Just after President Donald Trump signed the 2018 Farm Bill into law on Thursday, legalizing industrial hemp, the Food and Drug Administration (FDA) published a lengthy press release responding to the legislative development—including a pledge to pursue pathways that would allow businesses to legally market products containing cannabis or cannabis-derived compounds.
The federal agency stressed that it retains the right to regulate products containing cannabis and would take enforcement action against businesses that make unsanctioned claims about the therapeutic potential of cannabidiol (CBD) products, including those derived from hemp, or attempt to introduce such products into interstate commerce.
“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,” FDA Commissioner Scott Gottlieb said. “We’ll also continue to closely scrutinize products that could pose risks to consumers.”
My statement on the signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds and new steps we plan to take: https://t.co/mDsLqGGM0s
— Scott Gottlieb, M.D. (@SGottliebFDA) December 20, 2018
Specifically, Gottlieb emphasized that, because components of marijuana such as THC and CBD are “active ingredients in FDA-approved drugs” such as the epilepsy medication Epidiolex, it remains illegal to “introduce drug ingredients like these into the food supply, or to market them as dietary supplements.”
In preserving these authorities, Congress recognized #FDA’s important public health role for products it regulates & allows us to continue enforcing the law to protect patients and the public while also providing potential pathways for cannabis and cannabis-derived products.
— Scott Gottlieb, M.D. (@SGottliebFDA) December 20, 2018
But the commissioner also said the agency nonetheless has the authority to grant businesses the ability to legally market cannabis or cannabis-derived products under certain circumstances, and it is actively exploring those options.
“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 a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process.”
Gottlieb also recognized that certain foods derived from the hemp plant don’t contain regulated cannabinoids (or contain just trace amounts), and the FDA used the press release to announce that it’s completed evaluations of “hulled hemp seeds, hemp seed protein and hemp seed oil” and determined that the products are safe based on “generally recognized as safe,” or GRAS, standards.
“Therefore, 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,” he wrote.
In a separate press release, the agency expanded on that determination:
“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.”
The FDA said it will be holding a public meeting soon, soliciting input from stakeholders, to “gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient.”
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