JULY 27, 2023 UPDATE: CRN Asks Congress to Demand FDA ‘Complete the Work’ to Allow CBD to be Marketed as a Dietary Supplement
MAY 11, 2023 – UNLOCKED STORY — CRN SUPPLEMENT MEMBER NEWSLETTER
FDA has access to safety data that is absolutely relevant to the ingredients intended for use in dietary supplements at levels that would be commonly used in supplement products, but has repeatedly disregarded this evidence, continuing to rely heavily on safety concerns related to high dosage Epidiolex, CRN noted in a letter to the agency, responding to the recent publication, “Review of the Oral Toxicity of Cannabidiol (CBD).”
Determination of safety must include consideration of the totality of relevant evidence—data on substances that reflect the ingredients intended for use and at the levels that will be consumed, CRN stated.
CRN pushed back on the authors’ disclaimer that the “review is not a risk assessment and does not seek to identify levels of exposure that may result in adverse effects or levels of exposure that are safe for test animals or for humans.”
Hear more from CRN SVP Scientific & Regulatory Affairs Andrea Wong, Ph.D., about CBD science and safety data.
In its letter to FDA, CRN noted:
Considering that the vast majority of the data cited in the review article has been available for FDA’s evaluation for years, it is unclear why the authors did not conduct a risk assessment.
FDA has had ample access to data and sufficient time to determine a safe level of exposure.
Other government bodies, including the United Kingdom’s Food Safety Authority, Health Canada, and the Australian Therapeutic Goods Administration have established recommended maximum upper intake levels of CBD.
Industry stakeholders have responded to FDA’s call for scientific evidence on the safety of CBD by investing in research on their ingredients, which encompass a range of CBD-containing hemp extracts, as well as CBD isolate, CRN further noted in the letter.
This research, conducted under regulatory test guidelines, provides evidence to support the safe use of various CBD-containing ingredients for their intended uses.
The studies have been published in peer-reviewed literature, submitted to the public docket that FDA opened to facilitate submission of CBD data, or shared with the Agency.
Identifying potential hazards without consideration of exposure levels does not serve public health interests, CRN stated.