<<Disclaimer: Verify this information before applying it to your situation.>>

Because I have had several queries as to where I got my information on the
herb comfrey I'll cut & paste from FDA.  This herb is TOXIC if taken
internally.

Wishing Well ~
Jude


For Release: July 6, 2001Latest FTC Case in "Operation Cure.All" Focuses on
Safety Risks of Comfrey Products Promoted Via Internet

FDA Issues Simultaneous Letter to Industry Warning Against Marketing of
Comfrey In Dietary Supplements

As part of its latest efforts in its ongoing and comprehensive "Operation
Cure.All" to combat Internet health fraud, the Federal Trade Commission today
is announcing an additional case challenging the marketing of unproven and
dangerous products via the Web. The target of today's action is Christopher
Enterprises, Inc., a manufacturer and marketer of a variety of products
containing the herbal ingredient comfrey, for both external and internal
uses. The FTC charged that the company, its president, Norman Bacalla, and
vice president, Ruth Christopher Bacalla, made unfounded claims that the
products were beneficial in the treatment of a wide variety of serious
diseases and conditions and that they were safe. In fact, according to the
FTC's complaint, comfrey contains toxic substances and, when taken
internally, can lead to serious liver damage. The defendants have agreed to a
preliminary injunction requiring them to stop marketing comfrey products for
internal uses or on open wounds, and to include a warning on comfrey products
marketed for external uses. They have also agreed to stop making the
challenged safety and health benefit claims.

"The Internet is a powerful tool for consumers searching for health
information," said Howard Beales, Director of the FTC's Bureau of Consumer
Protection. "Unfortunately, unscrupulous marketers also use it to peddle
products with unproven and false claims.

"Consumers can lose their money and increase their health risk, especially if
they delay or forego proper medical treatment," said Beales. "Consumers
should avoid websites that promise quick and dramatic cures for serious
diseases and they should always consult a physician or other healthcare
professional before using any product or treatment," added Beales.

Christopher Enterprises, Inc., based in Springville, Utah, Norman Bacalla,
and Ruth Christopher Bacalla, marketed and sold a variety of products
containing comfrey to consumers throughout the United States by mail and
telephone orders, on the Internet at "www.drchristopher.com," and through
distributors, retail stores, and health care practitioners.

The defendants stated in their advertising and promotional materials that
their comfrey products were safe to take orally, as suppositories, or to be
applied to open wounds, and that even pregnant women, infants, and children
could safely use their products internally. The defendants also claimed their
comfrey products, recommended for internal consumption, were effective in
treating and/or curing asthma, colds, coughs, lung congestion, sore throats,
emphysema, bronchitis, tuberculosis, broken bones, curvature of the spine,
polio, multiple sclerosis, and spinal cancer. In addition, the defendants
claimed their suppository products were effective in treating prolapsed bowel
and uterus, yeast infection and herpes simplex. The defendants' herbal
antiseptic containing comfrey, recommended for application to open wounds or
taken internally, was claimed to be effective in treating, preventing, and/or
curing thrush, infection, pyorrhea, sore throat pain, and toothaches.

The FTC alleges that the defendants' representations that their comfrey
products were safe to use internally are false. In fact, the FTC said,
comfrey is not safe for internal use because it contains pyrrolizidine
alkaloids which are known to be toxic to the liver, and taken internally such
substances can lead to serious illness or death. The FTC further alleges that
the defendants did not have adequate scientific evidence to substantiate the
safety or efficacy claims they made for their comfrey products.

The defendants have agreed to a preliminary injunction order that would
prohibit them from marketing any comfrey product for ingestion, for use as a
suppository, or for external use on open wounds, unless they have evidence
that the product is free of pyrrolizidine alkaloids and is safe. They would
also be required to place the following disclosure warning in any
advertisement, promotional material or product label for any comfrey products
intended for topical use:


> WARNING: External Use Only. Consuming this product can cause serious liver
> damage. This product contains comfrey. Comfrey contains pyrrolizidine
> alkaloids, which may cause serious illness or death. This product should
> not be taken orally, used as a suppository, or applied to broken skin. For
> further information contact the Food and Drug Administration: <A HREF="http://www.ftc.gov/opa/2001/07/http/vm.cfsan.fda.gov">
> http//vm.cfsan.fda.gov</A>



In addition, the order would prohibit the defendants from making the specific
health claims alleged in the complaint or any unsubstantiated representations
about the safety, health benefits, performance, or efficacy of any food,
drug, dietary supplement or other health-related product or service. The
order further would require them to notify distributors of their products
that unsubstantiated claims violate the law and that the defendants will
terminate distributors who make false or unsubstantiated claims. The order
will remain in effect until further order of the court. In simultaneous
action today, the Food and Drug Administration issued a <A HREF="http://www.cfsan.fda.gov/~dms/dspltr06.html">letter</A> to industry
communicating concern about the safety of supplement products containing
comfrey. FDA's letter, which has been sent to trade associations and other
industry groups, advises that, because comfrey contains certain toxic
substancesBpyrrolizidine alkaloidsBthat have been associated with liver
damage and other health hazards, it should not be used as an ingredient in
supplements. FDA further recommends that firms should immediately stop
marketing comfrey-containing supplements and alert consumers to stop using
the products. Finally, FDA is urging manufacturers to identify and report any
adverse events, including liver disorders that have been associated with
comfrey and other ingredients containing pyrrolizidine alkaloids. The letter
will also be posted on FDA's website at www.cfsan.fda.govThe Food and Drug
Administration has been a close partner of the FTC and assisted the agency in
today's enforcement action as well as many other aspects of "Operation
Cure.All."The Commission vote to authorize staff to file the complaint and
the preliminary injunction was 5-0. The case was filed in the U.S. District
Court, District of Utah, Central Division, in Salt Lake City, on July 3,
2001, and the injunction is subject to court approval.


NOTE: The Commission files a complaint when it has "reason to believe" that
the law has been or is being 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 defendant has actually violated the law. The case will be
decided by the court.
For More Information
<A HREF="http://www.ftc.gov/os/2001/07/index.htm#6">Copies</A> of the complaint and the stipulated preliminary injunction in this
case are available from the FTC's web site at <A HREF="http://www.ftc.gov/">http://www.ftc.gov</A> 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 <A HREF="https://rn.ftc.gov/dod/wsolcq$.startup?Z_ORG_CODE=PU01">complaint</A> form. 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 in the U.S. and
abroad. 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, <A HREF="http://www.ftc.gov/healthclaims">www.ftc.gov/healthclaims</A>, and FDA's Buying
Medicines and Medical Products Online website, <A HREF="http://www.fda.gov/oc/buyonline">www.fda.gov/oc/buyonline</A>.

* Visit the Celiac Web Page at www.enabling.org/ia/celiac/index.html *