2002-07-20 / Columnists

Notes On Consumer Affairs

By Assemblywoman Audrey Pheffer

Dietary supplements have become increasingly popular over the last couple years. Sales are increasing at approximately 20% per year and in 1999, consumer sales were estimated by the National Business Journal at over $29 million.

Ephedra is an herbal ingredient found in dietary supplements designed to help people manage their weight. Ephedra supplements have become increasingly popular with young adults as a means of increasing metabolism, reducing appetite and building muscle mass. The widespread use of ephedra has been accompanied by the misconception that this substance has no associated serious medical consequences.

While the FDA has regulatory authority over dietary supplements, supplements must be proved "unsafe" before they can be withdrawn from the market. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA must bear the burden of proof that a marketed dietary supplement presents a serious or unreasonable risk under the conditions of use on the label or as commonly consumed. This regulatory approach contrasts with the regulation for drugs in which standards of safety must be met before the drug is made available to the public.

Concerns over safety and health issues, substantiated by FDA adverse actions reports, have led to the introduction of legislation to regulate the sale of dietary supplements containing Ephedra. Major complaints found in adverse action reports include cardiovascular and central nervous system problems including; stroke, arrhythmia, heart attacks, chest pain, seizures, and hypertension.

Concerns on the health and safety of dietary supplements containing Ephedra have spread to the sporting industry. The National Football League (NFL), National Collegiate Athletic Association  (NCAA) and International Olympic Committee (IOC) have added Ephedra to their banned lists. The NFL supplied the New York State Assembly Committee
on Consumer Affairs with written statements during a hearing over the safety of dietary supplements. NFL players may neither use nor endorse supplements containing Ephedra because such products may present significant health risks to athletes.

The current regulatory environment, health concerns and the popularity of such Ephedra based dietary supplements, have led to my sponsorship of Assembly bill 9796. This legislation would prohibit the sale of dietary supplements to minors and require retailers to post signs warning consumers about potential risks.

A.9796 is consistent with an FDA warning that consumers under the age eighteen or pregnant and nursing women should not use Ephedra. The legislation also warns adult consumers with high blood pressure, heart or
thyroid disease, depression, seizure disorder, diabetes, prostate enlargement or glaucoma to consult a doctor before use.

A.9796 has passed the Assembly and is awaiting Senate action.


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