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Top US Food and Drug Administration officials have acknowledged the difficulties they face in regulating products containing cannabidiol, CBD, admitting that regulators are far from answering a multitude of questions when addressing their new terrain.
Acting FDA Commissioner Ned Sharpless went straight to the point at the start of a 10-hour public hearing on May 31, admitting that the agency did not know if there was a amount of safe CBD that can be consumed in a given day or period. should be used, if there are risks of use during pregnancy, whether it should be administered to children in any form whatsoever and how it can possibly interact with drugs or drugs. other prescription products.
He added that the FDA had formed an internal task force to address the CBD's knowledge gaps and to find a way to regulate products, which are increasingly being illegally traded in the United States. under different forms.
Sharpless acknowledged that Congress had confused the legality of the CBD in the United States when it removed hemp – cannabis or its derivatives containing less than 0.3% delta-9-tetrahydrocannabinol, or THC, in dry weight – of the definition given in the Controlled Substances Act. marijuana under the Agriculture Improvement Act of December 2018 or the Farm Act.
Although marijuana remains an Schedule I drug under the 1970 Act – drugs for which no medical use is currently accepted and that have a high potential for abuse – hemp is no longer considered a substance controlled by the 2018 Farm Bill.
But the new law has not changed FDA authorities to regulate cannabis or by-products, and CBD remains a drug in the eyes of the agency.
"What this means is that under current legislation, CBD and THC can not be added legally to a food or marketed as a dietary supplement," Sharpless said.
While stores and websites illegally market more and more CBD-based products in the United States – soft drinks, herbal teas, lotions, make-up, pet treats, and so on. – the FDA has sent warning letters to only a handful of companies.
Hot topic
The popularity and concern over the legalization of CBD consumer products in the United States was evident at the busy meeting at FDA headquarters in Silver Spring, Maryland on May 31.
More than 400 people had asked to speak at the public hearing, but the FDA said it could only accommodate about 120 presenters.
Lisa Gill of Consumer Reports, a non-profit organization, said a survey of 4,355 US adults conducted by her organization in January found that 26 percent of respondents said they had tried at least one CBD product. once in the last two years.
Of these, 37% reported using CBD to reduce stress or anxiety or to help them relax, while 24% reported using the products to relieve joint pain. About 11% reported using CBD for recreation or recreation and 10% reported using the products to improve their sleep.
A large number of respondents reported replacing their prescription or over-the-counter medications with CBD, 36% of whom said they were now using it instead of a prescribed opioid.
However, the survey also revealed that many Americans mistakenly believed that the CBD-based products they used had been subjected to FDA testing and regulatory processes to ensure their effectiveness and safety .
Cowen & Co. badysts estimate that the US CBD market could reach $ 16 billion by 2025, while the Brightfield Group, a market research firm, estimated it at $ 22 billion. here 2022.
Clinical tests
Many stakeholders at the FDA meeting argued that the agency could use its food supplement framework for CBD and does not need to create a new pathway, while others have insisted that products be required to submit clinical data demonstrating efficacy and safety. Other presenters fell somewhere in between.
"Ladies and gentlemen, the genie has come out of his bottle and it is probably impossible to force him to go back inside," said Colorado lawyer Dave Rodman, whose law firm is currently in charge. lawyers represents a number of cannabis producers, investors and dispensaries.
Andy Snyder, author of the online news bulletin Manward Press, criticized the FDA for its "slow to non-existent" response to the CBD, which, he said, would be "just a few years from the perception by most Americans from vitamin C or any other common medication or vitamin. "
"We've been in a multi-billion dollar industry for five years now and we're talking to you about it, but you were not even aware of the problems that researchers are having to test that kind of stuff," he said. Justin Blehar, co-founder of Genco Pura Oil Co., which sells CBD products.
Some witnesses said that the US CBD market had already become the "Wild West", devoid of standards and uniformity and operating under a patchwork of unclear state rules.
Peter Pitts, president of the Center for Medicine in the Public Interest and former badociate commissioner at the FDA, warned that the agency should put an end to "aggressive and misleading marketing campaigns" by manufacturers and distributors of CBD, insisting that the United States could end up in another epidemic like the opioid crisis.
Given the rapid expansion of the CBD market, Amy Abernethy, senior deputy commissioner to the FDA, who was part of the regulator group at the May 31 hearing, acknowledged that it was essential to clarify in due course the way forward.
"But it is our responsibility to ensure that the regulatory route is scientifically sound and in the interest of public health," Abernethy tweeted at the public meeting.
Clear differentiation needed
The FDA has already approved a drug containing CBD – Epidiolex from GW Pharmaceuticals PLC, an oral solution indicated for the treatment of convulsions badociated with Lennox-Gastaut syndrome and Dravet syndrome in patients as young as 2 years old.
"The FDA's approval process is the only way to answer important questions about a drug, the illness it's trying to deal with and the safety considerations specific to the patients who will take it," he said. Alice Mead, Vice President of Greenwich Biosciences. a subsidiary of GW Pharmaceuticals PLC.
Mead noted that no one knew that CBD was potentially toxic to the liver before GW conducted preclinical and clinical studies on the compound.
It has also been discovered that CBD has drug interactions with other drugs, such as warfarin, a common anticoagulant, Mead said.
"There is still so much we do not know about the CBD," she added.
Steve Schultz, Vice President of Investor Relations at GW, told S & P Global Market Intelligence that it is critical that the FDA make a clear distinction between products like Epidiolex, which has gone through the approval process drugs in the United States, and retail products.
"The scientific evidence regarding Epidiolex can not be extrapolated to another CBD-based product, and I think that part of that is happening – patients and companies are confusing the two," Schultz said.
Washington lawyer Will Garvin, shareholder and co-director of the Buchanan cannabis group, Ingersoll and Rooney PC, argued that even though anecdotal information does not reach the level of clinical trials although well conducted, they nevertheless remain useful for knowing if there are undesirable events. or therapeutic benefits.
"If the use of these products lessens the impact of opioid addiction, the FDA should investigate this property that would have a beneficial effect on public health," Garvin told S & P Global Market Intelligence .
But he stressed that "first and foremost, the FDA is a government health institution and therefore needs to focus primarily on science".
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