The FDA does not have the luxury of waiting
The Food and Drug Administration (FDA) held a May 31 hearing to gather public feedback on the CBD and industry stakeholders say the agency's next directions will likely be to develop industry standards and regulate the claims on the labels.
The Food and Drug Administration (FDA) held its first ever public hearing in search of scientific data and information on cannabis and cannabis compounds. With more than 100 speakers and 9,5 conference hours, a wide range of opinions have been initiated.
The problem is not related to security
The main concerns were security and time. Megan Olson, Associate General Counsel Council for Responsible Nutrition (CRN), speaking on behalf of the industry, urged the FDA to "act as quickly as possible to create a legal pathway for supplements and foods," noting that the CBD market is in full swing. expansion. "The FDA does not have the luxury of waiting," she said.
La National Cannabis Industry Association (NCIA) provided the panel 50 testimonial pages written on health and safety issues, product quality and labeling. Andrew Kline, Director of Public Policy, NCIA, in his speech to the lawyer, said: "The overwhelming preponderance of evidence indicates that cannabis and cannabis compounds pose little risk to safety."
Case of epidiolex
Karen Howard, CEO and Chief Executive OfficerOrganic and Natural Health Association, told WholeFoods (organic food distribution company): "The scientific corpus documenting safety is available and growing rapidly." Regarding the CBD, she noted that the problem is not even safety : "The central question is whether hemp extracts are the equivalent of the drug FDA approved.
Howard argues that this is not the case for the Epidiolex : "Hemp extract with its low natural concentrations of CBD is not the same as this patented and approved drug and it has not been researched or marketed with the intended use to treat disease.
1500 CBD products have been on the market in the past three years solely because the FDA has no regulations or rules of thumb. security.
In other words, there is currently a large subset of products without any oversight. Responsible industry members can invest in work and research and spend money on third-party tests to prove that their products are safe and trustworthy, but they must compete with companies that do not do not do it, because there is no regulation that requires them and these companies can develop potentially dangerous products that can be sold cheaply by undercutting the responsible members of the industry.
In this regard, Howard told Whole Foods "Creating more policies will not help retailers or consumers. The application of labeling and manufacturing rules that protect people from bad claims and substandard products will do so. "
Loren Israelsen, president of the United Natural Products Alliance (UNPA), has submitted comments calling on the FDA to create a legal path in the next six months or to help Congress create a legal path. Michael McGuffin, president of the American Herbal Products Association (AHPA), made a similar appeal: "The FDA should use the authority granted under the law to create a regulation authorizing the CBD as a legal ingredient in dietary supplements and foods.
One of the main concerns of the FDA will likely be to develop unified standards and regulations to eliminate bad actors.
Many stakeholders have testified that there are some very good products, but there are also actors who take advantage of them to put on the market products that do not provide the amount of CBD expected and registered where no cbd at all but rather synthetic cannabis and other molecules that should not be there
La first conclusion of the meeting is that the FDA has reservations about the CBD and its effectiveness. This should not surprise anyone, especially as the FDA recognizes only two diseases that respond with CBD: Lennox-Gastaut syndrome and Dravet syndrome.
Thus, without additional and costly clinical studies, it may be difficult to influence the FDA, at least without a prolonged debate of several months.