GSC Products, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your SINUS PLUMBER Headache Nasal Spray is intended to be applied inside the nostrils. Under M013.1, only an OTC internal analgesic drug product in a form suitable for oral administration is generally recognized as safe and effective if it meets the conditions of M013. Thus, your internal analgesic drug product intended for administration inside the nostrils, does not conform to the conditions of M013.

Passage 2

In addition, your SINUS PLUMBER Headache Nasal Spray labeling includes intended uses that are not permitted for OTC internal analgesic drug products in M013. Specifically, claims such as “This formula is commonly used for headaches that feel sinus-related or pressure-driven, including sinus headaches, tension headaches, migraines, and cluster headaches.” and “Purpose . . . Relieves . . . nausea . . . inflammation . . . increase circulation” that suggest SINUS PLUMBER Headache Nasal Spray is intended to treat sinuses, tension, clusters, and migraines, and is intended to relieve nausea, inflammation, and increase circulation go beyond the general intended uses for an OTC internal analgesic drug product and do not conform to the permitted uses set forth in M013.50(b).

Passage 3

Furthermore, your SINUS PLUMBER 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.

Passage 4

Additionally, SINUS PLUMBER 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.