The FDA and CBD

by Madison Green | Dec 3, 2021 | CBD, Compliance, Consulting Group, FDA, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards

21st Century Cures Act, FDA regulatory changes,

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As more and more states legalize the use of medicinal and recreational marijuana, and as more consumer products are beginning to incorporate CBD, it begs the question – what is the FDA’s role in all of this? Since many marijuana and CBD products are edible consumables, how does the FDA intend to keep public health a priority among this wave of legalization?

The first step in this discussion is to understand the mechanics of marijuana and CBD, as they are not one in the same. CBD refers to cannabidiol, which is a single compound in the cannabis plant. Marijuana refers to a type of cannabis plant that contains many naturally occurring compounds, including CBD and THC (delta-9-tetrahydrocannabinol, which produces the “high” effect).[1]

In this regard, the FDA is working on the regulatory framework for both. For any products that intend to treat a condition, or otherwise make a drug claim, they will be regulated under the drug approval process and 21 CFR § 210 and 211. Many new consumer products are popping up that incorporate CBD, some with illegal claims of treating medical conditions due to the CBD ingredient. The FDA has issued warning letters to companies that make these claims, and also has cited further violations of CBD food products that were marketed as “dietary supplements”.[2]

It is on the docket for the FDA to evaluate the appropriate regulatory framework for Marijuana and CBD products. There have been talks of updating regulations or introducing new legislature entirely. In October of this year, the FDA published its Cannabis Derived Products Data Acceleration Plan (CDP DAP) to identify safety vulnerabilities in the CDP market, and to best determine how to mitigate them in the interest of public health.[3]

While the FDA is working on regulating this new market sector, any CBD or Marijuana consumable goods manufacturers should start reviewing their processes and regulatory standings. If you receive an enforcement action from the FDA for your cannabis derived product, EMMA International can help! Call us at 248-987-4497 or email info@emmainternational.com to learn more.

[1] FDA (n.d.) What you need to know about products containing cannabis retrieved on 12/2/2021 from: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

[2] FDA (Dec 2020) FDA Warns Companies Illegally Selling CBD Products retrieved on 12/2/2021 from: https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-cbd-products

[3] FDA (n.d.) Cannabis-Derived Products Data Acceleration Plan retrieved on 12/2/2021 from: https://www.fda.gov/news-events/public-health-focus/cannabis-derived-products-data-acceleration-plan

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Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.