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 properlya 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 agencys 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 Kesslers 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 industryinformed 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 Waxmans 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.
In retrospect, the entire dietary supplement industry owes its current stature and economic strength to David Kessler. Without him, DSHEA would never have been enacted. It was his arrogance and political insensitivity that allowed the champions of dietary supplements to carry their message to the American public, and it was the American public that rejected Kesslers attempt to ban dietary supplements. I have often remarked that the dietary supplement industry should erect a monument to David Kessler in commemoration of his tremendous service to the industry.
Implementation of DSHEA
DSHEA did not give dietary supplements a free pass to the marketplace. In fact, I have published a detailed analysis of DSHEA that concludes the law provides FDA with ample legal authority to prohibit all unsafe or mislabeled dietary supplements in the marketplace. In some respects, its enforcement provisions are stronger than those applicable to other food categories.
Kessler was so infuriated by the enactment of DSHEA, however, that he ordered FDA not to enforce the new law. Initially, this was not widely understood. As time has gone on, however, former FDA enforcement officials have admitted that, for the first full decade under DSHEA, FDA took virtually no enforcement action because of Kesslers policy. Kessler was convinced if the law was not enforced and the worst elements of the dietary supplement industry were allowed to run wild, Congress would repeal the law. Of course, that did not occur. For a full decade, however, Kessler sacrificed protection of the public health to his own personal animosity toward DSHEA.
When Mark McClellan, M.D., became FDA commissioner in November 2002, he put an end to this absurd policy and began to enforce DSHEA to the same extent that any other provision of the FD&C Act is enforced. For the next five years, however, enforcement of DSHEA was hampered by the lack of adequate congressional appropriations. For example, it took more than a decade for FDA to promulgate the GMP (good manufacturing practice) regulations that were authorized under DSHEA. Even when the policy against enforcement of DSHEA was lifted, sufficient funds were only available to support a limited number of warning letters against dietary supplement claims. CRN was forced to step into the void to fund a special program for review of dietary supplement claims under the National Advertising Division (NAD) of the Better Business Bureau.
Kesslers adamant refusal to consider disease prevention claims for dietary supplements inevitably clashed with the First Amendment to the U.S. Constitution. In the landmark case of Pearson v. Shalala, the U.S. Court of Appeals for the District of Columbia held in 1999 that FDA could not constitutionally ban dietary supplement claims supported by credible scientific evidence. Although FDA persisted in attempting to get around that decision, it has lost case after case in the courts. FDA has been forced to recognize so-called qualified disease prevention claims as well as the statutorily established significant scientific agreement claims. The agency has repeatedly stated the qualified claims are permitted under its enforcement discretion. This is, of course, nonsense. They are permitted because the Constitution requires it.
For the most part, FDA has done a reasonable job in distinguishing between permissible structure/function claims for dietary supplements and impermissible disease claims. The 50-page preamble to the January 2000 FDA regulations defining the difference between a permitted structure/function claim and an illegal disease claim establishes guidelines that are workable, even if large parts are unintelligible. FDA has not sought to erect barriers to reasonable structure/function claims for dietary supplements.
Although it took a long time for FDA to act, the agency showed DSHEA is adequate to protect the public from unsafe dietary supplements when it removed ephedra from the market as an unreasonable risk. This decision has properly been upheld in the courts.
The Future of DSHEA
By now, it should be clear, with proper enforcement, unsafe or mislabeled dietary supplement products can readily be removed from the market by FDA, leaving safe and properly labeled products for the consuming public. And for the first time in years, FDA now has sufficient appropriations for proper enforcement of DSHEA. In the fall of 2007, FDA Science Board issued a report documenting the increased responsibilities and reduced appropriations available to the agency. The House Oversight and Investigations Subcommittee held a bipartisan hearing in January 2008 documenting the devastating impact this has had on the entire agency. As a result, FDA appropriations have increased from $1.4 billion to $2.3 billion, a large part of which has been allocated to the Center for Food Safety and Applied Nutrition (CFSAN), where dietary supplements are regulated.
With the election of President Obama, an entire new leadership has been installed in FDA. Both the new commissioner, Margaret (Peggy) Hamburg, M.D., and the new deputy commissioner, Joshua Sharfstein, M.D., have led large complex scientific organizations (the New York City Department of Health and the Baltimore Department of Health, respectively) and bring an entirely new public health perspective to FDA. With the increased appropriations, they have the funds to implement DSHEA more effectively than at any time in the past 15 years.
Commissioner Hamburg announced a major priority will be enforcement of the FD&C Act, including DSHEA. She has outlined a program of increased warning letters and seizure actions against significant violations. As some of her first actions, she has singled out dietary supplement products that contain active pharmaceutical ingredients or that act like illegal steroid products. This is a good sign for the dietary supplement industry, which has argued for 15 years that adequate enforcement is essential for the proper implementation of DSHEArenegade companies and products harm the entire industry.
The policies and programs the new leadership in FDA is likely to adopt under DSHEA cannot be predicted. But because DSHEA is a very sound statute that balances industry flexibility with strong enforcement power lodged in FDA, the dietary supplement industry should have little to fear in the future.
Peter Barton Hutt is a senior counsel with the Washington, D.C., law firm of Covington & Burling LLP. Hutt served as chief counsel for FDA from 1971 to 1975. He participated, along with many others, in the drafting of DSHEA in 1994 on behalf of the Council for Responsible Nutrition (CRN), and has served as outside counsel to CRN for many years.