Testimony to the FDA Testimony to the FDA
Good afternoon. My name is Brett Kay and I am the Health Policy Associate for the National Consumers League, America’s oldest nonprofit consumer advocacy organization. NCL has represented consumers and workers in the marketplace for over 100 years. Assuring that consumers can purchase safe and effective products is of primary concern to our organization. NCL has a long history of working with the Food and Drug Administration and its predecessors to require manufacturers to produce safe and effective products with truthful and not misleading label claims. The League supports the FDA’s efforts to reduce the risk associated with dietary supplements containing ephedrine alkaloids (Ephedra). This product has demonstrated that it has serious safety concerns, with numerous adverse events reported to FDA.
In 1997, NCL submitted comments to the FDA regarding products containing Ephedrine Alkaloids, urging FDA to move in a timely manner to adopt the then proposed regulations, which included limiting the amount of ephedrine in these products to eight milligrams per serving and 24 milligrams per day, and requiring warning labels regarding recommended length of use. Unfortunately, the proposed regulations were never finalized, and the dosage and duration recommendations were withdrawn. Since that time in June 1997, 134 new complaints, added to the 685 documented complaints between 1993 and 1998, have been filed. It seems clear that ephedra products pose a serious health threat and consumers are at risk.
Dietary supplements containing ephedra are currently sold for a variety of purposes, including weight loss, increased energy, and bodybuilding. Because they are marketed to such a diverse population, many of whom are vulnerable to the often-tantalizing claims, these products are ripe for abuse. Dieters seeking quick weight loss, or young men looking to “pump up” quickly are often desperate for fast results, and may take more than the recommended dose and for longer periods than recommended. Because these products are often portrayed as natural, most consumers assume they are safe. As more consumers turn to dietary supplements to self-medicate and improve their health, the safety of these products must be ensured. Further, as consumers take more responsibility for their own health care, they need the proper tools to make safe and effective decisions. Without adequate labeling, consumers are deprived of important and necessary information to make the proper decisions. Currently, dietary supplements containing ephedra do not contain adequate labeling. As a result, reports of seizures, heart attacks, stroke, and even death are too common.
NCL supports the FDA’s previously proposed rule as a necessary step to ensure that consumers are provided appropriate instructions and warnings about these products. Most of the adverse events reported occurred in otherwise healthy young to middle-aged adults who used the products for weight control or increased energy. With proper label instructions and warnings, consumers can be educated on how to use the products safely. We are also concerned about abuse of these products by adolescents. Teenagers and young adults are particularly conscious of their physical appearance and products promoting weight loss or bodybuilding could be subject to misuse by this population. Further, the inclusion of ephedra in products marketed as natural alternatives to illicit drugs such as Ecstasy contribute to possible misuse and abuse by a vulnerable and impressionable population, one that often sees itself as invincible. All to often, however, this is not the case.
I would now like to talk about the issue of labels and consumer behavior.
NCL recently conducted a survey of consumer attitudes and behaviors with
over-the-counter drugs. While OTCs and dietary supplements are very different
products, with drastically different regulatory requirements, to consumers they
are not so different. The line between dietary supplements and OTCs has been
blurring in recent years, and many consumers do not differentiate the two
products. They are next to each other on the shelves at pharmacies,
supermarkets, and convenience stores, and are often advertised in very similar
ways. Adding to the confusion is the fact that many well-known pharmaceutical
manufacturers offer dietary supplements with the same brand names as their OTC
products. Because of these similarities, I feel it is relevant to provide some
data about OTC use to gain perspective on dietary supplements. In fact, some of
the data regarding reading the labels on our survey may be conservative
estimates for dietary supplements.
Since labeling is the most direct method of communication to consumers about a product, it is important see how consumers use the labels. Please keep in mind that this was a telephone survey and there is often a disconnect between what people say they do, and what they actually do, so these results represent a best case scenario.
While the League supports the previously proposed rule, we also urge the FDA to continue to evaluate the safety of these products. Because many of the health conditions that increase the risk of adverse events are not self-evident, such as hypertension and diabetes, people with such conditions who use these products are unaware of the health risks. Further, more and more people are turning to dietary supplements, and there is increased attention of body image on adolescents and young adults that often leads to inappropriate behaviors. Thus, if the scientific data shows there is no safe level of ephedrine alkaloids that can be used, then dietary supplements containing ephedrine alkaloids should be removed from the marketplace.
Thank you for this opportunity to comment.
For more information, write the National Consumers League at 1701 K Street, N. W., Suite 1200, Washington, DC 20006; 202-835-3323.
The National Consumers League, founded in 1899, is America's pioneer consumer organization. NCL's three-pronged approach of research, education and advocacy has made it an effective representative and source of information for consumers and workers. NCL is a private, nonprofit organization representing the consumer on marketplace and workplace issues.