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Report: Infant Formula Manufacturers Face New FDA Standards in September

NEW YORK, Aug. 6, 2014 /PRNewswire-USNewswire/ -- Manufacturers in the infant nutrition market, moderately stable in the U.S. over the last several years according to Kalorama Information, must comply with a June FDA rule setting standards for infant formula by September 8, 2014.  By overseeing the manufacture of infant formulas, the FDA is supporting healthy growth through proper nutrition.  Clinical nutrition is an essential part of patient care not just in the infant market, but in the enteral and parenteral product markets as well.  These three primary segments of essential medical nutrition are the focus of Kalorama's report, Clinical Nutrition Products: A Worldwide Perspective.

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The report can be found at KI:

Melissa Elder, author of the healthcare market research publisher's report, applauds the FDA initiative, "Nowhere is the balance among dietary constituents more important than in the nutrition of the growing infant and child."

Under the final FDA rule, infant formula standards include:

  • Current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter.
  • A requirement that manufacturers demonstrate that the formulas they produce support normal physical growth.
  • A requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products' shelf life.

Kalorama's Clinical Nutrition report runs the gamut of infant nutrition, including discussion of milk-based, soy-based, elemental, follow-up, organic, probiotic/prebiotic, premature, newborn and other specialized formulas.  In terms of enteral nutrition, standard and fiber-containing and elemental and semi-elemental products are explored, as specialized for chronically ill patients.  Parenteral nutrition is examined in the context of its indication for a variety of disorders including gastrointestinal disease, burns, extensive wounds, cancer and AIDS.

A handful of companies, ranging from global nutritional manufacturers to leading pharmaceutical companies, dominate competition in the clinical nutrition market, according to the report.   The majority of competitive participation takes place in developed regions such as the United States, Western Europe, and Japan.  Many companies, however, are expanding into less developed regions, intensifying competition in less-tapped markets.  China, for example, is among the expanding competitive regions where companies continue to break into the growing demand for clinical nutrition in new world markets.

Kalorama Information's report, Clinical Nutrition Products: A Worldwide Perspective, provides an overview of market segments, description of products on the market, recent business activities, market estimates and forecasts, and competitive analysis of leading providers.  

About Kalorama Information -- Kalorama Information, a division of, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at

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