FDA WARNING_LETTER - HemaCenter LLC - August 15, 2023

The FDA issued a Warning Letter to Hekmac.com on June 2, 2023, following a February 2023 review of their website and social media, which revealed that the company sells products marketed as natural supplements for various diseases. The FDA determined that products such as "Natural Supplements for Anemia," "Lymf (Galium aparine)," "Natural Supplements for Cardiomyopathy," "Magic1 (Moringa oleifera)," "Natural Supplements for Diabetes Mellitus," "Cinna (Cinnamomum Zeylanicum)," "Natural Supplements for High Blood Pressure – Hypertension," "kraph (Apium graveolens)," "Natural Supplements for Stroke – CVA," "Cam1 (Silybum marianum)," "Danshen (Red sage)," "Multiple Sclerosis Package," and "Smile Package" are unapproved new 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 diseases.

The letter cites numerous claims from Hekmac's website and social media, including testimonials, that establish the products' intended use as drugs. These products are not generally recognized as safe and effective for their claimed uses, making them "new drugs" under section 2