You’ve got until **July 2nd to give the FDA a piece of your mind regarding CBD

Jun 21, 2019

After last month’s big hearing, the U.S. Food and Drug Administration is still collecting information about CBD. If you have something to say about the non-intoxicating cannabinoid produced in hemp, the door is still open.

The FDA is gathering information on a number of aspects of the production and use of CBD oil and purified CBD. Some of the specific areas where the FDA is requesting information include the health risks of CBD, the effects of ongoing exposure to CBD if obtained across a broad range of consumer products, and whether or not some threshold levels of CBD could be permitted in foods.

[Sugary cannabis treats will not be banned in Washington State]

The first hearing was held on May 31, 2019. At the hearing, 120-plus interested professionals spoke in front of 12 FDA bureaucrats in Silver Spring, Md. The majority of witnesses asked for expedited FDA action, or temporary emergency rules, citing the consumer "explosion" of interest.

Speakers hoping to avoid potential two-to-five-year clinical trials called for expedited approval for New Drug Ingredient or GRAS status claiming that it would enable expeditious research into safety and efficacy.

A common FDA response to testimony was "please send us more data to back up what you just said." The window for comments is now open until July 2nd.

“Stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products.” — Former FDA Commissioner, Scott Gottlieb

The FDA’s reaction to CBD so far

Five years in a row, from 2015 to 2019, the FDA has sent threatening letters to CBD marketers demanding that all references to medical conditions be removed from products, websites, and other marketing collateral on the grounds that CBD oil has not yet been approved for the treatment of any medical condition. (And frankly, although purified CBD might someday receive the FDA’s blessing as a dietary supplement and drug, CBD oil will probably never be approved for the treatment of a disease. This is because each batch has a unique combination of active compounds.)

In June of 2018, the FDA approved a drug called Epidiolex for the treatment of two rare and severe forms of epilepsy, Lennox-Gastaut Syndrome and Dravet Syndrome. Although in the past the FDA has approved synthetic versions of cannabinoids such as Marinol, Epidiolex was the first FDA-approved drug to contain a substance actually derived from cannabis.

[New York state legislature has one week to collect enough votes for legalization]

If you’d like to submit comments or information to the FDA regarding CBD you can do so here.

Public comment will be accepted until July 2.

If you’d like more information on the FDA’s current stance on CBD, CBD oil, and other CBD products, the FDA website includes an extensive FAQ:

FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers

**Update: The deadline for submitting comments has been changed to July 16.**

(Photo courtesy of Element5 Digital via Unsplash)
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