Christopher W. Shade, PhD
Quicksilver Scientific
1960 Cherry Street
Louisville , CO 80027
United StatesFEI 3016181636Issued Oct 13, 2021Office of Human and Animal Food Operations Division West 4
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016181636.
Violations1
Issue DateOct 13, 2021
Product TypeDrugs
StatusClosed
Closeout LetterOct 3, 2024
Letter Details
Firm
Quicksilver Scientific
Location
Christopher W. Shade, PhD
Quicksilver Scientific
1960 Cherry Street
Louisville , CO 80027
United States
FEI Number
3016181636
Country
United States
Issue Date
October 13, 2021
Issuing Office
Office of Human and Animal Food Operations Division West 4
Product Type
Drugs
Status
Closed
Closeout Letter
October 03, 2024
Summary
Quicksilver Scientific was cited for marketing four products (Nanoemulsified Milk Thistle, Cat's Claw Elite, Nanoemulsified CoQ10, and Liposomal GABA with L Theanine) as drugs without FDA approval by making disease claims on their website that established the products were intended to cure, mitigate, treat, or prevent disease. Specific violations included claims that CoQ10 reduced death from heart disease and fatty liver disease, and that the ingredient could fight pathogens and bacteria—statements that positioned the products as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. The FDA's review of the company's website in June and September 2021 documented these drug claims, which violated interstate commerce regulations by introducing or delivering the products for such medical uses without proper FDA authorization.
Quicksilver Scientific FDA Warning Letter, October 13, 2021