 65 FR 999

Substantiation of Section 403(r)(6) Dietary Supplement Claims

• Jan. 5, 2009 Federal Register; 74 FR 304• http://www.fda.gov/Food/

GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm073200.htm

• Describe the nature of the claim and the amount, type, and quality of evidence

Inflammation – Healthy Response

What is the substantiation standard?

• “Competent and reliable scientific evidence”– “tests, analyses, research, studies, or

other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results”

4 principal issues guide whether a claim is substantiated

• Meaning of the claim being made• Relationship of the evidence to the

claim• Quality of the evidence• Totality of the evidence

Pitfalls

• Over-reliance on anecdotal/historical• Fail to consider negative evidence• Mistake number of publications as

direct indicator of totality of evidence• Over-reliance on disease treatment

studies• Not considering implied

message/claims

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cGMPs• FDA is finding that the basic tenets of

cGMPs, and manufacturing in general, are not being adhered to, or in many instances are completely absent

• This is concerning as there isn’t much help that the agency can offer to assist with compliance in these instances

• Solutions

21 CFR 111 Inspections*

• FY 2008 7• FY 2009 34• FY 2010 84• FY 2011 175• FY 2012 341

21 CFR 111 Inspections*

• FY 2012 Inspection Classification by field:– No Action Indicated: 92 27%– Voluntary Action Indicated: 119

35%– Official Action Indicated: 116 34%

– No decision 14 4%

– Total: 34122

*-accounting isn’t final or QC-ed

FSMA

• PC regulations for ingredients previously left uncovered by 21 CFR Part 111

• If in compliance with Part 111 and requirements of Sec. 761, exempt from PC regs.

• Are cGMP problems an indication of similar problems with DI’s?

• How do manufacturers “broaden” their quality systems? 23

Closing

• Some disparate playing ground?• How do firms operate with “multiple

personalities”?• FSMA implementation, resources?

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