In June 2010, the FDA’s Final Rule on Dietary Supplement cGMPs became effective and all companies that manufacture, package, label, or hold dietary supplements and nutraceuticals, as well as products imported into the U.S., were expected to be in compliance. cGMPs require a comprehensive system of process controls, and document each stage of the manufacturing process, in order to minimize and detect problems early if they arise.
It’s difficult to know the types and extent of product quality and safety testing by dietary supplement and nutraceutical (DS/N) companies prior to the FDA’s Final Rule. In interviews conducted for Strategic Consulting, Inc.’s (SCI) latest report, “Industrial Microbiology Market Review” (IMMR-4), however, many companies reported needing to move quickly to comply with the microbiological testing required by the FDA Final Rule. The regulations required DS/N companies to demonstrate that the microbiological levels in products are below target levels and that no “objectionable organisms” are present in view of the product’s intended use.
According to IMMR-4, DS/N companies conducted approximately 35 million microbiology tests in 2014. While this represents significant change for these companies, it accounts for just two percent of the micro testing conducted in the entire industrial market, which covers the food, beverage, personal care products/cosmetics, environmental water, and industrial processes sectors.
A good number of DS/N companies chose to go with a system that combined versatility and ease-of-use, and that enabled them to quickly comply with FDA’s micro testing requirements. The BioLumix system was a preferred choice early on, with the Soleris system gaining share in recent years. In total, these two systems, both of which are now owned by Neogen, have an estimated combined installed base of more than 500 systems in the DS/N segment. SCI research shows good adoption by companies in the U.S. as well as in Asia.