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U.S. Department of Health and Human Services

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Volume IV - 11.2 Historical Background

DFS Pyramid Logo

Orientation and Training

Food and Drug Administration

DOCUMENT NO.:
IV-11
VERSION NO.: 1.3

Section 11 - Nutrient Analysis

EFFECTIVE DATE: 10-01-03 REVISED: 02-14-13

In 1973, the Food and Drug Administration (FDA) issued regulations requiring nutritional labeling on food for the following:  food containing one or more added nutrients, food with labeling or advertising claims about the food’s nutritional properties, or its usefulness in the daily diet. Nutritional labeling was voluntary for almost all other foods. In 1975, voluntary nutritional labeling went into effect. In 1984, sodium was added to the list of required nutrients, and potassium to the list of optional nutrients, on the nutrition panel. Effective in 1985, the new regulation also defined terms such as “low sodium.” In 1990, FDA proposed extensive food labeling changes due to growing concern over diet, health, and labeling uniformity. These changes, now known as the NLEA, (The Nutritional Labeling and Education Act), included mandatory nutrition labeling for most foods, standardized serving sizes, and uniform use of health claims. Final regulations and health claims became effective in 1993; nutrient content claims became effective in 1994. In 1994, The Dietary Supplement Health and Education Act (DSHEA) was passed requiring mandatory nutritional labeling of dietary supplements.

The Atlanta Center for Nutrient Analysis (ACNA), established in 1976, performs nutrient profiles on all food products and dietary supplements. ACNA was established to analyze the products that had voluntary nutritional labeling. The mission of the branch has changed to accommodate the changes in regulations over the last 26 years. In addition to voluntary (then later mandatory) nutritional labeling for foods and supplements, the Infant Formula Act of 1980 impacted ACNA as well. In 1978 and 1979, two formulas were found to be deficient in chloride. The manufacturer wanted to reduce the amount of sodium in the formula, and reduced the levels of chloride below the levels found in human milk. After that incident, the Act was passed and placed infant formula in a category close to drugs in terms of strictness of quality. ACNA analyzes all infant formula to determine adherence to the Act.

ACNA performs laboratory analysis of samples for all FDA districts. The compliance program areas covered include 7321.002 Medical Foods, 7321.006 Infant Formulas, 7321.005 Domestic NLEA, 7321.007 Import NLEA, 7321.008 Dietary Supplements and 7304.839 Total Diet Study (folic acid).