FDA Warning Letter to GSC Products, LLC (May 18, 2026) — Nonprescription/OTC

FDA Warning Letter — Violations FDA cited at GSC Products, LLC

WARNING LETTER GSC Products, LLC MARCS-CMS 729653 — May 18, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Delivery and Read Receipt Requested Reference #: 729653 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Wayne Perry Recipient Title Founder and President GSC Products, LLC 1441 Van Patten Rd Duanesburg , NY 12056-2522 United States (b)(6), (b)(7)(C) Issuing Office: Center for Drug Evaluation and Research (CDER) United States May 18, 2026 WARNING LETTER To Wayne Perry: This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your websites. 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 a review of your websites, https://sinusplumber.com and https://www.greensations.com, in March 2026. Your https://sinusplumber.com website also directs consumers to your Amazon storefront to purchase your product. Based on our review, your SINUS PLUMBER Headache Nasal Spray product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act, 21 U.S.C. 331(d) and 331(a). This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs. Violations of the Federal Food, Drug, and Cosmetic Act Unapproved New Drug Violations 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. Based on a review of your websites, your SINUS PLUMBER Headache Nasal Spray is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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 from your product labeling, including your websites, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following: “ Drug Facts . . . Purpose …Relieves pain and nausea…Relieves pain & inflammation…Increases circulation . . . Uses : For the temporary relief of: ■ General headache and migraine symptoms.” [from the product label on the Sinus Plumber product website https://sinusplumber.com/products/sinus-plumber-migraine-headache-nasal-spray-with-capsaicin] “Powerful & Fast Headache Relief √ Tension √ Clusters √ Migraines” [from the product label on the Sinus Plumber product website https://sinusplumber.com/products/sinus-plumber-migraine-headache-nasal-spray-with-capsaicin and https://www.greensations.com/Cayenne-Pepper-Headache-Nasal-Spray-p/sp-4.htm] “Sinus Plumber Headache Nasal Spray targets a variety of headaches with the pain relief power of capsaicin, feverfew, peppermint and caffeine.”…“This formula is commonly used for headaches that feel sinus-related or pressure-driven, including sinus headaches, tension headaches, migraines, and cluster headaches.” [from the Sinus Plumber p