Amazon.com, Inc.(728814)

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

June 17, 2026

WARNING LETTER

Reference number: 728814

To Andy Jassy:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of drug products that were purchased on your website, www.amazon.com. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

FDA Review

Violations were identified and documented during review of the product labeling of products purchased on your website www.amazon.com in May 2026. FDA purchased “Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream,” through your website and these products were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.1 Based on our review, “Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream” 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).

This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.

Violations of the Federal Food, Drug, and Cosmetic Act

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.

Unapproved New Drug Violations

Based on a review of the product labeling, “Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream” 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 observed on the labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

Vajraang Phimosis Mini Combo

• “FOR PHIMOSIS”

• “Phimosis & Paraphimosis cream”

• “Coconut Oil for Phimosis”

Penile Heal Cream

• “Daily Phimosis Cream”

Beilloso Balanitis Relief Cream2

• “Helps relieve redness, itching & irritation from balanitis”

• “Balanitis Relief Cream”

“Vajraang Phimosis Mini Combo,” “Penile Heal Cream,” and “Beilloso Balanitis Relief Cream” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. 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 section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “728814” in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

Please note FDA posts warning letters on www.FDA.gov.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

______________________

1 Amazon distributed each of the products directly to individual U.S. consumers on behalf of third parties. Each of the products discussed below was “fulfilled” by Amazon; your website states, “Fulfillment by Amazon (FBA) is a program that lets you outsource order fulfillment to Amazon and offer customers free, two-day shipping through Prime. By enrolling in FBA, you can send your products into Amazon’s global network of fulfillment centers, and we’ll pick, pack, and ship orders, as well as handle customer service and returns. FBA is part of a fully automated set of services we call Supply Chain by Amazon.” (See https://sell.amazon.com/fulfillment-by-amazon).

2 The only permitted indications under “Over-the-Counter (OTC) Monograph M005: Topical Antifungal Drug Products for Over-the-Counter Human Use” (M005) are for the treatment of athlete’s foot, jock itch, ringworm and for relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch. Your product, “Beilloso Balanitis Relief Cream,” is intended to provide relief from balanitis symptoms, which goes beyond the permissible claims under M005. “Beilloso Balanitis Relief Cream” does not conform to M005 or any other final administrative order, thus there is no basis under section 505G of the FD&C Act under which this product could be legally marketed without an approved application. (see https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTC%20Monograph_M005-Topical%20Antifungal%20drug%20products%20for%20OTC%20Human%20Use%2012.16.2021.pdf).