FDA WARNING_LETTER - Amazon.com, Inc. - August 18, 2023

The FDA issued a Warning Letter to Amazon concerning the distribution of unapproved new drugs intended to treat molluscum contagiosum on www.amazon.com. The FDA purchased "Naturasil Molluscum Treatment Kit," "Conzerol 2 Step Treatment for Molluscum Contagiosum," "ZymaDerm for Molluscum," and "HealthyDerm Molluscum Contagiosum Treatment" via Amazon's Fulfillment by Amazon service.

These products are considered drugs under section 201(g)(1) of the FD&C Act due to their intended use for treating molluscum contagiosum, a condition not amenable to self-diagnosis or treatment, and for which no legally marketed OTC drugs exist. The FDA cited claims on product labels and inserts establishing their drug intended use, such as "Molluscum Treatment Kit," "Antiviral Molluscum Soap," and "Homeopathic Treatment for Molluscum Contagiosum."

The products are deemed "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective for their stated uses and lack FDA approval. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. The FDA expressed particular concern as these products are marketed for children, potentially delaying proper diagnosis and treatment of a