With the law changes that came with the Agriculture Improvement Act of 2018, also known as the Farm Bill, the need for FDA clarification and guidance on the regulatory framework has been voiced by advocates, industry representatives, regulators, health professionals, and legalization opponents.
In the remarks made by Dr. Sharpless after the May 31st Public Hearing, he clarified that depending on product type, FDA legal requirements vary. Drugs cannot be sold without FDA approval. However, food, including dietary supplements, is regulated differently. Only new food additives, those not already generally recognized as safe (GRAS), must be FDA approved before being used as a food ingredient.
Dr. Sharpless noted “that several cannabis-derived substances have already come to market through the GRAS pathway,” such as hemp seed ingredients. Nevertheless, CBD and THC are approved drugs and under the Federal Food, Drug & Cosmetic Act adding drugs to human or animal food in interstate commerce is prohibited. He also recognized that there are currently companies selling unapproved CBD products and some, especially those making disease claims have been issued FDA warning letters.
The statement was concluded acknowledging that there are still a lot of questions that need to be answered and the FDA continues to evaluate the use of cannabis and cannabis-derived compounds in FDA-regulated products.
The Tentamus Group, in particular, Tentamus North America, offers various services to assist in ensuring your foods and dietary supplements are compliant:
- Food and dietary supplement label claim review
- Food and dietary supplement full label review for FDA compliance
- Food and dietary supplement ingredient list review
- Product nutritional analysis and nutrition fact creation and review
The full summary of the Remarks by Dr. Sharpless at the FDA Public Hearing on Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds can be found here: https://www.fda.gov/news-events/speeches-fda-officials/remarks-dr-sharpless-fda-public-hearing-scientific-data-and-information-about-products-containing
Get in touch with our experts. We’re ready to discuss your requirements.
Vy Goddard, Regulatory Affairs Specialist
Tentamus North America