FDA warns Curaleaf against CBD claims

The Food and Drug Administration announced Tuesday it had issued a formal warning to  Curaleaf Holdings, Inc. (CSE: CURA) (OTCQX: CURLF) for illegally selling unapproved products.

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address http://curaleafhemp.comExternal Link Disclaimer in April and June 2019 and has determined that you take orders there for the products “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture” (5 versions), “CBD Disposable Vape Pen” (5 versions) and “Bido CBD for Pets” (3 versions), all of which you promote as products containing cannabidiol (CBD).1 We have also reviewed your social media websites at www.facebook.com/CuraleafHempExternal Link Disclaimer and http://twitter.com/curaleafhempExternal Link Disclaimer; these websites direct consumers to your website, http://curaleafhemp.comExternal Link Disclaimer, to purchase your products. FDA has determined that your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “Bido CBD for Pets” products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

The FDA has issued similar warning letters in the past, but this is the first since the agency began studying how it regulates CBD.

The FDA has announced that it will report on its regulatory approach this coming fall.

Earlier this year the FDA held a public hearing and received nearly public 4,500 comments.

CVS Health, one of the nation’s largest chain retailers to offer CBD products, issued a statement as outlining plans to remove Curaleaf CBD products from store shelves following the announcement of the FDA warning.

   

Curaleaf, which operates in 12 states, released a statement, but not before seeing its shares fall 8% as a result of the FDA warning.

“Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency’s letter. The Company will respond to the FDA letter within the required 15 working days. Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company’s cultivation and manufacturing processes. Curaleaf CBD products are all derived from hemp and meet the requirements of the Farm Bill.”