FDA erects case against supplement supplier

The FDA has taken action against the president of five nutritional supplement companies for the use of false disease-related claims and mislabeling for a selection of obesity and erectile disfuction supplements, some of which were found to contain the non-FDA-approved prescription ingredient taldalafil.

Last month US district court judge Robert J. Vining entered a Consent Decree of Permanent Injunction against Hi-Tech Pharmaceuticals, National Urological Group, National Institute for Clinical Weight Loss, American Weight Loss Clinic, United Metabolic Research Center, and Jared R. Wheat, president of the above companies, to prevent the sale and distribution of unapproved and misbranded products.

The FDA said it took this enforcement action because the defendants had continued to sell dietary supplements making disease claims for the treatment of obesity and erectile dysfunction despite repeated warnings from the FDA.

The government's complaint, filed by the Department of Justice in the US District Court for the Northern District of Georgia, alleges that Jared R. Wheat and his dietary supplement corporations violated the Federal Food, Drug and Cosmetic Act by distributing unapproved and misbranded drugs in interstate commerce.

In June this year the FDA issued a 'Public Health Alert' warning consumers not to purchase or consume certain dietary supplements sold by Hi-Tech Pharmaceuticals and related corporation National Urological Group, because FDA test results found the supplements were adulterated with the prescription-strength drug ingredient taldalafil. Taldalafil is the active drug ingredient in Cialis, an Eli Lilly prescription drug product approved in Europe.

An interaction between certain prescription drugs containing nitrates (such as nitroglycerin) and taldalafil may cause a drastic lowering of blood pressure. The FDA urged that there is a real danger these supplements may be taken by patients who take nitrates, since erectile dysfunction is often a common problem in people with diabetes, hypertension (high blood pressure), high cholesterol, heart disease and in people who smoke.

Wheat's corporations - all located in Norcross, Georgia - are now obliged to stop distributing all dietary supplements until the FDA has reviewed all revised product labeling, promotional literature, and detailed inspection reports from the defendants' consulting firm.

The FDA​ has been stepping up its action against supplements that make misleading claims, which are inevitably damaging industry reputation.