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CBD Claims: Fact or Fiction?

Nov 08, 2019

A company is under fire for selling unapproved cannabidiol (CBD) products and making false claims.

The US Food and Drug Administration (FDA) issued a warning to a Florida company by the name of Rooted Apothecary LLC. This company was accused of illegally selling unapproved CBD-containing products online.

The FDA said the company was claiming that its products could treat the following:

  • Teething pain (infants)
  • Ear aches (infants)
  • Autism
  • Acne
  • Cancer
  • Attention-deficit/hyperactivity disorder (ADHD)
  • Parkinson’s disease
  • Alzheimer’s disease

Some of these claims included the following:

  • "Increasing evidence suggests that CBD oil is a powerful option for pain ... anxiety ... and autism ... It seems like an attractive and safe option for children.”
  • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
  • "... Children can use high amounts of CBD safely and without any risk.”

There is also some concern that consumers may not seek appropriate medical care because they are trying to use CBD to treat serious medical conditions based on these misleading health claims.

Furthermore, this company marketed these products as dietary supplements. The FDA has stated that CBD-containing products can't be marketed as dietary supplements.

Rooted Apothecary has 15 working days to respond to the FDA with how it will correct the violations. If these violations are not corrected, the FDA said it may take further action.

The FDA has not approved any of Rooted Apothecary’s products. In fact, at the time of publication, the FDA had approved only one CBD product from any company: Epidiolex (cannabidiol), which was approved to treat rare, severe forms of epilepsy.

Currently, the FDA has not reviewed the ways CBD products are made. In addition, the FDA has not evaluated the following:

  • The effectiveness of CBD products
  • The right dose
  • Whether CBD can interact with other medications
  • Safety issues (side effects)

Speak with your health care provider if you have any questions about CBD products.

Written by Anyssa Garza, PharmD, BCMAS

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