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For Release: June 14, 2001 "Operation
Cure.All" Wages New Battle in Ongoing War Against Internet Health
Fraud FTC,
FDA and other law enforcement agencies move to stop As
part of an ongoing and comprehensive law enforcement and consumer
education campaign begun in 1997, the Federal Trade Commission today
announced a new round of enforcement actions against the fraudulent marketing of supplements and other health
products on the Internet. The FTC's action is part of a coordinated effort
with the U.S. Food and Drug Administration (FDA), Health Canada, and
various state Attorneys General to crack down on unscrupulous marketers
who use the Internet to prey on the sickest and most vulnerable consumers.
The six new FTC enforcement actions target companies marketing a variety
of devices, herbal products, and other dietary supplements to treat or
cure cancer, HIV/AIDS, arthritis, hepatitis, Alzheimer's, diabetes and
many other diseases. Among the many products for which unfounded claims
were being made were a DHEA hormonal supplement, St. John's Wort, various
multi-herbal supplements, colloidal silver and a variety of electrical
therapy devices. The FTC's cases were also prompted by representations by
some marketers that their products are safe when, in fact, there may be
potentially dangerous interactions with other medications. Among
the many false and unsubstantiated claims challenged in today's cases
were promises that:
People could cancel their surgery, radiation or chemotherapy in
favor of herbal cures that cost hundreds of dollars;
A device that delivered mild electric current would kill the
parasites that cause such serious diseases as cancer and Alzheimer's; and
Those with HIV or AIDS could use St.
John's Wort as a safe
treatment for the disease. In fact, the FTC alleged, there is
inadequate evidence to support the use of the herb to treat
AIDS. Indeed, St. John's Wort is known to interfere with proven
HIV/AIDS medications. "Many
of the Web sites targeted today are jeopardizing the health and safety
of consumers with outlandish promises and false hope," said FTC Chairman
Timothy J. Muris. "Unfortunately, examples of questionable products
being peddled on the Web abound, and the Federal Trade Commission,
with its partners, will step up its efforts to protect "The
Internet provides many benefits. But, its unique qualities - including its broad reach, relative anonymity, and ease of creating new
websites or removing old ones - pose new enforcement challenges,"
said Bernard A. Schwetz, DVM, Ph.D., Acting Commissioner of the FDA. "FDA and
the FTC are working together to protect the public from those who try to
take advantage of consumers through this new technology." "Health Canada fully shares the concerns of the U.S. FDA
and FTC about
the potential public health risks involved in the marketing of untested,
unlicensed, and in some cases, fraudulent and dangerous drugs and devices.
In an era of globalization, it is a problem that knows no borders, and
intergovernmental cooperation is essential. Health Canada accordingly
welcomes opportunities to work with its U.S. and other international
counterparts to ensure that devices and drugs are safe and effective, and
that they are compliant with the regulations and laws put in place to
protect the public," said Daniéle Dionne, Associate Director
General, Health Products and Food Branch, Health Canada. Today's
announcement by the FTC marks the fourth group of targeted enforcement
actions to address marketing of unproven health products on
the Internet. The cases in this phase of "Operation Cure.All,"
like earlier
cases, often involve dramatic treatment and cure claims, often for a
multitude of serious diseases. Some of the cases also raise serious safety
implications. Moreover,
two cases challenge the promotion of St. John's Wort as a safe
treatment for HIV/AIDS, a claim that presented serious drug interaction
risks. In February 2000, FDA issued a Public Health Advisory
to alert health care providers and consumers to the results of an NIH
study and other reports in the medical literature indicating that taking St. John's Wort may cause a loss of therapeutic effect for any drug
metabolized along the same specified pathway, including HIV medications,
drugs to prevent transplant rejection, and oral contraceptives.
The Advisory is posted on FDA's web site at http://www.fda.gov/cder/drug/advisory/stjwort.htm.
"Many herbal products
and other supplements are promoted as natural and having no side
effects. We want consumers to understand that these products are pharmacologically
active and can be very potent. Patients know to be careful
not to mix medications without consulting their doctor, about
combining supplements with their medications," cautioned Chairman
Muris. "It's
bad enough when someone, with little or no evidence, touts unproven
remedies to vulnerable populations such as people infected with
HIV/AIDS; it's even more frightening when they do so despite -- and
without so much as a mention of -- emerging risks that those remedies
pose to the very people to whom they are pitching their sale. St.
