International Threat Strikes at Home

Supplement Commission Recommends that Herbs be Regulated as Drugs

By John C. Hammell

A federal commission plays into the hands of big pharmaceutical companies, and strikes at the heart of health freedom.

The health care freedom of Americans is under attack again. The Commission on Dietary Supplement Labels (CDSL), which was created to fulfill a provision of the Dietary Supplement Health and Education Act (DSHEA), has violated the intent of that act by recommending that herbs be regulated as drugs if their therapeutic claims go beyond the claims allowed under DSHEA. DSHEA was passed by Congress in 1994 at the urging of millions of health-conscious Americans who were outraged at attempts by the Food and Drug Administration to restrict free access to supplemental nutrients and herbs, as well as health information about them.

The current move to restrict health care freedom in the U.S. is part of a new strategy that aims to avoid the defeats of the past by focusing initially on herbs rather than vitamins or amino acids, by moving the primary center of battle to the international arena, by having major, multi-national pharmaceutical companies buy dietary supplement companies, and by persuading key players in the dietary supplement industry to defect to the interests of the pharmaceutical industry.

Congress handed the Commission on Dietary Supplement Labels an historic opportunity to improve consumer welfare, recognizing that health benefits from dietary supplements would not be realized if consumers were unaware of these potential benefits. Congress charged the commission with developing recommendations on how best to reform the FDA's health claims review process in order "to provide truthful, scientifically valid, non-misleading information to consumers so that they can make informed and appropriate health care choices for themselves and their families."

Exceeding Their Authority

Unfortunately, the commission's members, who were appointed by President Clinton, have completely ignored their congressional mandate and the will of the American people by failing to reform the FDA's health-claims process, and by greatly exceeding their authority by recommending that herbs be reclassified as drugs when therapeutic claims are made. This may seem innocuous, but the Commission had no right to address the making of claims under anything but a food classification, and from a standpoint of emerging international law it is unwise to blur the lines between food and drugs that we worked so hard to create under DSHEA.

I was one of only a dozen people attending the commission's final public meeting in Reston, Va., Aug. 14-15. By holding its meeting with minimal publicity, at a time when many people were on vacation and when Congress was out of session, the commission tried to push its report through with as little criticism as possible.

The commission also minimized criticism by not releasing its draft report until shortly before the meeting. I had requested a copy the moment it became available, but the commission didn't send me the 77-page report until two weeks before the end of the comments period. They then ignored requests from more than two-thirds of the commentators for an extension of the comments period.

Several commentators at the Commission on Dietary Supplement Labels meeting lodged vigorous protests about the Committee report. One protester was attorney Suzanne Harris, representing the Life Extension Foundation and the National Health Federation, who warned that Codex harmonization would be devastating the the U.S. dietary supplement industry and to the health of Americans.

Harris contended that regulating herbs and other dietary supplements as drugs would "benefit the European phytopharmaceutical companies at the expense of American manufacturers and the consumer." She urged the U.S. government to put pressure on other governments to recognize the dietary supplements as foods and not give in to the international trend to regulation them as drugs.

Harris explained that any country trying to block American imports of dietary supplements would have a much harder time before the dispute-settlement body of the World Trade Organization if we adhere to a food classification in our own regulations. Foods are regulated under the Sanitary/Phytosanitary Measures Agreement, which from a standpoint of risk/benefit analysis, is much harder to restrict than drugs are, because drugs are regulated under the Technical Barriers on Trade Agreement, where risk/benefit analysis is far more stringent and prone to regulation.

The commission did not examine any of Harris' comments because to do so, they said, would be to "exceed their statutory authority." Another protester was attorney Jonathan Emord, representing 11 clients, including the American Preventive Medical Association and the National Health Federation, as well individuals well-known in the world of alternative therapy: Dr. Julian Whitaker, and Durk Pearson and Sandy Shaw. Emord's comments were presented to the commission as a legal brief that insisted they properly discharge their duties, and not go beyond their statutory authority by recommending that the OTC drug category be expanded to include herbs.

