Former FDA Boss Proposes Cannabidiol Regulatory Plan

Players in the CBD industry may finally get a reprieve from the industry’s current state of unlawfulness. On Friday, former Food and Drug Administration (FDA) Scott Gottlieb described a potential regulatory system for the U.S. CBD industry. He laid out steps that the agency could take to give the sector some structure while the final rules are being developed.

The former Commissioner urged consumers to use CBD products with caution, arguing that most of the medical benefits that the products claim haven’t been proven anyway. He added that for the time being, the FDA could implement specific measures to ensure the products meet basic safety standards. “The CBD hype has outpaced science,” he said in a public statement, “and there are risks. But with use so widespread, the question is whether the FDA can help prevent third rate purveyors from flooding the market with shoddy products outside the regulatory purview.”

The circumstances around the CBD industry are quite complicated. Last year’s Farm Bill made cultivating industrial hemp legal. CBD, one of the main extracts of the hemp plant, was legalized by extension. However, despite an enormous boom in the demand and supply of cannabidiol, there were no regulations around the sale and marketing of the extract.

As a start, Gottlieb suggested targeting CBD supplements for regulation. Although the FDA doesn’t allow the marketing and sale of CBD products as food supplements, there already exists a vast market for CBD supplements, with a ton of unregulated supply ready and willing to cater to that market.

“The FDA can start with supplements and put the burden on producers to prove CBD safety at very low levels while ensuring manufacturing standards, purity, minimum levels of the active ingredient during a transition period of enforcement discretion and sweep the market of non-compliant products.”

He added that safety must be the first principle and that all the claims of medical efficacy must be grounded in science. “CBD is not safe and has largely unproven benefits outside a small subset of very carefully studied indications. The vast majority of claims being made by illegal producers will never be substantiated.”

Last week, the USDA finally released its long-awaited interim final rule on hemp, but the CBD industry remains wildly unregulated. A couple of months ago, Gottlieb acknowledged that although there was keen interest among the cannabis industry and lawmakers in developing a regulatory framework for CBD, it would take several years for the FDA to come up with rules without any Congressional help.

It isn’t clear what cannabidiol industry players like Marijuana Company of America Inc. (OTCQB: MCOA) and SinglePoint Inc. (OTCQB: SING) think about Scott Gottlieb’s proposals for regulating the industry.

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