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FDA Consumer Warnings on Cannabis and CBD

Apr 23, 2020 1:23 pm

On March 3rd, the FDA issued a new consumer update entitled, "What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD".  This is part of the FDA effort to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD. A portion of this communique is shown below.

The Facts

  • Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the component that produces the “high” associated with marijuana use. Much interest has been seen around CBD and its potential related to health benefits.
  • Marijuana is different from CBD. CBD is a single compound in the cannabis plant, and marijuana is a type of cannabis plant or plant material that contains many naturally occurring compounds, including CBD and THC.
  • The FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy. 
  • It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement. 
  • The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason. 
  • Some CBD products are being marketed with unproven medical claims and are of unknown quality.
  • The FDA will continue to update the public as it learns more about CBD.

Potential Harms, Side Effects and Unknowns

  1. CBD has the potential to harm you, and harm can happen even before you become aware of it.
  • CBD can cause liver injury.
  • CBD can affect how other drugs you are taking work, potentially causing serious side effects.
  • Use of CBD with alcohol or other drugs that slow brain activity, such as those used to treat anxiety, panic, stress, or sleep disorders, increases the risk of sedation and drowsiness, which can lead to injuries.
  • Male reproductive toxicity, or damage to fertility in males or male offspring of women who have been exposed, has been reported in studies of animals exposed to CBD. 
  • CBD can cause side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced. 
    • Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness).
    • Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite.
    • Changes in mood, most commonly experienced as irritability and agitation.
  • There are many important aspects about CBD that we just don’t know, such as: 
    • What happens if you take CBD daily for sustained periods of time?
    • What level of intake triggers the known risks associated with CBD?
    • How do different methods of consumption affect intake (e.g., oral consumption, topical , smoking or vaping)?
    • What is the effect of CBD on the developing brain (such as on children who take CBD)?
    • What are the effects of CBD on the developing fetus or breastfed newborn?
    • How does CBD interact with herbs and other plant materials?
    • Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?

    Unproven Medical Claims

    • The FDA’s top priority is to protect the public health.
    • CBD products are not FDA approved and have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.
    • CBD products are being marketed for pets and other animals, but without evidence or study. The FDA has not approved CBD for any use in animals and the concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals. 
    • The FDA has taken action against companies who claim CBD products can be used in cancer, Alzheimer’s disease, psychiatric disorders and diabetes.
    Disclosures
    The author has no conflicts of interest to disclose related to this subject

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