Emord presented an alternative "split label" approach to the regulation of dietary supplements, which would enable both the FDA and the manufacturer of the product to state their case on the label, and then let the consumer decide. Commissioner Margaret Gilhooley insisted that Emord was taking too narrow a view of their Congressional mandate under DSHEA. The commission agreed to state in its final report that Emord's First Amendment lawsuit against the FDA was in progress in the courts. Emord's full split-label proposal and the latest news about his First Amendment lawsuit can be viewed on his web site: http://www.emord.com. Emord's and Harris' comments on the commission report can be downloaded from the International Advocates for Health Freedom web site. The commission was to have finalized its report by Sept. 30. The FDA is now required to issue a notice of proposed rule-making within 90 days from that date, and to complete rule-making no later than two years later.

Getting Involved

Below, there is a form letter that you are urged to photocopy, sign and mail or fax to President Clinton, your congressional representatives and the CDSL. This form letter protests the commission's report, and demands that the FDA submit to the will of Congress and the American people by not regulating herbs as drugs, and by urging the FDA to recognize a wide variety of legitimate health claims for dietary supplements.

One reason the focus is on herbs and botanicals in general rather than vitamins or amino acids is that herbs are relatively new to the American market, and have yet to generate the kind of passionate commitment that many Americans have for vitamins, minerals and amino acids. Herbs have been used safely throughout the world for thousands of years, but are unfamiliar to most Americans.

By now, Americans know that vitamins are extraordinarily safe, but many of them can still be persuaded that exotic-sounding herbs with unfamiliar names are "dangerous." Amino acids are found in abundance in foods that Americans eat every day, but herbs often are not thought of as foods. As a result, herbs are the ideal dietary supplement for the FDA to use to attempt to blur the distinction between foods and drugs. Once herbs are regulated as "drugs," the FDA will have its foot in the dietary supplement door, and will continue to push for the regulation of more and more supplements as drugs.

Another reason to focus on herbs is that they already are being sold extensively in other countries as drugs. The recent growing popularity of herbs in the United States has drawn the attention of international pharmaceutical companies, which have been selling herbs as drugs in many other countries. They recognize the enormity of the American market, and want to be able to monopolize it by selling herbs here as drugs rather than as foods.

Continuous Harmonization

Ever since the collapse of the Soviet Union and the end of the Cold War, there has been an accelerating drive towards the development of a global economy. With the advent of such international trade treaties as NAFTA and GATT, and the prospect a looming multilateral agreement on investments, the United States continues to yield much of its sovereignty to such international regulatory bodies as the World Trade Organization, World Health Organization, the U.N.'s Codex Alimentarius Commission and the International Council on Drug Regulating Authorities. In fact, the Department of Health and Human Services (which oversees the FDA) has an Office of International Relations that has been taking steps to ensure that the process of harmonizing U.S. food and drug law with international regulatory requirements is continuous.

When it comes to harmonization of the laws regulating dietary supplements, we need to spread the freedom we have here to other countries, rather than become bound by their restrictions. However, in the current efforts to harmonize these laws, the U.S. has only a single vote, and there are many countries with far stricter regulatory schemes that can easily outvote us. Germany, the country that has proposed the harmonization of regulatory laws within Codex, is extremely restrictive when it comes to dietary supplements.

When I was in Germany for a Codex meeting recently, I was appalled to find that the only nutrient products I could purchase were in pharmacies at very high prices. I wasn't even allowed to touch a nutrient product without first having a pharmacist hand it to me from behind the counter. The only nutrient products available in Germany are made by pharmaceutical companies. There are simply no dietary supplement companies, as we know them, operating in Germany. Harmonization with German regulatory laws would utterly destroy freedom of access to dietary supplements in the U.S. and cripple preventive health care efforts while sending the profits of the multinational pharmaceutical companies soaring.

