Lixiviant Product Development and FDA Regulation

Lixiviants, the science, the biotechnology and intended use, are well-known to the industry. Lixiviant biotechnology dates back to the time of Egyptian slaves who used lixiviant-like ingredients and processes to clean clothes and preserve food. The word lixiviant comes from Latin - "lix" - lye. The process is based on basic science where adjusting "pH" of solutions releases insoluble materials from soluble. In 2010, several companies inquired about FDA testing requirements, preclinical and clinical trial guidance pertaining to lixiviant product development.

Lixiviants fall into a category that is FDA regulated through GRAS, "generally recognized as safe". All GRAS ingredients allow for safe use for food contact areas such as but not limited to counter tops, cooking utensils and food containers. This applies to all contact, tactile or ingested GRAS substance, detailed processes for the quality management and development leading to successful marketed products. GRAS is a list which provides safety guidance and recommendations, issued by FDA, pertaining to "how to use, the use of certain ingredients, compounds, chemicals and otherwise that preserve, protect, sustain food, clothes and surfaces". Lixiviant ingredients, found on GRAS, are "generally recognized as safe" by industry standards of testing, invitro and invivo. FDA emphasizes that although ingredients are suggested to be acceptable to the environment, vegetation, animals and humans, on touch or consumption, testing is recommended to determine and ensure safety and effectiveness.

Testing required, such as but not limited to:

• mutagenicity
• toxicology
• reproductive
• organ
• carcinogenicity
• otherwise.

FDA recommends testing, invitro and invivo, preclinical and clinical testing in tissue culture (mammalian cells), bacteria, animals, rodents to canine and human clinical trials to assess safety. It is recommended that although one formulation may test "ok" by safety standards, any change to the process, ingredient, sequence of ingredient addition, formulation, concentration, pH, new patent, new product, new intended use, must be re-tested to ensure safety and effectiveness. Similar to drug development CMC requirements.

It is essential for the consumer, the development company and the investor to ensure safety, product consistency, batch to batch, lot to lot, stability, shelf life, all constituents that apply to drug CMC development. All participants must consider consumer health, safety, risk and benefit. FDA with the Department of Labor, Public Health, Occupational Safety requires safety testing which must be addressed proactively when considering lixiviant-like products. Hazards may not be immediately apparent and thus must be researched in depth during development. As always, data results, preclinical testing and clinical trials must be conducted with FDA GCP. QC (quality control) of data and documentation must be accurate and consistent. Development, intended use must be in compliance with FDA and industry standards.