Anabolic Laboratories Inc – FDA Warning Letter, Aug 31, 2022
On November 14, 2022, the FDA issued a Warning Letter to Anabolic Labs (CMS # 636308) after reviewing their website, anaboliclabs.com, in August 2022. The FDA determined that Anabolic Labs sells CoQ10 Ubiquinol Prime and Policosanol Microtabs with claims establishing them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)].
Specific website claims indicate the products are intended for disease cure, mitigation, treatment, or prevention. Since these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)]. Introducing new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].
Furthermore, CoQ10 Ubiquinol Prime is deemed misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]
ID · 6ab36647-1493-4cf5-8913-057b9eb554f7
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