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WARNING LETTER

CC:
Amazon Associates Program
[email protected]

RE: #644773

Dear Eric Sminia:

This letter is to advise you that on October 31, 2022, the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.monkeypox-treatment.com. While reviewing your website, FDA observed that you participate in the Amazon Associates program. As an Amazon Associate, you earn commissions by promoting the sale of various products with claims on your website representing or implying that the products can mitigate, prevent, treat, diagnose, or cure mpox¹ in people, including but not limited to such as Advil, Aleve, Tylenol 8HR, Amazon Children’s Ibuprofen, Amazon Hydrocortisone 1% Lotion, and A+D PREVENT, as well as Garden of Life B12 Vitamin, and Crystal Star Adrenal Support (hereinafter these products are referred to as “Amazon associate products”).^{2, 3} Based on our review, these claims cause these products, which are purchased through links on your website, to be unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Causing the introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. 331(a) and (d). In addition, it is a prohibited act under section 301(k) of the FD&C Act, 21 U.S.C. 331(k), to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.

The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving mpox.⁴ Therefore, FDA is taking measures to protect customers from products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure mpox. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure mpox in people. We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox.

Unapproved New Human Drugs

Some examples of the claims on your website that establish the intended use of your Amazon associate products as safe and/or effective for the treatment or prevention of mpox include:

On your homepage, https://monkeypox-treatment.com/:
• “MONKEYPOX TREATMENT”
• “TREATMENT AND PREVENTION FROM MONKEYPOX. . .SHOP FROM OVER 500 PRODUCTS. . .VISIT STORE”

On your page, https://monkeypox-treatment.com/product-category/monkeypox-fever-reducer/:
• Advil, Aleve, and Amazon Children’s Ibuprofen include the statement “MONKEYPOX FEVER REDUCER” in the product description and are listed under the “MONKEYPOX FEVER REDUCER” category.

On your page, https://monkeypox-treatment.com/product-category/monkeypox-muscle-aches-pain-relief/page/6/:
• Tylenol 8HR includes the statement “MONKEYPOX MUSCLE ACHES & PAIN RELIEF” in the product description and is listed under the “MONKEYPOX MUSCLE ACHES & PAIN RELIEF” category.

On your page, https://monkeypox-treatment.com/product-category/monkeypox-rash-cream/:
• A+D PREVENT, and Amazon Hydrocortisone 1% Lotion includes the statement “MONKEYPOX RASH CREAM” in the product description and are listed under the “MONKEYPOX RASH CREAM” category.

On your page, https://monkeypox-treatment.com/product-category/monkeypox-fatigue-supplements/:
• Crystal Star Adrenal Support, and Garden of Life B-12 Vitamin include “MONKEYPOX FATIGUE SUPPLEMENTS” in the product description and are listed under the “MONKEYPOX FATIGUE SUPPLEMENTS” category.

Your Amazon associate products are not generally recognized as safe and effective (GRASE) for their above referenced uses for mpox 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 legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Misbranded Human Drugs

A drug is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1) if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) Your Amazon associate products are offered to mitigate, prevent, treat, diagnose, or cure mpox, which is a condition that is not amenable to self-diagnosis and treatment without the supervision of a licensed practitioner. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Accordingly, your Amazon associate products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. 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. It is your responsibility to ensure that your activities, including as an Amazon associate, do not violate the FD&C Act. We advise you to review your websites and other labeling and promotional materials to ensure that you are not misleadingly representing your Amazon associate products as safe and effective for an mpox-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act.

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 address these matters. 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 Amazon associate 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. Please direct any inquiries to FDA at [email protected].

Sincerely,
/S/

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

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1 HHS has adopted the World Health Organization’s renaming of monkey pox to “mpox” to reduce stigma. Department of Health and Human Services, Biden Harris Administration Supports the World Health Organization Renaming of Monkeypox to mpox (issued Nov. 28, 2022), available at https://www.hhs.gov/about/news/2022/11/28/biden-harris-administration-supports-the-world-health-organization-renaming-of-monkeypox-to-mpox.html.

2 These are only some examples of products that you promote to mitigate, prevent, treat, diagnose, or cure mpox. You state on your website, “TREATMENT and PREVENTION FROM MONKEYPOX . . .SHOP FROM OVER 500 PRODUCTS. . .VISIT STORE.”

3 Specifically, your website contains links that direct consumers to the Amazon.com website to purchase the Amazon products you promote. As described in the Amazon Associates Program Fee Statement (https://affiliate-program.amazon.com/help/operating/policies/#Associates Program Fee Statement), accessed October 27, 2022), Amazon calculates your commission or “fee” by using your website’s Amazon associate ID to track sales to consumers who are redirected to Amazon.com by clicking one of the links on your website.

4 Secretary of Health and Human Services, Renewal of Determination that a Public Health Emergency Exists (issued Nov. 2, 2022), available at https://aspr.hhs.gov/legal/PHE/Pages/mpx-renewal-2Nov2022.aspx.