December 21, 2018
FDA and CBD: New Hope for a New Path
Yesterday was one for the history books. Thanks to years of hard work from so many Hemp Supporters, the era of hemp prohibition is now over. Check out our press page for some of the media clips that highlight our monumental victory. But the 2018 Farm Bill’s passage was just the beginning.
As we’ve been reminding you, while the Drug Enforcement Administration (DEA) is now officially out of the hemp regulation business, the Food and Drug Administration (FDA) retains its authority to regulate all ingestible and topical products, including those that contain hemp and hemp extracts such as cannabidiol (CBD). We’ve been concerned about FDA overreach, particularly in light of a non-binding Q&A posted on the FDA web site starting about three years ago which suggests that CBD products cannot be marketed as foods or dietary supplements.
Fortunately, no enforcement actions have been taken against CBD sellers, with the exception of those that inappropriately marketed their products with disease remediation claims. Shortly after the Farm Bill signing, a letter was released by FDA Commissioner Scott Gottlieb that restated FDA’s current position, opining that it’s a violation of federal law to introduce CBD ingredients “into the food supply or market them as dietary supplements.”
That’s nothing new. But the letter also contained, for the very first time, new hope for a new path toward FDA’s acceptance of hemp-derived CBD as a food additive or nutritional supplement. For the very first time, the FDA is seriously considering using its authority to issue a regulation that will specifically allow hemp-derived ingredients in foods and supplements:
[P]athways 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.
Better yet, as it makes this decision, the FDA is reaching out to the industry and the public:
Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products. We’ll use this meeting 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. We’ll also solicit input relevant to our regulatory strategy related to existing products, while we continue to evaluate and take action against products that are being unlawfully marketed and create risks for consumers. At the same time, we recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities. We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.
We can assure you that the Roundtable will be in the room where it happens.
With the guidance of our FDA counsel, Amin Talati Upadhye, and the partnership with other industry organizations such as the American Herbal Products Association and the Hemp Industries Association, the pursuit of this approval path will be one of our top priorities for 2019. And some more good news from the FDA: Yesterday as well, FDA issued a statement opining that the “agency has no questions”about the conclusion that hulled hemp seed, hemp seed protein powder and hemp seed oil are generally recognized as safe (GRAS) under their intended conditions of use. While the GRAS evaluation was made at the request of a specific company, Fresh Hemp Foods, “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.”
Much work is yet to be done. But just as FDA scientists recently concluded that CBD has no abuse potential and does not pose a risk to public health, the agency is reevaluating its positions on hemp and hemp products. And the Roundtable will be there to help ensure that they reach the right conclusions.