The dietary supplement industry played a major role in the struggle against the FDA and the pharmaceutical industry that lead to the passage of the Dietary Supplement Health and Education Act. A striking difference today is that the Utah Natural Products Alliance, the National Nutritional Foods Association, the American Herbal Products Association and the Council for Responsible Nutrition (as well as a consortium of pharmaceutical interests called the European-American Phytomedicines Coalition) have all been pushing hard for the OTC drug status for herbs and botanicals. This reflects a changing perception of self-interest on the part of these trade associations, as the pharmaceutical industry moves into the dietary supplement industry via mergers, acquisitions and strategic alliances.

Blurring The Line

These trade associations (and Citizens for Health, which also supports drug status for herbs), would have us believe that consumer access to nutrient products will not be threatened if the FDA expands its OTC drug category to include herbs and botanicals. They argue that nutrient products still will be able to be sold as dietary supplements . . . just that the right to make health claims will require OTC drug status.

While such a move might benefit large companies that are already FDA-certified to manufacture OTC drugs, what about the many smaller companies that may not be able to meet the regulations for OTC drugs? What about the push toward Codex harmonization that would be fostered, thus blurring the line between foods and drugs that we worked so hard to establish through he passage of DSHEA? What about our First Amendment right to make truthful health claims for nutrient products?

The international movement to achieve harmonization of regulatory law recently moved into the national arena. The FDA's Office of International Relations inserted several "harmonization clauses" in S.830, the FDA Reform Bill discussed during the early fall in the U.S. Senate. This harmonization language is intended to force U.S. food and drug law to conform to European Union law, where dietary supplements are heavily restricted and regulated as drugs.

Sean Donahue, Health Policy Analyst for the Senate Labor Committee, claims that passage of the bill would not affect dietary supplements, and that it was introduced to help offshore sales of medical device manufacturers by slashing red tape. I believe this is just a smoke screen. Bruce Artem in Sen. Orrin Hatch's office (the Utah Republican was one of the sponsors of DSHEA) was unaware of the threat posed by this bill when I talked to him. It is clear that we have a major education campaign ahead of us on this issue, because Congressional staff members aren't following what's going on.

It may already be too late to stop the harmonization clauses in S.830, in particular since a companion bill was being fast-tracked through the House at the time we went to press. It may be necessary to generate an extensive and aggressive campaign against this attempt to turn the law against us. Even many of the dietary supplement organizations that fought for health freedom in the past are now in favor of herbs and botanicals being regulated as drugs, and see no threat in harmonizing with Codex.

Right now, however, our most pressing need is to inform President Clinton and the members of Congress about how the Commission on Dietary Supplement Labels has abdicated its responsibility under DSHEA, and exceeded its authority by recommending that herbs be regulated as drugs.

To help you protest the commission report, send the accompanying form letter to your senators, representatives, President Clinton, and to the Commission on

Dietary Supplement Labels

The Fight For Health Freedom

For most of this century, people who took vitamins were considered "health nuts" and the medical establishment had disdain for the practice. Until the 1980s, the overwhelming majority of physicians in this country thought that taking vitamins was virtually worthless, and laughed at the idea that high doses of vitamins and other nutrients can help prevent heart disease, stroke, cancer and other degenerative diseases.

However, despite ridicule by the medical profession and the media, lack of insurance coverage, and relatively little supporting research, the dietary supplement industry grew rapidly in the 1940s, 1950s and 1960s as increasing numbers of Americans found that taking vitamins improved their health and made them feel better. Throughout this period, Americans had free access to vitamins, but the FDA prohibited all health claims and took stern action against anyone who made such claims.

A Growing 'Threat'

By the late 1960s, the supplement industry had become large enough to threaten the interests of the medical establishment and the pharmaceutical industry, both of which had focused their attention, and built their fortunes, on treating diseases with surgery, radiation, vaccines and drugs. After notable successes with infectious diseases in the first half of the century, doctors were finding it much harder to deal with the lethal diseases of aging.

The failure to deal with these diseases had led a growing portion of the public and a few maverick doctors to focus their attention on preventing diseases with diet, exercise, good health habits and dietary supplements.

Under pressure from the medical establishment and the pharmaceutical industry, the Food and Drug Administration tried to curtail the public's access to vitamins by insisting that high doses of certain vitamins be regulated as over- the-counter and prescription drugs. Their stated rationale for this move was the "risk" to the public health of "megadoses" of vitamins.

