Greater regulatory control required for dietary supplements - Part Two

To the growing alarm of medical experts, dietary supplements companies have begun marketing their products aggressively to children and their parents, writes Henry Miller.​ They peddle a variety of potent concoctions that supposedly will help them to gain strength or lose weight, or will treat illnesses ranging from colds and flu to depression and even attention deficit disorder. As a result, increasing numbers of children are gulping supplements, often at the insistence of parents in search of "natural"​ remedies or "healthful"​ alternatives for youngsters who eat too much junk food. In 1999, a study conducted by National Public Radio, the Kaiser Foundation, and the Kennedy School of Government found that 18 percent of parents were giving their children dietary supplements other than vitamins or minerals. Labelling ignores content​ Although many supplements companies advise youngsters under 18 not to take the stimulant ephedra, many products contain this toxic ingredient, and a few industry representatives still recommend it for kids with attention deficit disorder. In a report earlier this year, the FDA documented 134 cases linking ephedra to serious reactions, including insomnia, nervousness, seizure, hypertension, stoke, and death, over a 33-month period ending in March 1999. Ten of the reports involved children younger than 18. But the manufacturers' position remains ambiguous. The industry opposes a proposed New York ordinance that would prohibit ephedra sales to minors, claiming that "it would be more effective as a labeling issue," said Wes Siegner, counsel to the ephedra committee of the American Herbal Products Association. "You don't want to cause trouble for salesclerks." Despite the warning labels, however, ephedra still enjoys considerable popularity among teenagers trying to lose weight. Adverse effects mounting​ Supporters of herbal supplements who scoff at reports of adverse reactions retort that with tens of millions of people consuming them in this country alone, there would be a significant body count if the products were genuinely dangerous. There are several answers to such an assertion. Even with profound underreporting of problems, reports of serious adverse effects are mounting. In the absence of compelling evidence of benefit from the use of the vast majority of herbal supplements, severe -- even life-threatening -- side effects are particularly worrisome (some would say unacceptable). Finally, problems are likely to increase with some large retailers now selling new higher-potency formulations and consumers taking large doses for long periods of time. Manufacturers stop short​ The supplements industry is moving voluntarily toward standards for "good manufacturing practices," a concept borrowed from drug makers that includes "adequately equipped manufacturing facilities, adequately trained personnel, stringent control over the manufacturing processes, reliable and secure computerized operations, and appropriate finished product examination and testing." But these measures address only the identity, purity and potency of the products, neglecting the fundamental question of whether the active ingredients themselves are safe and effective, and they offer no independent verification that the standards have been met. Regulation of the herbal supplements industry is so lax, and some of the products so dangerous, that a public health catastrophe seems inevitable. For example, a mislabeled or contaminated product could cause numerous cases of organ failure or death. After such a major incident, Congress would probably reclassify herbal supplements as drugs -- which are stringently regulated by the FDA -- requiring a demonstration of safety and efficacy before they could be marketed. Every product would have to gain approval from the FDA, a process that takes twelve to fifteen years and costs, on average, more than $400 million. Few of the herbal remedies now in stores could meet such criteria, and consumers would thus be denied access to many of them. Regulatory obstacles​ It is tempting to suggest, as some have, that herbal supplements might be provided a regulatory shortcut, in the form of a requirement for certification only of safety, but this proposal presents difficulties. For one thing, the safety of a drug (or herbal supplement) in normal clinical use is difficult to judge in a vacuum; safety and efficacy together are often necessarily a global judgement. The level of risk -- side effects, or adverse reactions -- that is acceptable varies widely and depends on the product's particular use, or "indication." For example, severe and frequent side effects that might be tolerable in a drug offering a definitive cure for AIDS or pancreatic cancer would be unacceptable if the product were intended to treat baldness or hay fever symptoms. The current unregulated commerce in dietary supplements poses a real threat to public health. Before a calamity occurs, the worldwide industry should find better ways to police itself. Models – the alternatives​ What models for oversight exist? The FDA enjoys an absolute monopoly over regulation, a situation that can produce delays, increased expense, and inefficiency. A wide range of other institutional models for product oversight exists. At the opposite pole from a government monopoly is laissez faire, a self-regulating system in which government has no role at all and decisions about testing and marketing are made unilaterally by manufacturers. This is the system that currently exists for dietary supplements. Between the two extremes, other institutional alternatives offer various configurations of government oversight and non-governmental mechanisms that could regulate and monitor the nation's supply of dietary supplements (and other products, for that matter). These alternative organizational arrangements involve varying degrees of privatization and FDA control of the certification process. Monopoly or “laissez-faire”​ Recent history provides evidence of the failures of the extremes of monopoly and laissez faire to serve the public interest; abuse of power is too easy in both. Government monopolies can foster abuses by bureaucrats. Laissez-faire creates similar temptations for companies, with more obvious public risk. Proponents of laissez-faire maintain that in the absence of government oversight, companies would be induced to protect the integrity of their products by goodwill, a desire to preserve their reputations, and the fear of civil litigation or, rarely, criminal prosecution. But while an acceptable level of safety might be achieved much of the time, inevitably some manufacturers take dangerous shortcuts in production, testing or surveillance. The public reaction to isolated incidents of poisonings that led Congress to pass the Biological Act of 1902 and the Food, Drug, and Cosmetic Act of 1938 illustrates some of the pitfalls of a laissez-faire system. Independent third party?