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WARNING LETTER

Quicksilver Scientific MARCS-CMS 612476 —

Delivery Method:
VIA UPS
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Christopher W. Shade, PhD
Quicksilver Scientific

1960 Cherry Street
Louisville, CO 80027
United States

Issuing Office:
Office of Human and Animal Food Operations Division West 4

United States

October 13, 2021

WARNING LETTER


Ref: CMS Case #612476

Dear Dr. Shade:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the internet address www.quicksilverscientific.com in June and September 2021 and has determined that you take orders there for the products Nanoemulsified Milk Thistle, Cat’s Claw Elite, Nanoemulsified CoQ10 and Liposomal GABA with L Theanine. The claims on your website establish that the products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Nanoemulsified CoQ10

QuickSilverScientific.com/Blog

• Eight Ways to a Healthy Heart, (which references the ingredient Coenzyme Q10 contained in the product Nanoemulsified 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.”

• Holiday Hangovers: After All That Partying, Which Nutrients Do You Need the Most (which references the ingredient Coenzyme Q10 contained in the product Nanoemulsified CoQ10)

o “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.”

o “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.”

Cat’s Claw Elite

QuickSilverScientific.com/Blog

• 6 Tips for having a Healthy, Happy Holiday Season

o “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 . . ..”

o “Monolaurin [an ingredient in Cat’s Claw Elite] . . . has immune modulating properties and antimicrobial effects against a variety of bacteria and viruses.”

Nanoemulsified Milk Thistle

QuickSilverScientific.com/Blog

• 6 Tips for having a Healthy, Happy Holiday Season

o “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.”

Liposomal GABA with L-Theanine product web page:

• “Stress and mental strain can . . . impair sleep. Return to a state of balance with . . . GABA + L-theanine . . ..”

Your products Nanoemulsified Milk Thistle, Cat’s Claw Elite, Nanoemulsified CoQ10 and Liposomal GABA with L Theanine are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your Nanoemulsified Milk Thistle, Cat’s Claw Elite, Nanoemulsified CoQ10 and Liposomal GABA with L Theanine products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, your Nanoemulsified Milk Thistle, Cat’s Claw Elite, Nanoemulsified CoQ10 and Liposomal GABA with L Theanine products fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.

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. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. You may reach Ms. Potter at (303) 236-3094 if you have any questions about this matter.

Sincerely,
/S/

E. Mark Harris
Denver District Director & Program Division Director
Office of Human and Animal Food Operations Division West 4

 
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