Hemp, CBD, and GRAS Status: Challenges Faced From the FDA
In January 2019, the FDA completed its evaluation per a notice filed by Fresh Hemp Foods, Ltd. for the generally recognized as safe (GRAS) status of three hemp-seed derived food ingredients (de-hulled hemp seed, hemp seed protein powder, and hemp seed oil). The subject of the notice was the use of hemp-seed derivatives as an ingredient in ready-to-drink beverages, soups, sauces, smoothies, dairy product analogs, grain products, baked goods, baking mixes, dressings, cereals, meat analog products, nutrition bars, and snacks. In its response, the Agency had no questions regarding Fresh Hemp Food's conclusion that de-hulled hemp seed, hemp seed protein powder, and hemp seed oil were GRAS under their intended conditions of use. However, the FDA noted that their response letter was "not an affirmation" that hemp seed protein powder, hemp seed oil, and de-hulled hemp seed is GRAS under 21 CFR 170.35.
The FDA announcement came shortly after the Agricultural Improvement Ace of 2018 (also known as the Farm Bill) was signed into law. Updates to the 2018 Farm Bill allow farmers to cultivate, process and sell hemp. Hemp seeds are produced from the Cannabis sativa plant, and do not naturally contain tetrahydrocannabinol (THC), which is the psychoactive component of marijuana associated with making consumers "high". However, hemp-seed derivatives "contain only trace amounts of THC and [cannabidiol] CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant" (Farm Bill 2018). In the United States, for example, the acceptable level for THC-content in hemp is 0.3% on a dry weight basis (Sec. 297A: Agricultural Improvement Act of 2018). Currently, there are foods marketed in the U.S. that contain hemp-seed derivative ingredients.
Within their response, the FDA also cited Section 301(II) of the FD&C Act, which "prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act ... unless one of the exemptions in section 301(II)(1)-(4) applies" (FDA 2018). This reference is important since CBD has been investigated and recently approved by the FDA as a new drug (Epidiolex). The FDA did not consider whether section 301(II) or any of its exemptions applied to food containing hulled hemp seed, hemp seed protein powder, and hemp seed oil. The FDA did not, however, that its response "should not be construed to a statement that food containing de-hulled hemp seed, hemp seed protein powder, and hemp seed oil if introduced or delivered for introduction into interstate commerce, would not violate section 301(II)" (Keefe 2018).
The uncertainty surrounding this issue was recently echoed during testimony provided by FDA Commissioner Dr. Scott Gottleib to the House Committee on Appropriations on the FDA's status of operations. Commissioner Gottleib referenced CBD's status as an approved drug, indicating that it therefore cannot be added to foods. He did, however, offer his opinion on possible pathways by which CBD products could be available "in a high concentration, pure formulation as a pharmaceutical product" and "at a different concentration as a food product or dietary supplement" (FDA Statement 2018). Commissioner Gottleib went on to state that "this is not a straightforward process. There's not a good proxy for us doing this through regulation," highlighting the complexity related to using and regulating hemp and CBD in the U.S. The FDA plans to hold a public hearing on hemp and CBD in April 2019 (FDA Statement 2018).
According to the Hemp Business Journal, the U.S. hemp industry is estimated to reach $1.6 billion in sales by 2020. It is likely that the latest FDA GRAS evaluations and the 2018 Farm Bill will further encourage companies to produce hemp-based products for various applications. While the FDA had no questions regarding Fresh Hemp Foods's GRAS notice, the Agency noted that "[f]ood ingredient manufacturers and food producers are responsible for ensuring that marketed products are safe and compliant with all applicable legal and regulatory requirements" (Keefe 2018).
Cardno ChemRisk scientists have extensive professional experience evaluating the possible hazards posed by chemicals in consumer products and foods. For more information on Cardno ChemRisk's capabilities, please contact Elise de Gandiaga at Elise.DeGandiaga@cardno.com.