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FDA Warning Letter Explorer
FDA warning letter · Drugs

LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA

Issued · Posted by FDA

FDA published a close-out letter on Jul 5, 2022. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Accordingly, Thyroid Support, DHH‐B, Balance, Balance+, Clarity, Twilight, and Meditate products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C.352(f)(1)].

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.5