Posted July 23, 2019

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

On July 22, 2019, the FDA issued a warning letter to Curaleaf, Inc., following an inspection of the company's website which found the company's products, including its CBD Lotion , CBD Pain-Relief Patch, CBD Tincture and Bido CBD for Pets to be "unapproved new and misbranded" drugs. The FDA noted that CBD cannot be sold as a dietary supplement. It also pointed to statements made about the products on the company's website and social media sites that it has determined are drug claims because they promote the products as preventing or treating diseases.

For example, statements made about CBD oil on the company's website include claims such as:
  • "CBD has also been shown to be effective in treating Parkinson's disease."

  • "CBD has been linked to the effective treatment of Alzheimer's disease . . ."

  • "CBD has been demonstrated to have properties that counteract the growth of spread of cancer."

  • "Heart disease is one of the leading causes of death in the United States each year, and CBD does a number of things to deter it. The two most important of these are the ability to lower blood pressure, and the ability to promote good cholesterol and lower bad cholesterol."
The company must reply in writing within 15 days of receipt of the letter and explain the specific steps it has taken to correct these violations.

This is the second warning letter the FDA has issued this month to companies selling CBD products as dietary supplements.

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 Magnesium and CBD

FDA Warns Seller of Reishi, Joint Supplements, Ginseng & More for Pesticides, Other Violations

Seller of Astaxanthin, Cinnamon, Pine Bark and More Warned for Manufacturing Violations

FDA Warns Seller of Joint Health Supplements & More for Manufacturing Violations

Seller of Prostate, Immune Supplements & More Warned for Manufacturing Violations

Seller of Liquid Aloe & Mineral Supplement Warned for Manufacturing Violations

To read the FDA's warning letter, use the link below.