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When making a new product, whether that product is a drug, a medical device, or a combination product, understanding the regulations related to that product is incredibly important. A product subject to regulation, by the FDA or other regulatory that confuses many firms as to its regulatory ramifications. Being relatively new to the legal market the regulations surrounding CBD can be confusing, even to the point where the labeling can often be incorrect. While having a compliant product label is incredibly important, knowing when and how to sell the product is even more so.

While CBD is legal in many areas of the US now, an unapproved drug still cannot be put on the market. This applies even to over-the-counter (OTC) drugs. Recently the FDA issued warning letters to several companies that were selling unapproved OTC drugs that contained CBD.[1] It is important to note that having CBD in the products was not the reason for the warning letters. The letters were issued for several reasons, one of which is that the CBD in the products was listed as an inactive ingredient.[1]

Again, having CBD in the product is not the issue, acknowledging the effects of CBD is. Since CBD affects the body it cannot be listed as an inactive ingredient, instead, it should be an active ingredient. An active ingredient is defined by the FDA as “any component that provides a pharmacological activity or another direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.”[2]

Another important note is that the warning letters issued to the companies selling the OTC drugs were not only for the CBD claims made. Several other issues were included in the letters, including an issue with the manufacturing and that the drugs had not undergone the proper approval process.[1] With that in mind it is very possible for a drug containing CBD to be approved, even for OTC use. It is simply a matter of undergoing the proper approval process. Unfortunately, because CBD is still so new to the legal market, many manufacturers do not understand that approval is needed. If they do know, they may be confused about which approval pathway to undertake, as there are several possible paths to approval for drugs. EMMA International can help understand which pathway is best for your product and even handle the submission process. EMMA International provides Full Circle Consulting services, give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (March 2021) FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief, Retrieved 01/23/2022 from https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-over-counter-cbd-products-pain-relief

[2] FDA (November 2017) Drugs@FDA Glossary of Terms, Retrieved 01/23/2022 from https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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