FDA WARNING_LETTER - Anna Health, LLC - March 30, 2021

The FDA reviewed Anna Health's website (annahealth.com) from October 2020 to March 2021 and determined that products including Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health are marketed with claims establishing them as unapproved new drugs. Specifically, the Immune Health product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed "drugs" under section 201(g)(1)(B) of the Act due to their intended use in disease cure, mitigation, treatment, or prevention. They are also "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering these new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for use by a layperson. As they are intended for conditions not amenable to self-diagnosis or treatment, safe use requires supervision by a licensed practitioner, making it impossible to provide adequate directions for lay use. The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act.

Anna Health must notify the FDA in writing within 15 working days of receipt of the letter