John's Wort and protease inhibitors: THEY DON'T MIX." said Walter
H. Carr, Partnership Council Chairman of the National AIDS Health
Fraud Task Force Network. To
alert consumers to the drug interaction risks, today's actions by the FTC
will require the two companies that had been promoting St. John's Wort
as a safe treatment for HIV and other diseases to include a disclosure
warning of interaction risks in certain future marketing of St. John's
Wort products. In
the six FTC cases announced today, the companies were charged with making
false and unsubstantiated health and safety claims for a variety of
products advertised on the Internet. Five of the companies agreed to settle
the charges and the proposed settlement agreements were announced
today for public comment. The Commission has filed a complaint
in federal district court against the sixth company. Panda
Herbal International, Inc., also doing business as Viable Herbal
Solutions, and its owner, Everett L. Farr III According
to the agency, Panda Herbal International, based in Bensalem,
Pennsylvania, and its owner, Everett L. Farr III, marketed and sold two
products: "Herbal Outlook" - a dietary supplement that contains
St. John's Wort; and "Herb Veil 8," -- a topical ointment. Panda
claimed that consumers could safely use Herbal Outlook to treat such
diseases as HIV/AIDS, herpes simplex, tuberculosis, influenza and
hepatitis B infections. They also claimed that ingestion of Herbal Outlook
has no known contraindications or drug interactions. In addition, the
respondents claimed that Herb Veil 8 is effective in the treatment of
carcinomas, adenocarcinomas and melanomas. The complaint alleges that the
Herbal Outlook and Herb Veil 8 treatment claims are unsubstantiated and
that the claim that Herbal Outlook has "no known contraindications or
drug interactions" is false. The
proposed settlement would resolve the charges by prohibiting Panda from
making any unsubstantiated claims that Herb Veil 8, Herbal Outlook,
or any covered product or service, is effective in the mitigation, treatment,
prevention, or cure of any disease or illness, or about the health
benefits, performance, safety, or efficacy of any such product. The
proposed consent order would require the respondents to place a disclosure
warning in any advertisement, promotional material or product label
for any Herbal Outlook or similar product that states:
WARNING: St. John's Wort can have potentially dangerous interactions with some prescription drugs. Consult your physician before taking St. John's Wort if you are currently taking anticoagulants, oral contraceptives, antidepressants, anti-seizure medications, drugs to treat HIV or prevent transplant rejection, or any other prescription drug. This product is not recommended for use if you are or could be pregnant unless a qualified health care provider tells you to use
it. The product may not be safe for
your developing baby. The
disclosure would be required in connection with any claim made about
the efficacy, performance, or safety of such product. This disclosure
was developed after discussions with the FDA. FDA has announced
that it intends to initiate a rulemaking for dietary supplements for women
who are or who may become pregnant. In the event that FDA issues a final
rule requiring a warning for pregnant women on dietary supplements,
respondents must substitute that warning for the relevant part of the FTC
disclosure. In
addition, the settlement would require Panda to send a notice to all purchasers
of Herbal Outlook and Herb Veil 8 informing them of the Commission's
settlement, and to offer full refunds upon request to consumers
who purchased HerbVeil 8 products during the relevant time period. ForMor,
Inc., doing business as ForMor International, and its president,
Stan Gross ForMor,
Inc., based in Conway, Arkansas, and its president, Stan Gross,
made numerous health-related claims for the products: St. John's Kava
Kava, colloidal silver, and Ultimate II Shark Cartilage The
proposed settlement would resolve the charges by prohibiting the ForMor
respondents from making the specific health claims for its St. John's
Wort, colloidal silver and shark cartilage treatments, unless they have
competent and reliable scientific evidence to support such claims, and
from misrepresenting the results of any tests, study or research. The settlement
would require the respondents, in connection with any claim about
the performance, benefits, safety, or efficacy of any product containing
St. John's Wort, to place a disclosure in any advertisement, promotional
material or product label for the product. The disclosure language
and the provision for substituting warning language promulgated by FDA
parallel that in the Panda settlement described above. In
addition, the settlement would require ForMor to send a notice to all purchasers
of St. John's Kava Kava, colloidal silver, and Ultimate II Shark
Cartilage Concentrate informing them of the Commission's settlement
and would require them to give refunds upon request to people
who purchased colloidal silver and Ultimate II Shark Cartilage Concentrate
during the relevant time period. MaxCell
BioScience, Inc., also doing business as Oasis Wellness Network,
and its president, Stephen Cherniske MaxCell
BioScience, based in Broomfield, Colorado, and its president, Stephen
Cherniske, marketed and sold dietary supplements through a multi-level
marketing scheme. The respondents made numerous allegedly false
and unsubstantiated health claims in cassette and audio and video tapes,
as well as on their website, for two products: "Longevity Signal Formula"
("LSF") - a dietary supplement containing the hormone DHEA; and
their at-home urine test called the "Anabolic/Catabolic Index™² Test"
("ACI Test"). MaxCell claimed that LSF reverses the aging process
and prevents, treats or cures numerous age-related diseases and conditions,
