Many are accusing the FDA of dragging their feet when it comes to approving and regulating CBD products. Following a dedicated public meeting recently, many expected some long-awaited guidance by now.
Lawmakers are now putting pressure on the Food and Drug Administration to get moving and draft their rules on the regulation of CBD products. However, to their defense, the whole issue is so complex, it’s taking the FDA longer than expected to get their heads around the matter and issue some guidance.
One has to have some sympathy for the FDA after they were forced to scramble to get a hold on hemp-derived CBD (cannabidiol) products following the Farm Bill 2018. The bill allowed for the industrial cultivation of hemp and sent many people into a tailspin; not least, the good people over at the FDA.
CBD is both considered to be a health supplement and a drug, and that’s the main reason why the FDA has such a difficult battle on their hands. Some lawmakers have even gone as far as to threaten that they won’t wait for FDA guidance and will proceed as they see fit at the legal level. Like Jonathan Miller, general counsel for the industry advocacy group U.S. Hemp Roundtable said according to a report from The Hill, “In Congress, some are itchy [for action]. If their patience ends [and FDA doesn’t act], there will be an effort for legislation,” Miller said.
The FDA’s public hearing on May 31st was supposed to resolve the matter, as expert after expert stood and spoke about CBD and its numerous benefits. Despite 10 hours back and forth at that meeting, the FDA Commissioner, Ned Sharpless did not indicate timeframes.
“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” Sharpless said. One sticking point is dosing levels; another is the long-term effects of CBD (if any) that are not known about due to decades of cannabis prohibition. CBD from hemp is legal, but a separate issue arises when it comes to CBD in food, beverages or as a dietary supplement due to consumption and other issues.
As Miller pointed out, those inside the cannabis industry are willing to wait for the FDA to get their act together, but only because they believe it’s good for business. “We want to give FDA the appropriate space to come up with their conclusions,” Miller said. “They are under a lot of pressure from Congress, and Congress is under pressure from the public. I think they realize they need to move quickly.”
At the same time, Senators on a bipartisan level are pushing the FDA to get moving and offer some clarification. More than $100,000 was earmarked and set aside as part of a House appropriations package to study CBD. Senate Majority Leader Mitch McConnell even met last week with Sharpless and told him to get a move on.
“Congress’s intent was clear with the passage of the Farm Bill that these products should be legal, and our farmers, producers, and manufacturers need clarity as well as a workable pathway forward regarding the agency’s enforcement,” McConnell said to reporters.
While the process for approving new products with the FDA traditionally takes at least a couple of years, it’s taking much longer than that to get a hold on CBD. While everyone is mainly on the same team here; all wanting a better understanding of CBD, it’s effects and level of safety, lawmakers don’t want the FDA to use that as an excuse to drag their feet on this occasion.
As attorney Jessica Wasserman noted, “FDA needs to create a pathway without taking years worth of safety data,” she said. “[CBD] has been on the market for a long time, and they [FDA] haven’t been using their enforcement powers on it.” And while that may be true, the buck stops with the FDA, and that’s one of the reasons why they need to proceed with extreme caution when it comes to hemp-derived CBD and CBD products.
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