FDA WARNING_LETTER - Paradigm RE LLC - December 01, 2020

On December 7, 2020, the FDA and FTC issued a Warning Letter to Paradigm Peptides regarding their website, paradigmpeptides.com. The FDA observed that the website offered "Thymosin Alpha 1" for sale, claiming it could mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined that "Thymosin Alpha 1" is an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 of the FD&C Act (21 U.S.C. § 352). The introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter emphasizes that FDA is taking urgent measures due to the COVID-19 public health emergency and national emergency declarations. Paradigm Peptides was instructed to immediately cease the sale of such unapproved and unauthorized products.

The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and