With the popularity of CBD and CBD products skyrocketing in recent years, including the Agriculture Improvement Act of 2018 (2018 Farm Bill), there is a rapidly increasing demand for CBD and CBD food products. The 2018 Farm Bill explicitly preserved the US Food and Drug Administration’s (FDA’s) responsibility and right to regulate all products containing cannabis or products derived from cannabis under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This means that any product containing CBD or hemp is regulated under the same authorities and requirements as any other FDA-regulated product. With the increasing demand for CBD products, it is important to have a basic understanding of CBD and the requirements as a food manufacturer laid out by the FDA.
Cannabidiol (CBD) is a naturally occurring chemical compound found in the Cannabis Sativa plant. A common strain of the Cannabis Sativa plant is industrial hemp, which is what we get our CBD and hemp from. Cannabis Sativa is also a source for tetrahydrocannabinol (THC). THC is the psychoactive ingredient from the cannabis plant that produces the commonly known “high.” CBD contains less than .3% THC on a dry weight basis and will not produce any sort of “high”. CBD was defined as legal as part of the 2018 Farm Bill which explicitly removed industrial hemp from the Drug Enforcement Administration’s (DEA’s) controlled substances list and allowed farmers to grow industrial hemp under specific requirements.
On April 2nd, 2019 FDA Commissioner Scott Gottlieb, M.D. announced that the FDA and the Federal Trade Commission had issued warning letters to three different companies in regards to unsubstantiated health claim benefits that could come from the use of CBD. The FDA has specific rules for what health claims you can make when it comes to food products and ingredients. CBD is currently being sold in many different product types (oil drops, capsules, syrups, teas and topical lotions and cream), all of which the FDA is responsible of regulating health claims for. CBD is not currently allowed to be advertised as being able to prevent, diagnose, treat, or cure any serious diseases. CBD is also currently forbidden as being sold as a dietary supplement.
FDA Public Hearing
As part of the FDA’s April 2nd press release, FDA Commissioner Scott Gottlieb, M.D. also announced that on May 31, 2019, the FDA would be holding a public hearing to give stakeholders the opportunity to provide the FDA with input regarding the marketing of cannabis products and products made from cannabis-derived compounds. Electronic and written comments are currently being accepted until July 2, 2019. The FDA specifically prohibits food containing CBD to be introduced into interstate commerce although this will be under discussion as part of the public hearing. Also a part of the public hearing will be open questions regarding the safety considerations brought on by the widespread use of CBD. In 2018 the FDA approved the new drug Epidiolex, a purified form of CBD for use in treating seizure disorders. In this particular drug, the FDA identified safety risks which included the potential for liver injury. This speaks to the need for FDA oversight when it comes to labeling these new products. These points will be a determining factor in how the FDA decides to regulate and oversee CBD. In this public hearing the FDA will aims to make the legal pathways more efficient with the information obtained.
As it stands now, the FDA strictly prohibits adding CBD to food products. This is likely to change in the coming months and years as the FDA obtains new information regarding the different uses of CBD along with the risks that come with it. The public hearing in May will be a key step in the future of CBD and food products.
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