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From GMA…

In comments filed with the U.S. Food and Drug Administration today, the Grocery Manufacturers of America said plant-made pharmaceuticals (PMPs) require stringent new regulations to ensure continued consumer confidence in the absolute safety of the U.S. food supply.

GMA's comments were filed in response to proposed guidelines published by the FDA that outline requirements for developing and manufacturing PMPs. In its comments, GMA addressed the need to include clear direction in the final guidelines for maintaining the purity of the U.S. food supply as well. GMA stressed its support for the potential benefits of the technology but said the FDA and U.S. Department of Agriculture must implement more stringent regulations before the technology is more widely used in new field trials approved by the USDA or in large-scale commercialization. GMA's comments apply to plant-made industrial products as well as PMPs.

"Biotechnology has great potential to bring new benefits to consumers," said GMA Senior Vice President of Government Affairs Mary Sophos. "However, now is the time to ensure that the appropriate and necessary regulations for PMPs are in place, and that safeguards for the U.S. food supply are implemented before this technology is more widely used."

"Plant-made pharmaceuticals aren't meant to make it to the dinner table," added Sophos. "To minimize the possible risks, a clear system of regulatory enforcement and liability needs to be in place for the development, testing and eventual commercialization of PMPs - just as we require strict regulations for conventional drugs made in brick and mortar facilities. Until then, no permits for new field trials or for commercialization should be issued by USDA because there is no room for trial and error."
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