Quicksilver Scientific
FDA issued a warning letter to Quicksilver Scientific (Louisville, CO) on October 13, 2021, finding that website claims for four products — Nanoemulsified Milk Thistle, Cat's Claw Elite, Nanoemulsified CoQ10, and Liposomal GABA with L-Theanine — established drug intent by referencing disease treatment, prevention, and mitigation (e.g., heart failure mortality reduction, liver protection from alcohol, antimicrobial effects). FDA determined the products are unapproved new drugs under the FD&C Act and misbranded because they lack adequate directions for use. The company was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.
Flagged claims (7)
Stress and mental strain can . . . impair sleep. Return to a state of balance with . . . GABA + L-theanine . . ..
Vitamin D [an ingredient in Cat's Claw Elite] supports immunity by increasing the activity of monocytes and macrophages, immune cells that directly fight pathogens, and by increasing the production of antimicrobial peptides . . ..
Feed Your Mitochondria with CoEnzyme Q10 . . .—breakthrough research into these tiny energy powerhouses that stud our cells has now connected them to . . . our ability to . . . directly fight pathogens and bacteria. If there is one nutrient that is essential for mitochondria, it is CoQ10.
study on CoQ10 . . . found a 44% reduction in death from heart disease in heart failure patients supplemented with CoQ10, and a 42% reduction in death from any cause.
Milk thistle [an ingredient in Nanoemulsified Milk Thistle] . . . protects liver cells from the harmful effects of alcohol . . . Supplementing with milk thistle after a particularly indulgent holiday party may ease your discomfort and help you recover faster.
Alcohol can deplete CoQ10. Supplementing with this nutrient has been found to protect the liver from oxidative stress and improve inflammation associated with fatty infiltration of the liver. It has also been shown to protect the liver from alcohol-related damage.
Monolaurin [an ingredient in Cat's Claw Elite] . . . has immune modulating properties and antimicrobial effects against a variety of bacteria and viruses.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker