When legislators signed the 2018 Farm Bill into law in December 2018, it included provisions from the Hemp Farming Act of 2018 that removed industrial hemp—defined as Cannabis sativa bred to have less than 0.3 percent of the psychoactive cannabinoid tetrahydrocannabinol (THC)—from the list of Schedule I controlled substances, thereby making it a legal agricultural commodity. This development immediately catalyzed efforts to start using hemp-derived cannabidiol (CBD), a non-psychoactive cannabinoid with multiple promising health benefits, in foods and beverages nationwide.
However, the Farm Bill explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act. So while food and beverage products containing CBD have hit the market with unprecedented force since the Farm Bill’s passage, these products remain adulterated in FDA’s view and are prohibited from entering interstate commerce. FDA’s reluctance to approve cannabis-derived ingredients for use in foods and beverages essentially boils down to consumer safety.
In order to help bring the benefits of CBD and other non-psychoactive cannabinoids to a wider, national audience unencumbered by federal restriction, the industry needs to provide data assuring the ingredients’ safety.
To that end, this past June a group of seven CBD companies—Boulder Botanicals & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway—announced a new research project with ValidCare, clinical research outsourcing company serving the consumer packaged goods and life sciences industries. The project will center on conducting observational research to evaluate the impact of daily CBD use (both full-spectrum, hemp-derived CBD and CBD isolate) on the liver function of healthy adults.
Once the safety of CBD has a larger body of evidence behind it, FDA’s long-established generally recognized as safe (GRAS) ingredient approval process will likely form the basis for using cannabis-derived ingredients in foods and beverages.
Under sections 201(s) and 409 of the federal Food, Drug, and Cosmetic (FD&C) Act, any substance that is intentionally added to food is defined as a food additive subject to premarket review and approval by FDA unless the substance is generally recognized, among qualified experts, as safe under the conditions of its intended use.
General recognition of the ingredient’s safety through scientific procedures is based upon the application of generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods.
A substance that will be added to food is subject to premarket approval by FDA unless it is generally recognized, among qualified experts, to be safe under the conditions of its intended use. FDA has issued a GRAS final rule (81 FR 54960) that formalized a notification procedure. A company may notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use (21 CFR 170 Subpart E outlines how to notify FDA of a GRAS notice).
In general, FDA will respond to a GRAS notice in one of two ways:
- The agency does not question the basis for the notifier’s GRAS conclusion
- The agency concludes that the notice does not provide a sufficient basis for a GRAS conclusion, usually because the notice does not include appropriate data and information, or because the available data and information raise questions about the safety of the notified substance
FDA maintains a database of GRAS Notice Inventory entries, including the agency’s response to those notices (from 1998 to present).
The GRAS approval process seems like a logical course of action for FDA approval of non-psychoactive cannabinoids for use in foods and beverages. This notion is supported by the fact that FDA has already permitted GRAS designation for ingredients derived from hemp seed.
In December 2018, FDA completed its evaluation of three GRAS notices for food ingredients derived from hemp seed. FDA noted that it had “no question” about the notifier’s conclusion that hulled hemp seed, hemp seed protein powder, and hemp seed oil are GRAS under their intended conditions of use. FDA also notes—without objection—that these ingredients may contain trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. The intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to a wide range of foods and beverages.
As the industry works to establish a strong enough body of evidence documenting the safety of CBD and other non-psychoactive cannabis-derived ingredients, we expect FDA to finally begin taking the next requisite steps toward enabling an unencumbered CBD-infused food and beverage market.