Several forces led Congress to pass the Nutrition Labeling and Education Act of 1990 (NLEA). As public interest in foods and nutrition, especially the relationship between diet and health, continued to grow, a number of food manufacturers had begun in the mid 1980s to make health and nutrition claims on certain product labels. Probably the best known of these was the claim that fiber in the diet was believed to reduce the risk of cancer. Because government regulations did not provide for this and other claims, questions and controversies arose that led to pressure on both Congress and FDA for labeling reform. In 1990, in what amounted to a race with Congress, FDA was the first to propose extensive labeling revisions. These were all superseded when, on its own, Congress passed the NLEA in October. The president signed NLEA in November 1990.
The key provisions of the NLEA, prescribing exactly what Congress wanted on food labels, are as follows:
All food products had to provide nutritional labeling, with very few exceptions. Exceptions included foods served in restaurants and food-service operations, foods containing insignificant levels of nutrients, and products from small manufacturers. Produce sold at retail, including fresh fruits, vegetables, and seafood, was expected to provide nutrition information voluntarily. Requirements would become mandatory if there was not "substantial compliance," as defined by FDA, by 30 months after the signing of the NLEA.
Serving sizes were to be established by government regulation, derived from amounts that were "commonly consumed" by the public. This provision was based on a perception that manufacturers often set unrealistically small serving sizes for high-fat/high-calorie products, or, conversely, unrealistically large serving sizes for foods with low levels of nutrients.
The nutrition information had to include specific nutrients that were considered to represent major public concerns and interest. These were calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrates, sugar, dietary fiber, and protein. The door was left open for FDA to require additional nutrients on labels.
The information was to be presented in a form the public could easily understand. In effect, this provision required the government to establish a clear and consistent format for the nutrition information.
Government to Define Which Health and Nutrition Claims Would Be Permitted
The government was required to set detailed and specific requirements for any health or nutrition claims on labels. No claim could be made that was not government-approved. NLEA further required FDA to define terms such as "free," "low," "light" or "lite," "reduced," "less," and "high."
Federal labeling regulations preempted any state or local regulations with respect to nutritional labeling but not with respect to safety. This added to clarify and ease of understanding label information across the country. It also prevented individual states from setting different labeling requirements, which might result in manufacturers having a different label for each state. This provision did not apply to specific warning statements, which states could still require individually.
Labels had to provide more details on certain ingredients, such as listing all certified Food, Drug and Cosmetic (FD&C) artificial food colors by name. NLEA also required declaration of the amount of juice in products that contain fruit juice.
NLEA set a deadline of November 8, 1992, for all regulations based on the requirements of the act to become final. Any proposals not formally finalized would automatically become final on that date. This hammer provision was designed to make sure that the responsible government agencies published the detailed rules that would be required without undue delay.
NLEA officially amended the federal Food, Drug and Cosmetic Act. Technically this required only FDA to develop new regulations for packaged foods under its authority. USDA, however, also developed NLEA-based regulations for meat and poultry products that are essentially the same as those of FDA.
FDA and USDA began to harmonize the earlier proposals with NLEA requirements. Both agencies issued the first new proposals in late November 1991, a little over a year after the signing. In July 1992, FDA followed up by publishing several different format designs. USDA proposed its own slightly different formal in August. Allowing time for review of public comments, final rules were scheduled for publication early in November to meet the hammer deadline. This was delayed at the last minute due to differences of opinion between the two agencies over several issues. Agreement was reached in December, and the final rules were formally published in the Federal Register of January 6, 1993. But this was not quite the end. On April 2,1993, FDA published corrections to the final rules. These were followed on August 18 by additional technical revisions based on comments from the public. At this point, the major labeling provisions based on NLEA were finally complete.
The original target date for compliance was May 1993. Because of the delays, however, FDA extended the deadline to apply to all foods labeled on or after May 8, 1994. Exceptions were meat and poultry products, for which USDA extended the compliance date to July 6, 1994.
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