FDA submits draft CBD recommendations to White House

Jul 24, 2020

Following this week’s draft guidance from the Food and Drug Administration on clinical trials and cannabis medications, there appear to be reports from Washington that regulations on non-drug CBD could soon follow. According to a recent article featured in Hemp Industry Daily, FDA officials submitted a long-awaited policy document that would finally bring much-needed regulations to the CBD industry.

The reports from HID state that the FDA submitted its latest version of draft guidance for the cannabidiol industry to the White House Office of Management and Budget on Wednesday. Word is that once the OMB signs off on the document — something they are required to do when new regulations come down from any federal agency — the policy could be made public in just a few short weeks.

As The PotNetwork first noted earlier this week, the industry has been clamoring for new regulations for over a year now. While the draft guidance issued regarding cannabis-derived drugs was considered useful by many, it did little to change the status quo of the CBD industry at large. 

The FDA has been content to hand out warning letters over the past 12 months to any company that has run afoul of the agency, although, without official regulations, no one has been quite sure of what rules they were running afoul.

Should it receive a final okay from the White House, this new action could change the face of the consumer CBD market. As HID noted, cannabis attorney Jonathan Havens, a Washington DC-based partner with Saul Ewing Arnstein & Lehr, called it a welcome moment of clarity.

In a LinkedIn post, this week, Havens wrote that these new regulations would most likely focus on the myriad of unsubstantiated claims made by bad actors in the CBD industry. Over the past 12 months, a slew of companies has claimed that cannabidiol can cure everything from opioid use disorder to COVID-19, all without anything to back up their statements.

“It’s hard to believe that the agency will back off completely from its ‘ingestibles aren’t permitted’ stance,” he noted.

According to HID, Havens told them that it is still unclear which direction the FDA is leaning with the regulations.

“It could be claims-based, serving size-based, (which is) less likely, product standards-based, some combination of the three, or something else,” Havens wrote, according to HID. “On the standards front, it’s possible FDA could start to hold ingestible CBD marketers to the agency’s dietary-supplement regulations, for example good manufacturing practice requirements.”

“It would raise the bar for the industry, push out unsavory firms who are producing unsafe products and allow marketers to say that they comply with FDA requirements, which would hopefully smooth out the true patchwork of state requirements, among other benefits,” he continued.

Havens did tell HID that this week’s draft guidance for cannabis-based drugs could give the industry some insight into the FDA’s line of thinking.

“In the normal course of how the FDA generally goes about things in the food and beverage docket,” Havens told HID, “you’re going to have multiple steps: an advanced notice of proposal rule-making, a proposed rule, comments, FDA considers the comments, the final rule and implementation.”

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