‌ 

One of the main reasons the Federal Food and Drug Administration issued warning letters to CBD companies or retailers is inaccurate label claims[1]. While the FDA has limited regulation over the CBD market, it is not federally legal, but it still regulates labels. Here are four things to consider when designing a label for a CBD product.

  1. Be wary of the label claims being made.

You mustn’t make any health claims about the medicinal value of CBD, whether they may be substantiated or not. Making health claims on the effects of CBD is regulated by the FDA as it is with all drugs. In the eyes of the FDA, making health claims on a product renders the product an unapproved drug.

2. Do not claim CBD-containing products are dietary supplements.

In August 2021, the FDA announced they would not allow CBD-containing products to be advertised as dietary supplements[2]. Additionally, the FDA has taken this stance on ingestible products containing CBD under the exclusion rule and section 201(ff)(3)(B) of the Food, Drug, and Cosmetics Act. It is important to note that while bills attempt to change the laws, they have not passed.

3. Confirm the laws in each state.

In addition to the federal regulations, some states have enacted laws that products need to comply with. Many of these restrictions have to deal with labeling or advertising the products.

4. Ensure the product contains the advertised amount of CBD.

Routinely engaging in product quality testing helps ensure the product being sold will contain the advertised amount of CBD. Testing procedures should align with standardized test methods and scientific best practices.

The laws around CBD and hemp-containing products are quickly changing. Maintaining quality procedures and records can help avoid enforcement action from the FDA in any regulated industry, especially CBD. If you need help reviewing your label, processes, or receive enforcement action from the FDA, EMMA International can help. Call us at 248-987-4497 or email infor@emmainternational.com.


[1] Office. (2019). Warning Letters and Test Results for Cannabidiol-Related Products. Fda.gov. https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products

[2] “FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers” on the FDA. (Accessed 2 Jan 2022.). https://www.fda.gov/media/131878/download

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This