January 22, 2018

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FDA Launches “Organ Chip” Project to Support Food and Dietary Supplement Safety Research

  • “Organs-on-Chips” technology has been the focus of a public-private collaboration between FDA, the federal Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH).  “Organs-on-Chips” essentially involves creating miniature-sized human organ systems on micro-engineered chips about the size of an AA battery.  This technology has revolutionized the manner in which scientists can study the effects of potentially harmful chemical and biological hazards in foods, cosmetics, drugs or dietary supplements. Substantial grants have been awarded to universities nationwide to advance this research, including Harvard University and the Massachusetts Institute of Technology.  A company called Emulate Inc., founded by researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University, has been at the forefront of this work.

  • On April 11, 2017, FDA announced a collaboration with Emulate Inc. to evaluate the company’s “Organs-on-Chips” technology in laboratories at the FDA’s Center for Food Safety and Applied Nutrition.  FDA reports that the flexible polymer organ-chips contain tiny channels lined with living human cells and are capable of reproducing blood and air flow just as in the human body. The chips are translucent, affording researchers a window into the inner workings of the organ being studied. 

  • The success of this public-private venture could ultimately lead to a reduction in the animal testing needed to support the safety of various FDA-regulated products, particularly in the area of new drug development.

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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...