On June 14, 2022, the Senate Health, Education, Labor and Pensions Committee voted to pass the FDA Safety and Landmark Advancements (FDASLA) Act (S.4348). While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to …
Last month, the FTC announced and posted a prepublication of its proposed changes to its guides concerning the use of endorsements in advertising (Endorsement Guides). The Endorsement Guides date back several decades. Since the publication of the original Endorsement Guides in 1975, FTC has made several …
On Monday May 9, 2022, FDA issued an “update” announcing that it had sent 11 Warning Letters to companies that distributed dietary supplements alleged to be adulterated because one or more ingredients in the companies’ products contained an illegal dietary ingredient. (Two days later, one …
As readers of this blog may recall, in March 2020, as part of the CARES Act, the FDC Act was amended to include statutory provisions that (1) reform and modernize the way over-the-counter (OTC) monograph drug products are regulated in the United States and (2) …
On February 18, 2022, the US Consumer Product Safety Commission’s (CPSC) Office of Compliance and Field Operations issued a guidance for household substances not intended for household use under the Poison Prevention Packaging Act (PPPA). No, that is not a typo. The revised immediately effective guidance …
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 …
