In recent years, the marketing of cannabidiol (CBD) products in the United States has grown exponentially. With this rise in popularity, Registrar Corp often receives questions about the legality and regulation around CBD products and marketing them to consumers in the United States. Despite widespread CBD inventory in US stores, the U.S. Food and Drug Administration (FDA) prohibits the marketing of CBD food and supplement products in the United States.

What is Cannabidiol (CBD)?

cannabidiol is a single compound of the cannabis plant. It is often extracted as an oil and then applied to foods, beverages, lotions, and supplements. Some claim that CBD can reduce pain, depression, anxiety, and other ailments.  However, FDA has not permitted CBD for these intended uses due to concerns about the full effects of CBD consumption. FDA warns that CBD can cause liver damage, changes to alertness, and may interact with other medications in a harmful way.

FDA and CBD Regulation

According to FDA, “It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” FDA is uncertain about to the impact of long-term daily use, how different methods of consumption may affect users, and how it may affect children. The Agency continues to explore the benefits and adverse effects of cannabidiol.

Conventional food ingredients must be approved by FDA as food additives or be “generally recognized as safe” (GRAS). FDA has published statements that CBD is neither and is illegal to market in a food in interstate commerce.

Dietary ingredients (the key ingredient in a supplement) are not subject to food additive/GRAS regulation, but are subject to other limitations including whether it was ever the subject of clinical investigations as an investigational new drug. Currently, FDA has approved cannabidiol as an ingredient for use in one drug product, Epidiolex, which is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

FDA prohibits the use of CBD in dietary supplements as it violates the definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Act states “if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved … or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.” Since CBD is considered an active ingredient in Epidiolex, it is prohibited from use in dietary supplements.

FDA “is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know.” Should research determine that CBD meets FDA safety standards, these regulations could change.

Legality of CBD

While only one CBD Product is approved by FDA, nearly all U.S. states allow CBD products in one form or another.  However, even for states in which CBD products are legal, many provide additional provisions on its uses. For example, in many states (like California, New York, and Pennsylvania) CBD is prohibited for use in food and beverages, while other states (Florida, Texas, Indiana) are implementing labeling requirements or have implemented age limits similar to those of tobacco or alcohol. CBD is illegal in any form in Idaho, Iowa, and South Dakota.

Additionally, under the Agricultural Improvement Act of 2018, CBD is no longer federally illegal to make or possess in the United States. However, CBD does not conform to the regulations that govern conventional food ingredients or dietary supplements. The conditions of the 2018 Farm Bill do not alter the requirement that cannabidiol meet the requirements of the FD&C Act if incorporated into a food or dietary supplement.

More questions?

The CBD industry is relatively new and evolving rapidly. Read Registrar Corp’s blog to stay up to date on FDA regulations surrounding CBD products.

Registrar Corp is a private company that assists businesses in complying with FDA regulations.  Our Regulatory Specialists can help businesses register with FDA, meet FDA labeling requirements, and more. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.