Debra Borchardt
The FDA provided an update on its efforts at evaluating CBD products over the past year. The agency said that it is taking several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.
“We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons,” said the FDA’s statement.
“We are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.”
The FDA said it was wanting to get more data on the following conditions:
- The sedative effects of CBD
- The impacts of long-term sustained or cumulative exposure to CBD
- Transdermal penetration and pharmacokinetics of CBD
- The effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile
- The safety of CBD for use in pets and food-producing animals
- The processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products
Reopening Public Comments
The FDA said it was re-opening the public docket that was created for the May 2019 public hearing. “We have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential.”
The FDA’s Office of the Chief Scientist was also recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. “Additionally, we’ve initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration.”
No New Guidance on Products
While the FDA did decide to reopen the docket and has begun to dip its toes into research, the agency gave very little new guidance with regard to products. It only stated, “We also have serious concerns about products that put the public at risk in other ways. For example, we are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.”
The agency merely stated It was evaluating the issuance of a risk-based enforcement policy.
