Dietary Supplement Obesity, Erectile Dysfunction Claims Barred By Court

An FDA consent decree barring the sale of dietary supplements purporting to treat obesity and erectile dysfunction follows repeated warnings to the marketers of the products, the agency announced Oct. 8.

The Atlanta federal court entered a permanent injunction consent decree Sept. 22 against several marketers operated by Jared Wheat.

The decree names Hi-Tech Pharmaceuticals, National Urological Group, National Institute for Clinical Weight Loss, American Weight Loss Clinic and United Metabolic Research Center.

FDA stated that disease claims made by Wheat for a number of supplements render the products unapproved new drugs.

The marketers also compared the effectiveness of the products to prescription drugs in violation of the FD&C Act, the agency said. FDA's complaint against the firms was filed Sept. 17, 2003.

The consent decree requires that Wheat's corporations stop all dietary supplement distribution until FDA has reviewed all revised product labeling, promotional literature, and detailed inspection reports from the defendants' consulting firm.

Wheat is specifically barred from marketing Cyclovar , Dioxadren , Vigor-Rx , Zebutol , Uroprin , Sigra , Spontane-ES , Stamina Rx , Stamina Rx for Women, Thermo-Z , Dexalean , Lipodrene and Thermalean with drug claims without an approved NDA.

Past regulatory actions against Wheat include a March 2002 warning letter informing the marketer that Metanabol - intended to treat erectile dysfunction - was misbranded and an unapproved new drug.

Labeling included unsupported claims stating the product was "intended to support the erectile function of all men who have experienced any degradation in erectile health, and is virtually safe for all people," the warning letter states.

Metanabol's labeling is "false, and misleading because it suggests that this product is safe and effective for its intended use, when in fact, this has not been established," the letter continues.

The decree does not specifically mandate that Wheat pay any monetary fines. However, it does not preclude such action, FDA says.

FDA also notes that unsolicited free sample tablets to treat erectile dysfunction have been sent to men nationwide from Hi-Tech Pharmaceutical and National Urological Group.

Some individuals who consumed the samples experienced adverse reactions including hypertension, headaches, nausea, vomiting and dizziness, according to the agency.

A June 20 public health alert issued by FDA warned consumers "not to purchase or consume" certain dietary supplements marketed by Hi-Tech Pharmaceuticals and National Urological Group (¹ 'The Tan Sheet' June 23, 2003, In Brief).

Supplements named in the alert included Sigra, Stamina Rx, Stamina Rx for Women, Spontane ES, and Y-Y . The products were manufactured by NVE Pharmaceuticals, the agency noted.

The six supplements named in the alert contained the ingredient taldalafil found in Eli Lilly's prescription drug for impotence Cialis . The alert explains "an interaction between certain prescription drugs containing nitrates...and taldalafil may cause a drastic lowering of blood pressure."

The alert also noted "there is real danger that this product may be taken by patients taking nitrates since erectile dysfunction is often a common problem in people with diabetes, hypertension, hyperlipidemia, ischemic heart disease and people who smoke."

Announcing the consent decree, FDA Commissioner Mark McClellan, MD/PhD, noted the action is part of the agency's renewed effort to crack down on supplements marketed with false or misleading labeling claims.

"FDA will continue to take strong action to protect American consumers from dietary supplements that are not accurately labeled or that make false and misleading claims unsupported by scientific evidence," he said.