What happened
Original notice title
Living Foods LLC MARCS-CMS 622648, July 05, 2022
From the archived source record
We have also determined that your firm is marketing the Relax Far Infrared Ray Sauna in the United States without marketing clearance or approval, in violation of the Act. Unapproved New Drugs Your Bion+Plus Silver Ozone and ZeoHeal The Miracle Mineral products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. I always keep a bottle on hand.” [see original source] and [see original source] ZeoHeal The Miracle Mineral Supplement “Zeolite cage can easily trap varieties of articles, working hierarchically as the article below describes: heavy metals first, then toxic chemicals, plastics, and viruses. The mineral detoxifier removes the metals and toxic molecules from the body” “Zeolite traps and nullifies nitrosamines in the digestive track. Nitrosamines are cancer-causing agents” “Nitrosamines are a causative factor in type-II diabetes.” “Zeoheal *** the ultimate heavy metal detoxifier with a unique zeolite-fulvic acid compound for effective and safe deep tissue cleanse of all contaminates ” “Metal Chelator/Chlathrator Toxic Chemical Eliminator” “Taking ZeoHeal and Bion 3x a day with much improved gut and other symptoms related to ovarian cyst removal” “Traps and Neutralizes carcinogenic Nitrosamines” “Exhibits broad spectrum anti-viral activity” Misbranded Drugs A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). 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)].
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- e031fbe40735
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →