FDA enforcement examples for prescription drugs, dietary supplements and medical devices.
FDA Enforcement Examples: Prescription Drugs
An emergency room physician from Kentucky was sentenced to a year in prison in October 2004 for conspiring to unlawfully distribute controlled substances over the Internet.
The FDA warned the public in February 2004 about Internet sites outside the United States selling counterfeit contraceptive patches that contained no active ingredients.
In August 2004, the FDA announced the filing of a consent decree that stopped Rx Depot and Rx of Canada from facilitating the illegal importation of drugs.
In September 2003, the FDA issued warning letters to Internet companies that were selling unapproved versions of Accutane (isotretinoin), a drug used to treat severe acne.
FDA Enforcement Examples: Dietary Supplements
Consumers should be wary of claims related to diseases or conditions that are prominent in the news. For example, when Severe Acute Respiratory Syndrome (SARS) was in the news in 2003, the FDA found several dietary supplement products promoted on the Internet for treating or preventing SARS. The FDA took action against 10 of these firms, as there was no evidence of safety or effectiveness of the products for use against SARS. Cleland says he sees a lot of miracle claims for major diseases and weight loss. "Criminals also prey on people's fears about terrorism," he adds. After the anthrax attacks in 2001, some sites falsely claimed that dietary supplements such as colloidal silver and oregano oil could protect against biological and chemical contamination.
Since 2003, the FDA has taken action against street drug alternative products called "Black Beauties" and "Yellow Jackets," seizing millions of dollars worth of these products. Although labeled and marketed as dietary supplements, such products are actually unapproved drugs and cannot be sold as dietary supplements.
In February 2004, the FDA warned consumers against purchasing a liquid product called "Green Hornet." Although it was promoted on the Internet and sold in stores as a dietary supplement, the product was actually an illegal drug because it was promoted as an herbal version of Ecstasy. After taking the product, four teen-agers were rushed to the hospital with seizures, excessive heart rates, severe body rashes, and high blood pressure.
In March 2004, the FDA and the FTC announced that SeaSilver USA Inc. and Americaloe Inc. of Carlsbad, Calif., signed a consent decree of permanent injunction and agreed to stop manufacturing a bogus cure-all liquid supplement called SeaSilver and other products.
In June 2004, the FDA announced the sentencing of a man who swindled cancer patients by heavily advertising and selling Laetrile, also known as vitamin B-17 or apricot pits.
The FDA issued a warning letter to Cellular Wellness Foundation in September 2004, citing claims made on its Web site that the product Cellular Tea was effective in treating serious diseases such as cancer.
In 2004, the FDA issued warning letters to 25 firms that promote their products on the Internet with claims that the products are useful for weight loss. The claims are not supported by scientific evidence.
In July 2004, the U.S. District Court for the District of New Jersey found that three products sold by Lane Labs-USA Inc. and its president Andrew J. Lane as dietary supplements and a cosmetic--Benefin, MGN-3, and SkinAnswer--are in fact unapproved new drugs under federal law because they were being marketed as treatments for cancer, HIV, and skin cancer without FDA approval.
FDA Enforcement Examples: Medical Devices
In 2003, The FTC and the FDA warned Web site operators, manufacturers, and distributors who suggested their products can protect against SARS that the agencies were aware of no scientific proof for such claims and that any misleading or deceptive claims must be removed from the Internet. They found 48 sites touting SARS treatment and prevention products. Some sites falsely said consumers could ward off SARS with disinfectant sprays, wipes, and respiratory masks. There is no device or drug approved to prevent SARS.The FTC announced in January 2003 that it had charged a Switzerland-based company and its U.S. counterpart with making unsubstantiated claims on the Internet for a variety of dietary supplements and devices. The products included "The Zapper," a device they claimed could kill disease-causing parasites in the body with electricity, and "The Syncrometer," which the marketers claimed could diagnose disease.
Source: Use Caution Buying Medical Products Online, By Michelle Meadows, FDA Consumer Magazine, January-February 2005
