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FDA Warning Letter Explorer
FDA warning letter · Drugs

Living Foods LLC

Issued · Posted by FDA

FDA published a close-out letter on Oct 3, 2024. 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

Your ZeoHeal The Miracle Mineral product is intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your ZeoHeal The Miracle Mineral fails to bear adequate directions for its intended use and, therefore, the product is 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
  • 21 CFR 807.81(a)(3)(ii)
  • 21 CFR 807.81(b)
  • 21 CFR 882.9
  • 21 CFR 890.5500
  • 21 CFR 890.9