FDA Opens Pandora’s Box on CBD Oil Products’ Interstate Commerce with 2018 Hemp Farm Bill Passing

As expected, President Trump signed the 2018 Farm Bill into law, thus narrowly legalizing an industrial hemp industry. Right at the heels of the freshly signed legislation, the Food and Drug Administration (FDA) published a press release in response. Therein, the FDA pledges to pursue methods that would enable businesses to legally market products that feature cannabis or cannabis-derived substances.

Such action would also enable the agency to take enforcement action against those who are non-compliant with the FDA’s requirements and that may make unattenuated claims concerning the therapeutic benefits of CBD, hemp-derived products, and the like. According to Scott Gottlieb of the FDA, “ In view of the proliferation of products containing cannabis or cannabis-derived substances, the FDA will advance new steps to better define our public health obligations in this area. We’ll also continue to closely scrutinize products that could pose risk to consumers.”

Gottlieb further added that the components of marijuana, including THC and CBD are active ingredients in FDA-approved drugs. One such drug is Epidiolex, which is used to treat epilepsy. Nonetheless, it is still illegal to “introduce drug ingredients like these into the food supply, or to market them as dietary supplements.”

Interestingly enough, Gottlieb still stressed that the FDA has the power to provide businesses with permission to legally market CBD-derived products. The grant is circumstantial, though. He stated,

“In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of pharmaceutical ingredients in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process.”

There are also food substances that can be derived from the hemp plant, and that that contain either a trace amount to no cannabinoids. For example, substances include hulled hemp seeds, hemp seed protein, and hemp seed oil. These, according to the FDA, are safe based on “generally recognized as safe.” Further, “these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims.”

The FDA released another press statement, in which it expanded on the concept of the use of hemp-based food substances in products. The agency added,

“The GRAS notices are for three different hemp seed-derived ingredients. The GRAS conclusions can apply to ingredients from other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.”

In the coming months, the agency is planning on holding a public meeting to generate input from stakeholders. The additional information will help determine the next steps for creating lawful pathways for cannabis or cannabis-derived compound marketing.