FDA says more scientific data needed to move forward with CBD regulation

hemp derived cbd, FDA says more scientific data needed to move forward with CBD regulation

Federal health regulators say the lack of scientific data about cannabidiol explains their delay issuing new guidance on over-the-counter CBD products.

The U.S. Food and Drug Administration (FDA) continues to accept comments on hemp- and cannabis-derived ingredients, months after the comment period closed, according to Sharon Lindan Mayl, senior policy adviser in the agency’s Office of Food Policy and Response.

Mayl said this week that the FDA needs more data about CBD, despite the more than 4,500 comments it has received since it began its review of regulations for hemp-derived cannabidiol.

The agency wants to know about additional data as it’s being developed.

landmark public meeting about cannabis at FDA headquarters in May and the many online submissions didn’t yield enough scientific evidence in support of CBD, according to Informa Pharma Intelligence, a health care industry news source.

At that hearing, an exchange between FDA analysts and a Colorado doctor underscored the problem. FDA officials asked Dr. Kevin Chapman, who was testifying on behalf of the American Epilepsy Society, how parents of epileptic children know how much CBD to give them.

“They’re making it up as they go along,” Chapman said.

The request for public comments about CBD research wasn’t much better, according to Mayl.

“It’s safe to say that in 4,500 comments, we did not receive a lot of hard data around the issues that we specifically requested comments on,” Mayl told a group of attorneys and regulators at a conference on Monday.

Law-blocked research

Mayl said the FDA recognizes that safety studies on CBD and other cannabis extracts were rare before hemp was descheduled as a controlled substance last December.

The agency is open to being convinced through scientific data about the safety of CBD as an ingredient, Mayl said.

Particularly, Mayl said, the agency needs to see total exposure data, as the use of CBD in the consumed products raises concerns about the potential risk to consumers. (Safety data related to the FDA-approved drug Epidiolex is not being considered in the agency’s evaluation of CBD safety for use in nondrug products.)

Mayl reiterated comments made a week ago by Lowell Schiller, the FDA’s principal associate commissioner for policy, who told a gathering of nutritionists that there is no bias for or against CBD.

“We do not hold CBD to a higher standard of safety, but we won’t hold it to a lower standard, either,” she said.

The FDA also has to weigh whether the lawful use of CBD and other cannabis derivatives in food, beverages and dietary supplements will hinder further drug development, Mayl said.

More of Mayl’s comments are available here.

4 comments on “FDA says more scientific data needed to move forward with CBD regulation
  1. Ray on

    I found this with a google search, can someone buy the FDA a computer with internet access?

    The patent (US6630507) is titled “Cannabinoids as antioxidants and neuroprotectants” and was awarded to the Department of Health and Human Services (HHS) in October 2003.

    It was filed four years earlier, in 1999, by a group of scientists from the National Institute of Mental Health (NIMH), which is part of the National Institutes of Health (NIH).

    The patent claims exclusive rights on the use of cannabinoids for treating neurological diseases, such as Alzheimer’s, Parkinson’s and stroke, and diseases caused by oxidative stress, such as heart attack, Crohn’s disease, diabetes and arthritis.

    The government’s patent does not cover THC, the main ingredient in marijuana. On the other hand, cannabidiol (CBD) is specifically mentioned as an example of a cannabinoid that is covered. The patent describes CBD and other non-psychoactive cannabinoids as superior when taken in higher doses.


    • Nathan on

      This does not mean it is has been proven to be effective in treating these neurological diseases. It just means that whenever whomever eventually does find evidence for this and ultimately tries to make a drug for it, they will be unable to without paying some kind of royalty to the DHHS

    • Michael Spangler on

      Yes, the USA government has an expired patent for CBD. The reasons for the delay is that they are trying to calculate the total number of cannabinoids (inclusive of CBD) that people can tolerate.

      As an API for Big Pharma, CBD must be given at overdose levels often in the thousands of ML which is way too much; however, if CBD is not isolate then it cannot be patented in medications which is the goal in order to replicate and continue the synthetic medication chemical holocaust.

      Full plant medications are more efficacious and the public will soon know this: full plant medicines cannot be patented because there are too many compounds involved.

      If people are consuming their cannabinoids (inclusive of CBD) in their CPGs and in their daily life, then Big Pharma cannot sell and use its overdose levels of CBD isolate and the single-molecule medicine cash cow and monopoly is extinct.

      Every town in the country needs to learn and “build out” its own Wellness because the federal government is controlled by businesses that make synthetics which kill us like the opioids.

  2. mark dalane on

    So the double standard continues with the 1000s of annual deaths from opiods….68,000 deaths from opiods in 2018. Down from 72000 in 2017. And yet Big Pharma is aloud to continue making and selling this garbage. Me thinks USDA and the FDA are positioning to give all manufacturing and research and sales to big pharma….then they will be ok with allowing the public to consume CBDs. Pretty obvious….just like Epstein didn’t kill himself….!

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