FDA WARNING_LETTER - Omega Wonders LLC. - June 01, 2021

The FDA issued a Warning Letter to Omega Wonders, LLC, following a review of their websites (omegawonders.com, tersuslifesciences.com, and amazon.com) in March and May 2021. The FDA determined that the products "Cardia 7 Heart Health OMEGA 7" and "Advanced Tear Health OMEGA 7" are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because website claims and testimonials indicate their intended use for the cure, mitigation, treatment, or prevention of diseases. Examples for Cardia 7 include claims about supporting healthy cholesterol and CRP levels, and testimonials regarding reduced LDL, normalized cholesterol, and lowered blood pressure. For Advanced Tear Health, claims include managing dry eye symptoms, increasing tear production, and soothing irritation.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses, and lack prior FDA approval. They are also "misbranded" because they are intended for conditions not amenable to self-diagnosis or treatment, making it impossible to provide adequate directions for layperson use.

Introducing or delivering these unapproved and misbranded drugs into interstate commerce violates sections 301(a), 301(d), 505(a), and 502(f)(1) of the Act [21 U.S.C. 331