FDA exec: Don’t expect an exception for CBD

CBD treatments are promising, but far more research needs to be done before federal authorities can allow them in foods and dietary supplements, according to a leader of the U.S. Food and Drug Administration’s new cannabinoid work group.

Talking to the National Industrial Hemp Council, Lowell Schiller warned CBD producers in attendance that the FDA plans to treat hemp extracts like any other new ingredient going into foods or drugs – meaning that without research on dosing and drug interactions, the agency is unlikely to approve over-the-counter use.

“We don’t hold a grudge against (cannabinoids), but we also don’t hold them to a lower standard of safety or absolve them of other requirements,” he told the gathering in Portland, Oregon.

“Consumers have a right to expect the same level of FDA protection with respect to hemp and derivatives like CBD as they would expect with respect to any other substance.”

Schiller repeated FDA concerns about:

  • Potential adverse effects from CBD use, including liver damage.
  • The lack of data on long-term use of CBD.
  • Unproved claims of therapeutic benefits from CBD.

“If we don’t think we’ll have the data to say that some level of CBD can be safely added to a food or dietary supplement, then we wouldn’t want to create an exception for CBD,” he said.

Schiller told the industry group the FDA is excited about cannabinoids’ potential for therapeutic use, but more research is needed. He said the agency would report progress on its cannabinoid review in “early fall.”

15 comments on “FDA exec: Don’t expect an exception for CBD
  1. Ray on

    There is that “more research” propaganda again. No one believes the FDA simply because they play the Fake News card and because they know they picked the wrong side when it came to the cannabis plant. There is plenty of research and testimonials on the side effects and benefits of cannabis including CBD if they really want to find it.

    The FDA gave us Fentanyl and:

    Brand Name: Remicade
    Used For: Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and ulcerative colitis.
    Side Effects: Cancer (Skin, Lung, breast cancer, gastrointestinal) labored breathing, joint pain, pneumonia.

    Do you know what product helps patients with Chron’s disease? Yep, cannabis. And cancer is not a side effect.

  2. Deetew on

    Wow, the FDA wants a lot of information on CBD before jumping to conclusions. Keep in mind that the GW Pharmaceuticals study that showed liver damage from CBD used acute doses of 180,000 mg of pure isolated CBD in a 75 kg individual —beyond anything anyone would ever use or afford. Also, I can buy a barrel of Ibuprofen and destroy my kidneys and stomach lining, and the FDA won’t care about my safety. —Why, because it already gave me chronic gastritis, and the FDA doesn’t care. Don’t believe that the FDA isn’t biased against CBD, because they most certainly are either receiving revolving door promises from GW Pharmaceuticals, or they are getting straight up bribed. Investigate.

  3. Bev on

    The FDA allows neurotoxic, endocrine disrupting, fluoride to be given to children. Fluoride was NEVER tested, but can be prescribed because it was grandfatered! Spare us your concern about CBD products, oh font of wisdom FDA, you merely want control.

    Fluoride is a drug that has only been approved for topical application. Children’s sodium fluoride anti-cavity supplements were never found safe or effective by the Food and Drug Administration (FDA). Sodium fluoride supplements are routinely fed to little children to prevent tooth decay. They are drugs requiring a dentist’s or physician’s prescription. FLuoride supplements were “grandfathered in” before the 1938 law was enacted requiring drug testing. So, products on the market before 1938 were presumed safe by the FDA who allowed grandfathered drugs to be sold without any testing. Once a drug is on the market for any reason, doctors can use them to treat any disease or condition. Sodium fluoride was on the market pre-1938, but not to stop cavities and not for any medical reason. Sodium fluoride sold as a rat poison.

  4. Cyrus Emerson on

    CBD needs to be approved before Hemp can move into the textile market. Ha ha.

    As an investor this has been a painful adventure with my stock going lower and lower all the time.

    Even after becoming Federally legal my investment continues to find all time lows.

    If the FDA doesn’t approve CBD a lot of other investors will feel the pain too.

  5. Poncietta M Chavez on

    It would seem to me that the FDA would want a drug with few side effects. CBD has been proven to help many medical conditions when nothing else could. The testimonials are out there, it is no big secret. When one look at the side effect of many of the drugs that are currently on the market and are FDA approved, I do not understand how they can even consider that the side effects far outweigh the disease/condition that is being treated. Many of these approved drugs are more harmful than the condition that they are treating but doctors do not hesitate to prescribe these to their unsuspecting patients because they have something to gain from the big pharmaceuticals. The big pharmaceutical could care less because it’s the bottom line that counts … to heck with human life … consider it collateral damage. I’d bet anything that none of these individuals would take or allow their loved ones to take any of these meds. Through the years, there have been drugs that have been approved and it’s not until there is a rash of deaths or other serious side effects does the FDA decide to pull the drug from the market.

    PRIME EXAMPLE: Celecoxib Safety Debated

    The safety of the COX-2 inhibitor celecoxib (brand name Celebrex) came under scrutiny when the other COX-2 inhibitors were taken off the market more than a decade ago.

    The medical literature includes studies showing an increased risk of serious cardiovascular problems with celecoxib, as well as other NSAIDs.3,4,5
    The Food and Drug Administration (FDA) position is that the risk for certain patients is worth the benefit of celecoxib. Taking the lowest effective dose of celecoxib, for the shortest time possible, is advised by the FDA, and prominent warnings are required on packages for all nonsteroidal anti-inflammatory (NSAIDS), including celecoxib, highlighting the risks.6
    Results of a long-term, multinational clinical trial that began in 2006 to assess and compare the risk of celecoxib with other common NSAIDs have not yet been released.7


  6. Serg on

    This is such an absurdity. The FDA does not care about your safety, all they care about is the almighty dollar. Their line about research on long term effects is a farce. The perfect example: Just watch any commercial on medication and listen to the ridiculous amount of side effects on each and every product, some of which include death or suicidal tendencies. All they say is consult your doctor or discontinue use. What a joke.

  7. Mike W. on

    Big Pharma knows the benefits of CBD and is pushing the FDA to delay it as long as possible so they can corner the market. They obviously control FDA just they and the other big corporations do congress….

    • Chas on

      “We are concerned that widespread availability of CBD in products like foods or dietary supplements could reduce commercial incentives to study CBD for potential drug uses, which would be a loss for patients.”

      Amy Abernathy (Principal Deputy Commissioner of the Food and Drug Administration)

      Before coming to FDA, Dr. Abernethy served as chief medical officer, chief scientific officer, and senior vice president for oncology at Flatiron Health (a member of the Roche Group), where she led the research oncology, clinical operations and data science teams, and contributed to the overall strategic vision of the company, including directing their research vision on real world evidence.

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