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US: FDA warns company against making unsupported medical claims

A Florida-based CBD company is under fire from the federal government for making unsupported medical claims about CBD.

The Food and Drug Administration (FDA) and Federal Trade Commission (FTC) sent a joint letter to Rooted Apothecary LLC demanding action within 15 working days.

The company claimed that CBD could be used to treat teething pain and earache in infants, attention-deficit/hyperactivity disorder (ADHD), autism, Parkinson’s and Alzheimer’s, among other conditions.

Acting FDA commissioner Ned Sharpless said:

“We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions.

“This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children.”

Sharpless said that the FDA had sent ‘numerous’ warning letters to CBD companies about making such claims on non-FDA-approved products.

Examples of unsubstantiated medical claims made by the company include:

“Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”

“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.”

“[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help.

Children can use high amounts of CBD safely and without any risk.”

The FDA is currently exploring potential regulatory pathways for the many different types of CBD product now available.

Principal deputy commissioner Amy Abernethy, M.D., Ph.D, said:

“We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products.

“We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence”

UK-made childhood epilepsy drug Epidiolex is the only FDA-approved CBD medicine available in the US.

Source: FDA

Photo by Kimzy Nanney on Unsplash

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