QUICKSILVER SCIENTIFIC, INC – FDA Warning Letter, Oct 13, 2021

The FDA issued a Warning Letter to Dr. Shade of Quicksilver Scientific, Inc. on October 13, 2021, following a review of their website, www.quicksilverscientific.com, in June and September 2021. The FDA determined that the company sells products, including Nanoemulsified Milk Thistle, Cat’s Claw Elite, Nanoemulsified CoQ10, and Liposomal GABA with L Theanine, with claims that establish them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The violations stem from website claims indicating the products are intended for the cure, mitigation, treatment, or prevention of disease. Examples include claims for Nanoemulsified CoQ10 regarding heart disease and liver protection from alcohol, Cat’s Claw Elite for immune support and antimicrobial effects, Nanoemulsified Milk Thistle for liver protection and recovery from alcohol, and Liposomal GABA with L-Theanine for stress and sleep impairment.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their intended uses and lack prior FDA approval. Introducing or delivering such products into interstate commerce without approval violates sections 301(d) and 505(a