The U.S. Food and Drug Administration has expanded the permitted use of hydrogen peroxide as a secondary direct food additive, creating significant new market opportunities for disinfection technology companies. The final rule, published on September 3, 2025 (90 FR 42535), amends 21 CFR §173.356 to allow broader applications of food-grade hydrogen peroxide in food production.
TOMI Environmental Solutions, Inc. (NASDAQ: TOMZ), a global disinfection and decontamination company, announced it is well-positioned to capitalize on this regulatory change. The company's SteraMist Binary Ionization Technology (BIT) Solution utilizes a low concentration of hydrogen peroxide combined with deionized water, both recognized as safe for food use.
Regulatory Requirements and Technology Alignment
The new FDA rule permits the use of food-grade hydrogen peroxide that complies with Food Chemicals Codex (FCC), 14th Edition specifications, in food production. The critical requirement is that any trace residues must be completely removed before food reaches consumers.
TOMI's SteraMist application method ensures no detectable residues remain on the final food product, aligning with the new FDA requirements. The SteraMist iHP formulation contains a small, non-residual proprietary component that is not expected to pose safety concerns under the conditions of use.
Scientific Validation and Market Applications
"We are very pleased with the FDA's new rule, as it formally recognizes the potential for hydrogen peroxide to be used more broadly in the food industry, further validating the science behind our SteraMist iHP technology and opening up a significant market opportunity for TOMI Environmental," said Elissa J. Shane, COO of TOMI Environmental Solutions.
Supporting research published in the Journal of Food Protection demonstrates that hydrogen peroxide residues on fresh produce treated with ionized hydrogen peroxide technology decomposed rapidly and did not appear to pose a safety concern after one day of storage.
Technology Platform and Applications
TOMI's Binary Ionization Technology platform was originally invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense. The BIT solution utilizes a low percentage hydrogen peroxide as its only active ingredient and uses patented ionized Hydrogen Peroxide (iHP) technology in all SteraMist systems.
The expanded FDA approval opens multiple verticals in the food industry, including food safety, food transportation, food storage, food packaging, direct spraying of food pre- and post-harvest, outbreak control, and preventive pathogen reduction. The technology also has potential to increase the longevity of all food types.
Broader Market Reach
TOMI products currently serve a broad spectrum of use sites, including hospitals and medical facilities, biosafety labs, pharmaceutical facilities, commercial and office buildings, schools, restaurants, meat and produce processing facilities, and police and fire departments. The FDA's updated regulation provides a clear path for food processors to adopt advanced, residue-free technologies like SteraMist iHP to enhance food safety and protect consumers.
