warning letter
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 ...
Amazon Receives FDA Warning Letter Over Tainted “Supplement” Products
On Dec. 20, the e-commerce platform Amazon received a warning letter from the U.S. Food and Drug Administration (FDA) regarding the distribution of products in violation of the Federal Food, Drug and Cosmetic Act. An FDA investigation revealed that various products labeled as “energy-enhancing supplements” or “dietary supplements” on Amazon contain undisclosed and potentially dangerous ...
Homeopathic Companies Suspend Marketing of Eye Care Products After Receiving FDA Warning Letters
In September, the U.S. Food and Drug Administration (FDA) sent warning letters to eight companies, including six homeopathic product manufacturers, for “manufacturing or marketing ophthalmic drug products in violation of federal law.” According to FDA, the letters are part of an ongoing effort to crack down on ophthalmic products that are illegally marketed to treat ...
CRN Dismisses FDA Response on N-acetyl-cysteine (NAC)
The Council for Responsible Nutrition (CRN) on March 31 denounced FDA’s decision regarding the legal status of n-acetyl-cysteine (NAC) as a dietary ingredient. “CRN is extremely disappointed and unconvinced by FDA’s response today that it has chosen to deny CRN’s citizen’s petition while holding out the possibility that it may open a rulemaking specific to NAC instead,” ...
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