FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.
Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of 301(ll), and therefore might be able to be added to food. For example, as discussed in Question #12, certain hemp seed ingredients can be legally marketed in human food. However, all food ingredients must comply with all applicable laws and regulations. For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]). Aside from the three hemp seed ingredients mentioned in Question #12, no other cannabis or cannabis-derived ingredients have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food by FDA. Food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the food additive and GRAS processes.
Questions and Answers
Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).
Right now, the only CBD treatment that has strong enough evidence to become FDA-approved is for treating childhood epilepsy, particularly the cases that typically don’t respond to anti-seizure medications. In a number of studies, pure CBD administered orally via an oil was shown to reduce the number of seizures and in some cases, stop them altogether. In 2018, the FDA gave its stamp of approval to Epidiolex, the first cannabis-derived medicine for seizures.
✘ DON’T trust labels. A 2017 study published in the journal JAMA found that of 84 CBD products researchers bought online, 43% had more CBD than indicated, 26% had less, and some even had unexpected THC.
CBD is everywhere these days: You can get it in dispensaries and drug stores or at your local bar and corner store. You can drink it, eat it, vape it, and slather it on your skin. One thing you can’t do? Get stoned on it. While CBD comes from the same plants that produce pot, it’s more about healing than about getting high.
✔ DO talk to your doctor if you’re going to try CBD. While research on drug interactions with CBD is in its infancy, we do know it has the ability to either stimulate or inhibit the enzymes that metabolize other drugs you might be taking, which could impact the effectiveness of those medications. While the doses in consumer CBD products are typically so low that the risk is likely minimal, says Wallace, it’s still a good idea to talk to your doc about any supplement you’re taking — including CBD.
But wait — is CBD even legal?
✔ DO choose products made with organic American hemp, which makes it easier to find out if the soil it was grown in has been properly tested. (Hemp is a bio-accumulator, which means it absorbs everything in the soil — including herbicides, pesticides, metals, and fungus, says Wallace.) Better yet: Buy from a state such as California or Colorado that has some sort of cannabis control in place, adds Wallace; this offers another layer of protection against buying a contaminated product.