"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, the FDA
recommends purchasing only from state-licensed pharmacies 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 and
meets state quality standards. 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 and in good
standing, 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:
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:
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
