In recent years, the political and bureaucratic pressures surrounding dietary supplements have exploded with new attempts by the United States Food and Drug Administration (FDA) to restrict the flow of information about them. Through a misguided fear of "snake-oil salesmen" and a mission to promote the development and safety of new drugs, the FDA has been on a vendetta against the dietary supplement industry since early in its history. They apparently see dietary supplements as a threat to patented pharmaceutical agents.
This situation in the United States has implications for other countries, since many of them take their regulatory cues from the actions of the FDA. In Norway, for example, doses of supplements beyond the RDA were at first banned, and then the government opened a chain of stores that became the only ones allowed to sell high-dose supplements. In 1994, I had an opportunity to testify at meetings in Great Britain concerning European Economic Community regulations of dietary supplement doses. The issue has not yet been resolved there. This is an ongoing struggle in many countries and seems to threaten the status quo wherever anyone wants to take charge of their own health care.
Protecting You from Information
The FDA's regulatory efforts are purportedly aimed at protecting the public from misinformation that the marketers of dietary supplements might use to sell their products. It is true that this has happened in the past and is happening, although to a lesser extent, today. However, the issue has come to the fore because in their zeal the FDA is "protecting" the public from accurate information that will do them a world of good.
The truth is, there has been an explosion of new research data showing the value of dietary supplements in almost every sphere of health care. From cancer to heart disease to AIDS to headaches, dietary supplements are being shown to be of value. They are helping people stay off drugs and they are reducing the costs of health care, in terms of both money and undesired side effects.
In spite of official opposition to supplements (from both government agencies and much of mainstream medicine), the public demand for them is growing. In response to this, the FDA has used rule making and legal maneuvering to subvert the intent of the laws that Congress passed designed to increase the flow of nutrition information to the public.
In 1992 and 1993, Congress considered bills that would restrict the ability of the FDA to skirt around the intent of the laws. During the hearings held by the Senate Labor and Human Resources Committee in 1993, the commissioner of the FDA, David Kessler, made some erroneous statements about supplements. He also put on a show of some bottles of dietary supplements that he claimed were "misbranded" because they made health claims.
Any health claims for dietary supplements were against the regulations of the FDA if they were made by supplement manufacturers or distributors, even if they were truthful and not misleading and even if they were the same health claims that other agencies of the US government were making. For example, if the US Public Health Service suggested folic acid supplements for pregnant women, it was illegal for a company marketing folic acid to quote that agency in its promotional literature.
The bill then being considered, the Dietary Supplement and Health Education Act, eventually passed despite the opposition of some vehement protectors of the FDA. However, many of the most important sections of the Senate version of the bill, which would allow the easiest public access to supplement information, were deleted before the bill was passed by the House of Representatives. This was the result of compromises with powerful committee chairpersons.
As of this writing, in 1995, efforts are underway to correct some of the omissions of the final version of the bill as passed into law. Other committees are considering stricter oversight of the FDA, in order to prevent them from making laws through "regulations" and interpretation.
I testified at those 1993 Senate hearings and had to depart from my prepared testimony in order to address some of the misinformation presented by the director of the FDA. I then submitted to the committee some written follow-up testimony which included most of the statements that I felt compelled to present ad lib. Although I have seen it many times, I am always surprised when scientific information is misrepresented for political purposes. Here is the original version of my testimony, and the follow-up testimony.
My name is Michael Janson. I am a physician in Massachusetts with an office in Barnstable, on Cape Cod. I received my MD from Boston University 23 years ago in 1970, and then did a 4-year residency in pathology. I developed an interest in nutrition, preventive medicine and vitamin therapy after graduation, and proceeded to found the Cambridge Center for Holistic Health in 1976 and more recently, the Center for Preventive Medicine, in Barnstable, Massachusetts, on Cape Cod.
I am a charter member of the American Holistic Medical Association. I am a Fellow and member of the Board of Directors of the American College for Advancement in Medicine, and the Chairman of their Scientific Advisory Committee. I am a Fellow of the International Academy of Nutrition and Preventive Medicine. I have a weekly Boston area call-in radio show reporting the latest in nutrition and preventive medicine. I am also the Vice President of the
American Preventive Medical Association.
I want to thank Senator Kennedy and the members of this committee for the opportunity to clarify some of the important issues regarding dietary supplements and the FDA. I am particularly eager to relay the concerns of many of my patients and radio listeners in and around Massachusetts about their continued ability to purchase all forms of dietary supplements and to have information about their use. Many ideas relating to this form of medical care and self-care are coming out of Massachusetts. You are no doubt familiar with the reports on alternative health care by Harvard physician Dr. David Eisenberg, from the recent PBS series with Bill Moyers.
