Washington, D.C.—The Food and Drug Administration (FDA) held a public hearing on Friday looking for scientific data and information regarding cannabis and cannabis-derived compounds. With over 100 speakers, it easily took up the allotted 9.5 hours, and offered a range of opinions.
The top concerns were safety andtime. Megan Olson, assistant general counsel for the Council for Responsible Nutrition (CRN), spoke for the industry when she urged FDA to “act as quickly as possible to create a legal pathway for supplements and food,” noting that the CBD marketplace is exploding. “FDA does not have the luxury of time,” she said.
Those commenters looking to hold off on rulemaking until safety has been thoroughly established were often nervous about the effects of cannabis, rather than CBD itself: For instance, James Beck, representative for the Parkinson’s Foundation, noted that cannabis can cause symptoms that match up with those of Parkinson’s, so that someone suffering from that disease would actually exacerbate their symptoms by using something so often purported to be helpful.
However, there were plenty who felt that the safety of cannabis and cannabis-derived compounds has been thoroughly proven. The National Cannabis Industry Association (NCIA) provided the panel with50 pages of written testimonyregarding health and safety, product quality, and labeling issues. Andrew Kline, director of public policy for NCIA, in his speech to the counsel, said: “An overwhelming preponderance of evidence indicates that cannabis and cannabis-derived compounds present minimal safety concerns.”
Karen Howard, CEO and executive director of the Organic and Natural Health Association, toldWholeFoods: “The body of science documenting safety is available and growing rapidly.” With regards to CBD in particular, she noted that the problem isn't even safety: “The central issue at hand is whether hemp extracts are the equivalent to the drug approved by FDA, Epidiolex." Howard contends that it is not: "Hemp extract with its naturally occurring low levels of CBD is not the same article as this patented and approved drug, nor has it been researched or marketed with the intended use to treat disease."
For many in the industry, legalization of CBD would solve the safety issue. CRN’s position on this issue is, as stated by Olson: “There is already regulatory framework in place that is proven to ensure safety of dietary supplements in food, one that will automatically be implemented should FDA develop a regulation providing CBD in food and supplements.” As noted by David Spangler, SVP of policy and general counsel at Consumer Healthcare Products Association (CHPA), the act of legally bringing a CBD product to market would require supplement makers to submit NDIs for CBD, which would require "sufficient information to provide reasonable assurance the ingredient does not present a significant or unreasonable risk."
As is, however, no NDIs need to be submitted--meaning that there's no guarantee of safety. Daniel Fabricant, president and CEO of the Natural Products Association (NPA), noted that around 1,500 products have come to market in the past 3 years, and that, thanks to the fact that FDA has no regulations or rules around them, FDA is not testing them for THC, inspecting facilities to ensure GMP compliance, or receiving GRAS notices. In other words, as the Industry keeps saying, there is currently a large subset of products with no oversight. Responsible industry members can put in the work and the research and spend money on third-party testing to prove that their products are safe and trustworthy, but they have to compete with companies that aren’t doing that—because there’s no regulations insisting that they do—and these startup companies can produce potentially unsafe products that can be sold cheaply, undercutting responsible industry members. On this topic, Howard toldWholeFoods: “Creating more policy won’t help retailers or consumers. Enforcement of the label and manufacturing rules that protect people from bad claims and poor quality products will.”
Loren Israelsen, president of the United Natural Products Alliance (UNPA), submitted comments calling FDA to create a legal pathway within the next six months or assist Congress in the creation of a legal pathway. Michael McGuffin, president of the American Herbal Products Association (AHPA), issued a similar call: “FDA should use the authority granted under the FTC act to create regulation permitting CBD as a lawful ingredient in supplements and foods. Alternatively, FDA should issue guidance as to safety, the agency’s intent to exercise formal enforcement discretion with respect to the provisions of the FD&C act.” The U.S. Hemp Roundtable, too, seems to be looking to legislation to solve the problem: Jonathan Miller, general counsel at U.S. Hemp Roundtable, said that his organization has been working with lawmakers to draft legislation regulating CBD if FDA determines that the task is too complicated to take on without new legislation.
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