The state of New Jersey is going after a dietary supplements manufacturer. Attorney General Peter Harvey says N.V.E. Pharmaceuticals advertised its ephedra-based supplements as safe despite receiving hundreds of complaints from consumers who reported that they experienced significant adverse side effects from using the products.
The state seeks to bar the company from making false and misleading claims and seeks civil monetary penalties as well as restitution to affected consumers.
Prior to the federal Food and Drug Administration's ban on the sale of all dietary supplements containing ephedra, which took effect April 12, 2004, N.V.E. promoted more than 80 products that contained ephedra - including Stacker 2, Stacker 2 Lite, Stacker 3 with Chitosan, Yellow Jacket (later known as Yellow Swarm), Black Beauty (later known as Midnight Stallion), and Sizzle.
The manufacturer still makes Stacker 2 Ephedra-Free, a caffeine-based weight-loss supplement. Harvey says the company made unsupported claims about the products' ability to burn fat and boost energy, and failed to provide consumers with meaningful warnings about the dangers of using products containing ephedra.
"The defendants allegedly received numerous complaints from consumers who, after using their products, reported adverse effects such as high blood pressure, rapid heart beat, chest pains, seizures, abnormal bleeding, kidney problems and insomnia," the attorney general said. "These symptoms are typical of those who use other ephedra products, and the public should have been warned of these dangers."
New Jersey Consumer Affairs Director Reni Erdos says the state alleges that even after receiving complaints from consumers about serious adverse effects, the defendants continued to advertise the products as being safe.
"In essence, they recklessly risked the health and lives of consumers to make a buck, which is shameful," he said.
Ephedra is a stimulant derived from the Chinese herb ma huang that has been proven to cause headaches, irritability and heart palpitations, and has been associated with strokes, seizures, high blood pressure and heart attacks. The dangers of using ephedra and other ephedrine alkaloids as a diet supplement for weight loss are, especially when used with caffeine, widely documented in medical literature.
The complaint alleges that the defendants repeatedly violated the New Jersey Consumer Fraud Act by making false claims in their catalogue, Internet and television promotions that wildly exaggerated the benefits of the supplements while downplaying the risks.
For example, the complaint says the defendants' promotional materials stated:
that a typical consumer who used Stacker 2 would lose between 2 and 3 pounds per week and between 24 and 36 pounds in 12 weeks;
that Stacker 2 and some of its other ephedra-based products were the "World's Strongest Fat Burner," and
that Stacker 2 and some of its other products were safe when taken as recommended.
Additionally, the complaint states that the defendants did not have evidence to substantiate these claims and that, despite having more than 100 full-time employees on staff, they never employed a scientist to test the products' safety or efficacy.
The complaint alleges that once the defendants began manufacturing and marketing Stacker 2 Ephedra-Free, they also advertised the supplement as being the "world's strongest fat burner." In reality, the supplement has the same stimulant effect on the body as drinking coffee that contains an equivalent amount of caffeine, according to the complaint.
This is the third lawsuit that New Jersey has filed against a manufacturer of ephedra-based dietary supplements for alleged violations of the Consumer Fraud Act.
In July 2003, the state filed suit against Cytodyne Technologies, the manufacturer of Xenadrine RFA-1 and Xenadrine EFX, alleging it misrepresented the efficacy of the dietary supplements and deliberately withheld troubling information about the potentially life-threatening side effects of the products.
Last October, New Jersey sued Goen Technologies and its founder Alex Szynalski, promoters of Goen weight-loss and stop-smoking seminars, charging that they and other defendants intentionally misled consumers through a series of false and deceptive claims that extolled the benefits of hypnosis as a drug-free alternative to other weight-loss and smoking-cessation programs. In fact, the complaint contends, the seminars were nothing more than a ploy to sell dietary supplements, including ephedra-based TrimSpa.