including atherosclerosis, arthritis, high blood pressure, elevated
cholesterol levels, weight gain, and poor liver function. They also
claimed that their ACI Test provided a clinical gauge of an individual's
overall healthiness and youthfulness. The
proposed settlement would prohibit the respondents from making unsubstantiated
health claims and from disseminating deceptive marketing material to distributors. It would prohibit the respondents
from making any representations about the health benefits of their
products or any other food, dietary supplement or drug, without adequate
substantiation. In addition, it would require MaxCell to pay $150,000 for
consumer redress to the FTC, and to notify their distributors of the
settlement and warn them of possible termination if they do not conform
their representations to the requirements placed on MaxCell. Robert
C. Spencer and Lisa M. Spencer, doing business as Aaron Company
Robert
C. Spencer and Lisa M. Spencer, d/b/a Aaron Company, based in
Palm Bay, Florida, sold three products: Colloidal Silver - a dietary supplement
allegedly containing suspended particles of silver, intended to be taken
orally for the cure and treatment of more than 650 diseases; Chitosan
with vitamin C -- a tablet purportedly containing chitin for weight
loss; and Ultimate Energizer -- a product containing ephedra (ma huang)
marketed as a stimulant. The
complaint alleges that the respondents disseminated deceptive advertising
for Colloidal Silver, Chitosan with vitamin C and Ultimate Energizer
through the Internet. The ads allegedly contained false and unsubstantiated
claims in the text of the site, as well as in the embedded source
code or "metatags" for the Web site, that the colloidal silver product
has been medically proven to kill over 650 disease-causing organisms
in the body; that its colloidal silver product is effective in curing
diseases ranging from cancer and multiple sclerosis to HIV/AIDS; and that its colloidal silver product was medically proven to work. The complaint
also alleges that the respondents made unsubstantiated claims that
the Chitosan product enables consumers to lose substantial weight without
a restricted calorie diet and that the Ultimate Energizer product, which
contains ephedra (ma huang), a natural source of ephedrine, is safe and
has no side effects. The
proposed settlement would prohibit the respondents from making the types
of claims alleged in the complaint, unless they have competent and
reliable scientific evidence to substantiate those claims. The proposed
settlement would require the respondents to possess competent and reliable
scientific evidence to substantiate any future claim that any covered
product or service is effective in mitigating, treating, preventing, or
curing any disease, illness or health condition; or about the health
benefits, performance, safety, or efficacy of any such product or service.
In addition, they would be prohibited from misrepresenting the results of
any tests, studies or research. The order would also require that all
future advertising and labeling of products containing ephedra include
affirmative disclosures concerning the serious risks associated with that
botanical. The primary warning would state: WARNING: This product contains ephedra or ephedrine alkaloids, which can have dangerous effects on the central nervous system and heart and can result in serious injury. Risk of injury can increase with dose, and may even include heart attack, stroke, seizure or death. Consult a healthcare provider prior to use if you have high blood pressure, heart or thyroid disease, diabetes, difficulty urinating, prostate enlargement, or glaucoma, or are using any prescription drug. Do not use if you are taking a MAO inhibitor or any allergy, asthma, or cold
medication containing ephedrine, phenylpropanolamine. Discontinue use if you experience rapid
heart beat, chest pain, severe
headache, shortness of breath, dizziness, sleeplessness or nausea. This product is not recommended for use if you are or could be pregnant unless a qualified health care provider tells you to use it. The
product may not be safe for you or
your developing baby. A
shorter warning is permitted for television and radio advertisements. The
warning was developed after discussions with FDA and contains a provision
parallel to that in Panda and ForMor. Michael
Forrest, doing business as Jaguar Enterprises of Santa Michael
Forrest, d/b/a Jaguar Enterprises, based in Mesquite, Texas, and
using business addresses in Black Mountain, North Carolina and Miami,
Flordia, sold, distributed, promoted, and advertised various products,
including various electronic therapy devices known as the Black
Box; Magnetic Pulser; Magnetic Multi-Pulser; Beck-Rife unit; Portable
Rife Frequency Generator; PC-Rife #1; PC-Rife #2; PC-Rife #3;
as well as a combination of herbal ingredients known as "Miracle Herbs,"
a purported cure for cancer and other serious diseases. The
complaint alleges that Jaguar made unsubstantiated claims that their electronic
devices will cure or prevent serious diseases, such as cancer, AIDS,
arthritis, Gulf War Syndrome, and Chronic Fatigue Syndrome, by passing
an electric current or magnetic pulse through the body, and that Miracle
Herbs is effective in treating cancer of all types, AIDS, bacterial and
viral infections. It also alleges that the respondent falsely represented
that Miracle Herbs has been scientifically proven to be safe and effective
and that the electronic devices have been scientifically proven to kill
bacteria and viruses and other parasites in the body. The
proposed settlement would prohibit the respondent from making the challenged
claims or any other claim about the health benefits, performance,
safety or efficacy of its products or services without adequate
substantiation. The settlement also would prohibit the respondent
from misrepresenting the results of any test, study or research.
