When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.
Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.
Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).
There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.
A. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.
It’s been over a year since the 2018 Farm Bill legalized the commerce of hemp and CBD. Yet, CBD is still not regulated as a dietary supplement by the FDA.
CBD is the new kid on the block
It’s hard to say as there are many potential outcomes. The FDA could declare that CBD is not permitted for dietary supplements, food, or beverages. This formal opinion would be the worst-case scenario. But, even then, their final determination would not be able to stop the train that is the CBD industry. Stephen Hahn, the FDA commissioner, said that any attempt to shut down the CBD industry would be “a fool’s errand.”
So what’s next for CBD companies?
In the meantime, CBD business leaders can take action immediately. It’s up to every company to show that their products are safe and trustworthy, and the U.S. Hemp Authority certification program serves this very purpose. This certification is the industry’s initiative to provide high standards, best practices, and self-regulation to companies, giving consumers and retailers confidence in hemp and CBD products. Hemp companies can and should earn this certificate to demonstrate to both consumers and regulators that their products meet federal and state standards for manufacturing, safety, labeling, and more.
In recent years, the availability of CBD-infused products (and/or products claiming to contain CBD) has skyrocketed, causing concern among health officials as well as drug reform advocates and retailers’ groups – not because CBD itself (a.k.a. cannabidiol) poses a health risk, but because consumers have no way of knowing what’s actually in those products so long as they remain unregulated.
“The FDA has pledged to give consumers the information they need to make smart choices about CBD products – but estimates that it could take up to five years to establish federal CBD regulations,” GMA president and CEO Geoff Freeman wrote in an op-ed for The Hill. “That timeline is unacceptable for a booming market.”
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“By contrast,” NORML wrote, “CBD-infused products sold at state-licensed [cannabis] dispensaries are typically subject to state-specific regulations and lab testing protocols.”
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Overall, the survey data may be a further indication that Americans need greater education around cannabis products such as CBD, as well as government regulation.