FDA Issues Warning Letter to GSC Products for OTC Nasal Spray

GSC Products of Duanesburg, NY received a warning letter from the United States Food and Drug Administration (FDA) for violations regarding its Sinus Plumber Headache Nasal Spray sold on Amazon and its website.

FDA Letter Highlights

According to the FDA:

Violations were identified and documented during a review of your websites in March 2026. Your 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.

Unapproved New Drug Violations

The FDA letter continues:

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.

In addition, your Headache Nasal Spray labeling includes intended uses that are not permitted for OTC internal analgesic drug products in M013.

Furthermore, your Headache Nasal Spray is formulated with active ingredients that are not permitted for OTC internal analgesic drug products under M013.10. Specifically, feverfew, arnica montana, oleoresin capsicum, caffeine anhydrous and peppermint oil are not permitted as single active ingredients under M013.10, nor is this combination of active ingredients permitted under M013.20.

Therefore, your Headache Nasal Spray product does not conform with the conditions for lawful marketing of an OTC internal analgesic drug product as set forth in M013.

Thus, your Headache Nasal Spray product does not comply with the applicable conditions specified in M013 and has not otherwise been found GRASE.

Misbranded Drug Violations

In the FDA letter:

Additionally, Headache Nasal Spray is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Read the full FDA letter here.