FDA WARNING_LETTER - Saffron Health Sciences - November 30, 2021

The FDA issued a Warning Letter to Saffron Health Sci, LLC, on November 18, 2021, after reviewing their websites (saffronhealthsci.com, facebook.com/saffronhealthsci/) and Amazon store in November 2021. The review found that the company sells "Crocin Rich," "Crocin Rich II," and "Crocin Rich Plus" with claims establishing them as unapproved new drugs intended for disease treatment, including COVID-19, stroke, multiple sclerosis, Alzheimer's, age-related eye diseases, and depression.

These products are deemed "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 FDA approval. Introducing them into interstate commerce without prior FDA 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(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because they lack adequate directions for use by a layperson, as they are intended for conditions requiring supervision by a licensed practitioner. This misbranding