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 […]
Manufacturers selling products in California, including food and dietary supplement manufacturers, are subject to the state’s Safe Drinking Water and Toxic Enforcement Act of 1986, which is commonly referred to as Prop 65. Prop 65 was enacted as a ballot initiative, and it was intended to protect California’s drinking water sources from chemicals known to […]
Emord & Associates has published an FDA Inspection Guide to help food and dietary supplement companies avoid common pitfalls associated with FDA inspections. The guide, available for download online here, covers routine, cGMP, FSMA, and adulteration inspections. It identifies the kinds of documents FDA ordinarily can and cannot obtain lawfully. The guide provides general information […]
As previously reported here, in the prior administration, FDA had an unwritten and informal enforcement policy that 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. […]
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 […]
In response to mounting public pressure, Senator Barbara Boxer (D-CA) and Representative Peter DeFazio (D-OR) introduced companion bills in the Senate and House of Representatives requiring GMO labeling. The Genetically Engineered Food Right-to-Know Act would amend the Federal Food, Drug, and Cosmetic Act to state that a genetically engineered food or a food that contains […]
In the midst of supposed cinching of financial waist belts and hard budget choices, the FDA announced this past week that it would begin investigating the “trend” in foods that are being manufactured to include caffeine. The announcement was thereafter memorialized on the FDA’s website. This news arrives in the advent of Mars, Inc. announcing […]
Do you think you are intelligent enough to decide for yourself the relative worth of scientific findings concerning the disease treatment and risk reduction effects of nutrients and foods? The FDA thinks you are not and that it must decide such questions for you in the first instance. Indeed, the FDA bans from the grocery […]
Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.
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