The concept of specially formulated foods for seriously ill patients was defined as Foods for Special Dietary Use (FSDU) in 1941, with such products being regulated as drugs. However, in late 1972, they were removed from the drug category to be regulated by FDA solely as an FSDU. At the time, their usefulness was widely accepted and they were very limited in number. Removing them from the burden of drug status eliminated the increased time, expense and review of the drug approval process.
The 1973 preamble to the final rule on nutrition labeling exempted two types of FSDU from general labeling requirements, at which time the term “medical food" came into being. Since then, FDA issued an Advance Notice of Proposed Rulemaking (ANPR) on the regulation of medical foods, withdrew it, and published “Draft Guidance for Industry. Frequently Asked Questions About Medical Foods; Second Edition." Today's products must meet specific requirements to be considered medical foods.
In this free SupplySide Omega-3 Insights Report, "The Emerging Market for Omega-3s in Medical Foods," Greg Stephens, president of strategic consulting firm Windrose Partners, details the ongoing regulatory landscape and provides an overview of the market and its potential.
Currently, the entire U.S. medical food market is dominated by two key players. However, the category is experiencing significant growth, including new product launches. Emerging competitors are primarily companies from the health practitioner channel, startup companies with novel technologies, and traditional dietary supplement companies venturing into the space.
The U.S. distribution of medical foods is primarily through three channels. Early products were sold through health care institutions, then later expanded to retail distribution. Albeit on a much smaller scale, recently medical foods are entering the health practitioner channel. Medical reimbursement can be tricky, but these products are invaluable to human health and will continue to occupy the market.