Neptune's Fix Dietary Supplements are being recalled because they contain Tianeptine, which is not FDA-approved for any medical use. The presence of this ingredient makes the products unapproved drugs for which safety and efficacy have not been established. Life-threatening side effects can occur. No adverse events have been reported to the company to date. The recalling firm is Neptune's Resources, LLC of Kansas City, Missouri. Risk statement: The FDA has advised that there is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger with the consumption of these products. In addition, individuals could unintentionally overdose and experience serious and potentially life-threatening risks … [Read more...]
Supplement Makers Warned by FDA About Tianeptine in Dietary Supplements
The FDA is warning two companies for illegal marketing of dietary supplements that contain tianeptine. One of the warning letters was sent to MA Labs LLC, for Vicaine, and the other was sent to Jack B Goods Outlet Store, for Tianaa Red, Tianaa White, and Tianaa Green. Tianeptine has caused serious adverse events, according to that agency. Tianeptine is illegally used to treat opioid use disorder, and pain and anxiety. It is not a vitamin, mineral, herb, among acid dietary substance; or a concentrate, metabolite, constituent, extract, or combination of those substances. Dr. Scott Gottlieb, FDA Commissioner, said in a statement, "The bottom line is this: we’ve seen growing instances where profiteers are pushing potentially dangerous compounds – often with unproven drug claims and … [Read more...]
