REGULATORY REPORT FDA: Regulation of Food Packaging Produced Using Nanotechnology

Food packaging is a target opportunity for the commercialization of nanotechnology. One respected industry analyst has reported that there are already 250 packaging products on the market incorporating substances manufactured using nanotechnology (nanopackaging). These products generated over $860 million in sales worldwide last year, and the same analyst projects that within10 years, nanopackaging will be a $30 billion market.

Food packaging materials must comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Nanopackaging for the most part involves the use of materials that are not intended to have any effect on the food in the package, but may contact the food if the material migrates from the packaging. Such materials are regulated as indirect food additives or food contact substances. There are precedents that permit the marketing of indirect food additives without the need for clearance, and there is a regulatory process in place to review additives that require approval. The critical question in the food packaging area, as in every regulated industry, is whether existing precedents and process will be sufficient to address any issues that arise as the application of nanotechnology matures.

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