Yesterday the U.S. Hemp Roundtable provided formal written comments to the Food and Drug Administration, as part of the FDA’s efforts to develop a regulatory path for the sale of hemp-derived CBD.
After testifying at the FDA hearing that CBD was safe and to encourage regulations for the sale of hemp-derived CBD products, Roundtable leadership met privately with a dozen senior FDA officials to provide further analysis. Following this meeting, the Roundtable shared a 29-page report with extensive safety data to back its recommendations that came from dozens of Roundtable member companies and organizations – including substantial assistance by its grassroots partner, the Hemp Industries Association.
The ultimate recommendations that came from the Roundtable centered around the safety and lack of risk to consumers. In fact, in a test including millions of products sold, less than 0.1% reported ‘adverse events’ related to human ingestion or topical application of CBD products. This data clearly showed that CBD does not appear to pose unreasonable safety risks to consumers and therefore can be regulated by the FDA like any other botanical ingredients used in these products.
Further, they found that the FDA, not the states, should determine whether the current labeling of dietary supplements and food containing hemp-derived ingredients should include additional language to inform consumers, in particular vulnerable sub-populations (pregnant women, children, etc.). Finally, they concluded that when using advisory language for products, the FDA should consider utilizing the advisory language provided in the U.S. Hemp Authority Guidance.
The FDA has announced they will report on its progress in late summer or early fall. We look forward to continued collaboration with the agency as it develops its final regulations.
Stay tuned for more updates as they continue to come in!