# FDA WARNING_LETTER - Purecraft LLC - January 06, 2023

Source: https://www.keypedia.com/records/warning_letter/purecraft-llc/27421e76-79b7-4f6a-948c-af234feb2904

> FDA WARNING_LETTER for Purecraft LLC on January 06, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Purecraft LLC
- Inspection Date: 2023-01-06
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/purecraft-llc/d8aced91-76aa-48ba-aacc-7ce420c4deb6

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c