July 16, 2019
Norman M. Sharpless, MD
Acting Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments (Docket No. FDA-2019-N-1482)
Dear Dr. Sharpless,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the U.S. Food and Drug Administration (FDA) proposed request for comment on the "Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds" (Docket No. FDA-2019-N-1482) (the "request for comments") originally published in the Federal Register on April 3, 2019. Representing over 108,000 registered dietitian nutritionists (RDNs),1 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation’s health through food and nutrition. Our members work in a variety of clinical and community settings across the continuum of care, and work with industry and consumers to develop and effectively utilize product labels that encourage individuals to make safe, healthy, informed food choices.
The Academy strongly supports a science-based, public health-driven approach to the regulation of products containing cannabis or cannabis-derived compounds, including delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). We recognize this approach is essential in developing the type of objective, consistently-applied process that will be required as the legality of cannabis continues to change over time at both the State and Federal levels. We encourage the FDA to consider how to effectively ameliorate consumer confusion arising from changing legal interpretations.
A. Academy's Labeling Principles
The Academy adopted in 2014 the following principles for labeling initiatives to guide development of our regulatory comments and policy stances. Those principles specifically relevant to the regulation products containing cannabis or cannabis-derived compounds and the Academy's response to the FDA's request for comments are bolded below.
- Label claims should be clear and understandable to consumers; consumers' nutrition literacy is key to promoting understanding.
- The label must be truthful and not misleading.
- Content on the label should help consumers make informed decisions to build a healthy diet.
- Labels should help to provide understanding about the nutrient density and overall healthfulness of overall food rather than a focus on particular nutrients.
- Label content should have consistent type and format so products can be read and consumers can make product comparisons.
- Labeling should enhance consistency among the various government nutrition recommendations.
- All claims should include labeling of accurate quantitative information about the dietary substance, including percent of Daily Value in a single serving of the products, when known, or the daily dietary intake necessary to achieve the claimed effect.
- Consumer research is imperative before making changes to the label.
- The label is only a source of information, and thus sustained support for educational programs and individual counseling by registered dietitian nutritionists is essential.
B. Research and Regulation
As the request for comments notes, "The 2018 Farm Bill explicitly preserved FDA's authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized FDA's important public health role with respect to all the products it regulates." (Internal citations omitted.) The Academy appreciates the work the FDA is doing on this subject and the questions posed in its request for comments.
As the National Academies of Sciences, Engineering, and Medicine2 concluded in its 2017 review of the scientific literature published since 1999, there is a need for additional research about the health impacts of cannabis and cannabis-derived products. We support efforts to secure funding to close the research gap regarding CBD or tetrahydrocannabinol (THC) as food additives, specifically including research on differential effects across the lifecycle. Given the paucity of rigorous scientific trials or studies to rely on regarding the effects and limitations outside of childhood epilepsy syndromes, we eagerly anticipate additional information and research data provided by the public in written comments to supplement brief comments offered at the public meeting.
The Academy recognizes that at present, "Selling unapproved drug products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk as the marketing of unproven treatments raises significant public health concerns." The marketing of CBD in food products and the use of health claims raises concerns about the potential for misuse, consumer confusion, and a lack of sufficient scientific substantiation. At this time, the Academy suggests that consumers should be advised to use caution when purchasing and consuming products and food items that contain CBD given insufficient information about dosing, effectiveness, mode of transmission, or safety.
The Academy appreciates the opportunity to comment on the request for comments regarding the "Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds." Please contact either Jeanne Blankenship at 312/899-1730 or by email at email@example.com or Pepin Tuma at 202/775-8277, ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 National Academies of Sciences, Engineering, and Medicine. 2017. The health effects of cannabis and cannabinoids: Current state of evidence and recommendations for research. Washington, DC: The National Academies Press.