FDA pledges action against ‘unlawful CBD products’ while offering confidentiality for research

The U.S. Food and Drug Administration said it will continue to “take appropriate action against unlawful CBD products that pose a risk of harm to the public,” even as the federal agency implored the industry to collaborate with the government to study CBD’s possible benefits and dangers.

The statement Thursday from new FDA Commissioner Dr. Stephen Hahn did not mention a timeline for when the agency will release CBD-usage guidelines, which businesses have been expecting for several months.

But there were some new positions staked out in the memo issued in response to pressure from Congress to issue regulations allowing the sale of hemp-derived CBD without a doctor’s prescription.

The FDA said for the first time that it wants to learn the difference between full- and broad-spectrum CBD products.

The FDA also said it will:

  • Keep some CBD comments private, allowing companies to share proprietary, confidential research without being asked.
  • Explore the creation of a “risk-based enforcement policy” to increase transparency about which CBD violations will be enforced by federal authorities.

Hahn said the FDA is “concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe,” or that CBD is harmless.

He emphasized that the FDA must “work to educate the public and close the knowledge gaps” about CBD.

Stephen Hahn

Hahn promised the agency will “monitor the marketplace” and punish sellers who make claims about the benefits of CBD that have not been substantiated by the FDA.

Still, he said he wants to “work together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety and quality of many of these products, as well as further evaluate any potential benefits outside of the one FDA-approved drug product to treat two rare, severe pediatric epilepsy disorders.”

Hahn also repeated the agency’s appeal for better scientific data about what CBD does.

The FDA has repeatedly extended the deadline to submit evidence about cannabinoids in hopes of getting “reliable and high-quality data,” as Hahn put it.

He talked up the confidentiality option as an inducement to help the agency.

“We hope that this will enable responsible industry participants, academic researchers and other stakeholders to share relevant information with the FDA,” he wrote.

The comments were somewhat more muted than what Hahn told a group of state agriculture officials last month.

Hahn said it would be a “fool’s errand” to try to stop people from getting over-the-counter CBD.

“We have to be open to the fact that there might be some value to these products, and certainly Americans think that’s the case,” Hahn told the National Association of State Departments of Agriculture.

Ivan Moreno can be reached at [email protected]

8 comments on “FDA pledges action against ‘unlawful CBD products’ while offering confidentiality for research
  1. Luke on

    All of the “scammers” should be shut down. There are too many companies that sell “CBD” just for a quick profit and not for consumers benefits…

    Reply
    • Robin on

      I agree there’s TOO MANY that are taking advantage, scamming. That’s wthy it’s so important for us consumers to really look at the ingredients and the third party testing analysis before purchasing.

      Reply
  2. Joy on

    University of California San Diego published research dated 2009 showing that cannabis was effective in treating neurological diseases, i.e. parkinson’s, m.s. etc. plus glaucoma. It took three years to get the cannabis from the Feds to do this study, yet the FDA & DEA ignore it.

    Reply
    • PAL on

      If they would just stop with the nonsense red tape. Seriously. When they legalized one of the most poisonous drinks in the world that has not only killed millions and ruined other people’s lives that did not drink alcohol. No Doctor prescription necessary and not one warning that it was extremely harmful to your health and recommended dosages. How ignorant do they think the American Public is? No one ask the alcoholics why they drink.. In the meantime, there are good people many ages that find the cbd to be beneficial in one form or another. Lets not forget the money people have lost because of the crazy regulations and the jobs that have gone by the way side. The FDA wants to protect consumers, spend more time making certain our food products are good and our water and air is better. Please.

      Reply
  3. David Warren Goodknife on

    Blessings Readers, My suggestion is that not only the FDA reviews current stakeholders works
    but also historic data as well. As we all know that in today’s reality it common for the business world to “lie or adulterate data” under the law, they call it “spin”, a new word. Sorry to have to say that. That said the true data was always keep for thousands of years by the Indigenous medicine people from all over the world. My opinion is there will be more truth in those sources. However that would require culturally appropriate request be made. Be prepared that it may be a song that needs to be translated.

    To that I am sure George Washington must of had some Journals entries addressing the topic as well. Perhaps there is a good trustworthy source to start with. Bottom line is we need to rediscover the data prior to the era’s of Quackery and Reefer madness. Further to that ensure we do not include any fear base ideologies that are associated to those era’s in the discovery.

    To my knowledge Hemp grown in the wild was 5% THC naturally. My concern is now we are forcing the plant threw genetics to be less than .3% . As well a shamefully destroying if non compliant. Re-purposing options are better suited than total crop lose and a lesser hardship on the Farmers. The question is what will be the outcome of this manipulation. What values will this provide or lose? Where is the NON GMO factor playing out in this evolution?

    My Blessing, to all who are studying this matter may insights of this Sacred Plant stimulate truth
    for Humanities well being.

    Conservatively,

    D W Goodknife
    ONAC Minister
    Diplomatic Liaison
    Veteran Fire Chief
    Big Mountain SDN

    Reply
  4. The Mad Yooper on

    The FDA better get it’s act together and move on this quickly.
    It is eerily similar to vaping. Every one and there dawg was saying it’s safe it’s a safe way to quit smoking. Then people started dying.
    The bad players need to be identified and eliminated.
    After all there’s a sucker born every minute.

    Reply

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