Launching a new food product or dietary supplement in the United States: industrial, regulatory, and nutritional considerations.
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.
United States Department of Agriculture, Agricultural Research Service, Beltsville, Maryland 20705; email: john.finley@ars.usda.gov.
John Weldon
JW
Finley
John Wescott
JW
Finley
Kathleen
K
Ellwood
James
J
Hoadley
D000818:Animals; D019587:Dietary Supplements / Q000009:adverse effects* / Q000191:economics / Q000592:standards; D005503:Food Additives / Q000009:adverse effects / Q000191:economics / Q000592:standards; D005515:Food Labeling / Q000592:standards; D059022:Food Safety; D057141:Food, Preserved / Q000009:adverse effects / Q000191:economics / Q000592:standards; D005525:Food-Processing Industry / Q000191:economics; D019648:Foods, Specialized / Q000009:adverse effects* / Q000191:economics / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D009753:Nutritive Value; D014481:United States; D016885:United States Department of Agriculture; D014485:United States Federal Trade Commission; D014486:United States Food and Drug Administration
D005503:Food Additives
Food and Drug Administration; food product development; food science; label claims; nutrition; regulations