FDA Responds to Three GRAS Notices for Hemp Seed-Derived Ingredients for Use in Human Food
December 20, 2018
The U.S. Food and Drug Administration has completed its evaluation of three generally recognized as safe (GRAS) notices for hemp seed-derived food ingredients. The GRAS notices were submitted by Fresh Hemp Foods, Ltd. The agency has no questions about Fresh Hemp Food’s conclusion that the following ingredients are GRAS under their intended conditions of use: hulled hemp seed (GRN765), hemp seed protein powder (GRN771), and hemp seed oil (GRN778).
Foods containing hemp seed and hemp seed-derived ingredients are currently marketed in the US. Hemp seeds are the seeds of the hemp plant, Cannabis sativa. Although hemp is from the same species as cannabis (marijuana), the seeds themselves do not naturally contain tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high”.
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.
These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food. As stated on FDA and Marijuana: Questions and Answers, it is a prohibited act under section 301(ll) of the Federal Food, Drug, and Cosmetic Act to introduce into interstate commerce a food to which CBD or THC has been added.
- Statement from FDA Commissioner Scott Gottlieb, M.D., on Signing of the Agriculture Improvement Act and the Agency’s Regulation of Products Containing Cannabis and Cannabis-derived Compounds
- Agency Response Letter GRAS Notice No. GRN 000765
- Agency Response Letter GRAS Notice No. GRN 000771
- Agency Response Letter GRAS Notice No. GRN 000778
- FDA and Marijuana: Questions and Answers