False Labeling of Dietary Supplements Triggers FDA Seizures

The U. S. Food and Drug Administration (FDA) defines a drug as a product labeled to prevent, treat, or cure disease. A dietary supplement, on the other hand, is defined as a product taken by mouth that contains a “dietary ingredient,” intended to supplement the diet, and which makes no claims to its effectiveness in preventing, treating, or curing disease.

A drug can be legally manufactured, marketed, and sold in the United States only after it has been thoroughly scrutinized by the FDA; a process that consists of many trials, testing its effectiveness, and any possible side effects.

Drugs proven to be safe and effective are given FDA approval and, with proper labeling, are allowed to be marketed and sold to the general public. This process ensures that consumers do not rely on unapproved products, or unsubstantiated product claims, to make important decisions affecting their health.

Dietary Supplements are not classified as drugs, but rather come under the general umbrella of “foods.” FDA approval is not required for dietary supplements to be marketed or sold. Examples of dietary supplements are vitamins, minerals, herbs and plant derived products, and amino acids. No prescription is required to purchase dietary supplements. They are sold in health food, drug, and grocery stores; and also often purchased through the mail and over the internet.

In 1994, President Clinton signed the Dietary Supplement Health and Education Act. This amended the Federal Food, Drug, and Cosmetic Act, and created a new regulatory framework for the safety and labeling of dietary supplements. It states that the responsibility for the safety of dietary supplements rests directly on its manufacturers and distributors. Dietary supplements cannot claim to treat, or cure, serious medical conditions or diseases. Labels and ingredient lists on dietary supplements must be accurate and the dietary ingredients must be safe, and be in the amount stated on the label.

Although it does not approve or analyze dietary supplements before they are sold to consumers, the FDA does try to monitor the marketplace for potentially illegal dietary supplements. These are products felt to be either unsafe, fraudulent, or in violation of law because of false or misleading claims on their labels, or in their promotions or advertising.

Recently two dietary supplement distributors came under heavy fire from the FDA. In August of 2007, U.S. Marshals in the Northern District of Florida, at the request of the FDA, seized an estimated $41,000 worth of capsules distributed by Charron Nutrition of Tallahassee, Florida. These capsules were being promoted for use in the treatment of diabetes and arthritis. This type of promotion removed the products from the FDA’s dietary supplements category, and placed them squarely in their unapproved, and therefore illegal, drug category. The products seized were Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000, and Atri-E-400.

An even larger drug seizure occurred in mid-October, 2007, after an FDA investigation, warning, and subsequent inspections revealed that FulLife Natural Options, Inc., of Boca Raton, Florida, despite FDA’s warnings, continued to promote its Charantea Ampalaya Capsules and Tea for the treatment of diabetes, anemia and hypertension.

When the firm failed to bring its marketing into compliance, and subsequent inspections found that the claims were still being made both on the products’ labels, and in promotional literature on FulLife’s Internet web site, a complaint was filed by the U.S. Attorney’s Office for the Southern District of Florida, charging the products were in violation of the drug and misbranding provision of the Federal Food, Drug and Cosmetic Act. U.S. Marshals, at the FDA’s request, seized $71,000 worth of the products.

These seizures give emphasis to the fact that the FDA takes its role as watchdog for the American public, against unapproved drugs, very seriously; and that it will take action against mislabeled products that make false claims.