FDA won’t be hurried to create CBD exceptions amid safety concerns, official says

A top official for the U.S. Food and Drug Administration (FDA) said the agency is concerned that developing a legal exception for supplements containing CBD could send the wrong message, both to companies interested in entering the market and consumers.

Lowell Schiller, the FDA’s principal associate commissioner for policy who is leading a panel investigating CBD as an ingredient in food, beverages and dietary supplements, told a group of nutritionists this week that the agency’s biggest concern is whether CBD is safe to consume in food and supplements, according to nutraceuticals industry trade publication Nutritional Outlook.

Speaking at a conference for the Council for Responsible Nutrition (CRN), Schiller conceded the FDA is getting pressure to move forward with a legal pathway for using CBD as an ingredient.

But he said the agency still does not have enough data to determine whether CBD is safe for long-term use, especially among vulnerable populations.

The CRN was one of several trade organizations that sent a joint letter to Congress in October, asking for legislation to establish CBD as a lawful dietary ingredient by waiving the Federal Food, Drug and Cosmetic Act.

Schiller said CBD is not risk-free, pointing to concerns like potential liver toxicity and drug interactions, as well as animal studies indicating risk for the male reproductive system.

“We look at an FDA-regulated product containing CBD the same as we would look at an FDA-regulated product containing any other substances,” he said. “We apply the same tools and authorities and statutory provisions.

“At FDA, we don’t have one set of rules for cannabis-derived substances and another set of rules for other substances. We don’t approach CBD or other cannabis-derived substances with any sort of animus or imposing new burdens.”

Schiller said creating an exception for CBD without adequate safety data could:

  • Set a dangerous precedent for other unregulated substances in the future.
  • Encourage more bad actors to enter the market.
  • Impede the FDA’s ability to identify and address safety violations in the CBD market and send the incorrect message that FDA endorses CBD safety.

He said the agency plans to report on its progress soon. To read the full comments from Schiller’s address, click here.

11 comments on “FDA won’t be hurried to create CBD exceptions amid safety concerns, official says
  1. Ted Stevens on

    “Given the widespread availability of unregulated CBD products, growing consumer demand, and the expected surge in hemp farming in the near future, we believe that FDA must quickly act to provide legal clarity and to establish a regulatory framework that supports this exciting new opportunity.”
    -26 House members

    Do as you’re told, Lowell. Quickly.

    Reply
  2. Calt Tomasek on

    Ironic that we consume products with alcohol and high doses of caffeine in them. One proven to be toxic to your liver, the other related to high blood pressure which can lead to heart disease. Yet CBD which I have taken on a regular basis for the last year with no side effects and find to be helpful, is illegal.

    Reply
    • John Arnold on

      ? Calt! Quality and legitimate CBD products have proven to offer positive results for many. A uniform set of standards will shake out the poor product that unfortunately floods this industry. If someone gets poor product they will most likely interpret that CBD doesn’t work and take the opportunity of natural medicine away from themselves. With the increase in interest, more CBD research and information will come out to prove what those who have peeled the onion already know! I have personally witnessed hundreds of stories from our customers over three years with game changing results positively effecting their quality of life. Let’s get it right this time!

      Reply
  3. Dana on

    It’s really sad that people are so gullible. Even if the fda could be trusted, logic should tell the tale. This agency is a joke. Trusting them makes you a fool!

    Reply
  4. Jim Morey on

    The state of CA has already enacted AB228 – it takes the word “adulterated” away from the law stating that you cannot inject any foreign substance into a food product, thus making it “adulterated”.

    CA came out and made the distinction in a legal form – Hemp derived CBD is OK to infuse into food products. So I can sell my products in the State of CA, hopefully all other states where they have legalized MJ will also make this distinction in their state laws as well. Once that ball starts rolling, the Federal Govt MUST act, or be left in the dust…..

    Reply
    • Farmer J Hemp on

      The FDA is working for big pharma.
      Yes CBD should be used with caution just the same as alcohol with medication. We should make grapefruits illegal too since many Pharmaceuticals May interact negatively also with it.

      Reply
  5. Robin on

    But alcohol and tobacco are okey dokey. Not to mention the multitude of drug reactions to pharmaceuticals.

    And how many food recalls have we had?

    Smdh

    Reply
  6. Ronald Purgatorio on

    Just sent to FDA

    I find it ironic that you would put something out about the effects of a product that was introduced in 2018 but have yet to include an update on testing CBD overall which was promised to the public. You also have big market companies selling this in pharmacies and grocery stores and you have done nothing about it. No updates of its approval and as you can see by the many health benefits its helping millions of people. I would like to know what the side effects are, I would like to know the hazardous effects of taking it but you sure are dragging your feet in coming out with a statement of its overall health benefits. Would you once an for all regulate it and this way the wild west of CBD will end.

    Rp

    https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

    Reply
    • Ronald Purgatorio on

      FDA response:

      CDER DRUG INFO
      11:53 AM (39 minutes ago)
      to me

      Dear Ron,

      Thank you for writing to the Division of Drug Information in the FDA’s Center for Drug Evaluation and Research (CDER).

      We are so sorry to learn of your frustrations, and we appreciate that you chose to share your concerns with us.

      Please note, the FDA has approved only one CBD product, Epidiolex, a prescription drug product to treat two rare, severe forms of epilepsy. FDA is aware that some other CBD products are being marketed with unproven medical claims and are of unknown quality.

      The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.

      For information on potential side effects of CBD, please visit: What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.

      The FDA will continue to update the public as it learns more about CBD. For additional questions or concerns, please contact your health care provider.

      Best Regards,

      KC

      Pharmacist

      Division of Drug Information

      Center for Drug Evaluation and Research

      Reply

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