pharmacy plus, inc. – FDA Warning Letter, Sep 4, 2020
On September 9, 2020, the FDA and FTC issued a Warning Letter to Vital Care Compounder regarding unapproved and misbranded products related to COVID-19. The agencies reviewed the websites www.vitalcarecompounder.com and https://vitalcarecompounders.ecwid.com on August 28 and September 4, 2020, respectively.
The FDA observed that the websites offered "COVID PACK" and "COVID ‘POSITIVE’ PACK" products, claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs, violating 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 letter cites the ongoing COVID-19 public health emergency and national emergency declarations as context for urgent FDA action. The firm is required to immediately cease selling these unapproved and unauthorized products for COVID-19 related uses. Examples of claims establishing intended use and misleading representations were noted.
Vital Care Compounder must email COVID-19-
ID · 6bc87a47-7330-43ae-945e-1391272d38ed
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