Finally, the settlement requires the respondent to offer refunds to
purchasers of the challenged products. Western
Dietary Products Co., doing business as Western Herb & Dietary
Products, Inc. and its owners Marvin and Miguelina The
complaint against Western Dietary Products, based in Blaine, Washington,
and Marvin and Miguelina Beckwith, the company's owners,
charges that the defendants marketed various herbal formulas and
herbal cure packages including Black Walnut Tincture, Wormwood Tincture,
and Cloves Tincture to treat and cure cancer, Alzheimer's, diabetes,
arthritis, and HIV/AIDS; that they marketed the "Zapper Electrical
Unit" to treat and cure Alzheimer's and HIV/AIDS; and that the defendants
claimed their herbal products would make surgery and chemotherapy
unnecessary for persons with cancer. According to the complaint,
all of these claims were unsubstantiated. The complaint against Western
Dietary Products Co. was filed in the U.S. District Court for the Western
District of Washington, in Seattle, on June 4, 2001. At a June 13th
hearing, the defendants agreed to entry of a preliminary injunction. FDA As
part of the coordinated Cure.All effort, FDA is also highlighting a variety
of initiatives it has taken in the past year to combat Internet Health
Fraud. Colloidal
Silver The
FDA and FTC have identified firms that marketed Colloidal Silver as a
cure, treatment, or prevention of serious diseases. As part of Cure.All, the
FDA identified forty-eight (48) Web sites that made serious drug claims
for Colloidal Silver, as well as a number of other products. The FDA
sent these Web sites Cyber Letters, untitled letters sent via electronic
mail, informing them that their products were being promoted for
conditions that may cause the products to be considered drugs and therefore
may be in violation of the Federal Food, Drug, and Cosmetics Act.
As a direct result of these Cyber Letters, 27 percent of the sites complied
by removing or changing the violative claims. Rife
Frequency Generators and Zappers Rife
Frequency Generators and Zappers are devices that purportedly send
different amounts of electrical energy into the body to destroy parasites
and/or shatter cells to cure serious diseases, such as cancer and AIDS. As
part of "Operation Cure.All," the FDA has taken several actions
with respect to these devices: FDA issued warning letters to several firms selling these devices informing them that they were in violation of the Federal Food, Drug, and Cosmetic Act. FDA also issued several untitled letters to firms questioning the legality of the
marketing of these devices. removed or modified their Web sites; and FDA placed the Zapper promoted by one foreign firm on automatic detention without physical examination, which will prevent this device
from legally entering the United
States. Aristolochic
Acid The
FDA has determined that aristolochic acid -- a substance found in some
traditional herbal medicines -- poses significant health risks to consumers
because it is carcinogenic and extremely toxic to the kidney. FDA
has taken several actions in response to the marketing of dietary supplements
containing aristolochic acid: FDA
has issued two public warnings to consumers, health care providers,
and dietary supplement manufacturers; FDA
has prohibited the importation of botanicals that are suspected
to contain or be contaminated with aristolochic acid, unless
firms can prove that their products are free of the toxic substance;
FDA has warned manufacturers that they must take steps to ensure
that their products are free of these toxic substances; FDA
has issued warning letters to several firms informing them that their
products are adulterated within the meaning of the Food, Drug,
and Cosmetic Act, present a significant risk to consumer health,
and should be immediately recalled from the marketplace; and
FDA has worked with a number of firms to initiate recalls of the affected
products and ensure that customers were immediately Consumer
Education In
addition to announcing today's enforcement actions, the FTC will continue
its education campaign to alert consumers to health fraud online. Because
promoters of fraudulent healthcare products often use similar claims and
practices to lure consumers into buying their products, the FTC advises consumers to be suspicious of:
Claims that the product is "natural" or "non-toxic,"
suggesting it
does not have side effects.
