FDA
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Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 

T98-13                        Print Media:         202-205-4144
March 25, 1998                
                              Consumer Inquiries:  800-532-4440

"HEALTHY" MAY BE USED TO DESCRIBE CERTAIN PROCESSED FOODS AND GRAIN PRODUCTS

FDA has issued a new rule allowing the use of the term "healthy" on the labels of certain frozen and canned fruits and vegetables and enriched cereal grain products. The new rule is designed to encourage greater use of foods whose consumption is recommended in the U.S. Dietary Guidelines as important for the maintenance of good health.

FDA's first definition of the implied nutrient content claim "healthy," published in May 1994, said the descriptor could be used on an individual food if it was low in fat and saturated fat, met limits for sodium and cholesterol, and contained at least 10 percent per serving of the Daily Value of one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, and fiber.

The agency, however, recognized that raw fruits and vegetables can contribute significantly to a healthy diet and to achieving compliance with dietary guidelines. The rule therefore specified that raw produce could be labeled "healthy" without meeting the 10-percent nutrient contribution requirements, provided it met the other requirements.

After publication of that rule, the American Frozen Food Institute (AFFI) and the National Food Processors Association petitioned FDA for the same exemption from the 10 percent nutrient contribution requirement for processed single-ingredient fruits and vegetables on the basis of evidence that such products are nutritionally equivalent to raw produce.

In addition, the American Bakers Association petitioned for a similar exemption from the 10 percent nutrient contribution requirement for enriched cereal-grain products and enriched breads that conform to FDA's standards of identity (which define required ingredients in certain traditional foods) and that meet the rest of the conditions in the 1994 rule for use of the descriptor "healthy."

In response, FDA published in February 1996 a proposed rule tentatively concluding that the term "healthy" should be allowed on single ingredient frozen fruits and vegetables and certain enriched cereal-grain products. Following a comment period during which the agency received approximately 100 generally supportive letters from industry, trade organizations, consumer interest groups and academia, FDA in today's final rule is allowing the use of the term "healthy" for frozen or canned fruits and vegetables that do not contain ingredients that would change the nutrient profile, as well as enriched grain products that conform to the standards of identity.

The final rule is effective upon its publication in the Federal Register.

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