FDA WARNING_LETTER - Synaptent, LLC - October 31, 2021

The FDA issued a Warning Letter to Liftmode.com after reviewing their website from August to October 2021. The FDA determined that products sold on the website, including Phenibut FAA, Phenibut HCl, Baicalein, Berberine HCL, Curcumin, Fisetin, Lion’s Mane, Milk Thistle, Quercetin, Boswellia Serrata Extract, Dihydromyricetin (DHM), Honokiol, Magnolia Bark Extract, Tongkat Ali Extract, L-Tetrahydropalmatine (L-THP), Tribulus Terrestris Extract, and Garlic Extract, are unapproved new drugs. This is based on website claims indicating their intended use for disease cure, mitigation, treatment, or prevention, or to affect body structure/function, violating section 201(g)(1) of the Act [21 U.S.C. §321(g)(1)].

Specific products, including Berberine HCL, Magnolia Bark Extract, Tongkat Ali Extract, Tribulus Terrestris Extract, and Garlic Extract, are also cited as misbranded drugs under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision.

Furthermore, Baicalin, Curcumin, DHM, and Milk