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D.C. Circuit: FTC’s Two RCT Requirement Violates the First Amendment

On January 30, 2015, the Circuit Court of Appeals for the District of Columbia entered its decision in the case of POM Wonderful, LLC (“POM”) v. Federal Trade Commission (“FTC”), No. 13-1060.  In that decision, the D.C. Circuit upheld the FTC’s findings that POM violated the Federal Trade Commission Act (“FTCA”) by misleading consumers through […]

FDA’s Expansion of IND Regulations Impose Yet Another Major Regulatory Hurdle for Medical Food Companies

On September 10, 2013, FDA published a new guidance document restricting the scope of research permitted for dietary supplements and medical foods without first submitting an Investigational New Drug application (“IND”).  The document titled, “Guidance for Clinical Investigators, Sponsors, and IRBs:  Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted […]

FDA’s Qualified Diabetes Health Claims are Unreasonable

As reported in an article from FoodNavigator-USA.com, the Food and Drug Administration (“FDA”) responded to ConAgra Foods Inc.’s petition for a qualified health claim for whole grains and reduced risk of diabetes mellitus type 2. ConAgra’s petition proposed that the following two model health claims be allowed on the labels or in the labeling of […]

Does FDA’s Interpretation of “Nutrient Deficiency Diseases” in the Draft Medical Foods Guidance Create Room for Dietary Supplement Disease Claims?

The FDA’s revised Medical Food guidance turned heads last week when the agency declared that certain diseases related to nutrient deficiencies were off limits to medical foods.  We previously reported on that draft guidance document here.  By eliminating an entire class of diseases from the ambit of medical foods, the FDA left many existing products […]

Commercialization of Qualified Health Claims

Qualified Health Claims permit nutrient-disease risk reduction claims to be made for dietary supplements without fear of FDA or FTC enforcement.  The FDA allows such claims in reliance on its “enforcement discretion,” following submission of a health claim petition.  The FDA’s “enforcement discretion” is a euphemism because the agency is constitutionally barred by precedent in […]

How FDA and EFSA Prior Restraints Defeat Government Objectives and Foster Fraud and Deception

By Jonathan W. Emord FDA and EFSA censorship regimes are based on an anti-fraud or anti-deception rationale.  In short, FDA presumes that deprivation of all information not officially sanctioned that expressly or impliedly links a nutrient with a disease helps prevent consumers from being misled.  Likewise, EFSA presumes that deprivation of all information not officially […]

FTC’s POM Wonderful Decision Will Dumb Down the Marketplace

In a recent opinion, the Federal Trade Commission (“FTC”) affirmed in part and reversed in part an Administrative Law Judge’s decision that Pom Wonderful deceptively advertised its products.  According to the Commission, Pom Wonderful did not have sufficient substantiation to support claims the FTC deemed implied that POM’s products could treat, prevent, or reduce the […]

DSHEA Needed for Animal Supplements

Walk into any mainstream pet store and it is evident that the pet supplement industry is booming.  Pet store shelves are packed with animal counterparts to human supplements, such as joint health supplements for cats and dogs.  Because of the prevalence of such products, one would never guess that FDA does not recognize dietary supplements […]

The FDA’s and FTC’s Reliance On Randomized Clinical Trials For Dietary Ingredients Is Impractical and Unethical

The FDA and FTC intend to require randomized clinical trials (RCTs) in support of promotional claims for dietary supplements and dietary ingredients.  That much is clear.  The FTC took that position in the recent POM Wonderful case, and the FDA memorialized that position in its Evidence Based Review System (EBRS).  In practice, the FDA will […]

Current FDA Appears Not to Follow FDA’s Informal Two-Click Policy

During the Bush Administration, FDA had an unwritten and informal enforcement policy that allowed a website selling dietary supplements to link to scientific literature discussing nutrients in those supplements and diseases, provided that the page containing the scientific literature was at least “two clicks” away from product pages in question.  That Bush era policy appears […]


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Telephone: (202) 466-6937
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