FDA Stalling on CBD Regulations Raises Further Marijuana-Related Problems for Congress!

FDA’s inaction on CBD regulations means more marijuana questions for Congress

With the FDA’s declaration on Thursday that it will not regulate CBD products and will instead shift the buck to Congress, the present, unsettling status quo will continue.

That means more work for a Congress that is becoming more and more divided, and more doubt for businesses debating whether to enter the CBD market, which is estimated to be worth more than $4 billion.

Congress must decide what to do about psychoactive hemp-derived cannabinoids like delta-8 and delta-10 THC, in addition to wrestling with larger marijuana policy changes, such as banking access, tax relief, and the topic of federal legalization.

“I don’t think this changes anything for now, whether you’re in the CBD space, the delta-9 space, or the delta-8 space - at least not for today,” said Jonathan Havens, a former counsel at the FDA and now a lawyer in Baltimore who co-chairs the cannabis law practice at Saul Ewing.

The FDA has consistently maintained, “We don’t want to deal with this, Congress needs to get involved,” which is a position that has been consistent throughout.

What happens next is up to Congress.

The FDA has remained rather hands-off with regard to CBD products thus far, sending only enforcement letters to businesses marketing goods with unproven medical claims.

The federal Food, Drug, and Cosmetic Act prohibit the making of such statements.

This is permanent.

Farm Bill Could Come Into Play

One of the questions that could be answered when Congress negotiates a new version of the 2018 Farm Bill, which expires this year, is whether or not cannabinoids are allowed in candy, drinks, and other items.

The 2018 Farm Bill, championed by then-Senate Majority Leader Mitch McConnell and signed into law by former President Donald Trump, authorized hemp farming across the country and addressed a wide range of other issues.

Additionally, it predicted the subsequent growth in the popularity of cannabidiol (CBD) and other innovative, psychoactive cannabinoids derived from hemp.

The Food and Drug Administration (FDA) has been put on notice to figure out how to regulate an avalanche of products containing CBD and other cannabinoids derived from hemp since then.

Instead, on Thursday, the FDA said it would not regulate CBD products or any other dietary supplements since the agency’s current regulatory frameworks were insufficient and the Congress should direct the FDA on the matter.

FDA’s inaction on CBD regulations means more marijuana questions for Congress

The FDA’s lead deputy commissioner, Dr. Janet Woodcock, issued a statement on Thursday saying the agency “has decided that a new regulatory approach for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory monitoring needed to limit risks.”

Woodcock also noted that “the use of CBD raises significant safety risks, particularly with long-term use.”

The agency “is ready to cooperate with Congress on this issue.”

The FDA has taken note of the “serious health risks” posed by so-called alternative cannabinoids and has been tracking reports of adverse health effects, even though Woodcock did not mention them. These include delta-8 and delta-10 THC, which can be derived from CBD via a chemical process, and delta-9 THC.

Shawn Hauser, the partner at Vicente Sederberg and chair of the Denver office’s Hemp and Cannabinoids Department, said that implies either the next Farm Bill or a separate stand-alone act would likely have to address those substances.

This is something Congress has done before, so there is precedent.

Colorado and Utah are just two of the states that have adopted marijuana-style regulations for hemp goods.

Trade Groups ‘disappointed’

Hemp farmers’ and manufacturers’ trade groups expressed “disappointment” with the FDA’s news on Thursday, saying they had hoped for clear regulations rather than a deferral.

Michael Bronstein, president of the American Trade Association for Cannabis and Hemp in Washington, DC, stated that the scenario will inject a sense of urgency into existing lobbying efforts.

It is the firm’s intention to “work hard with Congress to design and push a pathway that protects consumers, creates confidence in the marketplace for CBD items, and allows for sensible regulation,” he stated.

Meanwhile, the existing product manufacturers will continue to face a period of uncertainty.

Perhaps Congress will determine that the Food and Drug Administration should also oversee the cannabis industry.

As an unintended but permanent consequence of the Farm Bill modification, Congress now has the additional task of deciding whether or not a new agency should be in charge of regulating cannabinoids derived from hemp.

“I think the reality is, people, want access to all different kinds of cannabis, both medicinally and recreationally,” Hauser said.

And in other areas, like Texas, Tennessee, and Kentucky, this is the only way to get your hands on them.

“This may be the tipping point that convinces some states that legalizing and regulating cannabis and establishing product safety standards is preferable to prohibition.”

Sales of CBD extracted from hemp are expected to reach almost $6 billion by 2023, up from almost $4.5 billion in 2022, according to the MJBiz Factbook 2022.

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