![]() On the homepage, under the heading “Discover NOW what Red Pill product is right for you": “There are numerous anecdotal accounts of CBD doing great things including curing cancer, stopping seizures, chronic pain, treating obesity…the list goes on and on.”.On the webpage titled “Blog” under the heading “Cure for Cancer”: 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.Įxamples of claims observed on your websites and that establish the intended use of your products as drugs include, but may not be limited to, the following: Cream,” “Pain Relief CBD Bath Bombs,” “Gold,” “Balance,” “Pain Freeze Cream,” “Fit,” “Crave,” “Romance for Men,” “Romance for Women,” “Sleep,” “Relax,” “Focus,” and “Relief” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary substance definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence bearing on this issue.īased on our review of your websites, your “ Formula 1,” “Red Pill Nano I.P.R. ![]() There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized however, based on available evidence, FDA has concluded that this is not the case for CBD. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. 321(ff)(3)(B)(i) and (ii).Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. ![]() However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. For example, your “Formula 1 – Full Spectrum CBD,” “Gold CBD,” and “Crave CBD” products contain a Supplement Facts panel. It appears that you intend to market at least some of your CBD products as dietary supplements. You can find specific information about how FDA regulates CBD at. You can find the FD&C Act and FDA regulations through links on FDA’s home page at. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. FDA has also determined that your “Red Pill CBD Pet” product is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. ![]() Cream,” “Pain Relief CBD Bath Bombs,” “Gold,” “Balance,” “Pain Freeze Cream,” “Fit,” “Crave,” “Romance for Men,” “Romance for Women,” “Sleep,” “Relax,” “Focus,” and “Relief” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). The claims on your websites and social media websites establish that your “Formula 1,” “Red Pill Nano I.P.R. We have also reviewed your social media websites at and these websites direct consumers to your website, to purchase your products. Cream,” “Pain Relief CBD Bath Bombs,” “Gold,” “Balance,” “Pain Freeze Cream,” “Fit,” “Crave,” “Romance for Men,” “Romance for Women,” “Sleep,” “Relax,” “Focus,” “Relief,” and “Pet,” all of which you promote as products containing cannabidiol (CBD). Food and Drug Administration (FDA) reviewed your websites at and in September and October 2019 and has determined that you take orders there for the products “Red Pill Formula 1,” “Red Pill Nano I.P.R. This letter is to advise you that the U.S. Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
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