In the comments, NPA president and CEO Dr. Daniel Fabricant wrote, "we understand that the public meeting and added comment period are part of the agency’s strategy to promulgate a final NDI guidance. While we understand that this is a priority to some at the agency, we believe that effort in this area should be secondary to a comprehensive NDI enforcement strategy...Does the agency have a plan and metrics that can provide the agency and the American people confidence that FDA is aware of the gaps in compliance as it pertains to NDIs?"
Dr. Fabricant went on to note: "While much discussion has centered on asking congress for new authorities, which is inconsistent with the present administration’s goals, where there is a commitment to remove two regulations with every one that is added, nothing that has been presented from the agency’s behalf has clearly demonstrated the metrics of compliance and where the actual gaps are regarding compliance."
In anews releaseannouncing the comments, Dr. Fabricant said, “CBD is the biggest product that hasn’t cleared an NDI, demonstrating that FDA doesn’t need new authorities. Rather than seeking new authorities from Congress, we urge the Agency to develop a comprehensive NDI enforcement strategy. The Agency already has the authority to take this approach and it is consistent with the Trump Administration’s commitment to streamlining regulations to make them more responsive and efficient for consumers and businesses. The U.S. dietary supplement supply is the safest in the world thanks to the regulatory regime we have in place, and we want to keep it that way. Our top priorities are safety, access and keeping supplements affordable for the growing number of Americans who use them every day."NPA also submitted comments to the FDA focused on the Association's effort to secure federal regulations for cannabidiol (CBD) products. The comments follow the passage of legislation in the House of Representatives that would appropriate $100,000 for the FDA to perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. NPA noted that the process would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe.
"The government has the authority to provide clarity for this new promising product for consumers and the emerging billion-dollar market it will produce,” said Dr. Fabricant. “NPA is leading this effort because we believe strongly in a clear and fair regulatory approach for all new ingredients."
NPA's full comments on issues related to CBD, including Health and Safety Risks; Manufacturing and Product Quality; and Legal Authorities, can be foundhere. Regarding legal authorities, Dr. Fabricant stressed in the letter: "While FDA has not made any written statements on it exercising enforcement discretion, the fact that approximately 1,500 products have come to market and FDA has not acted on them based on the definitional aspects of the ingredient means that they are allowing the product to stay on the market via enforcement discretion. The definitional aspects can be addressed by notice and comment rulemaking, in the interim rulemaking does NOT prohibit the agency from stabilizing the marketplace now while adding real regulatory oversight and effort."
Related: Congress Urges FDA To Move Forward With CBD Legalization House Passes Amendment Designed to Ensure CBD is Regulated by FDA FDA Cannabis/CBD Public Hearing: “FDA Does Not Have the Luxury Of Time”
