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  5. Thrasio, LLC D/B/A ZymaDerm - 649788 - 08/18/2023
  1. Warning Letters

WARNING LETTER

Thrasio, LLC D/B/A ZymaDerm MARCS-CMS 649788 —


Delivery Method:
Via Email
Product:
Drugs

Recipient:
Recipient Name
Greg Greeley
Recipient Title
CEO
Thrasio, LLC D/B/A ZymaDerm

85 West Street, Suite 4
Walpole, MA 02081
United States

support@naturopathix.com legal@thras.io
support@naturopathix.com legal@thras.io
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

August 18, 2023

RE: 649788

Dear Greg Greeley:

This letter is to advise you that, on May 11, 2023, the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://naturopathix.com, which appears on the container label and packaging of your product “ZymaDerm for Molluscum.” We also reviewed your social media website at www.facebook.com/ZymaDerm, where you direct consumers to your website, https://naturopathix.com, to purchase your product. The FDA has observed that your website offers “ZymaDerm for Molluscum” for sale in the United States. Based on our review, this product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering this product for introduction into interstate commerce violates the FD&C Act.

Molluscum contagiosum is not a condition amenable to self-diagnosis and treatment, and there are no legally marketed over-the-counter (OTC) drug products to treat this condition. Molluscum contagiosum is a viral skin infection characterized by small, raised lesions on the skin that are known as Mollusca. Molluscum affects both children and adults; however, it is more common in children. In healthy individuals, the lesions usually disappear spontaneously within 6 to 12 months, although in some cases, it could take years to resolve. In sexually active individuals, the lesions found in the genital region are considered a sexually transmitted disease/infection (STD/STI). In addition, patients with new or existing skin lesions should seek out a healthcare professional to be evaluated. A healthcare professional is needed to rule out the possibility of a more serious condition, such as, skin cancer, fungal infection, and for the genitalia, anogenital warts. Your “ZymaDerm for Molluscum” is especially concerning from a public health perspective because it is marketed for use in children. In addition, FDA is concerned that people are forgoing or delaying proper diagnosis and treatment of a potentially serious, undiagnosed health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.

Unapproved New Drug

Based on a review of your website, your “ZymaDerm for Molluscum” product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Examples of claims from your websites https://naturopathix.com and www.facebook.com/ZymaDerm that provide evidence of the intended use of this product as a drug include, but may not be limited to, the following:

On your firm’s webpage https://naturopathix.com/studies/:
• “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.”
• “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.”
• “‘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.’”

On your firm’s webpage https://naturopathix.com/complete-guide-molluscum-contagiosum-virus/:
• “Molluscum Contagiosum can also be screened and self-diagnosed in the majority of cases because of their distinctive look . . . 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.”

On your firm’s webpage https://naturopathix.com/products/:
• “ZymaDerm is a safe proven treatment to painlessly eliminate molluscum contagiosum.”
• “ZymaDerm is safe for babies nine months and older; and equally effective on adults.”
• “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.”

On your firm’s webpage https://naturopathix.com/molluscum-contagiosum-treatment-faq/:
• “ZymaDerm is a natural topical agent to aid in effective and safe molluscum treatment.”
• “ZymaDerm is effective in adults who have molluscum contagiosum. It is safe for use on the genital areas.”

On your Facebook Social Media page www.facebook.com/ZymaDerm:
• May 11, 2017 post – “Our FDA registered formula will effectively and gently treat your child’s molluscum symptoms.”
• June 2, 2016 post of the testimonial – “‘I have used previously with patients with positive feedback. I recommend for all my molluscum patients as the first line of treatment’”

Your “ZymaDerm for Molluscum” product is not generally recognized as safe and effective (GRASE) for its above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). There is no FDA-approved application in effect for “ZymaDerm for Molluscum.”1 Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

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. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.

Sincerely,
/S/

Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

_______________________________

1 We recognize that the “ZymaDerm for Molluscum” labeling describes the product as being “homeopathic.”

First, we note that under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same statutory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or FDA approval.

In addition, FDA issued a guidance in December 2022 that describes how the Agency intends to prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval. (See Homeopathic Drug Products: Guidance for FDA Staff and Industry, available at https://www.fda.gov/media/163755/download). For purposes of this guidance, FDA defines a “homeopathic drug product” as “a drug product that is labeled as ‘homeopathic,’ and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).” Your “ZymaDerm for Molluscum” product includes non-homeopathic ingredients that, although listed as “other ingredients,” are considered active ingredients under 21 C.F.R. 201.66(b)(2) because they are promoted on your website in various places with claims to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or any function of the body. These other active ingredients are not listed in dilutions and at least some are not listed in the HPUS, and thus this product falls outside the scope of products addressed in this guidance. Notwithstanding, even if your “ZymaDerm for Molluscum” product was considered a “homeopathic drug product” under this guidance, this product would fall under the guidance’s categories of homeopathic drug products marketed without the required FDA approval that FDA views as potentially posing higher risks to public health, and thus intends to prioritize for enforcement and regulatory actions.

 
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