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Dietary supplements and NLEA

Dietary supplements and NLEA – Nutrition Labeling and Education Act of 1990

Vitamin tablets, mineral pills, herbs, and other “dietary supplements” need not comply with FDA’s new food labeling regulations until at least December 1993, according to a law passed by Congress and signed by President Bush last October.

The Dietary Supplement Act of 1992 placed a one-year moratorium on implementing the Nutrition Labeling and Education Act (NLEA) of 1990 with regard to such supplements. However, FDA is allowed to approve for use on supplement labels health claims about the relationship of certain nutrients to specific diseases or health conditions.

In November 1991, FDA issued proposed regulations to implement the NLEA. A special provision of the NLEA stated that final regulations were to be issued by Nov. 8, 1992, or else the proposals would automatically become final. Since FDA did not issue its planned final regulations by that date, the proposals, which included four approved health claims, did become final regulations, with an effective date of May 8, 1993.

It is those regulations from which the Dietary Supplement Act is exempting supplements.

The new law also calls for reports and studies about dietary supplements: FDA must report to Congress on its enforcement priorities and practices concerning supplements; the General Accounting Office, an arm of Congress, will study FDA’s management activities; and the Office of Technology Assessment, also run by Congress, will study the relationship between regulation of supplements and “health outcomes” in the United States and other countries.

The new law also prohibits until November 1993 any regulations that use recommended daily intakes for vitamins and minerals other than the Recommended Dietary Allowances set by the National Academy of Sciences in 1968. FDA had proposed issuing new recommended intakes based on more recent data.

FDA will continue to ensure the safety of dietary supplements, taking action against products that are dangerous or whose claims are misleading.

COPYRIGHT 1993 U.S. Government Printing Office

COPYRIGHT 2004 Gale Group