Use Caution Buying Medical Products Online
By Michelle Meadows
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 wallet.
Prescription Drugs
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.
Enforcement Examples:
- 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.
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.
Dietary Supplements
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.
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 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 for consumers who choose to buy dietary supplements on the internet.
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.
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 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.
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 for consumers when buying medical devices on the internet.
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.
Legislation
In March 2004, the Federation of State Medical Boards (FSMB) voiced support
of federal legislation that would protect consumers from dangerous Internet drug
prescribing practices.
"The Internet Pharmacy Consumer Protection Act would remove the veil of
secrecy surrounding many rogue Internet pharmacies and the physicians who serve
them," FSMB President James Thompson, M.D., told Congress during a hearing.
The bill, which was introduced in early March 2004 by Rep. Tom Davis, R-Va.,
and Rep. Henry Waxman, D-Calif., targets domestic Internet pharmacies that sell
drugs over the Internet without a valid prescription. These are the main
provisions of the bill:
- Sites would be required to make specific disclosures of the names of
Internet prescribing physicians, dispensing pharmacies, the states in which
practitioners are licensed, and contact information.
- Sites would be barred from dispensing prescription drugs solely on the basis
of an online questionnaire. An in-person medical evaluation would be required.
- State attorneys general would be allowed to go to federal court to enforce a
nationwide injunction against illicit online pharmacies, rather than just in
their individual jurisdictions.
A companion bill, The Ryan Haight Act, also has been introduced by Sen.
Dianne Feinstein, D-Calif., and Sen. Norm Coleman, R-Minn. The bill is named for
a teen-ager who died as a result of obtaining dangerous drugs over the Internet.
The administration has not stated a position on the proposed legislation.
Reporting Problems
To report a problem with a Web site selling human drugs, animal drugs,
medical devices, biological products, foods, dietary supplements, or cosmetics:
- If the problem involves a serious or life-threatening situation, call your
health care professional immediately for medical advice. To report the situation
to the FDA, call (301) 443-1240.
- If the problem involves a serious reaction or problem, contact your health
care professional for advice. To fill out the FDA's MedWatch reporting form, go
to www.fda.gov/medwatch.
- For problems that do not involve a serious or life-threatening reaction,
fill out the form at www.fda.gov/oc/buyonline/buyonlineform.htm.
- To report e-mails or Web sites promoting medical products that might be
illegal, forward the material to webcomplaints@ora.fda.gov.
- To report false claims to the Federal Trade Commission, call (877) 382-4357.
- If you lose your money, contact the credit card company, your state attorney
general's office, or the Better Business Bureau.
Online Resources
FDA buying online page
www.fda.gov/buyonline/
FDA online guide: "Buying Prescription Medicines Online: A Consumer Safety
Guide"
www.fda.gov/buyonlineguide
FDA report on combating counterfeit drugs
www.fda.gov/counterfeit/
List of dietary supplement ingredients for which the FDA has issued
warnings
www.cfsan.fda.gov/~dms/ds-warn.html
List of enforcement actions taken against the promoters of products
www.fda.gov/oc/enforcement.html
Posted on Profcentral: Fri Nov 24 2006 14:18:07 GMT+0800 (Phils.)
Content Source: USFDA
NOTE: For more consumer information visit: www.fda.gov.
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