FDA WARNING_LETTER - Saffron USA LLC - September 23, 2022

The FDA reviewed Saffron USA's website (saffronusa.com) in September 2022 and determined that five products—Allergy Blend, Chamomile Tea Petals, Diabetic Support Blend, Orange Blast Tea, and Saffron Loose Tea—are unapproved new drugs and misbranded.

The FDA cited claims on the company's website that establish these products as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of claims include "Allergy relief," "Treating diabetes," "Cancer-Fighting Properties," "Lowers cholesterol," and "Fights Anxiety."

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval. Introducing or delivering these products into interstate commerce without approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].

Furthermore, the products are misbranded under section 502