The short answer is no. Food and beverages containing cannabidiol (“CBD”) cannot be placed into interstate commerce.
The reason is that the FDA takes the position that CBD is a substance that is an ingredient in a drug that they approved. In this case, the FDA is referring to Epidiolex. Epidiolex …”contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome [or tuberous sclerosis complex] in patients 1 years of age and older.”
What would need to change before CBD is allowed in food and beverages?
The FDA would need to issue a regulation allowing CBD to be added to food and beverages.
Can hemp be added to food and beverages?
Yes for the following hemp derived ingredients:
- hulled hemp seed,
- hemp seed protein powder, and
- hemp seed oil
The FDA stated that the above three ingredients can be used 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.”
What are the requirements for adding the approved hemp derived ingredients to food and beverages?
- Products that contain any of the three hemp derived ingredients must list them on the ingredient list
- Hulled hemp seed must comply with the specifications and standards contained in the FDA’s GRAS Notice GRN 000765
- Hemp seed protein powder must comply with the specifications and standards contained in GRAS Notice GRN 000771
- Hemp seed oil must comply with the specifications and standards contained in GRAS Notice GRN 000778
What do the GRAS Notices require?
The Generally Regarded As Safe (“GRAS”) notices require the following:
- That the source of the hemp derived ingredient is from an authorized grower
- That the hemp is of a low THC variety
- That the hemp derived ingredient meets listed specifications (related to THC concentration, heavy metals, and contaminants) in the GRAS Notice which can be confirmed by testing
- That the intended use of the hemp derived ingredient is the same as described in the GRAS Notice
Can CBD products be sold as dietary supplements?
The short answer is no. The FDA would need to specifically allow CBD to be added to dietary supplements before it would be legal.
What could change the regulatory landscape?
Sen Ron Wyden of Oregon indicated last month to Hemp Industry Daily that Congress may enact legislation to assist the hemp industry if the FDA’s rules on CBD continue to be a problem.