Andrei B

Primal Queen: "My Menopause Killer." Facebook ad library link: facebook.com/ads/library/?i… FDA guidance: "A claim that a product is a substitute for a drug or other therapy for disease is an implied disease claim. Such claims carry with them the clear implication that the dietary supplement is intended for the same disease treatment or prevention purpose as the therapeutic product." Menopause is a recognized medical condition and hormone replacement therapy (HRT) is its prescribed treatment. The headline in this ad, Menopause Killer, does not imply support. It implies elimination of a medical condition. Under 21 U.S.C. § 321(g)(1)(B), it makes this product a drug. Now you might say well their subtext says "Support hormonal balance naturally." This does not neutralize the headline. The FDA has stated explicitly that qualifying language does not undo an implied disease claim when the overall impression of the ad conveys disease treatment. "My Menopause Killer" is what a consumer sees first. Everything after it is read in that context. Also, the checkmarked claims beneath the headline, hormonal health, energy, stable mood, clarity, "raging" libido, are recognized menopause symptoms. Together with the "My Menopause Killer" headline, they describe a product designed to treat a specific medical condition symptom by symptom. That is treatment language and positioning a supplement as the solution to menopause symptoms is, under FDA Criterion 6, the same as positioning it as an alternative to HRT, which is approved drug territory.