FDA WARNING_LETTER - Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary - October 23, 2020

On November 10, 2020, the FDA and FTC issued a Warning Letter to SageWoman Herbs regarding unapproved and misbranded products related to COVID-19. The agencies reviewed the company's websites (sagewomanherbs.com and facebook.com/pg/sageconsultingandapothecary/) on September 9 and October 23, 2020.

The FDA observed that SageWoman Herbs offered products such as X-tra Strength CV Bundle, Golden Mushroom Blend, Moducare Chewables, Vitamin C with Bioflavonoids, Sovereign Silver Bio-Active Silver Hydrosol, Super Elderberry Syrup, Respiratory Tonic, Cistus Incanus Tea, Manuka Honey, Respiratory/Head Lungs, Shuang Huang Lian, Winter Rescue, and Winter Rescue Tincture for sale, claiming they mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).