Loading…
Ayuryoga, Inc. was cited for selling unapproved new drug products under the brand name Kottakkal Ayurveda USA, including items such as Arjuna Arishtam, Ashwagandha Arishtam, and various other ayurvedic formulations in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company made disease treatment and body function claims on its website and social media platforms (Facebook, Instagram, LinkedIn, and Twitter) that established these products as drugs requiring FDA approval before marketing. The products were being sold directly to consumers through the company's e-commerce website without the required new drug applications or approvals.