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Three Significant Supplement 1st Amendment Suits filed versus FDA – Part I

Supplement lawyer Jonathan Emord has filed three important suits this summer challenging FDA administrative action on first amendment grounds.  The suits were all filed on behalf of long-time Emord clients Durk Pearson, Sandy Shaw, the Alliance for Natural Health, and the Coalition to End FDA and FTC Censorship.
The complaints in all three cases were filed [...]

FDA stares down supplement seller based in Utah

After an FDA warning letter told True Renewal to either register its products with the agency or change claims on its Web sites, the supplement maker has altered product descriptions. The FDA targeted five products, saying the Web sites claimed the items could be used to cure, treat or prevent disease.
Product descriptions on the Web [...]

Better Business Bureau Issues Acai-berry Warning

The Better Business Bureau has issued a nationwide warning cautioning consumers to be suspicious of online ads relying on celebrity endorsements to sell acai berry-related weight loss products.
The acai berry has been credited by supplement companies with fighting cancer and other diseases.  The acai berry comes from the acai palm.
According to Steve Cox, BBB spokesperson, [...]

Adverse Event Reporting (AER) Label Compliance

Although Section 403(y) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 343(y), does not require a dietary supplement label to include anything other than a domestic address or phone number for the responsible person, the FDA recommends that the label also bear a clear, prominent statement informing consumers that [...]

AHPA Seeks FDA Clarification on OTC/Supplement Combos

The American Herbal Products Association (AHPA) has requested that FDA clarify its policy on products combining over-the-counter drugs and dietary supplement ingredients. To read the letter from AHPA to FDA, click here.
According to this article in Natural Products Insider, AHPA sent the inquiry following the launch of an “analgesic phytosterol supplement”, Bayer Aspirin with [...]

Dietary Supplement Regulatory Consultants launch NutriCompliance

Your editor, dietary supplement regulatory attorney Joel Rothman, and seasoned supplement industry regulatory consultant Vincent Annunziata, in cooperation with the law firm of Seiden, Alder, Matthewman & Bloch, P.A., have announced the formation of a new FDA regulatory consultancy for small to medium size dietary supplement companies, Nutritional Supplement Compliance Solutions, LLC and the launch [...]