08.05.19
The U.S. Food and Drug Administration (FDA) issued a warning letter on July 22, 2019 to Curaleaf, Inc., Wakefield, MA, for selling products as unapproved new drugs, including a CBD lotion and CBD pain-relief patch, in addition to CBD tinctures, vape pens and pet treatments containing cannabidiol (CBD). FDA said it reviewed the company’s website as well as the firm’s social media websites (like Facebook).
FDA said it determined that the company's CBD lotion, CBD pain-relief patch, CBD tincture, and CBD Ddsposable 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), noted FDA.
Examples of claims observed on Curaleaf’s website and social media accounts related to relief of pain and anxiety, according to FDA. The FDA stated that the CBD lotion, pain-relief patch, tincture, disposable vape pen products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use
FDA also said that the company’s CBD lotion product’s labeling stated that it is intended to be applied directly to the skin; the CBD pain-relief patch product’s labeling states that it is intended to be applied to the body for transdermal use. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) as a product that is “intended for ingestion.” Because these products are not intended for ingestion, this is an additional reason those products do not meet the definition of a dietary supplement under the FD&C Act.
You can read the full letter here.
FDA said it determined that the company's CBD lotion, CBD pain-relief patch, CBD tincture, and CBD Ddsposable 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), noted FDA.
Examples of claims observed on Curaleaf’s website and social media accounts related to relief of pain and anxiety, according to FDA. The FDA stated that the CBD lotion, pain-relief patch, tincture, disposable vape pen products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use
FDA also said that the company’s CBD lotion product’s labeling stated that it is intended to be applied directly to the skin; the CBD pain-relief patch product’s labeling states that it is intended to be applied to the body for transdermal use. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) as a product that is “intended for ingestion.” Because these products are not intended for ingestion, this is an additional reason those products do not meet the definition of a dietary supplement under the FD&C Act.
You can read the full letter here.