The FDA's attempt to regulate vitamins as drugs in the early 1970s led to a monumental fight over a seven-year period, which culminated in the passage of a bill, sponsored by Sen. William Proxmire of Wisconsin in 1976, temporarily halting the FDA from regulating supplements as drugs and in the process protecting the public against erosion of its access to vitamins.

By the late 1980s, two things had become clear: first, the dietary supplement industry was growing at an unprecedented rate, and would likely grow even faster in the future. And, second, the major impetus behind this growth was an explosion of scientific studies showing that vitamins, minerals, amino acids, phytochemicals and herbs not only can prevent diseases, but also can be effective in treating them.

Increasing Reactions

Once a laughing matter to the medical establishment, vitamins had become a thorn in its side, and were rapidly becoming a major threat to its profits and control of medicine. So the screws again were turned on Congress and the FDA, which led to the next serious attempt to curtail health care freedom in the U.S.

In 1990, a bill designed to attack the dietary supplement industry, the Nutrition Labeling and Education Act, was passed into law. This bill was fast-tracked through the House before consumers became aware of it, and was headed for the Senate when health freedom activists jumped into the fray to try to curb its worst excesses.

The legislation affected nutrition labeling, and blocked the making of truthful health claims by requiring the undefined (and undefinable) standard of "significant scientific agreement" to be met before a health claim by the manufacturer of the product could be allowed. Since then, the FDA has used this standard to block a host of truthful, well-documented health claims, leading to unnecessary death and suffering.

A Landmark Attack

On June 18, 1993, the FDA published an Advanced Notice of Proposed Rulemaking (ANPR) concerning the regulation of dietary supplements. This document referred to a number of factors that had led the FDA to revise dietary supplement regulations. These factors included increased consumer use of dietary supplements, an internal FDA three-year review of possible new regulatory approaches, the occurrence of eosinophilia myalgia syndrome from a contaminated batch of l-tryptophan, and (alleged) reports of serious illnesses from the use of botanical supplements.

The ANPR also was called the Dykstra Report, after its author, Gary Dykstra of the FDA. It proposed that free access to vitamins and minerals be limited to low multiples of the recommended daily allowances (RDAs). It also declared that some botanical products are inherently drugs, not dietary supplements, and that many other dietary supplements, including amino acids, are unapproved food additives.

The Dykstra Report infuriated the public and the dietary supplement industry because the FDA was proposing regulations that either had been prohibited by Congress or struck down in court actions in previous years. The blatant attempt of the FDA, through the Dykstra Report, to ignore the mandate of Congress and the public was a significant motivating factor in efforts to develop and secure passage of the Dietary Supplement Health and Education Act in 1994. During this struggle, more letters protesting the FDA's attempt to restrict access to vitamins were received by members of Congress than on any subject since the war in Vietnam.

When President Clinton signed DSHEA into law in 1994, he said, "In an era of greater consciousness among people about the impact of what they eat on how they live, indeed, on how long they live, it is appropriate that we have finally reformed the way the Government treats consumers and these supplements in a way that encourages good health."

Consumer Empowerment

In enacting DSHEA, Congress estimated that "almost 50 percent of the 260 million Americans regularly consume dietary supplements as a means of improving their health." In that same year, 1994, the U.S. spent an estimated $1 trillion-plus on health care-about 12 percent of the country's gross national product. Congressional findings reported in DSHEA state that "preventive measures, including education, good nutrition, and appropriate use of safe nutritional supplements, will limit the incidence of chronic diseases, and reduce long term health care expenditures."

The act adds that "consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements."

Instead of following the mandate of the president, Congress and the American people, all of whom had resoundingly rejected the move towards the pharmaceutical takeover of the dietary supplement industry envisioned by the FDA's Dykstra Report, the Commission on Dietary Supplement Labels is instead moving behind the scenes to carry out the mandate of the rejected and discredited Dykstra Report.

John C. Hammell is a legislative advocate and founder of International Advocates for Health Freedom, based in Hollywood, Florida.