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Food Ingredients and Packaging

FDA has very limited authority to regulate food before it goes on the market. A significant exception is regulation of food and color additives, which must be approved by FDA as safe for intended uses prior to marketing. Definition of “food additive” includes not just the ingredients added to the food, but also any substance used in the production process that could end up in the food, including packaging material that could leach onto food and lubricants on the machines that touches the food during processing.

FD&C Act specifically excludes the following types of substances from the definition of food additives:

Any substance that is generally recognized as safe for its intended uses by scientific experts.

Pesticide chemical residues.

Pesticides.

Color additives.

New animal drugs.

New dietary ingredients.

Prior sanction: any substance approved or sanctioned for use prior to 6 September, 1958 under the FD&C Act of 1906 or the Poultry Products Inspection Act of 1957.

Reference: Fundamentals of US Regulatory Affairs, Sixth Edition, By; Regulatory Affairs Professional Society.

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