WARNING LETTER

Aja Health and Wellness Inc. MARCS-CMS 729644 — May 18, 2026

Delivery Method:: Via Electronic Mail - Delivery and Read Receipt Requested
Reference #:: 729644
Product:: Drugs
Over-the-Counter Drugs

Recipient:: Recipient Name

Sanjeev Parsad; Recipient Title

President and CEO; Aja Health and Wellness Inc.; 1199 West Pender Street, Suite 680
Vancouver BC V6E 2R1
Canada; sparsad@ajahw.com; info@getaja.com

Issuing Office:: Center for Drug Evaluation and Research (CDER); United States

May 18, 2026

WARNING LETTER

To Sanjeev Parsad:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. 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 website, https://easemyheadache.com/, in February 2026. Based on our review, your Aja Migraine Relief 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 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. Examples from your product labeling, including your website, 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:

“Aja MIGRAINE RELIEF NASAL SPRAY . . . Natural Relief from Migraine Symptoms” [from the product label]

“Natural fast-acting relief from migraines—pain, pressure, and discomfort. Uses proprietary BioFlora™ blend to ease pain and inflammation quickly….” [from the Aja Migraine Relief product webpage https://easemyheadache.com/products/aja-migraine-relief]

“Testimonials Real people. Real relief. Here’s what they’re saying: I have . . . very painful migraines. I have been using this spray for weeks now and I feel immediate relief.” [from the Aja Migraine Relief testimonials webpage, https://easemyheadache.com/pages/testimonials]

Based on the above labeling evidence, Aja Migraine Relief is intended for use as an internal analgesic drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its 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). 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.

Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription internal analgesic drug products, such as your Aja Migraine Relief, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (hereinafter “M013”).¹ However, Aja Migraine Relief does not conform to the conditions specified in M013 for the reasons described below.

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. Thus, your internal analgesic drug product intended for administration inside the nostrils, does not conform to the conditions of M013.

In addition, your Aja Migraine Relief labeling includes intended uses that are not permitted for OTC internal analgesic products in M013. Specifically, 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).

Furthermore, your Aja Migraine Relief product is formulated with an active ingredient that is not permitted for OTC internal analgesic drug products under M013.10. Specifically, according to the product labeling that appears on your website at the internet address described above, 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.² An example of such a statement includes, “Uses proprietary BioFlora™ blend to ease pain and inflammation quickly.” Consequently, this ingredient is an active ingredient and, because it is not an active ingredient permitted under M013.10, your Aja Migraine Relief product does not conform with the conditions for lawful marketing of an OTC internal analgesic drug product as set forth in M013.

Thus, your Aja Migraine Relief product does not comply with the applicable conditions specified in M013 and has not otherwise been found GRASE.³ Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug.

The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

Misbranded Drug Violations

Additionally, 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.

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).

Conclusion

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future compliance so that these violations and any others do not occur.

Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729644” in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

Please note FDA posts warning letters on www.fda.gov.

Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

____________________________

1 M013 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000027, available at FDA’s website OTC Monographs @ FDA [https://dps.fda.gov/omuf].

2 See 21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”

3 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that Aja Migraine Relief is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).