Use Caution Buying Medical Products Online Use Caution Buying Medical Products Online
U.S. Food and Drug Administration
Get prescription drugs fast–no doctor needed! Cure cancer with herbs! Zap your pain away with an amazing device! Absolutely safe–pull out your credit card NOW, and get rock-bottom prices.
It’s not hard to find statements like these floating around in cyberspace. “And if they sound too good to be true, it’s because they usually are,” says Rich Cleland, assistant director of the Division of Advertising Practices at the Federal Trade Commission (FTC).
Many legitimate Web sites bring customers health products with the benefits of convenience, privacy, and, sometimes, cheaper prices. “But consumers need to be aware that the Internet has also created a marketplace for unapproved medical products, illegal prescribing, and products marketed with fraudulent health claims,” says William Hubbard, associate commissioner for policy and planning at the Food and Drug Administration.
“And the unique qualities of the Internet, including its broad reach, relative anonymity, and the ease of creating and removing Web sites, pose challenges for enforcing federal and state laws,” Hubbard says. “Many sites are connected to other sites and have multiple links, which makes investigations more complex. And there are jurisdictional challenges because the regulatory and enforcement issues cross state, federal, and international lines.”
Government agencies work together to shut down illegal Web sites and prosecute criminals, but enforcement resources are limited. “Consumers need to take some responsibility for recognizing suspicious sites and turning the other way,” Hubbard says. So how can you spot the red flags? Here’s a guide to help you protect your health and your wall.
What are they? Prescription drugs are substances that are intended to diagnose, cure, treat, or prevent medical conditions or diseases. Before they can be legally marketed, they must undergo clinical studies on their safety and effectiveness and be approved by the FDA. The agency approves a drug if its experts determine that the benefits of the drug outweigh the risks associated with it. But no drug is absolutely safe; there is always some level of risk.
Problem sites: One way that illegitimate Web sites violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) is by dispensing prescription drugs without a valid prescription, says Steven Silverman, director of the Division of New Drugs and Labeling Compliance in the FDA’s Center for Drug Evaluation and Research. “FDA leaves it to individual states to decide what is a valid prescription. Web sites cannot dispense drugs in violation of those laws or with no prescription at all.”
In general, to be valid, a prescription must address a legitimate medical purpose, be written by a physician or other health care provider authorized to prescribe medicine, and be based on a legitimate doctor–patient relationship. But some Web sites dispense drugs after customers simply fill out an online questionnaire or engage in some other similar cyber “consultation.”
In June 2004, experts at the Government Accountability Office, formerly the General Accounting Office, reported that, as part of an investigation, they were able to obtain most of the prescription drugs they set out to order from various Internet pharmacy sites without needing to provide a prescription. Some of the drugs had special safety restrictions or were addictive narcotic painkillers.
“The FDA has taken action against Web sites selling drug products that are unapproved, misbranded, or that make fraudulent health claims,” Silverman says. Misbranded drugs include those with misleading labeling and those that aren’t adequately labeled with directions for use of the product.
Risks: “When you buy drugs from a questionable Web site, you just don’t know what you’re actually getting,” says Carmen Catizone, executive director of the National Association of Boards of Pharmacy (NABP).
The main concerns are that the drugs could be outdated, contaminated, too potent or not potent enough, improperly manufactured and handled, or counterfeit. “We have seen some reports of cases where people thought they ordered prescription drugs, but they received some kind of dietary supplement,” Catizone says.
Between February 2004 and August 2004, the NABP received more than 100 consumer complaints alleging harm related to buying drugs online. Consumers paid money but never received products, received medications different from what they ordered, or experienced worsening symptoms after taking the drugs they ordered online.
As for drugs imported from countries outside of the United States, the FDA can’t assure their safety. In July 2004, the FDA announced that its investigators bought three commonly prescribed drugs–Viagra, Lipitor, and Ambien–from a Web site advertising “Canadian generics,” and found that the drugs were fake and potentially dangerous.
“What’s creating consumer confusion is that several governors and mayors are pushing for importation and some have established pharmacy programs that allow their constituents to purchase drugs from foreign sources, leading the public to believe the practice is safe,” Catizone says. “But importation just opens the door to counterfeit drugs and other risks.”
Regulation: State medical boards regulate medical practice and state pharmacy boards regulate pharmacy practice. It is generally unlawful to prescribe or dispense drugs without a legitimate relationship between the health care provider and the patient. Penalties may include fines and license suspensions.
When Internet operators violate the FD&C Act, the FDA, sometimes in collaboration with other law enforcement agencies, may take enforcement action against a firm. Enforcement actions might take the form of warning letters, cyber letters, import alerts, seizure actions, injunction actions, or criminal prosecution. A warning letter, usually sent by mail, advises a company that it may be engaged in illegal activities. A cyber letter is similar to a warning letter, but is sent electronically through the Internet to the operators of a Web site. If the violation continues, the FDA could take enforcement action. A seizure action removes products from the marketplace, and an injunction action results in a court document that orders the firm to cease violating the law. An import alert identifies products that violate the law so that FDA field personnel and U.S. Customs and Border Protection staff can stop their entry at the border.
