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FDA Rejects Petition To Further Restrict Marijuana

The U.S. Food and Drug Administration (FDA) has denied a request from an anti-legalization group to place marijuana on a list of restricted substances that are not recognized as safe and effective. Janet Woodcock, the director of FDA’s Center for Drug Evaluation, stated that the move is “not necessary for the protection of public health.” The anti-legalization group filed its petition requesting the cannabis crackdown in December of 2017, writing that the it would “send an industry-wide warning to the estimated 33,000 marijuana businesses in the U.S., many of which are making unsupported medical claims for marijuana and THC drug products sold as ‘medical marijuana.'”

The FDA rejected the petition, stating that the agency “already has adequate authority to remove unapproved new OTC drugs containing marijuana or THC from the market.” In order for FDA to take enforcement action against illegal marketing of unapproved new OTC drugs containing marijuana or THC, it is not necessary for FDA to establish a negative monograph for marijuana or THC. While the decision by FDA not to assign so-called “negative monograph” status to marijuana and THC won’t do anything to make marijuana more available, or change its legal status- the rejection suggests that the Trump administration is not looking for excuses to go out of its way to deal public relations blows to the cannabis industry.

“It is the responsibility of companies marketing drug products in the United States to ensure that their products are safe and effective and marketed in compliance with the law,” FDA’s Woodcock wrote. “[A]s discussed above, FDA has existing authority to pursue regulatory or enforcement actions regarding unapproved new OTC drugs, including those containing THC or marijuana.” For now, FDA passed up the opportunity to add marijuana to the restrictive negative monograph list and it allows the cannabis industry to avoid another round of headlines about federal regulators calling them out.

If you or someone you love has been charged with a marijuana crime in New Jersey, be it possession or possession with intent to distribute, you must seek legal representation immediately. You likely have legal options you hadn’t considered, and you don’t want to face these charges without having explored every possible legal option for the best outcome.

Frank T. Luciano is a highly successful and experienced drug crime attorney operating in multiple areas throughout Northern New Jersey, including Hackensack, Jersey City, Elmwood Park and Fort Lee. In nearly 40 years as a criminal defense attorney, there is almost no legal situation that Mr. Luciano has not seen and successfully navigated his clients through.

Give yourself the best chance at a positive legal outcome by contacting Frank T. Luciano’s New Jersey law office immediately at 973-471-0004.

 

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