This letter notifies you of our concerns and provides you an opportunity to address them. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act. 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. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. 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. Prescription drugs, as defined in section 503(b)(1)(A) of the Act, can only be used safely at the direction, and under the supervision, of a licensed practitioner. “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). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.Ī drug is misbranded under section 502(f)(1) of the Act if the drug fails to bear adequate directions for its intended use(s). 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. 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. Liposomal GABA with L-Theanine product web page: Supplementing with milk thistle after a particularly indulgent holiday party may ease your discomfort and help you recover faster.” protects liver cells from the harmful effects of alcohol. has immune modulating properties and antimicrobial effects against a variety of bacteria and viruses.” O “Vitamin D supports immunity by increasing the activity of monocytes and macrophages, immune cells that directly fight pathogens, and by increasing the production of antimicrobial peptides.
As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
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) because they are intended for use in the cure, mitigation, treatment, or prevention of disease. This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the internet address 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. Issuing Office: Office of Human and Animal Food Operations Division West 4
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