Thrasio, LLC D/B/A ZymaDerm
FDA issued a warning letter to Thrasio, LLC d/b/a ZymaDerm on August 18, 2023, regarding their 'ZymaDerm for Molluscum' product marketed on naturopathix.com and Facebook. The agency determined the product is an unapproved new drug under section 505(a) of the FD&C Act because it makes drug-intended-use claims for treating molluscum contagiosum, a condition with no legally marketed OTC drug products. FDA flagged multiple efficacy, cure, and clinical-proof claims across the company's website and social media, and noted particular public health concern because the product is marketed for use in children. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.
Flagged claims (12)
Two clinical trials and two published reports prove that ZymaDerm for Molluscum's core ingredients work with a 84% success rate clearing molluscum. More people have been painlessly and successfully treated for molluscum with ZymaDerm than any other product for the condition.
Molluscum Contagiosum can also be screened and self-diagnosed in the majority of cases because of their distinctive look
ZymaDerm is a safe proven treatment to painlessly eliminate molluscum contagiosum.
The March 2012 issue of the Journal of Drugs in Dermatology published a study that demonstrated ZymaDerm for Molluscum [is] effective in reducing or eliminating molluscum lesions in over 84% of children in 30 days.
ZymaDerm is a natural topical agent to aid in effective and safe molluscum treatment.
Our FDA registered formula will effectively and gently treat your child's molluscum symptoms.
Naturopathix, Inc. has announced publication of scientific evidence that the ingredients in all natural ZymaDerm are effective and safe for molluscum contagiosum treatment in children.
ZymaDerm is effective in adults who have molluscum contagiosum. It is safe for use on the genital areas.
ZymaDerm is safe for babies nine months and older; and equally effective on adults.
ZymaDerm is a physician-trusted treatment that can reduce bumps without blistering or irritating the surrounding skin. A powerful, yet gentle, antiviral topical solution, ZymaDerm is applied directly to the bumps and can be safely used on the face and genital areas of the skin. It is a natural, non-toxic topical liquid that has been clinically tested and has been registered with the FDA as a homeopathic drug.
'Since ZymaDerm's introduction in 2003,' says Briant Burke,MD,MS Naturopathix's CEO and developer of ZymaDerm, 'hundreds of thousands of children and adults have easily gotten rid of visible molluscum simply by dabbing on a pleasant aromatic blend twice a day, usually for less than a month.'
'I have used previously with patients with positive feedback. I recommend for all my molluscum patients as the first line of treatment'
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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