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  1. Warning Letters

WARNING LETTER

Molluscumaway LLC MARCS-CMS 650100 —


Delivery Method:
Via Email
Product:
Drugs

Recipient:
Recipient Name
Erica Groussman
Molluscumaway LLC

5154 Lagorce Dr.
Miami Beach, FL 33140
United States

info@molluscumaway.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

August 18, 2023

445 W 40th St.,
Suite 403369
Miami, FL 33143

RE: 650100

Dear Erica Groussman:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://molluscumaway.com/ in July 2023. We also reviewed your social media websites at https://www.facebook.com/MolluscumAway and https://www.instagram.com/molluscumaway/, where you direct consumers to your website, https://molluscumaway.com/, to purchase your products. The FDA has observed that your website offers “MolluscumAway Hydrating Patches,” “Little Skins Smoothing Skin Ointment,” and “Little Skins Gentle Body Wash” for sale in the United States and that these products are unapproved new drugs 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 these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

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 genitalia is 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 “MolluscumAway Hydrating Patches,” “Little Skins Smoothing Skin Ointment,” and “Little Skins Gentle Body Wash” products are especially concerning from a public health perspective because they are marketed for use in children. In addition, FDA is concerned that people are forgoing or delaying proper diagnosis and treatment of a potentially serious health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.

Unapproved New Drugs

Based on a review of your website and social media websites, your “MolluscumAway Hydrating Patches,” “Little Skins Smoothing Skin Ointment,” and “Little Skins Gentle Body Wash” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are 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 website https://molluscumaway.com/ and your social media websites https://www.facebook.com/MolluscumAway and https://www.instagram.com/molluscumaway/ that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

MolluscumAway Hydrating Patches

On the product webpage for “MolluscumAway Hydrating Patches,” https://molluscumaway.com/products/copy-of-molluscumaway%E2%84%A2-hydrating-patches-for-skin-care:
• “MOLLUSCUM AWAY”
• “MAKE THOSE MOLLUSCUM RUN AWAY”
• March 2, 2023, customer review by Heathyr K: “If only I had known about and found this product sooner! My child suffered from molluscum for two long years. . .. After a few weeks ALL the molluscum is gone.”

On your Facebook social media page https://www.facebook.com/MolluscumAway:
• September 27, 2022 post:
  o “Have you thought about trying our #MolluscumAway patches? . . . #ByeByeMolluscum #MolluscumContagiosum.”
  o “PATCHES WORKED WONDERS ON MY LITTLE GUYS [sic] BUMP. AFTER ONLY A FEW PATCHES THE BUMP [IS] ALMOST GONE.”

On your Instagram social media page https://www.instagram.com/molluscumaway/:
• September 6, 2022 post – “Molluscum Patches products are formulated with specialized micro-darts that ensure these active ingredients penetrate the molluscum contagiosum lesions . . . Our #MolluscumAway solutions will have you saying goodbye to #MolluscumContagiosum in no time.”

Little Skins Smoothing Skin Ointment

On the product webpage for “Little Skins Smoothing Skin Ointment,” https://molluscumaway.com/products/copy-of-smoothing-skin-ointment https://molluscumaway.com/pages/molluscum-healing-ointment:
• “[M]olluscum away healing ointment for inflamed skin”
• July 31, 2021, customer review by Sarah J: “My 3 year old daughter’s pediatrician said there was nothing we could do for her molluscum. . .. the Molloscum [sic] Away ointment cleared it up right away! Within a couple of weeks there was hardly any more bumps left! I was skeptical that it was going to work but was amazed at the results!”

On your Facebook social media page https://www.facebook.com/MolluscumAway:
• September 27, 2022 post – “#MolluscumAway healing ointment . . . relieving skin irritation & soothe #MolluscumContagiosum symptoms!”
• October 6, 2022 post – “Treat your little one’s skin with our #MolluscumAway healing ointment . . . help with #MolluscumContagiousum”

On your Instagram social media page: https://www.instagram.com/molluscumaway/:
• April 5, 2021 post – “Our healing ointment is amazing for helping #MolluscumContagious bumps.”

Little Skins Gentle Body Wash

On the product webpage for “Little Skins Gentle Body Wash,” https://molluscumaway.com/products/copy-of-gentle-body-wash-for-daily-use:
• “Gently Nourishing Molluscum Away Body Wash”
• January 6, 2023, customer review by Asya L: “I bought this for my daughter. We have been dealing with these bumps for more than 6 months. This body wash and the patches cleared her skin in less than 3 weeks!! This works!”

Your “MolluscumAway Hydrating Patches,” “Little Skins Smoothing Skin Ointment,” and “Little Skins Gentle Body Wash” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs 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). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these products. Accordingly, these products are unapproved new drugs marketed in violation of 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 products are 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

 
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