by Peter Barton Hutt
We celebrate this year the 15th anniversary of the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). But landmark legislation like DSHEA does not spring full blown from the fertile imagination of members of Congress, nor does the enactment of such legislation follow a preordained result. The history that led to the enactment of the statute, and its subsequent implementation, are therefore worthy of full consideration.
The earliest dietary supplements marketed as such in the United States were cod liver oil products promoted in the 1920s for their vitamin A and D content. FDA soon discovered some were providing less of the promised vitamins than the label stated. FDA began a series of seizure actions in the courts that lasted a full decade. In part, this regulatory response was fueled by the conclusion of many in FDA that dietary supplements are unnecessary for any person who eats properly—a feeling that has continued to persist within the agency up to this very day.
When the Food and Drugs Act of 1906 was replaced with the Federal Food, Drug and Cosmetic Act of 1938 (FD&C Act), Congress included Section 403(j) to authorize regulations governing the labeling of food “for special dietary uses.” FDA promptly exercised this authority to require the labeling of both fortified food and dietary supplements. As dietary supplements expanded, however, and their claims became more aggressive, FDA reverted to the enforcement approach used in the 1920s. During the 1950s, FDA, with the assistance of FTC, launched the most intensive enforcement campaign in agency history. FDA brought hundreds of seizures, injunctions and criminal actions in the courts against what the agency concluded were misbranded dietary supplements.
When this failed to slow the steady expansion of the dietary supplement industry, FDA abandoned court enforcement and proposed new regulations designed to limit both the specific nutrients and their levels in dietary supplements. These regulations became the subject of the infamous evidentiary trial-type hearing before an Administrative Law Judge in 1968 and 1969, where FDA and the industry proffered testimony of 162 witnesses and introduced into evidence more than 2,000 documents.
FDA pushed ahead following those hearings, publishing final regulations in 1972 that mirrored the 1962 proposal. But in 1974, the U.S. Court of Appeals for the Second Circuit overruled parts of the regulations and stayed the remainder. Sen. William Proxmire (D-Wis.) spearheaded enactment of the Vitamin-Mineral Amendments of 1976, which further reduced FDA flexibility in regulating dietary supplements. Recognizing momentum had been lost, in 1979 FDA revoked all of the regulations it had promulgated in 1972, including those that had been upheld in the courts.
The Nutrition Labeling and Education Act of 1990
In 1990, Congress enacted the Nutrition Labeling and Education Act (NLEA), which gave FDA authority to approve disease prevention claims for all food, including dietary supplements. From the beginning, FDA Commissioner David Kessler, M.D., saw this as a way to win back the ground FDA had previously lost to the dietary supplement industry. Rejecting advice to be cautious on this matter, he announced in 1993 that FDA would not approve any proposed disease prevention claims for dietary supplements, even when they were approved for conventional food, and would attack dietary ingredients other than essential vitamins and minerals on the ground that they are illegal food additives and therefore must be removed from the market. It was one of the worst decisions by an FDA commissioner in the agency’s entire history.
DSHEA: The Kessler Act
The dietary supplement industry mobilized a grassroots campaign that is widely regarded as one of the most successful political movements in American history. Every health food store in the country campaigned for congressional action to stop FDA from carrying out Kessler’s policy. Outraged citizens showed up at speeches made by candidates seeking votes in the congressional election of 1994, when the Republicans eventually gained control of the House and Senate for the first time in more than 40 years, and harangued the candidates about FDA taking away their freedom to consume dietary supplements. Just weeks before the election, recognizing that dietary supplements were becoming one of the largest issues in the campaign, Rep. Henry Waxman (D-Calif.)—the strongest opponent in Congress of the dietary supplement industry—informed the industry he was prepared to negotiate a dietary supplement law. The industry had been drafting a bill, but few expected that it could be passed. The Council for Responsible Nutrition (CRN) was so surprised at Waxman’s capitulation that at first it did not believe it was true. But a final bill was quickly put together and enacted in October 1994, just before the election.