UPSY LLC – FDA Warning Letter, Mar 15, 2022
On March 28, 2022, the FDA and FTC issued a Warning Letter to Upsy.com following website reviews on February 17 and March 15, 2022. The letter states that Upsy.com offers CBD products for sale in the U.S. with claims 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 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FDA emphasizes urgent measures to protect consumers from unapproved COVID-19 related products, given the public health and national emergencies declared for COVID-19.
Upsy.com is required to immediately cease selling unapproved and unauthorized COVID-19 products. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction
ID · 2eb7544c-634a-4930-b3d9-c4cfb44f6a2a
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.