On December 20, 2018 hemp (Cannabis sativa L.) and derivatives with less than 0.3% on a dry weight basis of delta-9-tetrahydrocannabinol (THC) can be legally sold in the United States.

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On December 20, 2018, upon the signing of the Agricultural Improvement Act of 2018 – commonly known as the Farm Bill of 2018, hemp (Cannabis sativa L.) and derivatives with less than 0.3% on a dry weight basis of delta-9-tetrahydrocannabinol (THC) can be legally sold in the United States [1]. Immediately, the US food and Drug Administration (US FDA) issued a press release to remind the public that it is unlawful to introduce food containing added Cannabidol (CBD) or THC in interstate commerce or to market these products as, or in, dietary supplements, regardless of whether these substances are hemp derived [2].

Hemp product GRAS Notices

The US FDA did issue a response on “no questions” to three Generally Recognized As Safe (GRAS) notices for hulled hemp seed (GRN765) [3], hemp seed protein powder (GRN771) [4], and hemp seed oil (GRN778) [5]. This allows these ingredients, providing they meet the specifications as listed in the GRAS notice, to be used as a source of protein, carbohydrates, oil, other nutrients in beverages, soups, dips, spreads, sauces, dressing, plant-based meat-like products, desserts, baked goods, cereal, snacks and nutrition bars.

US FDA and Marijuana [6]

THC is the active ingredient in approved drug products. Clinical investigation regarding CBD as a drug has been made public. Because these two substances have been authorized for investigation as a new drug before they have been marketed as a food, food ingredient, dietary supplement or supplement ingredient, then these substances, per the US FDA, cannot be marketed in food and dietary supplements. The US FDA has concluded that marketing of these products did not happen before authorization for investigation as a new drug.

New Dietary Ingredients

Per the Dietary Supplement Health and Education Act, all new dietary ingredients must be submitted to the US FDA regarding their safety as a dietary supplement or supplement ingredient 75 days before they can be marketed, or have been present in the use food supply as an article used in food in a form that has not been a chemical article for that used in the food. Additionally, the US FDA has the authority to issue a regulation allowing the use of pharmaceutical ingredients in a food or dietary substances. So theoretically, there is still a possibility that CBD could be approved as a new dietary ingredient, providing the industry can prove that it was marketed as a dietary supplement before its authorization for investigation as a new drug. Additionally, drug claims are prohibited from being made on dietary supplement products and food, which makes it difficult to present a claim on a dietary supplement label that is also a drug.

Next step:

Suppliers or manufacturers are recommended to contact their local SGS office to employ one or more of the many SGS solutions that will enable operations to remain in compliance with this and future regulatory changes.

For enquiries, please contact:

James Cook
Global Food Inspection Technical Manager
t: +01 973-461-1493

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