Cannabidiol, commonly known as ‘CBD,’ is in all sorts of products these days like food, dietary supplements, and cosmetics, but consumers and businesses are often confused or unaware of CBD regulatory guidelines from the U.S. Food and Drug Administration (FDA). Learn more about the FDA’s guidelines for CBD and hemp-derived products to better understand this growing market. Count on SunDance to guide you through the process seamlessly.

The FDA and Cannabis

Before we discuss FDA regulations, it’s important to understand the FDA’s role when it comes to cannabis. The FDA has two main regulatory roles - the first of which is under the Federal Food, Drug & Cosmetic Act (FD&C Act). Under this act, the FDA provides:

• Scientific and regulatory support for research on potential therapeutic uses of cannabis
• Regulation of products (e.g., foods, drugs, cosmetics) from cannabis
• Enforcement actions as necessary against products made from cannabis or containing compounds found in the cannabis plant, particularly those presenting human health risks

The FDA’s second role is under the Controlled Substances Act (CSA) which includes:

• Assisting the Drug Enforcement Administration (DEA) on protocol registration for Schedule I drug research (Under 21 CFR 1301.18 and 1301.32)
• Conducts scientific and medical analysis (‘8-factor analysis’) to recommend appropriate controls under the CSA (working with NIDA)
• At the Drug Enforcement Agency’s request:
  • Responding to citizen petitions
  • New approved drug products with a need for scheduling action

There are also other players involved with cannabis regulation like states, Drug Enforcement Agency, U.S. Department of Agriculture, Substance Abuse and Mental Health Services Administration, National Institute on Drug Abuse, and Office of National Drug Control Policy.

The Farm Bill

The Agriculture Improvement Act of 2018 (Farm Bill) changed some federal authorities related to the production and marketing of hemp. It established a state-USDA process and gives USDA the authority to issue federal regulations and guidelines concerning hemp production.

Hemp is defined as cannabis (Cannabis stativa L), and derivatives of cannabis, with extremely low (not more than 0.3 percent on a dry weight basis) concentrations of THC. The bill removed hemp from the definition of marijuana in the Controlled Substances Act (CSA); marijuana is still regulated by the DEA under Schedule 1 of the CSA.

The FDA’s authorities were specifically preserved by the Farm Bill which means cannabis and cannabis-derived products are still subject to the same authorities and requirements as other FDA-regulated products containing any other substance.

Overview of FDA Drug Authority

Under the FD&C Act, any product, including a cannabis product (hemp or otherwise), marketed with a claim of therapeutic benefit, or with any other disease claim, is considered to be a drug. Drug development from cannabis has focused on two compounds - CBD and THC.

Over the last several decades, the FDA has approved the four following products:

• Marinol (dronabinol) (1985) Schedule III: Treats nausea from cancer chemotherapy
• Cesamet (nabilone) (1985 (2006)) Schedule II: Treats nausea and neuropathic pain.
• Syndros (dronabinol) (2016) Schedule II: Treats nausea from cancer chemotherapy
• Epidiolex (CBD) (2018) Schedule V: Treats childhood seizures

A new drug must be approved by the FDA for its intended use before it may be introduced into interstate commerce.

THC and CBD in Food

The FD&C Act prohibits THC or CBD from being added to food for humans or animals. Furthermore, it’s illegal to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) containing substances found to be active ingredients in an approved drug product or a drug undergoing public substantial clinical investigations.

However, ingredients derived from parts of the cannabis plant which contain only trace amounts of THC and CBD (which the seeds may pick up during harvesting and processing when they’re in contact with other parts of the plant) might be able to be marketed as dietary supplements and/or conventional foods.

These products must still comply with all applicable laws and regulations governing dietary supplements and conventional foods, including requirements related to safety, processing, and labeling.

Hemp Seed-Derived Ingredients

In 2018, the FDA completed three generally recognized as safe (GRAS) notices for hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. The FDA regards these as safe ingredients for humans and can be legally marketed in human foods without food additive approval, provided they comply with all other requirements and don’t make disease claims.

THC and CBD in Dietary Supplements

Under the FD&C Act, both CBD and THC are excluded from the dietary supplement definition and cannot be sold or marketed as such. If a substance (such as THC or CBD) is an active ingredient in a drug product and has been approved under the FD&C Act or has been authorized for investigation as a new drug, then products containing the substance are excluded from the dietary supplement definition.

The FDA considers a substance to be "authorized for investigation as a new drug" if the subject of an Investigational New Drug application (IND) has gone into effect. An IND is required for all clinical investigations of products subject to the FD&C Act (unless a clinical investigation meets certain criteria in regulation).

Cosmetics

While FDA regulations for CBD in cosmetics aren’t as stringent as food and dietary supplements, guidelines still exist. Here are the FDA guidelines cosmetics brands and consumers should know:

• No premarket approval needed for cosmetic products and ingredients, with the exception of color additives
• Must not be adulterated
• Safe for consumers when used according to the directions in labeling and under customary/usual conditions of use
• Must not be misbranded

If a topical product, including those containing CBD, is intended to affect the structure or any function of the body, or be used in the diagnosis, cure, mitigation, treatment, or prevention of disease, it is considered a drug, even if it is also a cosmetic (i.e. ‘dual classification’). New drugs must be approved by the FDA.

Conclusion & Solution

The FDA is integral in the regulation and development of products containing cannabis and cannabis-derived compounds. Despite rapidly changing legal frameworks and product markets, the FDA remains steadfast in advocating for more data and rigorous scientific research to protect the public’s safety.

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