One-third of all Americans are choosing to visit alternative health care practitioners and one-half take dietary supplements because they are willing to take personal responsibility for their own health. This costs the government nothing, and it can be clearly demonstrated that it will potentially save the government billions of dollars while enhancing the health of most Americans, with no significant risks.
The FDA has a long and clear history of bias against dietary supplements, recently evidenced by their attempted removal from the market of black currant oil capsules, claiming that it was an unsafe food additive and that the food to which it was being added was the gelatin capsule in which it was packaged. This was thrown out of court by three judges who said that the FDA was using "Alice-in-Wonderland reasoning in an effort to make an end-run around the law." FDA's own scientists and toxicologists testified that they were unaware of any safety problems with this oil. Following FDA's lead, the Texas Department of Health removed coenzyme Q10 from health food stores. Coenzyme Q10 is a remarkable, harmless substance that helps so many patients that I could hardly practice conscientiously without it. I have no doubt that it would be unavailable without passage of S. 784.
The FDA has disregarded or rejected competent scientific evidence that Serenoa repens, a standardized extract of the saw palmetto berry, can help shrink an enlarged prostate in middle-aged men. Meanwhile, another more expensive, more toxic, and less effective drug, for the same purpose, has been approved by the FDA. They knew that the published evidence showed the superiority of the Serenoa, but their action exposed 10 million men to unnecessary risks.
CSPI [Center for Science in the Public Interest] has referred to this bill as the "snake-oil promotion act." This is offensive to me and thousands of my colleagues who have clinically used supplements safely and effectively for many years. In fact, I started using them because of the vast medical literature substantiating their benefits. I have seen these benefits in 17 years of clinical practice. I have seen almost no side effects from these products in all these years and no serious side effects. FDA-approved prescription drugs, when used as directed, continue to kill and injure many people annually. Dietary supplements are remarkably safe. I have been taking large amounts of them myself for many years. FDA's stated concerns about the safety of such products is not justified. Supplements are probably safer than the water that you drink to take them.
The case of l-tryptophan is important, because the FDA continues to use it as an example. It was published in both the New England Journal of Medicine and in the Journal of the AMA, in 1990, that the eosinophilia myalgia syndrome was due to a contaminant in a particular company's product. In fact, l-tryptophan has not been removed from the market, but only from the health food stores. It is still used in intravenous feeding and in infant formulas. The FDA has adequate safety data to permit it as an ingredient in these products.
No one wants to be the victim of fraud, and labels must be accurate. S. 784 vigorously addresses fraudulent labeling. However, misleading labels are not as serious or dangerous a problem as the potential loss of health-enhancing dietary supplements. But FDA's proposed regulations, which essentially ban all health claims for dietary supplements, violate the intent of the NLEA [Nutrition Labeling and Education Act]. A textbook about supplements, or scientific studies, cannot be provided by a health food store, according to FDA. Last year the New York Times published an article supportive of the value of dietary supplements, but a manufacturer cannot send that article, nor any supportive scientific article, to its customers without concern for potential FDA regulatory action.
FDA's spokesmen mislead by carefully selecting their words when testifying before Congress in order to avoid saying what they really intend, as evidenced by their position papers. They say the debate is not about vitamins and minerals when sold in what they call reasonable potencies. What they call reasonable is far too low to be used as a guideline for optimum health. FDA considers as a drug any higher potencies of vitamins or minerals, or dietary supplements that have no essential requirement in human nutrition, or products consumed for health enhancement or therapy. Again, the real public health danger is from restricting access to dietary supplements, not their potential side effects.
1. Without the passage of S. 784, the FDA will increase its inappropriate enforcement of misinterpreted regulations to remove a number of safe and beneficial dietary supplements from the marketplace, thus decreasing the available health choices of Americans and raising health care costs.
2. The Dietary Supplement Health and Education Act would allow these products to remain on the market with substantiated health claims based on scientific data. FDA and CSPI do not speak for or protect the public on this issue, and their comments are usually unsubstantiated opinion.
3. I couldn't practice medicine responsibly without many of the substances that the FDA has already tried and will continue to try to remove from the market. I base this on what I have read from their own position papers.
4. The vast majority of the population do not want the FDA to restrict dietary supplements. To call this bill simply an industry attempt to avoid regulation belittles the enormous grass roots movement in its favor and the intelligence of the many constituents who take and depend on dietary supplements for their continued good health.
5. The FDA blatantly misrepresents the dangers of supplements when it reports to Congress that there have been deaths from vitamin A or toxicity from essential oils, which is contrary to fact.
6. It would be ridiculous in America to have restrictions on dietary supplements but ready access to
alcohol, tobacco, and "Big Macs," with all their known problems.