Enforcement

Virgin Scent didn’t respond to NAD attorneys’ “repeated outreach attempts” asking for evidence supporting ad claims for Artnaturals NAD+ challenged by another NAD+ supplement marketer, Reus Research.

BRS Analytical Services in St. Louis recalled more than 75,000 cases of redness and lubricating eye drops and committed “to permanently cease production of all drugs.”

The “Simple Reform” initiative would reverse a 2017 move to ensure FDA investigators were experts in the commodity they inspected or in clinical research regulations.

National Advertising Division says XF Agencija permanently discontinued benefits and efficacy ad claims for Lunavia undecylenic acid 25% nail pen challenged by Advantice Health, marketer of Kerasal fungal nail renewal brand.

National Advertising Division, on challenge by NAD+ trailblazer Niagen Bioscience, found substantiation lacking for Cata-Kor NAD+ and NAD+ Core product content and health benefit claims and no clear and conspicuous disclosures for brand’s influencer posts.

Emma Mittelstaedt Burnham prosecuted antitrust violations in healthcare sector in her previous work at DoJ, including leading investigation into antitrust cartels in the generic pharmaceutical industry.

FDA rejects NPAs arguments for clarity on when it recognizes start of investigational new drug programs and what constitutes “substantial clinical investigations” for an IND. Clock starts after FDA met twice-extended deadline to provide answers to NPA’s questions in a 2023 petition.

Continuing work includes “for cause and certain surveillance inspections of regulated facilities” and “criminal enforcement work and certain civil investigations” as White House mulls layoffs rather than furloughs during federal government shutdown.

President posts pro-hemp video on Truth platform as FDA maintains policy that cannabis and hemp are unlawful for use in supplements and food because both types of botanicals have been approved for use as drug ingredients in the US.

Holistic Alternative Recovery Trust advocacy group for 7-OH use to help people stop using opioids offers arguments from a variety of public health and consumer advocacy groups that scheduling 7-OH “would be a disaster.”

Recent FDA warning letters hit typical problems in consumer health space such as manufacturing quality control deficiencies, but also note honey offered for eye infections and nasal spray to enhance cognitive function.

Ryze Superfoods withdraws claims National Advertising Division asks to review from its ongoing monitoring of consumer products advertising, including that coffee enhances mental acuity and provides other health benefits.