As we previously explained, under the Food, Drug, and Cosmetic Act (“FDCA”), any substance that is intentionally added to food (including drinks) is a food additive. A food additive is subject to premarket review and approval by the Food and Drug Administration (“FDA”), unless the substance is generally recognized as safe (“GRAS”) by qualified experts under the conditions of its intended use.
Because the FDA has yet to approve CBD (including CBD derived from hemp) as a food additive, CBD-infused foods are deemed unsafe under the FDCA. But what about other hemp-derived ingredients free of CBD?
On December 20, 2018, the FDA completed its evaluation of three GRAS notices issued by Fresh Hemp Foods, Ltd. for hemp seed ingredients and concluded that (1) hulled hemp seed, (2) hemp seed protein powder, and (3) hemp seed oil can be lawfully marketed in human food.
According to Fresh Hemp Foods, Ltd.’s notices, hemp seeds do not naturally contain tetrahydrocannabinol (“THC”) or CBD. However, the hemp seed ingredients subject to these GRAS notices contained trace amounts of THC and CBD, which was likely caused by the seed’s contact with other parts of the plant during harvesting and processing. The FDA’s response to the GRAS notices (“Response”) suggests the agency does not take issue with very small quantities of CBD and THC in food ingredients. In fact, in its cannabis and cannabis-derived product Q&A, the agency explained that the three GRAS hemp seed ingredients could be legally marketed in human food, and thus, lawfully sold in interstate commerce.
However, in its Response, the FDA stated that all hemp seed ingredients are not inherently GRAS under 21 CFR 170.35. The agency clarified this point in its Q&A by stating that the GRAS conclusions could apply to hemp seed ingredients marketed by other companies, so long as (1) the ingredients are manufactured in a way that is consistent with the notices; and (2) they meet the listed specifications, including but not limited to the same specific use of the ingredients in food.
Some of the intended uses for these hemp seed ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages, soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars.
Therefore, these GRAS notices suggest that companies may lawfully add any of the three hemp seed ingredients to food products so long as their products are:
- intended for human consumption;
- manufactured in a manner that is consistent with the GRAS notices;
- contain no more trace amounts of THC and CBD than those found in the GRAS hemp seed ingredients;
- meet other specifications found in the notices; and
- comply with all relevant laws and regulations regarding food under the FDCA, including but not limited to good manufacturing practices and labeling requirements.