pro breath md, llc – FDA Warning Letter, Nov 10, 2020
On November 18, 2020, the FDA and FTC issued a Warning Letter to Martino Twins Lane regarding the sale of "OraCare Health Rinse" and "OraCare Operatory Pre-Rinsing Set" products. The agencies reviewed the websites https://www.oracareproducts.com/ and https://www.dentistselect.net on October 2 and November 10, 2020, respectively.
The FDA determined that these products are offered for sale in the U.S. and are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. This makes them unapproved new drugs, violating section 505(a) of the FD&C Act, 21 U.S.C. § 355(a). Furthermore, the products are deemed 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 under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
The letter cites examples of claims from the websites, such as those on "Human Coronavirus Testing - ORACARE" and "Pre-Rinsing - ORACARE" webpages, which establish the products
ID · ed7849c3-d1d4-4489-8acc-5f4b386b945c
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