FDA pressed for safety and efficacy assurances
Posted July 24, 2019
The Food and Drug Administration held a public hearing in late spring on the legality of selling certain food and dietary supplements containing cannabis and cannabis derivatives.
The hearing is part of an FDA plan resulting from growing interest in FDA-regulated products derived from Cannabis sativa L and its components. More than 500 people registered to attend the public meeting, held May 31 at FDA headquarters in Silver Springs, Maryland, and roughly 800 are thought to have viewed it remotely.
In addition to gathering stakeholder input, the FDA will convene an internal working group to study the sale of cannabis products, taking into account statutory and regulatory changes needed to legally market the products. The working group will also look at possible public health impacts resulting from the availability of such products as well cannabis’s potential to harm animals.
Norman Sharpless, MD, acting commissioner of the FDA, opened the hearing by reiterating that the agency’s role in regulating products containing cannabis or cannabis-derived compounds is not new. Cannabis, Dr. Sharpless said, contains more than 80 biologically active chemical compounds, including the two best-known compounds, delta-9-tetrahydrocannabinol and cannabidiol.
“If one of these compounds, or the plant itself, is added to a food or cosmetic, marketed as a drug, or otherwise added to an FDA-regulated product in interstate commerce, then it falls within FDA’s jurisdiction. As I said, this is nothing new for FDA,” said Dr. Sharpless, according to his remarks as prepared for delivery.
It is imperative that FDA provide a pathway that assures regulatory clarity and predictability, and the economic viability of the industry. Further, the agency must make its enforcement priorities known, and then consistently and intentionally act on those priorities. Otherwise, we will continue to face the wild west, and invariably greater numbers of therapeutic failures and toxicoses in our patients.”
Dr. Ashley Morgan, AVMA State Advocacy Division director
Dr. Sharpless noted that some relevant laws have changed. Many states have changed their laws to allow for medical use of marijuana or CBD, and others have decriminalized recreational marijuana use. Certain federal laws have changed as well. Late last year, the federal scheduling of cannabis changed. The Agriculture Improvement Act of 2018 removed hemp—cannabis or derivatives of cannabis with a very low THC content (below 0.3% by dry weight)—from the Controlled Substance Act’s definition of marijuana. As a result, while marijuana remains a Schedule I drug, hemp is no longer a controlled substance under federal law.
“As these laws have changed, FDA’s authorities have become more relevant,” Dr. Sharpless explained. “The 2018 Farm Bill explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds. In doing so, Congress recognized FDA’s important public health role with respect to all the products it regulates, including when those products are or contain cannabis ingredients.”
During the hearing, Dr. Ashley Morgan spoke on behalf of the AVMA, saying that the Association believes there may be therapeutic potential in some cannabis-derived and cannabis-related compounds—and that the AVMA would like to see that potential realized.
“There are FDA-approved cannabis products for human use that veterinarians may use in an extra-label fashion. However, we ultimately desire products for use in animals that come with the assurance veterinarians need that they are of good and consistent quality, and that they are efficacious and safe for use in our patients,” said Dr. Morgan, director of the AVMA State Advocacy Division, according to her prepared testimony.
Products intended for use in animals may be animal drugs, food or feed, or food or feed additives. Dr. Morgan said the FDA should clearly articulate where the various cannabis-derived and cannabis-related products fall in these categories and what may or may not be included in promotional and labeling materials for them.
There are many companies in the marketplace today selling unapproved cannabis-derived products for dogs, cats, and horses, some of which make what clearly appear to be therapeutic claims, Dr. Morgan continued.
She said: “And, while we know the Dietary Supplement Health and Education Act doesn’t apply to products intended for use in animals, other manufacturers say they are making no therapeutic claims, but are simply selling supplements or nutraceuticals for veterinary use. As justification they ask rhetorically, ‘What is the difference between CBD and a glucosamine supplement intended to support joint health?’
“Given known gaps in quality, limited information about these products’ efficacy in veterinary patients, and emerging concerns about their safety, the AVMA believes the FDA must seriously consider the need for efficacy and safety data when therapeutic claims are made or implied for these products.
“To facilitate the development of such products for veterinary use, it is imperative that FDA provide a pathway that assures regulatory clarity and predictability, and the economic viability of the industry. Further, the agency must make its enforcement priorities known, and then consistently and intentionally act on those priorities. Otherwise, we will continue to face the wild west, and invariably greater numbers of therapeutic failures and toxicoses in our patients.”
Related JAVMA content:
FDA open to possibility of legalizing some cannabis products (June 1, 2019)