U.S. Food and Drug Administration (FDA)
FDA and DOJ Seize 7-OH Products in Missouri
In December 2025, the U.S Food and Drug Administration (FDA) and the U.S. Department of Justice (DOJ) seized approximately 73,000 units of 7-hydroxymitragynine (7-OH) products—valued at about $1 million—from three firms in Missouri. The seizure focused on foods and dietary supplements products—including liquid shots and tablets—that contain 7-OH as an ingredient. Concentrated 7-OH has been ...
FDA Issues Letter on DSHEA Disclaimer Amendment, Industry Responds
On Dec. 11, the U.S. Food and Drug Administration (FDA) published a letter to the dietary supplement industry regarding the agency’s labeling regulations that govern the placement of the disclaimer on dietary supplements labels under the Federal Food, Drug, and Cosmetic Act (FD&C) and Dietary Supplement Health and Education Act of 1994 (DSHEA). The agency ...
FDA Updates Warnings on “Supplements” Containing Yellow Oleander
On Nov. 3, The U.S. Food and Drug Administration (FDA) completed analytical testing of additional “supplement” products that tested positive for toxic yellow oleander. The analysis determined that certain products labeled as tejocote (Crataegus mexicana) root or Brazil seed were adulterated because they contained yellow oleander (Thevetia peruviana) instead of the labeled ingredients. Yellow oleander ...
Hi-Tech Pharmaceuticals and CEO Convicted of $4.7 Million Wire Fraud Scheme
Dietary supplement company Hi-Tech Pharmaceuticals, Inc. and its CEO, Jared Wheat, were convicted by a federal jury of wire fraud after “fabricating documents to deceive customers into believing that the company was certified as compliant with industry manufacturing standards.” In 2007, the U.S. Food and Drug Administration (FDA) issued new mandatory guidelines on sanitary, hygienic ...
Industry Responds to Consumer Reports’ Protein Powder Testing Article
On Oct. 14, Consumer Reports (CR) published an article stating that testing of 23 protein powders and ready-to-drink shakes revealed high levels of toxic heavy metals and that two-thirds of the products contained more lead in a single serving than what its experts say is safe to consume in a day—some by more than 10 ...
FDA Declares NMN Lawful in Dietary Supplements, Industry Reacts
The U.S. Food and Drug Administration (FDA) has reversed course and confirmed that Beta (β) Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements. Responding to citizen petitions filed by the Natural Products Association (NPA), Council for Responsible Nutrition (CRN), and the Alliance for Natural Health (ANH), the FDA revised its interpretation of a ...
NPA Urges IRS to Include Supplements as Qualified Medical Expenses
The Natural Products Association (NPA) urged the Internal Revenue Service (IRS) to modernize IRS Publication 502 to expand “qualified medical expenses” to include nutritional and dietary supplements that carry U.S. Food and Drug Administration (FDA)-authorized health claims or structure-function claims. This update would allow consumers to use their Health Savings Accounts (HSAs), Flexible Spending Accounts ...
Florida Attorney General Files Emergency Rule on 7-OH Products
On Aug. 13, Florida Attorney General James Uthmeier filed an emergency rule to classify isolated and/or concentrated 7-hydroxymitragynine (7-OH) products as a Schedule I controlled substance in Florida. The rule takes effect immediately and makes it illegal to sell, possess or distribute any isolated form of 7-OH in the state. The announcement comes a ...
FDA Takes Steps to Restrict 7-OH Opioid Products
On July 29, the U.S. Food and Drug Administration (FDA) took “bold steps” to protect American consumers from dangerous illegal opioids. The agency recommended a scheduling action to control certain 7-hydroxymitragyine (7-OH) products under the Controlled Substances Act. According to FDA, 7-OH is increasingly recognized for numerous health and safety issues because of its ability ...
FDA Approves Natural Gardenia Blue Color Additive
On July 14, the U.S. Food and Drug Administration (FDA) announced it granted a color additive petition for the use of gardenia blue in various foods. It is the fourth natural color approved by the FDA after approving three other natural color additives in May 2025. According to FDA, gardenia (or genipin) blue is derived ...
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