JC Ayur Life LLC – FDA Warning Letter, Dec 15, 2020

The FDA issued a Warning Letter to Ayurdiatonic.com in December 2020, following an October 2020 review of their website and social media. The FDA determined that the product "Heritage of Ayurveda Dia-Tonic Incudil Herbal Dietary Supplement" is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The product is deemed a drug because of claims on the company's website and Facebook page, as well as through metatags and customer testimonials, which indicate its intended use in the cure, mitigation, treatment, or prevention of diseases. Examples of such claims include "Helps to inhibit the formation of skin cancer," "Helps in blood sugar control," "Helps liver to recover from alcohol and drug damage," and "To control diabetes and its side effects." Claims for individual ingredients also suggest disease treatment.

As a "new drug," the product lacks FDA approval, violating sections 301(d) and 505(a) of the Act. Furthermore, it is misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as it is intended for conditions requiring professional supervision. The introduction of this misbranded drug into interstate commerce violates section 301(a).

The company must take prompt action to correct these violations and notify the FDA within fifteen working days of the specific steps taken