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FDA Reader: Simplifying Food Regulation

CBD and FDA Food Regulation

What You Need to Know about CBD and the FDA

The FDA Regulation on CBD is not as lenient as the widespread presence of CBD would lead you to believe

The FDA Regulation on CBD is not as lenient as the widespread presence of CBD would lead you to believe

CBD is a Drug Ingredient, Not a Food Ingredient or a Dietary Supplement

CBD (Cannabidiol) is an active ingredient in an FDA-approved drug (Epidiolex) which was subject to the rigorous drug-approval process. According to FDA regulation, substances which are active ingredients in a drug cannot be introduced as ingredients into food or marketed as dietary substances.

Even if the FDA hasn't yet approved the drug yet, its active ingredients are typically disallowed as food or dietary supplement ingredients insofar drug trials are underway and publicly known.

This is the crux of the FDA's argument for disallowing CBD in food products prior to the June 2018 approval of Epidiolex, a CBD-based epilepsy drug. In 2017, the FDA sent warning letters to producers of CBD-infused food and cosmetic products, arguing that the use of CBD was illegal because publicly known drug trials for Epidiolex were already underway.

CBD Dietary Supplements are easy to come by

CBD Dietary Supplements are easy to come by

There is an exception to the rule: if the substance in question was marketed as a dietary supplement or conventional food ingredient before it became an drug ingredient, then it may continue to be used as a food ingredient. In the case of CBD, the FDA has determined that there isn’t sufficient evidence of it’s historic use as a food ingredient.

Still, in late 2018, the FDA acknowledged that they have the authority to approve the use of a pharmaceutical ingredient in a food or dietary supplement. And according to the commissioner’s statement in December 2018, they are currently deciding whether to pursue this as it relates to CBD (and THC too). What would compel the FDA to allow CBD in FDA-regulated foods? At this point, it’s unclear.

Bottom Line: It is unlawful to sell any food or dietary supplement containing CBD if that product enters interstate commerce.

CBD-Containing Cosmetics are Actually Drugs — even if they don’t make any claims

The difference between a cosmetic and a drug is whether the product "affects the structure or function of the body." Simply, if the product causes any sort of physiological change that is beyond "cleansing, beautifying, promoting attractiveness, or altering the appearance", then it is considered a drug.

For example anti-perspirant is considered an over-the-counter drug because its effects are not merely cosmetic: anti-perspirant causes a physiological change -- it blocks our pores-- which prevents the wearer from sweating.) While deodorant would be considered a cosmetic (it’s merely perfume), sunscreen is considered a drug.

Of course CBD has a physiological effect on the body —it’s the active ingredient in the FDA-approved prescription drug Epidiolex — so any product containing CBD would be classified as a drug. Even if you argued that the CBD served a cosmetic purpose or made no claims about the effects of CBD, it has a well known therapeutic use and this would classify it as a drug.

Does this mean CBD-containing Cosmetics are illegal?

Yes. Unless the FDA changes how they regulate CBD specifically, any producer of a CBD-containing cosmetic would need to submit a New Drug Application and receive pre-market approval from the FDA.

Still, CBD-containing cosmetics are widely available both online and in retail locations nationwide. It’s unclear when and how the FDA will crack down on the illegal sale of these drugs. Typically, they go after brands who make false claims about their drug’s ability to treat or cure a disease. CBD brands who list the therapeutic effects of CBD or directly state its ability to alleviate certain symptoms will no doubt be the first to receive an FDA warning letter.

How will retailers react? We’ll have to wait and see.

FAQ - CBD and FDA Regulation

Does it matter that the CBD is hemp-derived?

No. Regardless of the origin of the CBD, substances which are active ingredients in a drug cannot introduced as ingredients into food or marketed as dietary substances.

What if my CBD/THC product doesn't enter interstate commerce?

If a food product's packaging and ingredients (including the CBD) were sourced entirely in-state and your product is sold in-state, then the product may not be considered as participating in inter-state commerce.

In this case, the product would not be subject to FDA regulation. (Learn more in our article Does the FDA Regulate My Food Business?)

However, this doesn't mean you're in the clear -- check with your state and local health authorities to confirm there's no local law that automatically adopts FDA regulation at the local level or expressly prohibits CBD as a food ingredient.

Why are some companies allowed to sell CBD in foods?

They're not. Many food companies are operating in violation of FDA regulation. The FDA has sent warning letters to food products which contain CBD or cannabis-derived ingredients. However, due to the reactive nature of the FDA and a large array of responsibilities, not all of these companies have been approached.

The FDA regulates all types of new ingredients that are added to food. Whenever any sort of new compound (either a dietary supplement or something that wasn't considered "food") is added to a food, the FDA must first approve that new dietary ingredient.

Can hemp be used as a food ingredient if it doesn't contain CBD or THC?

Yes. There are hemp products that do not contain CBD or THC, such as hemp-seed-derived food ingredients. Three of these products have been added to the list of "generally recognized as safe (GRAS)" ingredients. They are:

1. Hulled hemp seed

2. Hemp seed protein powder

3. hemp seed oil

The reasoning is that they do not contain CBD or THC. If these food ingredients are manufactured in a way that is consistent with FDA regulations, then they are allowed as ingredients in FDA-regulated foods.


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