LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA – FDA Warning Letter, Sep 30, 2021

On November 23, 2021, the FDA issued a Warning Letter to Messrs. Frantz and Delk after reviewing their websites, tailormadehealth.com, www.infiniwell.com, and https://findharmonia.com/, in August-September 2021. The FDA determined that products sold on these websites, specifically Thyroid Support, DHH-B, Balance, Balance+, Clarity, Twilight, and Meditate, are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The claims made on the websites, such as those indicating the products are for the cure, mitigation, treatment, or prevention of disease, establish them as drugs under section 201(g)(1)(B) of the Act. Since these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) and require prior FDA approval before interstate commerce introduction, which they lack.

Furthermore, these products are misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson. As they are intended for conditions not amenable to self-diagnosis or treatment, they require supervision by a licensed practitioner, making it impossible to provide adequate directions for safe layperson use.

The introduction or delivery of these unapproved new drugs and misbranded drugs into interstate commerce violates sections 30