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WARNING LETTER
•Purecraft LLC•January 6, 2023

Purecraft LLC – FDA Warning Letter, Jan 6, 2023

Record Details

On January 10, 2023, the FDA and FTC issued a Warning Letter to Purecraft CBD after reviewing their website (purecraftcbd.com) and social media (Facebook, Instagram) on December 14, 2022, and January 6, 2023. The letter states that Purecraft CBD offers cannabidiol (CBD) products for sale in the U.S. that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are cited as unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 of the FD&C Act (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). The letter provides examples of claims from Purecraft CBD's website, such as "COVID Prevention & CBD," "therapeutic doses of CBD do have a protective effect against COVID," and "CBD has been shown to decrease the severity of COVID."

Purecraft CBD is required to take immediate action to cease the sale of all unapproved and unauthorized products

Company
Purecraft LLC
Inspection date
January 6, 2023
Product type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Tina Smith (Director)
  • Serena Viswanathan (Associate Director)
View Company Profile

ID · 27421e76-79b7-4f6a-948c-af234feb2904

Violation Codes4
21.U.S.C. 355(a)21 U.S.C. 35221 U.S.C. 331(d)21 U.S.C. 331(a)

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