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The Congress is putting more pressure on the Food and Drug Administration (FDA) to draft rules to regulate cannabis products.
Legislators have legalized the use of cannabis-based cannabidiol (CBD) products late last year in the agricultural law, forcing the agency to seek new rules to regulate a unique product that is both a drug and a dietary supplement.
But Congress says it's getting more and more impatient as the FDA looks for a solution and might not wait much longer.
"In Congress, some itch [for action]"Said Jonathan Miller, general counsel of the industry advocacy group, the US round table on hemp.
Miller said some lawmakers had privately circulated potential bills, but he expects no official push from Congress before at least later this fall.
"If their patience ends [and FDA doesn’t act]there will be an effort for legislation, "said Miller.
The FDA held a public hearing at the end of May. Experts and industry representatives said it was a good start, but had not made much progress with regard to clarifying the federal level.
The people who attended the meeting said they left without having a new idea of when the agency was going to create new regulations.
During the 10-hour hearing, FDA Acting Commissioner Ned Sharpless made no promise as to the date, but FDA officials made it clear that they wanted get more data from the public. Sharpless said the agency was operating mostly in unknown waters.
"Although we have witnessed an explosion of interest in products containing CBD, there are still many things we do not know," said Sharpless, adding that there were "some significant gaps in our knowledge.
In particular, the FDA wishes to obtain more information on doses, including the amount of CBD that can be safely consumed and the long-term risk of exposure. The agency also focuses on the effects of CBD on children, the elderly and pregnant women.
Public comments regarding the FDA's role are expected to arrive on July 16, after the agency has extended the deadline by two more weeks.
CBD is derived from the marijuana plant, but does not give a high image to users. Since the adoption of the Farm Bill, CBD-based products have appeared online and on convenience store, coffee shop and nutrition store shelves in some states.
Yet, according to the FDA, the addition of CBD to foods and dietary supplements being the subject of interstate commerce is illegal.
Miller said that for now, companies are ready to wait.
"We want to give the FDA the space it needs to formulate its findings," Miller said. "They are under a lot of pressure from Congress and Congress is under public pressure. I think they realize that they have to act fast. "
Meanwhile, lawmakers on both sides are trying to push the FDA to act.
A provision in House Appropriations passed last month reserves funding for the FDA to study and set specific levels of CBD for food and beverages.
The provision, sponsored by Rep. Jerry McNerney
Gerlad (Jerry) Mark McNerneyThe coal sector is in dire need of replacing its clean energy plan. House Dems Press The FCC President is asking for answers on a false claim for cyberattack. Senators say Trump has approved an agreement on ethanol | The automakers group wants to continue to raise the efficiency standards PLUS (D-Calif.), Provides $ 100,000 to the FDA to define a "level of safety for conventional foods and dietary supplements containing cannabidiol (CBD)".
Senate Majority Leader Mitch McConnell
Addison (Mitch) Mitchell McConnellThe Democratic Senate hopes to be able to count on Trump Tide Trump praises ICE, Border Patrol in the "Hi to America" speech. What do you know about your government? A civic quiz of July 4th MORE (R-Ky.) Met with Sharpless last week and urged the agency to speed up the CBD's regulatory process.
"The intention of Congress was clear with the adoption of the Farm Bill that these products should be legal, and our farmers, producers and manufacturers need clarity as well as a practicable path with regard to regards the application of the agency, "McConnell said in a statement.
"Like my constituents, I look forward to hearing about the FDA's plans to ensure public access to safe CBD products," he added.
Sen. Ron Wyden
Ronald (Ron) Lee WydenButtigieg wins the military parade on July 4th: I think America seems "smaller". Night energy: Democrats decry use of park fees for Trump's July 4 event as "makeshift fund" | Rick Snyder withdraws from Harvard Scholarship | Moody 's Analytics predicts that climate change could cost T by 2100; Democrats are decrying the use of park fees for the Trump event, July 4, as " makeshift funds »MORE (R-Ore.) Did not meet Sharpless personally, but last week she sent a letter to the agency urging the FDA to set an interim policy by August 1 allowing products containing CBD derived from hemp to be manufactured and sold as food and food products. food supplements.
Wyden said it was "totally unacceptable" for the FDA to suggest that it could take up to five years to enact rules.
"The confusion and regulatory uncertainty surrounding the CBD can not last that long," wrote Wyden.
Michael Werner, a lawyer representing clients in the DBC sector, said the FDA knew it had to act fast because, as a public health agency, she wanted to know the "rules of the road" as soon as possible".
"The problems the FDA faces are the same as those faced by all private sector players," said Werner. "I think that they feel a sense of urgency to solve these problems. Their challenge is that they want to do things right. "
Before former FDA Commissioner Scott Gottlieb left office in April, he said the FDA could take years to properly regulate the CBD.
The process of regulating conventional products may take two to three years, but since CBD is unique and has never existed before in the food supply, he said, it could take longer.
Lawmakers and industry sources said they did not necessarily have a problem with the FDA's insistence on collecting evidence, but they also did not want the agency to use security as a excuse for the regulation of idling.
"The FDA must create a path without taking years of security data," said lawyer Jessica Wasserman. "[CBD] has been on the market for a long time, and they [FDA] never used their enforcement powers. "
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