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WARNING LETTER

Amazon.com, Inc MARCS-CMS 649056 —


Delivery Method:
Via Email
Product:
Drugs

Recipient:
Recipient Name
Andrew Jassy
Recipient Title
CEO
Amazon.com, Inc

410 Terry Ave. N
Seattle, WA 98109-5210
United States

Regulatory-inquiries@amazon.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


WARNING LETTER

August 18, 2023

RE: 649056

Dear Mr. Jassy:

This letter concerns your firm’s distribution of products intended to treat molluscum contagiosum and sold on your website, www.amazon.com. As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce of these products, which are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

The United States Food and Drug Administration (FDA) purchased “Naturasil Molluscum Treatment Kit,”1 “Conzerol 2 Step Treatment for Molluscum Contagiosum,”2 “ZymaDerm for Molluscum,” and “HealthyDerm Molluscum Contagiosum Treatment” through your website, www.amazon.com. These products, which are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.3

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. The “Naturasil Molluscum Treatment Kit,” “Conzerol 2 Step Treatment for Molluscum Contagiosum,” “ZymaDerm for Molluscum,” and “HealthyDerm Molluscum Contagiosum Treatment” 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, undiagnosed health condition by purchasing and using an unapproved drug product claiming to treat molluscum contagiosum.

Unapproved New Drugs

“Naturasil Molluscum Treatment Kit,” “Conzerol 2 Step Treatment for Molluscum Contagiosum,” “ZymaDerm for Molluscum,” and “HealthyDerm Molluscum Contagiosum Treatment” are drugs as defined by 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 observed on the labels of “Naturasil Molluscum Treatment Kit,” “Conzerol 2 Step Treatment for Molluscum Contagiosum,” “ZymaDerm for Molluscum,” and “HealthyDerm Molluscum Contagiosum Treatment” that establish the intended use of these products as drugs include, but may not be limited to, the following:

Naturasil Molluscum Treatment Kit4
• In the name of the product – “Molluscum Treatment Kit”
• On the Drug Facts label under “Uses” – “Symptomatic homeopathic topical treatment of common molluscum contagiosum.”
• “Now you can eradicate Molluscum Contagiosum at home with our Two-Part Molluscum Treatment Kit.”
• “Naturasil Molluscum Treatment Kit is recommended as a fast, natural solution that eliminates the need for an expensive dermatologist’s visit.”

Conzerol 2 Step Treatment for Molluscum Contagiosum
• “Conzerol Antiviral Molluscum Soap”
o In the name of the product – “Antiviral Molluscum Soap”
o “Use in conjunction with Conzerol cream for treatment of Molluscum”
• “Conzerol Cream”
o “[Z]ero molluscum contagiosum”
o “Homeopathic Treatment for Molluscum Contagiosum”
o On the Drug Facts label under “Use” – “Molluscum Contagiosum lesion relief”
• On the product insert – “3-5 weeks most people are lesion-free. Keep applying Conzerol to each lesion until there is no rise in the skin.”

ZymaDerm for Molluscum
• On the product insert – “ZymaDerm is the first patented, full-strength topical homeopathic remedy developed to aid in the treatment of molluscum contagiosum. Regular use can result in a significant reduction in the number of lesions within three to four weeks; however[,] some results are often seen in a matter of days. ZymaDerm is non-caustic, effective, does not harm normal skin, and is safe for use on facial and genital areas. Dermatologist tested, we only use the highest purity organic extracts available. ZymaDerm is fully registered with the FDA.”

HealthyDerm Molluscum Contagiosum Treatment
• In the name of the product – “Molluscum Contagiosum Treatment”
• “Fast Safe Painless Molluscum Solution”

“Naturasil Molluscum Treatment Kit,” “Conzerol 2 Step Treatment for Molluscum Contagiosum,” “ZymaDerm for Molluscum,” and “HealthyDerm Molluscum Contagiosum Treatment” are not generally recognized as safe and effective for their above referenced uses and, therefore, 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 legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for these products.5 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).

We recognize that “Conzerol Cream” is labeled as a homeopathic drug with an active ingredient measured in homeopathic strength. 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.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of past or present violations that may exist in connection with the products you distribute. 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/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, including steps you will take to ensure that Amazon will no longer introduce, deliver, or cause the introduction or delivery into interstate commerce of, unapproved new drugs products claiming to treat molluscum contagiosum, as well as copies of related documentation. If you believe that the products you distribute are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within fifteen working days from the date of receipt of this letter.

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 The kit is composed of “Naturasil Molluscum Relief Soap” and “Naturasil Molluscum Topical Liquid.”

2 This is a kit that contains “Conzerol Cream,” a product labeled as a homeopathic drug, and “Conzerol Antiviral Molluscum Soap.”

3 Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a service that allows businesses to outsource order fulfillment to Amazon. Businesses send products to Amazon fulfillment centers and when a customer makes a purchase, we pick, pack, and ship the order.” (See https://sell.amazon.com/fulfillment-by-amazon.html).

4 This product is marketed as being “child-safe (2 Yrs & Above).”

5 We recognize that the “Naturasil Molluscum Treatment Kit” and “ZymaDerm for Molluscum” labeling describes the products 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).” These above-mentioned drugs include non-homeopathic ingredients that, although listed as “inactive” or “other” ingredients, are considered active ingredients under 21 C.F.R. 201.66(b)(2) because they are promoted 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 these products fall outside the scope of products addressed in this guidance. Notwithstanding, even if these above-listed products were considered “homeopathic drug products" under this guidance, these products 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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