More Pressure On FDA For Greater ‘Clarity’ In CBD Regulations

More Pressure On FDA For Greater ‘Clarity’ In CBD Regulations

Pressure continues to mount on the U.S. Food and Drug Administration to come up with a rational and efficient framework for CBD product regulation in the United States. The pressure is now coming from several different directions.

Externally, Marijuana Moment has just reported that a bipartisan letter is being circulated through Congress. It calls upon the FDA to:
 

  1. “Promptly issue guidance” concerning enforcement discretion with respect to hemp-derived CBD products.
  2. “Consider issuing an interim final rule” for this new regulatory framework.

It would be very difficult to brush off such a request from Congress – because of the other pressures building on the FDA.

A second external source of pressure is that the Department of Agriculture (USDA) has its own draft rules in place the national cultivation of hemp. MZBizDaily has reported that this draft has now been submitted to the White House for approval.

The FDA would look even worse for taking so long to produce its own regulatory framework if the USDA gets its own rules in place for cultivation – but there is still no reliable access for consumer products.

This is especially relevant for hemp-derived CBD products. Some sources are already projecting a market in the $10’s of billions in the U.S. But this huge market can’t/won’t materialize if the FDA hasn’t put in place a workable regulatory structure for this industry.

Then there is the internally mounting pressure. The lack of a national regulatory framework for either CBD products in general or even CBD derived from (100% legal) hemp is causing more and more problems for the FDA itself.

Without national regulations, technically none of the CBD products being sold in cannabis-legal states are fully legal. Naturally, many of these products offer health claims with these products.

However, without any clear standards for what is (and isn’t) acceptable, the FDA (and FTC) is spending increasing amounts of its time policing this gray market. Meanwhile, producers and distributors of these products are operating without any regulatory certainty. It’s a totally unsatisfactory scenario for all parties.

This also puts increasing pressure on Congress and the Trump administration to legalize cannabis nationally. Part of what explains the FDA’s lethargy in regulating the CBD market is the ambiguous status of cannabis in the U.S.

Hemp is legal but cannabis is not (federally). Regulators cannot distinguish between CBD derived from hemp and CBD derived from cannabis. Even worse, authorities have no scientifically valid testing to separate hemp from cannabis period.

It’s a headache for U.S. law enforcement as well as federal regulators. This is an area which requires some leadership from Congress. Not Mitch McConnell continuing to play his role as the legislative Grim Reaper, killing anything that doesn’t fit into his narrow ideological spectrum.

In the meantime, uncertainty reigns over the U.S. cannabis industry because of lack of regulatory certainty with CBD. Reports of “fake CBD products” continually crop up in the mainstream media – another symptom of an unregulated industry.

The U.S. federal government continues to fail the cannabis industry. Not only is there no fair, rational regulatory framework for CBD commerce, there are no regulations at all (yet).

Hemp is already legal in the U.S. A strong majority of Americans want cannabis fully legalized nationally. But U.S. consumers don’t even have a national, regulated market for hemp-derived products.

The U.S. government failed the American people with its misguided cannabis Prohibition. It continues to fail the people as Prohibition is (belatedly) swept away.
 

Published at Tue, 17 Sep 2019 15:07:38 +0000

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