Settled? Far from it! Over 100 representatives from academia, agriculture, the medical and veterinary community, manufacturers, coalitions and a few members of the public had their say at the first FDA CBD public hearing on Friday, May 31st, but at the end of the day there was far from a clear course of action.
What is clear is how to oversee and regulate cannabis is a complex issue not to be settled any time soon. The “good news” is the public comment period is still not over.
While the period is closed to make oral presentations and comments at the public hearing, electronic or written comments will be accepted by the FDA until July 2, 2019. Here is the general information from the FDA website:
“The FDA is establishing a docket for public comment on this hearing. The docket number is FDA-2019-N-1482. The docket will close on July 2, 2019. Submit either electronic or written comments on this public hearing by July 2, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 2, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of July 2, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.”
For complete information about how to submit, please visit the supplementary section of the FDA website here.
Transcripts of the original hearing will be accessible as soon as they are available at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm634550.htm. They will also be available at https://www.regulations.gov.
CBD products for pets have been big news but there is much confusion about the labeling, safety and efficacy of some products. Veterinarians cannot presently prescribe CBD products but can discuss them if the pet owner asks about them. The American Veterinary Medical Association (AVMA) has been closely monitoring a variety of issues since the Farm bill was passed in 2018. Webinar information is available to AVMA members on the AVMA member section of the website.
An American Veterinary Medical Association (AVMA) representative, Dr. Ashley Morgan, Director, State Advocacy Division testified at the FDA hearing. The AVMA plans to submit written comments. In addition a hot topics special session is planned for veterinarians and the veterinary healthcare team at the AVMA convention. For information about the session, visit the Goodnewsforpets calendar here.
The pet industry has many products on the market and it is anticipated exhibitors will showcase more products at SuperZoo, an industry trade show held in August. An educational session for retailers will be held at the show, visit the Goodnewsforpets calendar here.
According to the FDA, the public hearing was intended to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
While many pet owners are enthused about the possibilities of these products and many positive anecdotal results are being reported, experts at the FDA hearing made it clear not only do many more studies need to be conducted, but a clear regulatory pathway needs to be established. In the meantime, pet owners should educate themselves, read the labels carefully and as always, see their veterinarian about their own pet’s medical needs.
Goodnewsforpets will continue to follow this trend and is providing information pertinent to the pet products market. In the meantime, submit those comments. For the full FDAH hearing statement visit the FDA website here and the public notice here.
FDA Notice On Animal Food and Drugs
The full statement from the FDA is available on the FDA website, however, here is the section pertinent to animal food and drugs:
“The FDA regulates animal food in a variety of ways, including by approving safe food additives and establishing standards for animal food contaminants. FDA has not reviewed any food additive petitions for cannabis-derived animal feed, nor have any cannabis-derived feed ingredients been the subject of a GRAS determination by FDA, a GRAS notice that underwent FDA evaluation and received a “no questions” response, or otherwise been approved for use in animal feed by FDA. Animal food companies that wish to use cannabis or cannabis-derived compounds in their animal food products are subject to the relevant laws and regulations that relate to the food additive and GRAS processes. With respect to THC and CBD specifically, as discussed above, it is a prohibited act under section 301(ll) of the FD&C Act, to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added.
As stated above, a drug is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals (section 201(g) of the FD&C Act. A drug is also defined as an article (other than food) intended to affect the structure or any function of the body of man or other animals. Thus, the determination of whether a product is a drug turns in part on the “intended use” of the product.
Currently, there are no legally marketed new animal drugs that contain cannabis or cannabis-derived compounds. A new animal drug is deemed “unsafe” under section 512(a) of the FD&C Act (21 U.S.C. 360b(a)), and may not be sold into interstate commerce under section 301(a) of the FD&C Act), unless it has an approved new animal drug application (NADA), abbreviated NADA (ANADA), conditional approval (CNADA) or index listing. FDA reviews the data submitted in a marketing application to evaluate whether an animal drug product meets the statutory standards for approval. To conduct clinical research that can lead to an approved new animal drug, including research using materials from plants such as cannabis, researchers establish an Investigational New Animal Drug (INAD) file with FDA, and comply with the requirements described in 21 CFR part 511.”
The FDA also has an FAQ section here.
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