​ If the extremes are unworkable, what other models are available? One possible arrangement would be a private monopoly organization to review and certify new products, perhaps under the sanction of the FDA or some other federal agency. Still another would have supplements manufacturers contracting with competing private entities to perform the certification. Examples of these are discussed below. Companies could elect to contract voluntarily with a newly established foundation that could operate like Underwriter's Laboratories, a large, not-for-profit American organization that tests and certifies more than 16,500 types of products. Many of these items, such as electrical appliances and equipment, automotive and mechanical parts, fire-resistant building materials, and bullet-resistant glass, present inherent potential hazards to life and property. Using more than 650 discrete standards, or guidelines, certification from UL or its competitors currently offers assurance of safety but not of effectiveness, except in a few special cases where the two factors are inextricably linked, such as fire extinguishers and smoke detectors. These organizations charge a fee based on the cost of developing standards and testing, which in turn depends on the characteristics of the particular published standard for the product in question. UL does not underwrite any risk of the products it certifies nor are its liability concerns excessive. As an independent third party, UL is not jointly liable for any defects in the product's performance in situ, and UL certification does not connect the organization to any negligence by the manufacturer. UL and its rivals hold no monopoly on safety certification, and their endorsements are not equivalent to government approval. Many retailers, however, are reluctant to carry products that lack certification by UL or one of its competitors. Insurers also occasionally deny liability coverage for products without it. Companies, insurers, and the independent testing laboratories all have incentives to maintain high standards both for consumer products and for manufacturers. EU medical model​ Perhaps the most apposite model is the regulation of the majority of medical devices in the European Union, which employs the "competing private entities to perform certification" model. This system relies heavily on various sets of product standards and normally does not involve government regulators directly in product oversight. For low-risk (so-called Class I) devices, such as tongue depressors and eyeglasses, manufacturers themselves are allowed to certify that their products meet the necessary standards. For higher-risk, Class II devices, those that might inflict serious harm if they malfunction but that are unlikely to kill patients, manufacturers must obtain third-party review from private-sector, profit-making "notified bodies," which test products, inspect manufacturing systems, and ultimately verify that EU standards have been met. Following this certification, the products can be marketed. Since 1995, most Class II devices, such as X-ray machines, dentists' drills, heartbeat monitors, and hip implants, have undergone this sort of nongovernmental third-party examination within the EU. Because these "notified bodies" vie with each other for business, they have reason to be expeditious but thorough in their inspections. As a result, approval of new medical devices in Europe takes perhaps half as long as it does in the United States, shortening the overall development process by roughly two years, and without compromising safety. The more favorable regulatory climate within the EU has allowed many companies to establish a positive cash flow by introducing new products in Europe before marketing them in the United States. The British consultancy firm, The Wilkerson Group, has compiled a list of 100 medical devices that are already available to patients in other developed nations, but not in the United States. This trend is most evident in the fastest-moving areas of medicine, such as imaging and cardiology. Recently, Medtronics, one of the largest U.S. device makers, announced that it was transferring its entire venture group to Europe. Voluntary mechanisms of self-regulation such as UL could be adapted by the manufacturers of dietary supplements for effective oversight of their products, without involving federal regulators. The overseer should be a certifier, not a collaborator. Seal of approval​ Under any model of nongovernmental regulation that certifies on a voluntary basis the safety and efficacy of herbal supplements, manufacturers that choose to participate would gain a measure of protection from liability should a mishap occur, and also support for claims that they make a premium product. Most important, consumers would be assured that the products bearing the seal of approval had met certain criteria for safety, potency, and quality. They would retain the widest selection of herbal therapies, as well as the freedom to choose certified or non-certified brands. Perhaps paradoxically, this evolution to greater regulation - albeit voluntary and extragovernmental - would move us closer to a truly free market: consumers exercising independent and informed choice among a broad spectrum of competing products.

Dr Henry Miller is an academic researcher and regulatory consultant. From 1979-1994 he was an official at the US Food and Drug Administration. From 1989-1994 he was the founding director of the FDA's Office of Biotechnology. Mr. Miller is currently Senior research fellow at Stanford University.​