Here is the condensed version of what the hemp roundtable said to the FDA.
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. On May 31, the Roundtable testified at the FDA’s first public hearing that CBD was safe and that the agency should move expeditiously to promulgate regulations for the retail sale of hemp CBD products. On June 20, Roundtable leadership met privately with a dozen senior FDA officials that comprise the agency’s CBD Working Group to provide further analysis. Yesterday, the Roundtable shared a 29-page report with extensive safety data to back its recommendations.
Dozens of Roundtable member companies and organizations – including substantial assistance by its grassroots partner, the Hemp Industries Association – provided information for the Roundtable’s commentary. Of particular note is data about “adverse events” – company consumer reports about problems associated with CBD products:
As shown in the attached materials, one of our member companies sold approximately 580,000 products with zero serious adverse events reported to the company, and about 300 non-serious adverse reported for humans and animals. Another member company has sold over 1.4 million products, with zero serious adverse events and 623 non-serious adverse events. This company has also provided a thorough breakdown of its reported adverse events in the attached materials. A third member company provided a summary of adverse events/complaints related to human ingestion or topical application of their products along with the percentage of adverse events/complaints per units sold. A fourth company provided adverse events related to human ingestion and topical products reporting approximately 200 adverse events and zero serious adverse events, with over 2 million products sold. Notably, the percentage of AERs for these companies (serious and non-serious) is 0.01-0.1 percent.
Based on the data shared by Roundtable members, as well as significant research and public information, the Roundtable’s counsel concludes: “We believe that there are no unique safety concerns associated with the consumption of CBD that would preclude the use of FDA’s current regulatory framework in establishing product-specific acceptable levels of use.”
Ultimately, the Roundtable shared the following recommendations:
CBD does not appear to pose unreasonable safety risks to consumers and therefore can be regulated by FDA like any other botanical ingredient used in these products. This position is supported by clinical studies conducted at dosages at or above what is commonly used in dietary supplements, food, and cosmetics. Several of these studies are in sensitive populations.
Appropriate levels of CBD will be much lower in food and dietary ingredients than those used in pharmaceutical products. However, we advise against establishing arbitrary dose limits for these products as the effects of the CBD will vary greatly based on the intended use, formulation, and mode of delivery. Each manufacturer has the burden to establish its specific product formulation is safe for the intended population through FDA’s current regulatory framework.
Safety concerns that may arise from the lack of data in vulnerable populations such as children, pregnant or lactating women, and patients taking therapeutic levels of CBD can be addressed in the labeling of the product with adequate advisory language and directions for use.
FDA’s current regulatory system supports incentives for drug development, and clearly and sufficiently distinguishes these products from food and dietary ingredients based on their intended use and labeling.
The Roundtable urges FDA to use its existing authority under the FD&C Act to enforce the mandatory cGMPs to protect consumers from unsafe products and ensure that all hemp-derived products are produced in a quality, consistent manner and accurately labeled.
We also encourage FDA to consider adopting the standards provided in the U.S. Hemp Authority Guidance and work with standard-setting organizations such as ASTM, ANSI, AOAC, and USP to develop validated analytical testing and consensus-based standards for quality and safety. In future guidance or rulemaking, we also recommend that FDA to include consensus-based, validated standards and methods for cannabinoid content, specifically CBD and THC.
If FDA determines that standardized definitions are necessary, we encourage FDA to work with industry stakeholders to develop these definitions.
FDA should continue to actively enforce the adulteration and misbranding provisions of the FD&C Act to ensure consumers are informed of any risks associated with the use of hemp products.
Existing federal laws and regulations provide the most appropriate mechanism to inform consumers in a uniform, consistent manner of the potential risks of products that contain hemp-derived ingredients, thereby obviating the need for state restrictions.
FDA, rather than states, is best suited to 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.
Should FDA determine that advisory language is necessary for products containing CBD or other hemp-derived ingredients, we recommend that FDA consider utilizing the advisory language provided in the U.S. Hemp Authority Guidance.
The Roundtable’s comments were one of several thousand submissions made before the FDA’s July 16 deadline. The agency has announced that it 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.
