FDA WARNING_LETTER - Soaptronic LLC - December 12, 2019

The FDA issued a Warning Letter to Germstar on December 12, 2019, regarding their Germstar Hand Sanitizer product line, including "germstar ORIGINAL," "germstar Citrus," and "germstar NORO." The FDA determined these products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act.

The violation stems from claims on Germstar's website, www.germstar.com, which indicate the products are intended for disease prevention and treatment. Examples include claims of killing 99.9% of transient bacteria, viruses, and fungus, and effectiveness against H1N1, Norovirus, E. Coli, and MRSA. These claims classify the products as drugs under 21 U.S.C. 321(g)(1)(B) and (C).

The FDA states that Germstar Hand Sanitizers are new drugs because they are not generally recognized as safe and effective for their intended uses, and no FDA-approved applications exist. While the products contain deferred active ingredients (isopropyl alcohol or ethyl alcohol) under OTC Drug Review, the specific disease-prevention claims go beyond the scope of any OTC monograph or ongoing rulemaking. The FDA is unaware of adequate clinical trials supporting these claims or a similar OTC product available before the OTC Drug Review inception.

Germstar must promptly correct these violations. Within fifteen working days,