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FDA head, en route to retirement, calls for legislative solutions to hemp regulation

Scott Gottlieb. Source - Wikimedia Commons

In the days before he promised to leave the Food and Drug Administration, Commissioner Scott Gottlieb has made comments that the best route for clarity around CBD products is legislative action.

The 2018 Farm Bill that legalized hemp as an agricultural product may seem to many on its face to have been this solution, but Gottlieb in early 2019 announced the FDA was reserving its right to regulate CBD in food and drink products.

Now, according to reporting from Marijuana Moment, Gottlieb laid out his framework for how CBD regulation would have to progress at an event put on by the Brookings Institute earlier this week. [1]

His contention that more CBD regulation relates only to the fact that the non-psychoactive hemp extract is technically classified as a drug, and FDA rules mean it cannot be added to foods without further scrutiny.

Unfortunately, Gottlieb argues that following the standard rulemaking process of the FDA for CBD could take between two and three full years. [1]

“It can’t just be put into the food supply,” he said at the event, “[The FDA is only allowed] to contemplate putting a drug that wasn’t previously in the food supply into the food supply if it goes through a rulemaking process.” [1]

The rules FDA would have to build around CBD would likely categorize products by their type and concentration of the cannabinoid compounds present, Gottlieb said.

By the end of this week, Gottlieb expects that an FDA working group on CBD will produce a report on how best to handle the regulatory task at hand. [1]

This, at least, brings some amount of hope to those who have waited with baited breathe on the agency’s findings and worried the announcement of Gottlieb’s retirement could mean further opaqueness on the matter.

Despite the hope for more data and analysis from the FDA, Gottlieb’s claim that legislative approaches to fix CBD regulation are most optimal reveals that perhaps that working group will not be the most fruitful avenue. [1]

The irony of Gottlieb’s appeal to legislature should perhaps be apparent to those who have followed CBD news in recent months. The regulatory confusion was countered with an open letter to Gottlieb himself from 12 U.S. Congress members, including presidential candidate Tulsi Gabbard and Minnesota’s own Betty McCollum. [2]

That open letter called on Gottlieb to allow shops who sell CBD more clarity and transparency in wake of crackdowns in Ohio, Maine and New York City, where inventories were seized to the tune of thousands of dollars.

Now, Gottlieb’s comments put the ball in the legislators’ court. All hemp and CBD fans can do is continue to show support for the industry and let their representatives know how deeply they have come to appreciate and rely on cannabis products to improve their quality of life.




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Subd. 3.Industrial hemp. “Industrial hemp” means the plant Cannabis sativa L. and any part of the plant, whether growing or not, including the plant’s seeds, and all the plant’s derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. Industrial hemp is not marijuana as defined in section 152.01, subdivision 9.