Hemp GRAS

The FDA recognized Hemp as GRAS today. The FDA Atty law firm worked with Fresh Hemp Foods Ltd. (Manitoba Harvest) to file GRN 000765, GRN 000771, and GRN 000778 on ingredients derived from hemp seed.

Today is the first time hemp has ever been recognized as GRAS. A link to the announcement is here.

“GRAS” is an acronym for the phrase Generally Recognized ASafe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

A company may self-affirm GRAS but only by filing the notice can a company’s conclusions on the basis for GRAS be confirmed by the FDA. GRAS can be flippantly used as a sort of shorthand to say an ingredient is safe for use. Anyone who has filed a notice knows that’s not the case. GRAS requires exposure estimates and extensive data and literature explaining how the notified substance is safe. Hemp faced unique challenges in addressing THC and cannabinod effects, which are not safety issues traditionally discussed in a GRAS review, i.e., not traditional toxilogical concerns. Overall, the scientific literature demonstrated the safety of hemp both in human and animal studies.

Following today’s news, it’s likely that many hemp products will claim to be GRAS or self-affirm GRAS. Consumers should exercise caution, only Fresh Hemps products, manufacturing methods, intake levels, and exposure estimates were evaluated. Those are likely to be different company to company.


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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

1 Comment

  1. CBD - FDA Atty on March 2, 2020 at 7:34 pm

    […] Recognized As Safe (GRAS). Our office recently filed the first successful notice on hemp (see here) but the notified substance in those submissions wasn’t CBD […]

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