"Natural" or "non-toxic" does not necessarily mean safe. Some "natural" supplements contain potent stimulants; others, like St. John's Wort, can result in negative interactions with medicines. Testimonials from people who claim amazing results. Testimonials often are undocumented and are not a substitute for scientific proof. Claims that a product is a "scientific breakthrough," "miraculous cure," "secret ingredient" or "ancient remedy." Claims that the
product is an effective cure for a
wide range of ailments.
Claims that use impressive-sounding medical terms.
Claims that the product is available from only one source, and payment is required in advance. Claims of a "money-back" guarantee. Websites that fail to list the company's name,
physical address, phone number or
other contact information. To
ensure the safe use of supplements and other health-related products, consumers should let their health care provider know if they are
using these products. Additional
tips on buying healthcare products on the Internet and using supplements
and other healthcare products are on the FTC's Virtual Health Treatments website, www.ftc.gov/healthclaims, and FDA's Buying Medicines and Medical Products Online website, www.fda.gov/oc/buyonline. The
FTC expresses its appreciation for the assistance of FDA, Health Canada,
and the state Attorneys General who participated in this and earlier
phases of "Operation Cure.All." The
Commission vote to accept the five consent agreements for public comment
and the Commission vote to authorize the filing of the federal court
complaint was 5-0. NOTE:
The Commission files a complaint when it has "reason to believe"
that the law has been violated, and it appears to the Commission that a
proceeding is in the public interest. The complaint is not a finding or
ruling that the defendants have actually violated the law. The case will
be decided by the court. NOTE:
The consent agreements are for settlement purposes only and do not
constitute an admission of a law violation. When the Commission issues a
consent order on a final basis, it carries the force of law with respect
to future actions. Each violation of such an order may result in a civil
penalty of $11,000. A
summary of each of the proposed consent agreements will be published in
the Copies of the complaints, proposed consent agreements, and
analyses to aid public comment, as well as the consumer education information, are
available from the FTC's web site at http://www.ftc.gov and also from the FTC's
Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C.
20580. The FTC works for the
consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help
consumers spot, stop
and avoid them. To file a complaint, or to get free information on any of
150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357),
or use the complaint form at http://www.ftc.gov. The FTC enters Internet,
telemarketing, identity theft and other fraud-related complaints into Consumer
Sentinel, a secure, online database available to hundreds of civil and
criminal law enforcement agencies MEDIA
CONTACT:
Brenda Mack,
Office of Public Affairs
202-326-2182 STAFF
CONTACT:
Richard Cleland or Michelle Rusk
Bureau of Consumer Protection
202-326-3088 or 202-326-3148
Rae Jones (Print Media) Food
and Drug Administration
301-827-6242
Broadcast Media
Food and Drug Administration
301-827-3434
Panda Herbal International
Michael Bloom or Donald D'Amato - Northeast Region
212-607-2801or 212-607-2802
ForMor
Michael Bloom or Donald D'Amato - Northeast Region
212-607-2801or 212-607-2802
MaxCell BioScience Matthew
Daynard, Bureau of Consumer Protection
202-326-3291
Jaguar Enterprises
Michael Milgrom - East Central Region
216-263-3419
Aaron Company
James Rohrer - Southeast Region
404-656-1361
Western Dietary Products
Michael Milgrom - East Central Region
216-263-3419 (FTC
File No. 002 3229 -- Panda Herbal International, Inc.) (FTC
File No. 002 3226 - ForMor, Inc.,) (FTC
File No. 002 3098 -- MaxCell BioScience) (FTC
File No. 012 3091 - Michael Forrest d/b/a Jaguar Enterprises,) (FTC
File No. 002 3312 - Aaron Company) (FTC
File No. 012 3090 - Western Dietary; Civil Action No. C01-0818 R) http://www.ftc.gov/opa/2001/06/cureall.htm
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