WASHINGTON, DC, August 13 -- The National Consumers League is a national nonprofit
consumer organization that has represented consumers and workers in the marketplace and
workplace for almost 100 years. Assuring that consumers can purchase safe and effective
products is of primary concern to our organization. The League supports the Food and Drug
Administration's (FDA) efforts to reduce the risk associated with dietary supplements containing
ephedrine alkaloids by proposing limits on the amount of ephedrine alkaloids allowed in dietary
supplements and requiring warning labels regarding recommended length of use.
Today, more than ever, consumers are assuming greater responsibility for their own health. As
more consumers turn to dietary supplements to improve their health, the safety of these products
must be ensured. The League supports stricter regulation of dietary supplements to protect the
public from misleading and potentially harmful products. Dietary supplements are now widely
available and often aggressively promoted with unsubstantiated health claims. The lack of
evidence on the efficacy of many of these products makes specific regulation of their use
essential.
Dietary supplements containing ephedrine alkaloids are currently sold for a variety
of purposes, including weight loss, increased energy and body building. With over 800 reports of
adverse reactions to these products since 1993, the League urges the FDA to move in a timely
manner to adopt the proposed regulations.
The FDA's proposed regulations would prohibit the marketing of supplements
containing 8 mg or more per serving of ephedrine alkaloids in a six-hour period or a total
daily intake of 24 mg or more; require labeling instructing consumers that the product is not to be
used for more than 7 days; prohibit label claims for which long-term intake would be needed to
achieve the desired effects; require a warning statement that "taking more than the recommended
serving may result in heart attack, stroke, seizure, or death" for products encouraging short-term
excessive intake to enhance the claimed effect, such as energy enhancement; and prohibit the use
of other stimulant ingredients, such as botanical sources of caffeine, with ephedrine
alkaloids.
The League supports the FDA's 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 product safely.
In the proposed rule the FDA specifically asked for comments on whether the direction "not for
persons under the age of 18" should be included in the warning statement. Although the FDA
states in the proposed rule that it has received limited reports of adolescents abusing or misusing
dietary supplements containing ephedrine alkaloids, a warning statement on user age would
further educate the public on appropriate use of dietary supplements. Adolescents are particularly
conscious of their physical appearance and products promoting weight loss or body building
could be subject to misuse by this group.
While the League supports the proposed rule, we also urge the FDA to continue to evaluate the
safety of the these products. Because many of the health conditions that increase the risk of
adverse events are not self-evident, such as hypertension and diabetes, persons with those
conditions using the product are unaware of the serious health risk. If in the future the scientific
data shows there is no safe level of ephedrine alkaloids in dietary supplements, then dietary
supplements containing ephedrine alkaloids should be removed from the market.
Thank you for this opportunity to comment on the FDA's proposed regulations on dietary
supplements with ephedrine alkaloids.