This article was originally published on Hoban Law Group, and appears here with permission.
This article is authored by managing attorney, Garrett Graff.
Finished products containing hemp-derived ingredients are becoming increasingly popular as a myriad of products have and continue to enter the market since the passage of the Agriculture Improvement Act of 2018 (“2018 Farm Bill”). The 2018 Farm Bill reserved regulatory authority over finished products that contain hemp-derived ingredients to the U.S. Food and Drug Administration (“FDA”), where FDA generally regulates products based upon the product type and intended use. Unfortunately, at this time, the FDA has not issued specific regulations for products that contain hemp-derived cannabidiol (“CBD”).
Hemp Products
Finished products are not a category of their own; rather, finished products that contain hemp-derived ingredients fall under existing regulatory lanes for conventional products. Specifically, finished products are typically either a food, a supplement, a cosmetic, or a drug. Drugs impose the highest standard and require products to successfully complete clinical trials for efficacy purposes. At this time, FDA-approved Epidiolex is the only approved prescription drug. FDA asserts that ingredients in FDA-approved drugs are precluded from being included in other products such as foods and cosmetics; FDA’s draft regulations purportedly attempt to address this potential conflict between conventional product types and pharmaceutical forms.
However, not all ingredients derived from hemp face the same regulatory obstacles as CBD products. The FDA has recognized hulled hemp seeds, hemp seed protein, and hemp seed oil, as generally recognized as safe (“GRAS”). GRAS ingredients do not require additional approval prior to inclusion and pursuant to FDA regulation, including labeling.
Hemp, CBD and Federal Regulations
In the absence of federal regulation of CBD products, some states, like Colorado, have implemented product safety standards to regulate products that contain hemp-derived ingredients. Although this has created a patchwork of governing regulations, this has allowed for manufacturers of CBD products to produce and sell finished products that contain hemp-derived ingredients. However, the collective hemp industry is seeking FDA guidance to create a uniform and well-regulated federal framework.
Hemp and the FDA
The FDA has turned to researchers and stakeholders regarding the appropriate regulatory approach. In doing so, the FDA held a public hearing in 2019 and requested public comment regarding the safety and efficacy of CBD. Although CBD-related research has been stifled, researchers are exploring answers to the FDA’s questions to guide regulations, including potential drug interaction, dosage, uses, potential side effects, and potential impact on vulnerable populations, such as the elderly, women who are pregnant, or who are breastfeeding, and children.
The FDA has compiled information and has created a website dedicated to the FDA’s current understanding of cannabis-derived compounds. The FDA has opened the public docket indefinitely to allow for additional comments concerning particular topics the FDA seeks guidance on. Fortunately, the FDA has issued guidance on cannabis-related research and the drug approval process. Collectively, the FDA is taking the much-needed steps towards promulgating regulations for CBD products; however, there is no estimated time for when the FDA will issue rules.
Since the current regulatory environment continually evolves, we encourage businesses and researchers to contact the Hoban Law Group to discuss your particular needs regarding CBD products.
Read the original Article on Hoban Law Group.
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