Legality and the Current Commercial Value of Farm Bill Compliant CBD
The attractive commercial value of CBD arises from the 2018 Farm Bill (Farm Bill) legalizing hemp. Since CBD can be extracted from hemp that fully complies with the requirements of the Farm Bill, such CBD does not violate the Controlled Substances Act (CSA), and therefore is a legal and commercially viable byproduct in high demand. Importantly, CBD originating from hemp that fails to fully comply with the Farm Bill, or originates from cannabis, remains illegal pursuant to the CSA.
FDA Regulations Limit Marketability of Legal CBD
The Farm Bill explicitly preserved the FDA’s authority to regulate products containing cannabis-derived compounds under the Food Drug and Cosmetic’s Act (FD&C Act) as well as section 351 of the Public Health Service Act. FDA treats products containing cannabis-derived compounds as it does any other FDA-regulated product – and does so whether the cannabis-derived compounds are classified as hemp under the Farm Bill.
FDA Approval Not Required for Farm Bill Compliant CBD Cosmetics
Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by the FDA. Pursuant to the FD&C Act, cosmetics are defined as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering an appearance. As such, a cosmetic that includes CBD or CBD oil originating from Farm Bill compliant hemp is legal nationwide and can be shipped and transported across state borders. In fact, in June of 2019, the U.S. Postal Service issued new guidelines for mailing hemp-derived CBD products in a safe and legal manner.
Current FDA Regulations Prohibit CBD in Dietary Supplements, Drinks, or Food
Currently, the FDA does not allow CBD to be added to any product intended for human or animal consumption. Therefore, pursuant to section 301 of the FD&C Act, it is illegal to introduce or deliver in interstate commerce any CBD product intended for human or animal consumption.
FDA Revaluating Regulatory Framework Regarding Drug and Non-Drug Uses of CBD
In June of 2019, the FDA Office of Food Policy and Response announced it was evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate.
Additionally, in July of 2020, the FDA announced that it continues to support the science needed to develop new drugs from cannabis. The FDA stated the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds can be made available to patients.
Gordon & Rees, Your 50 State Partner®
Due to our training, each Cannabis, Hemp and CBD attorney at Gordon & Rees thrives at delivering sound and clear advice when faced with multiple federal, state and local questions affecting you and your CBD businesses. Our attorneys serve as Your 50 State Partner® helping you transport your CBD products to market, evaluating and minimizing the risks of seizeure, as well as helping you grow, market, and sell your products. We also counsel on proper labeling, disclaimers, warnings, and other aspects of risk avoidance. Should a dispute arise, we have seasoned attorneys ready to assist.
Return to the CBD page.