On November 25, 2019, FDA posted 15 warning letters from the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Drug Evaluation and Research (CDER) stating that certain products containing CBD were illegally labeled as dietary supplements and in many cases were also: unapproved new drugs, misbranded drugs, adulterated human foods, and in some cases were also unapproved new animal drugs and adulterated animal foods.
FDA explains its position about its regulation of CBD containing products in the letters which is also included on this webpage.
FDA has stated that CBD-containing products cannot be sold as 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. 321(ff). 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. 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. 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. 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.
As FDA has previously warned, it appears to be focusing on products that are advertised (by label and/or on websites) “for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or [are] intended to affect the structure or any function of the body” of a human or animal. FDA considers these products to be unapproved new drugs or unapproved new animal drugs pursuant to section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 321(g)(1), stating, that the products intended for use by people:
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 FD&C Act, 21 U.S.C. 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
There are similar allegations for products intended for use in animals.
FDA considers the human products to be misbranded drugs, pursuant to section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), which requires labeling that includes adequate directions for use of drugs labeling of drugs “under which a layperson can use a drug safely and for the purposes for which it is intended.” (See also, 21 CFR 201.5.).
FDA also warns against the use human and animal products as human or animal food. FDA has concluded that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll) prohibits the introduction into interstate commerce any food to which CBD has been added and no exception exists since CBD was not marketed in food before relevant drugs approvals. FDA also concludes that CBD does not qualify as a food additive or GRAS and has not received premarket approvals.
FDA invites those warned to provide evidence that would call into question FDA’s positions on these topics.
Until those positions change, and/or FDA is successfully legally challenged, CBD products should be carefully labeled and advertised to avoid warnings or worse.