Recalls and Warnings

Company Marketing CBD for Use in Infants and Children Gets Strong Warning

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(Date Posted: 10/22/2019)

On October 10, 2019, the FDA and FTC issued a joint warning letter to Rooted Apothecary LLC for "illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims" including that the products could treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson's and Alzheimer's disease.

The company sells CBD and hemp oil products including Teeth/TMJ -- Essential Oil + CBD Infusion, Ears -- Essential Oil + CBD Infusion, Hemp Capsules, 750 mg, Hemp Infused Body Butter and other hemp oil products.

In the warning letter, the agencies noted particular concern that Rooted Apothecary marketed "unapproved new drugs for uses in infants and children." The products were promoted for use in children with statements such as "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," and "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." Other statements suggested use for serious conditions in adults: "CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson's and Alzheimer's disease."

In a news release issued today about the warning, Acting FDA Commissioner Ned Sharpless, M.D. stated," Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. 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."

See ConsumerLab.com's CBD Oil and Hemp Extracts Review for tests of related products. Also see our answer to the question: Is CBD oil (cannabidiol) effective and safe? Is it legal?

See related recalls and warnings:

FDA Warns Seller of CBD Lotions, Patches, Tinctures and Pet Products

FDA Warns Seller of Magnesium and CBD

For more information, use the link below.

FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson's and Alzheimer's disease



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For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.


 

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