By Pet Product News Staff
Published: 2020.03.23 08:30 AM
The American Pet Products Association (APPA) is calling on its members to help the National Animal Supplement Council (NASC) in its efforts of assembling “a dossier of credible safety data” on products containing cannabis and cannabis derivatives, including cannabidiol (CBD). Four species are being targeted: dogs, cats, horses and humans.
The collection of data, which is in conjunction with the University of Illinois, is to help establish a responsible pathway forward with such products, according to officials. The target date for completing the project is the end of March.
“Many NASC member companies have already submitted studies that have been forwarded to the University of Illinois, but the FDA has now announced that it has reopened the docket for submitting information the agency can evaluate,” Julia Fidenzio, vice president of government affairs and general counsel at APPA, said in a letter addressed to APPA members.
The FDA reopened the docket to “provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available,” FDA officials said in its post. “In the notice reopening the public docket, FDA outlined areas where data would be useful to inform FDA on the safety of CBD. This notice also includes instructions on how to submit data…To promote efficient and expeditious development of high-priority data on the safety of CBD, FDA has identified areas where it would be most helpful for clinical data to be generated to further address data gaps related to safety. This includes both specific clinical studies and the development of systematic surveillance. FDA is actively working to address these gaps, with the limited available funds for research, but also seeks collaboration and data from stakeholders.”
Fidenzio is encouraging any APPA member company who has CBD data, information or study results related to dogs, cats, horses or humans to submit it to NASC (email email@example.com) or directly to the FDA through the FDA docket.
“Credible safety information undoubtedly is critical to NASC’s efforts to forge a responsible path forward for CBD products, so APPA members are strongly encouraged to submit any such information as soon as possible, through either of the above channels,” Fidenzio added.
In her letter, Fidenzio also noted that the NASC has been advised that one of its members currently has a similar CBD study underway. The NASC has scheduled an April meeting with the NASC member, officials from the FDA Center for Veterinary Medicine and NASC’s research partners at the University of Illinois.
“The purpose of the April meeting is to review the information from the dossier and from the research study already in progress, and to discuss additional studies that can help address the FDA’s concerns about animal safety in our three primary species,” Fidenzio said. “NASC will continue to issue updates on its initiatives following the April meeting, or possibly sooner should there be any new developments, and we will pass any updates along to APPA members.”
Fidenzio refers to NASC’s steps as “crucial” in remedying the uncertainty regarding CBD products.
“APPA supports these efforts on behalf of our members, especially those who currently are involved in—or even considering entering—the CBD product market in the future,” Fidenzio said.