June 17, 2026 FDA Warning Letter: Amazon.com, Inc. Cited for Unapproved New Drugs/Misbranded

FDA Warning Letter — Violations FDA cited at Amazon.com, Inc.

WARNING LETTER Amazon.com, Inc. MARCS-CMS 728814 — June 17, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Product: Drugs Recipient: Recipient Name Andy Jassy Recipient Title CEO Amazon.com, Inc. P.O. Box 81226 Seattle , WA 98108-1226 United States Regulatory-inquiries@amazon.com 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 Cream 2 “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).