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  5. MolluscumRx, Inc. - 648457 - 08/18/2023
  1. Warning Letters

WARNING LETTER

MolluscumRx, Inc. MARCS-CMS 648457 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
Frank Almeida
Recipient Title
President
MolluscumRx, Inc.

5349 Lake Jessamine Dr.
Orlando, FL 32839
United States

sales@molluscumrx.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

WARNING LETTER

August 18, 2023

RE: 648457

Dear Mr. Almeida:

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://molluscumrx.com in June 2023. We also reviewed your social media websites, https://www.facebook.com/molluscumrx, https://twitter.com/MolluscumRx and https://www.youtube.com/user/MolluscumRx, where you direct consumers to your website, https://molluscumrx.com, to purchase your products. The FDA has observed that your website offers “MolluscumRx” and “MolluscumRx Soap” for sale in the United States. Based on our review, 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 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 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 “Molluscum Rx” and “MolluscumRx Soap” 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 undiagnosed 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 “MolluscumRx” and “MolluscumRx Soap” 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://molluscumrx.com and your social media websites https://www.facebook.com/molluscumrx, https://twitter.com/MolluscumRx and https://www.youtube.com/user/MolluscumRx, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

On the product webpage for “MolluscumRx,” https://molluscumrx.com/product/2-bottles/:
• “‘My doctor said it was the best molluscum contagiosum medicine available. And he was right.’”
• “MolluscumRx Works[,] It works with just one bottle. You’ll see results in 5-7 days . . . It’s an Organic Molluscum Treatment[,] MolluscumRx is a molluscum treatment over the counter, made from all-natural, organic plant extracts.”

On the product webpage for “MolluscumRx Soap,” https://molluscumrx.com/product/soap/:
• “*MolluscumRx Soap is designed to enhance the treatment when using the MolluscumRx lotion . . . MolluscumRx Soap is made with all organic, antiviral ingredients that is designed to enhance the effectiveness of MolluscumRx.” This webpage statement is accompanied by an image of the “MolluscumRx Soap” product package, which bears the term “Antiviral.”

On the webpage entitled, “Best Natural Treatments for Molluscum,” https://molluscumrx.com/best-natural-treatments-for-molluscum/:
• “With more than 40,000 units of MolluscumRx successfully used to cure molluscum contagiosum in children and adults, we have never received any reports of adverse reactions from the treatment. MolluscumRx has been proven safe for use across the body, face and genital areas . . . In a physician-conducted test, MolluscumRx was found to be highly effective in the treatment for curing molluscum contagiosum.”

On the webpage entitled, “MolluscumRx Ingredients,” https://molluscumrx.com/molluscumrx-ingredients/:
• “MolluscumRx Ingredients[,] MolluscumRx uses a potent combination of natural plant extracts to cure molluscum contagiosum lesions. This proprietary blend of extracts makes MolluscumRx a safe and highly effective treatment for molluscum contagiosum . . . Procyanidins[,] Proanthocyanidins can be found in many plants. They have antioxidant activity and play an important role in the stabilization of collagen and maintenance of elastin . . . Calendula[,] The plant has long been known to promote healing of the skin. Other studies have indicated that calendula has anti-viral and anti-inflammatory properties. Calendula in suspension or in tincture is used topically to treat acne, reducing inflammation, controlling bleeding, and soothing irritated tissue.”

From a January 17, 2018 blog post entitled, “Molluscum on the Genital Areas,” and that includes an image of your “Molluscum Rx” with a link to purchase the product, https://molluscumrx.com/2018/01/17/molluscum-genital-areas/:
• “MolluscumRx is an organic solution to molluscum. Our medicine is safe for the entire body, including the genitals . . . Best of all, your lesions are typically gone within 4-6 weeks.”

On your Facebook social media page https://www.facebook.com/molluscumrx:
• September 7, 2022 post – An image of a flyer with the text “MolluscumRx is a safe organic treatment for the removal of molluscum lesions . . . Lesions respond within 5-7 days . . . Pain-free option for ages 6 months to adult” • November 10, 2021 post – “Treat molluscum contagiosum with MolluscumRx . . . MolluscumRx is pain free, effective, organic and safe! . . . Visit our website: Molluscumrx.com . . . The molluscum contagiosum virus is considered a poxvirus . . . The MC virus itself is complex, which can result in lesions lasting for years on patients if left untreated.”

On your Twitter social media page https://twitter.com/MolluscumRx:
• December 14, 2022 post – “Benefits of using MolluscumRx! . . . Lesions gone in 2-4 weeks[,] Visit our website to learn more . . . Molluscumrx.com”
• November 3, 2022 post – “Before and after! MolluscumRx works! Pain free, safe and effective[,] Before: The rounded, dome-like and waxy papules are easily spread from person to person, or across the body[,] After: Treatment with MolluscumRx provides a safe, all-natural alternative to harsh molluscum contagiosum treatments.” This statement is accompanied by photographs of skin lesions before and after treatment.

On your YouTube social media page https://www.youtube.com/watch?v=Q5Dp-7RsCoc:
• January 10, 2018 video post [00:01- 00:42] – “There’s a lot of choices on the internet. But as your doctor has probably told you[,] most of them don’t work. But relax, you found MolluscumRx, the best molluscum treatment there is and here’s why. First and foremost, MolluscumRx is highly effective. In a physician led study, MolluscumRx was proven to work over ninety percent of the time. That’s right, over 90 percent of the time. 210 patients were tested by a group of dermatologists and pediatricians and after five weeks 92.5 percent reported all lesions gone.”
  o The caption below the video states: “Molluscum is a pesky skin virus that affects many children and adults . . . Now, there is a better solution to get rid of your molluscum lesions! MolluscumRx is an organic, pain-free solution that is gentle on the skin. It is safe for children 6 months to adults. It is easy to apply and with consistent use, it resolves your lesions within 4-6 weeks.”

Your “Molluscum Rx” and “Molluscum Rx Soap” 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, the introduction or delivery for introduction into interstate commerce of these products 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 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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