Nasal Spray “Migraine” Drug Claims
Understanding product category requirements is essential to compliance
Many products sprayed into the nose are considered OTC drugs, which allow companies to make designated claims about them. This also requires nasal OTC drugs to follow strict monographs. These are recipes that clearly specify which ingredients can be used and which claims can be made. OTC manufacturers are also required to follow strict GMP standards and list their products. It’s a clear and pretty good regulatory structure and FDA has a long history of citing companies masquerading as OTCs (claims) or making therapeutic claims about inactive ingredients. Today’s WLW involves a nasal spray that was cited for making serious disease support claims.
Candidly, this product was an easy target because of its name “Migraine Relief” as there are no nasal migraine relief OTC products, just Rx or homeopathics. This signals to FDA that they intend to treat a disease. When FDA looked more closely at their website, they found many claims, including those about the BioFlora™ ingredient.
From warning letter. “Natural fast-acting relief from migraines—pain, pressure, and discomfort. Uses proprietary BioFlora™ blend to ease pain and inflammation quickly”
Also, FDA cites claims on a testimonial page. This is a reminder that congregating reviews on a single page may be considered an endorsement, similar to when companies showcase reviews in a banner.
From warning letter. ““=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.”
There’s more to this warning letter, and I invite you to give it a read.
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