The FDA is holding its first public hearing on how it should regulate cannabis and CBD, and the agency has asked Zynerba and other companies involved with the plant and its byproducts to offer up their opinions, information and data.
Ray Mannion, Zynerba’s vice president of manufacturing, will provide a slide show at the hearing in Maryland, entitled “Cannabinoid Manufacturing and Product Quality.”
In a prepared statement released in a run-up to Friday’s heaing, CEO Armando Anido weighed in on the matter, saying the use of products and treatments made from cannabis needs to be strongly regulated to ensure public safety.
“The FDA has a well-established history of protecting public health and safety through a variety of essential strategies, including existing regulations and processes that govern the manufacture of pharmaceutical products and establish controls to ensure necessary quality and safety standards are met,” he said. “This existing robust framework should be leveraged in the regulation of all cannabinoid products, as less stringent manufacturing and quality standards would create an unnecessary public health risk.”
Zynerba, based in Devon, Pennsylvania, is currently developing Zygel, a CBD gel, in children aged three to 17 with Fragile X syndrome. Topline results are expected in the second half of 2019 from a clinical trial that evaluated the gel’s potency and safety. The company also has started a trial to assess how Zygel can treat the pediatric behavioral and emotional symptoms of 22q11.2 Deletion Syndrome.
FDA just gathering information and data
The FDA is not expected to issue any decisions during what is a information-gathering process, but the agency will place a strong focus on how CBD is marketed and how much CBD should be added to food and drinks. That agency also has expressed concern that allowing CBD in food could dampen incentives for drug makers to conduct research into CBD’s health benefits.
The regulator has been under pressure to create a regulatory framework for CBD -- which took a new urgency when Congress make hemp legal in December under the Farm Bill. CBD was not legalized, but was moved under the purview of the FDA. Some 17 states have legalized CBD.
The vast majority of CBD is extracted from hemp, which is a cannabis plant that has trace amounts of THC (0.3% or less when dried). THC, or tetrahydrocannabinol, is the psychoactive compound that gets people “high.”
Zynerba’s position calling for robust regulations of CBD and other related cannabis products matches what other players in the industry say are needed to create a thriving yet safe marketplace.
Industry players want FDA guidance on critical matters such as establishing a credible verification process to guarantee product purity, quality manufacturing, and labeling transparency.
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