for our vets llc – FDA Warning Letter, Oct 8, 2020
On October 16, 2020, the FDA and FTC issued a Warning Letter to Patriot Supreme regarding the sale of unapproved and misbranded CBD products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed the company's website (https://patriotsupreme.com) and social media pages (Facebook, Instagram) on October 5 and 8, 2020.
The FDA determined these CBD products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and misbranded drugs under section 502, 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). Examples of violative claims include statements linking CBD to treating ARDS, shortness of breath, and lung inflammation caused by COVID-19.
The letter requires immediate action to cease the sale of these products. Patriot Supreme must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective steps, recurrence prevention, and supporting documentation. Failure to comply may result
ID · 1a4c83ed-3c3f-4322-92ff-39f12f8c286a
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