FDA WARNING_LETTER - Dr. Sam Robbins, Inc. - June 30, 2020

The FDA issued a Warning Letter to Dr. Sam Robbins regarding products sold on his websites (my4hfl.com, drsamrobbins.com, inflamepainrelief.com, alphaviril.com, healthfitnesslongevity.com), social media, and Amazon storefront. The FDA reviewed these platforms in June 2020.

The primary violation concerns "CholesLo," marketed as a dietary supplement, which FDA lab analyses found to contain lovastatin, an active ingredient in the FDA-approved drug Mevacor®. This renders CholesLo an unapproved new drug under 21 U.S.C. § 321(ff)(3)(B)(i), as lovastatin was approved as a new drug before being marketed as a dietary supplement or food. One sample contained 14.3 mg/capsule, exceeding Mevacor's maximum daily dose if taken as recommended. The FDA has issued a public warning against CholesLo.

Additionally, ten other products—AlphaViril, Blood Flow Optimizer, Blood Pressure Optimizer, Blood Sugar Optimizer, CHEATmeals, Inflame & Pain Relief, LeanOptimizer, Perfect Vitamin D & K, and ProVanax—are deemed unapproved new drugs and misbranded. This is based on claims on labels, websites, social media, and Amazon storefronts that establish their intended use for the cure, mitigation, treatment, or prevention of disease, or to affect body