Aja Health and Wellness Inc.

Selected passages from the FDA letter

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

Passage 1

Based on a review of your website, your Aja Migraine Relief 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.

Passage 2

No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this drug product identified above.

Passage 3

Your Aja Migraine Relief 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.

Passage 4

claims such as “natural relief from migraine symptoms,” “ease . . . inflammation quickly,” and your product name, “Aja Migraine Relief,” that suggest Aja Migraine Relief is intended to treat migraines and inflammation go beyond the general intended uses for an OTC internal analgesic product and do not conform to the permitted uses set forth in M013.50(b).

Passage 5

Aja Migraine Relief is formulated with the active ingredient BioFlora™ blend. We note that, although you do not explicitly identify BioFlora™ blend as an active ingredient, statements on your website show that it is an active ingredient because it is intended to furnish pharmacological activity for the treatment of a disease or condition.

Passage 6

Aja Migraine Relief 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.