|
Enforcement examples. 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. Although he purported it to be a dietary supplement, Laetrile is actually an unapproved drug. The highly toxic product hasn't shown any effect on treating cancer.
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 as dietary supplements and a cosmetic by Lane Labs-USA Inc. and its president Andrew J. Lane are in fact unapproved new drugs because they were being marketed as treatments for cancer, HIV, and skin cancer without FDA approval. The court permanently enjoined Lane and the company from distributing the products--Benefin, MGN-3, and SkinAnswer--unless they are first either approved for marketing by the FDA or distributed pursuant to an investigational new drug application for purposes of conducting a clinical trial. The court also ordered the defendants to pay restitution to purchasers of the three products since Sept. 22, 1999. The defendants appealed the court's decision.
Tips. Consumers who choose to buy dietary supplements on the Internet should consider who operates the Web site and what evidence is provided to substantiate claims.
Dietary supplement makers are responsible for making sure that their products are safe before they go on the market and that claims on labels are accurate, truthful, and substantiated with adequate scientific evidence. By law, supplement manufacturers are allowed to use these types of claims, when appropriate:
* Nutrient-content claims such as "high in calcium" or "excellent source of vitamin C."
* Health claims that show a link between the supplement and reduced risk of a disease or health condition, when the use of the claim has been approved by the FDA. For example, women who get adequate amounts of the B vitamin folic acid during pregnancy have a decreased risk of having a baby with a neural tube defect.
* Qualified health claims, which are for dietary supplements only. This type of claim came about as a result of a 1999 decision by the U.S. Court of Appeals for the District of Columbia Circuit in the case of Pearson v. Shalala. The court's ruling requires the FDA to allow appropriately qualified health claims that would be misleading without such qualification. These qualified claims are based on the weight of the scientific evidence. An example of this type of claim is "Supportive but not conclusive research shows that consumption of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) omega-3 fatty acids may reduce the risk of coronary heart disease."
* Claims regarding a benefit related to a classical nutrient deficiency disease, such as vitamin C and scurvy.
* Claims that a dietary supplement has an effect on the structure or function of the body, when such claims are supported by scientific evidence. An example of such a claim is "calcium builds strong bones" for a supplement that contains calcium.
* Claims that describe general well-being from consumption of the product.
The FDA recommends that consumers contact their health care providers before using dietary supplements. This is especially important for people who are pregnant or breast-feeding, chronically ill, older, younger than 18, or taking prescription or over-the-counter medicines.
Medical Devices
What are they? Medical devices are pieces of equipment, apparatus, machines, implants, test kits, or other similar articles intended to diagnose, heal, manage, or prevent diseases or conditions.
Problem sites. Examples of unlawful device sales include selling contact lenses or other prescription devices without a prescription or fitting by a qualified health care professional. Or a site may be selling an unapproved device and making fraudulent claims about it, such as promoting magnets to treat carpal tunnel syndrome and arthritis pain.
Some over-the-counter tests, such as pregnancy tests, are approved for consumer use, but most tests should be used by health professionals only, says Harold Pellerite, assistant to the director of the Office of Compliance in the FDA's Center for Devices and Radiological Health (CDRH). "And some companies claim you can rely on in-home results when results should be confirmed in a doctor's office."
Other Web sites advertise services on the Internet that entice consumers to come into a storefront to have questionable procedures. "It could be that the use of the device is unapproved or the device itself is unapproved," Pellerite says. For example, some companies promote full-body computed tomography (CT) scans as a way to detect early disease in people who have no symptoms of a problem. But the FDA has approved them only as a tool to diagnose disease when someone is experiencing symptoms or there is some reason for testing.
Risks. Consumers risk missing out on necessary medical treatment or being harmed if they use devices illegally marketed or sold through the Internet. The FDA has received reports of sight-threatening corneal ulcers from using non-corrective decorative contact lenses that were distributed without a prescription.
Joyce Iliya, an attorney in the Texas Office of the Attorney General in Austin, recently worked on several lawsuits involving one death and four serious injuries in patients who developed perforated colons as a result of a procedure advertised through the Internet. The companies in the suits were performing what they called "colonic hydrotherapy" without physician involvement.
"They claimed to be able to use a device to clean the colon as a way to prevent serious diseases," Iliya says. "In Internet ads, they claimed to ‘cure disease' and ‘re-energize life,' and people came in to get the procedure." According to the FDA, prescription colonic cleansing systems can be used only for medical purposes, such as before a radiological examination.
Pellerite says that, because of the nature of the Internet, it can be hard to know who is promoting a device. Someone can claim to be a health professional, but that's no guarantee of device safety.
And in the case of classified ads in which people are selling items over the Internet, consumers should consider the risks that may come with used devices, Pellerite says. "The FDA has received questions from Internet services about parents wanting to advertise and sell sleep apnea monitors, prescription devices sometimes used to monitor babies at risk for sudden infant death syndrome. But you can't sell a prescription device without a prescription and without physician involvement."
Regulation. CDRH regulates the safety and effectiveness of medical devices. Medical devices are categorized into Classes I, II, and III, with the degree of regulatory control increasing with each ascending level. The FDA's Center for Biologics Evaluation and Research (CBER) regulates medical devices related to blood collection and processing procedures, such as HIV test kits.
The FTC regulates device advertising. The FDA works with the FTC, the U.S. Department of Justice, and state attorneys general to crack down on devices that violate the FD&C Act. Enforcement activities include cease-and-desist orders that stop the illegal marketing of devices, as well as warning letters and cyber letters. Depending on the outcome of a case, companies may have to pay penalties and consumer refunds.
Enforcement examples. 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.
Tips. The FDA recommends checking with your health care provider before buying a medical device or before obtaining services that have been promoted on the Internet. "There are so many devices, it's hard for consumers to tell what is a prescription device and what isn't, or what is legitimate and what's not," Pellerite says. "But just like a prescription drug, if a device requires a prescription, it's because it should only be used under the supervision of a physician."
|
|
|
|
