Introduction
On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning letters to food manufacturers who were selling products containing cannabidiol (CBD). These letters were issued in response to an online search for companies selling foods or beverages containing CBD as a continued FDA CBD enforcement trend.
The FDA has made it clear that CBD is not an approved food additive, and it cannot be added to foods or drinks, including animal feed. Two of the warning letters targeted companies marketing products that were labeled as dietary supplements. The FDA emphasized that even if a product is marketed as a dietary supplement, it does not change how it will be evaluated by the agency.
The letters outline 2 major compliance violations: To learn more about CBD regulations click here:
- FDA stated that there is insufficient evidence to demonstrate that CBD could be generally recognized as safe (GRAS) for its intended use. With no GRAS pathway available, CBD can only be approved as a food additive, requiring premarket approval. Currently, there is no food additive regulation that authorizes the use of CBD.
- The fact that CBD was sold as an unapproved new drug was in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. This “drug preclusion” clause was invoked because the drug product Epidiolex containing CBD as its active ingredient, was first approved as an Investigational New Drug (IND) for the treatment of Dravet Syndrome.
Warning letters regarding cannabidiol (CBD).
There are companies that have been marketing food and dietary supplement products which have been making claims that their CBD-containing products treat and prevent various diseases, including cancer. However, the FDA made it clear that CBD is not an approved food additive, and it cannot be added to foods or drinks, including pet treats. In addition to this, manufacturers should not make any health claims about these products as there is no scientific evidence that supports such claims.
The FDA has been receiving reports from consumers who experienced adverse events after taking certain foods or drinks containing CBD oil over the last few years. These adverse events include severe vomiting and diarrhea which can lead to dehydration or even kidney failure if left untreated for long periods of time; therefore, it’s important for anyone who uses these types of products on a regular basis to contact their doctor immediately if they experience symptoms related with them getting sick after consuming them (e.g.., nausea/vomiting, etc.)
What are the safety concerns?
The use of CBD raises safety concerns, especially with long-term use. Scientific studies show possible harm to the male reproductive system, including testicular atrophy, harm to the liver, and interactions with certain medications. The FDA has not found adequate information showing how much CBD can be consumed, and for how long, before causing harm. This is particularly true for vulnerable populations like children and those who are pregnant. People should be aware of the potential risks associated with the use of CBD products.
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What consequences do these companies face?
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.
Conclusion
Currently, CBD is not permissible as a food additive or dietary supplement ingredient. The FDA has issued several warning letters to food manufacturers that are selling products containing CBD, which demonstrates the agency’s commitment to enforcing the law and protecting public health.
Quality Smart Solutions can help food manufacturers of hemp extracts for dietary supplements and food labeling to ensure its compliant with FDA rules, regulations, and guidance documents. We’ll help you through every step of the clinical trial design and execution and can also help with food products to obtain Generally Regarded as Safe (GRAS) status.
