On December 7, 2021, the Natural Products Association (NPA) filed a complaint seeking an injunction based on FDA’s actions excluding N-acetyl-L-cysteine (NAC) from the definition of dietary supplement. At issue is FDA’s interpretation of the “exclusionary clause,” section 201(ff)(3)(B)(ii) of the FDC Act, which among …
On December 6, 2021, FDA published a proposed rule to reorganize and amend the highly criticized agricultural water provisions of the Produce Safety Rule (PSR). This marks the Agency’s latest effort to balance public health protections with covered farms’ persistent concerns that the current provisions …
On October 5, 2021, California signed SB 343 “Truth in Labeling for Recyclable Materials” into law, amending the state’s law relating to environmental advertising. The result is a California law that is significantly more narrow than the Federal Trade Commission Guides for the Use of Environmental …
Last fall, when AMG Capital Management, LLC v. FTC was pending before the Supreme Court, former Federal Trade Commission (FTC) Commissioner Rohit Chopra (now Director of the Consumer Financial Protection Bureau) and Samuel Levine (recently appointed Director of the FTC’s Bureau of Consumer Protection) coauthored …
As readers of our blog know, FDA and the Food Safety Inspection Service of the USDA (FSIS) agreed to jointly oversee the production of human food products using animal cell culture technology. Under the Memorandum of Understanding signed in March 2019, FDA will oversee cell …
On July 1, 2021, the Federal Trade Commission (FTC) announced the availability of the pre-publication of the final rule on “Made in USA” (MUSA) claims in the Federal Register. The final rule was published on July 14, 2021. We previously reported on events that resulted …
On Friday April 23, President Biden signed into law the Food Allergy Safety, Treatment, Education and Research (FASTER) Act that designates sesame as the ninth major food allergen. The first eight major allergens – peanuts, tree nuts, fish, Crustacean shellfish, soy, milk, eggs, and wheat …
For more than five years now, FDA has pursued action regarding cannabidiol (CBD) products. FDA has taken the position that CBD is not a lawful food or dietary ingredient. But despite the agency’s strong statement about CBD, FDA has acted, primarily through Warning Letters (WLs), …
Welcome to the latest edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Food & Beverage Transition: As of this writing, Janet Woodcock is Acting Commissioner of Food …
Welcome to the latest edition of HPM’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. It’s been quite a January, hasn’t it? Food & Beverage Transition: As of this writing, Janet Woodcock is Acting …
On January 8, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced proposed amendments to Proposition 65 warning regulations that would limit use of the short-form version of the safe harbor warning. Proposition 65, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, mandates …
That did not take long. As we reported at the end of 2020, FDA announced in a notice the User Fees for OTC Monograph Drug Manufacturers and other fees. Then on Jan. 6, 2021, HHS announced that the fees are off the table. What happened? Well, …
Welcome to the final 2020 edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Happy New Year, everyone. Food & Beverage Make Every Bite Count: USDA and HHS …
As we previously reported, in March, as part of the CARES Act, OTC monograph reform was signed into law. This law amended the FDC Act to include, among other things, an OTC monograph drug user fee program, under which FDA is authorized to assess and …
Welcome to the latest edition of Hyman, Phelps & McNamara, P.C.’s (“HP&M”) monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Tooting our own Horn: HP&M has been named the “Law Firm of the Year” …
