Emmbros Overseas Lifestyle PVT LTD. – FDA Warning Letter, Oct 31, 2018

The FDA issued a Warning Letter to Emmbros Overseas Lifestyle PVT LTD. on February 5, 2019, following a review of their websites (www.ayurvediccure.com, www.musclexp.com, www.nourishvitals.com, www.stbotanica.com) and social media in September and October 2018. The FDA determined that several products, including Morpheme Remedies Arthcare Plus, Morpheme Remedies Cinnamon, and St. Botanic Fish Oil, are unapproved new drugs and misbranded.

The violations stem from disease treatment and prevention claims made on the company's websites and social media, which establish the products' intent 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)]. Examples of claims include "positive results were noticed in patients suffering from Crohn’s disease, Chronic Colitis, Rheumatoid Arthritis" for Morpheme Arthcare Plus, and "Cinnamon Powder To Reduce Diabetes."

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. Furthermore,