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.
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:
The FDA’s second role is under the Controlled Substances Act (CSA) which includes:
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 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.
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:
A new drug must be approved by the FDA for its intended use before it may be introduced into interstate commerce.
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.
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.
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).
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:
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.
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.
It is vital to the growth of any business in commercial food production and the pharmaceutical industry to find a printing vendor who really understands the considerations and liabilities involved in food and drug safe packaging. At SunDance we have the experience necessary to guide you through the process seamlessly. We understand your needs, legal requirements, and safety concerns. SunDance is one of the few printers who specialize in FDA-approved and food and drug safe printing techniques and practices, meaning we will keep your project safe, clean, and compliant. Sundance offers a wide range of FDA-approved materials, inks, and finishing techniques. Some of our food and drug safe in-house finishing services include stamping, UV coatings, AQ coatings, foils, and more. Our extensive array of printing and finishing capabilities allow for better oversight, strict adherence to regulations, and faster turnaround.
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For more information on SunDance’s FDA food and drug safe packaging visit, https://sundanceusa.com/industries/fda-food-and-drug-safe-printing.