FDA warns of false CBD health claims

FDA warns of false CBD health claims

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    In early May, the Food and Drug Administration (FDA) issued a warning to five companies that illegally sell THC products, falsely claiming they can diagnose, cure, prevent, mitigate, or treat various diseases.

    Gummy candies, chocolate, caramels, chewing gum… Many products contain THC and in particular “delta-8 THC” or Delta-8 tetrahydrocannabinol, a psychoactive cannabinoid present in the cannabis plant. This substance, whose health “benefits” are touted by many companies, poses a problem for the FDA – which has not yet assessed its safety or its side effects.

    Illegal marketing of delta-8 THC products

    At the beginning of May, five companies received a warning from the FDA because of “new unapproved drugs, poor branding and the addition of Delta-8 THC to food products“.

    This psychoactive substance – usually made from hemp-derived cannabidiol (CBD) – is suspected of being harmful to health.

    The agency of the United States Department of Health and Human Services has indeed received complaints from consumers, health professionals or law enforcement after consumption of Delta-8 THC. Some people even had to be hospitalized urgently.

    Adverse effects confirmed by national poison control centers.

    The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or reduce side effects related to a wide variety of diseases or medical conditions, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety.said Janet Woodcock, MD, senior deputy commissioner of the FDA.

    Additional FD&C Violations

    Several FDA warning letters describe additional violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). It is :

    • The marketing of CBD products that claim to diagnose, cure, mitigate, treat or prevent various diseases in humans and animals;
    • The promotion of CBD products as dietary supplements;
    • The addition of delta-8 THC in foods (gummy candies, chocolate, caramels, chewing gum, peanuts, etc.);
    • Mislabeling of drugs (eg, products without proper instructions for use).

    The companies involved are: BioMD Plus LLC, Delta 8 Hemp, Kingdom Harvest LLC and M Six Labs Inc. Other companies illegally selling CBD products have been warned in the past.

    To combat these deviations, the agency asked companies for written responses within 15 days of receiving the letter. They must do what is necessary to remedy violations of the law.

    As a reminder, the FDA has already received 104 reports of adverse events in patients who have consumed delta-8 THC products. 55% of cases required medical intervention or hospitalization.

    Consult a GP online

    French CBD regulations

    If in absolute terms, in France, only the consumption of THC is prohibited, the consumption of CBD is authorized, but subject to several legal conditions not always very well interpreted by manufacturers.

    French regulations therefore allow the use of certain varieties of hemp – devoid of narcotic properties – for industrial and commercial purposes under only three conditions:

    • The hemp used must be on a list of authorized varieties;
    • Only hemp seeds and fibers may be used, flowers being prohibited;
    • The hemp used must have a THC content of less than 0.2%.

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