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 site’s customers were able to obtain prescription drugs after filling out an online questionnaire. The FDA’s Office of Criminal Investigations and the Federal Bureau of Investigation investigated the case.
The FDA warned the public in February 2004 about Internet sites outside the United States selling counterfeit contraceptive patches that contained no active ingredients. With the cooperation of a U.S.-based Internet service provider, the FDA shut down service to the Web sites.
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. A judge found that the defendants’ actions posed a public health threat.
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. Because of serious risks, including birth defects if taken by pregnant women, Accutane is available under a restricted distribution program that allows only certain doctors to prescribe the drug.
Tips: For consumers who want to buy prescription drugs online, the FDA recommends purchasing only from state-licensed online pharmacies that are located in the United States. This helps to assure that the consumer will receive drugs that are manufactured, packaged, distributed, and labeled properly. Some legitimate Internet pharmacies are extensions of traditional brick-and-mortar chain drug stores such as Walgreens, Eckerd, and CVS.
“There are also smaller, and still legitimate, Web sites that consumers can use with confidence,” says Linda Silvers, who leads the Internet and health fraud team at the FDA’s Center for Drug Evaluation and Research. “Legitimate sites require valid prescriptions.”
“A Web site can look very sophisticated and legitimate, but actually be an illegal operation,” Silvers says. “If there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required, consumers should be especially wary.”
People should check with their state board of pharmacy or NABP to see if an online pharmacy has a valid pharmacy license, meets state quality standards, and is located in the United States . NABP’s Verified Internet Pharmacy Practice Sites program, also known as VIPPS, is a voluntary program that verifies the legitimacy of Internet sites dispensing prescription drugs and gives a seal of approval to sites that apply and meet state licensure requirements and other VIPPS criteria.
To find out if an online pharmacy is licensed, is in good standing, and is located in the United States, contact NABP at www.nabp.net. Legitimate pharmacies that carry the VIPPS seal are listed at http://www.vipps.info/. For a list of state boards of pharmacy, visit www.nabp.info.
What are they? Dietary supplements are products taken as a supplement to the diet. Examples are vitamins, minerals, herbs, botanicals, and amino acids, the individual building blocks of proteins needed for all life. Dietary supplements are classified as foods and not drugs.
Problem sites: Web sites cannot claim that dietary supplements will prevent, treat, or cure any disease. This would make the product an unapproved and illegal drug. Also, Web sites can’t make claims that a dietary supplement will have an effect on any structure or function of the body when the claims are not substantiated.
“Web sites selling dietary supplements with false or unsubstantiated claims sometimes use testimonials and advertisements touting a quick, miracle cure,” says the FTC’s Cleland. “And some sites claim a product will cure it all–heart disease, cancer, arthritis, you name it.”
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.
Risks: “In promoting some products, companies are telling patients not to undergo surgery, chemotherapy, or other needed treatment,” says Cleland. “So we are concerned about people forgoing legitimate medical treatment.”
Consumers also have to worry about ingesting harmful substances. Companies may call a product “natural,” but that doesn’t mean it’s safe. And dietary supplements are intended to supplement diets, not replace them. Too much of some nutrients can cause problems. There is also a danger of dietary supplements interacting with other drugs you may be taking. The prescription medicine warfarin, the herbal supplement gingko biloba, aspirin, and vitamin E all can thin the blood, so taking any of them together can increase the potential for internal bleeding.
Regulation: Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are products that are intended to supplement the diet and that contain one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance that supplements the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combination of these ingredients.
Dietary supplement manufacturers must notify the FDA at least 75 days before marketing products containing some “new dietary ingredients.” This includes providing the agency with safety information about the supplement. New dietary ingredients are those that were not marketed as dietary supplements before Oct. 15, 1994.
Except for those dietary supplements containing new dietary ingredients, the safety and labeling of most dietary supplements is monitored only after they reach the marketplace. The FDA evaluates the safety of dietary supplements after they are on the market, overseeing safety, manufacturing, and product information on the labeling. The FTC regulates the advertising of dietary supplements under the FTC Act, which prohibits deceptive claims in advertising.
Under DSHEA, the FDA generally has responsibility for showing a dietary supplement is unsafe before it can take action to restrict the product’s use. For example, in 2004, the FDA banned the use of ephedrine alkaloids in dietary supplements because the substances pose an unreasonable risk of illness or injury. Ephedrine alkaloids in dietary supplements have been linked to cardiovascular problems.
“If the FDA can establish that claims are false or misleading, or if a firm is making drug claims for a dietary supplement, the agency can take action using any of our enforcement tools, such as warning letters, cyber letters, seizure of products, and criminal prosecution,” says Jennifer Thomas, who leads the dietary supplement and labeling enforcement team in the FDA’s Center for Food Safety and Applied Nutrition, Office of Compliance.
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.
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 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. The court permanently enjoined Lane and the company from distributing 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 are appealing 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 and 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, elderly, under 18, or taking prescription or over-the-counter medicines.
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 Class 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.
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.”
Be wary if a device claims to diagnose more than one illness or promises a miracle cure. Consumers who want to find out if a medical device has been cleared by the FDA, cleared for home use, or cleared for use in the United States can visit the FDA’s device databases at www.fda.gov/cdrh/ or call CDRH at (800) 638-2041.