FDA WARNING_LETTER - Living Foods LLC - July 19, 2022

The FDA issued a Warning Letter to Living Foods (www.livingfoodsusa.com) on July 5, 2022, following a March 2022 website review. The letter identifies several violations related to unapproved new drugs and an unapproved/misbranded medical device.

The products Bion+Plus Silver Ozone and ZeoHeal The Miracle Mineral Supplement are deemed unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Act, as they are marketed with claims for disease cure, mitigation, treatment, or prevention without FDA approval. ZeoHeal The Miracle Mineral is also cited as a misbranded drug under section 502(f)(1) because it lacks adequate directions for layperson use, being intended for conditions requiring professional supervision.

Additionally, the Relax Far Infrared Ray Sauna is marketed without FDA marketing clearance or approval, violating section 201(h) as an unapproved device. It is adulterated under section 501(f)(1)(B) due to the absence of an approved PMA or IDE. The device is also misbranded under section 502(o) because Living Foods introduced it with major changes to its intended use (e.g., claims for cancer, kidney failure, diabetes, heart problems, skin conditions) without submitting a new premarket notification (510(k)), despite its original clearance