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Annual Review of Nutrition

Volume 34, 2014

Launching a New Food Product or Dietary Supplement in the United States: Industrial, Regulatory, and Nutritional Considerations

Abstract

Launching a new food/dietary supplement into the US market can be a confusing process to those unfamiliar with the food industry. Industry capability and product specifications are initial determinants of whether a candidate product can be manufactured in a reproducible manner and whether pilot production can be brought up to the market scale. Regulatory issues determine how a product can be produced and marketed; the primary federal institutions involved in regulations are the US Department of Agriculture, the Food and Drug Administration, and the Federal Trade Commission. A primary distinction is made between food and drugs, and no product may enter the food market if it is in part or whole a drug. Product safety is a major concern, and myriad regulations govern the determination of safety. New foods/dietary supplements are often marketed by health claims or structure/function claims, and there are specific regulations pertaining to claims. Not understanding the regulatory issues involved in developing a new product or failing to comply with associated regulations can have legal and financial repercussions.

Keyword(s): Food and Drug Administration, food product development, food science, label claims, nutrition, regulations
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2014-07-17
2024-04-20
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Launching a New Food Product or Dietary Supplement in the United States: Industrial, Regulatory, and Nutritional Considerations
Annual Review of Nutrition 34, 421 (2014); https://doi.org/10.1146/annurev-nutr-071813-105817
/content/journals/10.1146/annurev-nutr-071813-105817
/content/journals/10.1146/annurev-nutr-071813-105817
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