On July 16, 2019, the American Veterinary Medical Association (AVMA) published a letter to the acting commissioner of the Food and Drug Administration (FDA), Dr. Norman E. Sharpless. This was in response to the request for comments and input from industry stakeholders regarding: products containing cannabis or cannabis-derived compounds.
The opening remarks begin with “Veterinarians have a strong interest in, and enthusiastically support, exploring the therapeutic potential of cannabis-derived and cannabis-related products, but we want to be sure we can have continued confidence in the efficacy, quality, and safety of products used to treat our patients.”
The 8-page letter gives the Association’s responses to multiple specific questions posed in the Federal Register notice. A brief summary of the major points of concern are:
• The need for evaluation of safety and efficacy of products, including not only individual components, but the effects of combination products, including the “entourage effect.”
• The assurance that products marketed and labeled for animal use must “adhere to strict purity standards, tolerance levels, and verification protocols, and be subject to robust testing and controls, as is currently expected of manufacturers of labeled and approved products.”
• Concern for potential interaction between CBD and FDA approved drugs currently used in practice.
• Need for establishing withdrawal times for potential use in food producing animals.
• GRAS status for inclusion of cannabinoid products in pet foods.
• Clear delineation of products marketed as pharmaceuticals vs. those marketed as food products.
• Need for enforcement of manufacturers that are non-compliant.
• Lack of quality assurance associated with CBD products available to pet owners.
• Collaboration with the USDA to ensure uniform standard for sampling, testing and processing of the plant material.
• Clear, consistent labeling as for other FDA approved products, including package inserts.
• Clarification of “animal supplements.”
• The inclusion of veterinary professionals in the conversation at the state and local legislative and regulatory levels.
Overall, all reasonable, expected requests from an organization such as this. The goal being “for safe products that are effective for their intended uses to be brought to consumers through an efficient process.” In the conclusion, the letter states “The AVMA is a scientific organization that relies on evidenced-based medicine. We support additional research on cannabis-derived and cannabis-related products, so that veterinary practitioners may be better informed about their potential therapeutic uses and potential counterindications. Should this research result in FDA approval of such products, this would provide the assurance we need that products made available for use in veterinary patients are efficacious and safe.”
This letter, as well as the testimony from 100 speakers at the public hearing on May 31, as well as the over 4000 public comments will all be taken into consideration by the FDA to develop rules surrounding the regulation of hemp and its CBD products.
The FDA plans to report on their progress by late summer/early Fall, according to tweets by Dr. Amy Abernathy, the Chief Information Officer.
To view the comments on the FDA’s public docket, click the link below:
https://www.regulations.gov/docket?D=FDA-2019-N-1482
A copy of this letter is freely accessible on the AVMA’s website home page, under the Considering Cannabis link, or you can click the link below:
https://atwork.avma.org/wp-content/uploads/2019/07/2019_07_16_FDA-2019-N-1482.pdf