FDA WARNING_LETTER - Flor Nutraceuticals, LLC

The FDA and FTC issued a Warning Letter to Flor Nutraceuticals, LLC, regarding their products Herpaflor Outbreak Response Topical Liquid, Herpaflor Outbreak Response Tablets, and Herpaflor Daily Formula Tablets, marketed on www.herpaflor.com.

The FDA determined these products are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act. Violations include marketing as drugs intended for disease treatment/prevention (herpes, cold sores) without FDA-approved New Drug Applications (NDAs), violating sections 301(d) and 505(a). The products are also misbranded under section 502(f)(1) for lacking adequate directions for use, as genital herpes is not amenable to self-diagnosis/treatment. Furthermore, they are misbranded under section 502(j) as dangerous to health, potentially causing consumers to forgo or delay appropriate medical treatment.

Specific claims cited include "Put an end to Herpes Outbreaks!" and "seventeen of the most researched and proven herpes killers." The FDA noted that genital herpes is not covered by any OTC monograph, and oral cold sore treatments require an approved NDA. The active ingredients in Herpaflor products are not evaluated under the OTC Drug Review for fever blister/cold sore products.

Flor Nutraceuticals must take prompt action to correct these violations within fifteen working days, notifying the FDA of specific steps taken, including preventing recurrence