 NOTE: The following news brief appeared in an issue of the Reference Service, Advertising Compliance ServiceÔ and examined an advertising law-related action during the month of December 1997.
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HERBAL FEN PHEN ADVERTISERS WARNED BY FDA
DO YOU HAVE A LARGE WEB SITE?
The Internet and World Wide Web is an increasingly important place for advertisers of all kinds to promote and sell their products and services. As anyone who has constructed a large web site can testify, it can be very difficult to keep track of all the changes to every word and every line of copy at your site. But "someone" (more precisely, numerous "entities") do keep track. In fact, these entities keep robotic-like track of virtually all of the pages on the Internet. These are the search engines like ALTA VISTA, Excite, and Yahoo, which regularly send their "searchbots" across the Net so that netizens surfing the Internet can find the information they want. The system these searchbots use is a key word system using boolean logic. A recent search using the key words "advertising law", for example, turned up 6,693,675 web pages using those words. (The Advertising Compliance ServiceÔ web site at www.lawpublish.com had 51 of the top 100 of those pages.) In addition to this system is the capability of all current major web browsers enabling you to add any web page to your "favorite
places" with a click or two of your mouse.
It's a remarkable system that enables researchers to find huge amounts of information quickly and relatively easily. There is, however, a very large downside to the system. These searchbots are, of course, unable
to make any distinction as to information that's obsolete, wrong,
or--as this case illustrates--potentially hazardous, when followed.
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INCREASING PROMOTION OF HERBAL ALTERNATIVES TO "FEN PHEN"
The Food and Drug Administration (FDA) recently became aware of the increasing promotion of various dietary supplement-type products as "natural" herbal alternatives to the prescription drug combination commonly known as "fen phen." According to FDA, so-called "herbal fen phen" products are being marketed over the Internet and through weight loss clinics, print ads and retail outlets as natural alternatives to the prescription drugs phentermine and fenfluramine (commonly referred to as "fen phen" "fen-phen" or "fen/phen"). FDA considers these products to be unapproved drugs since their names reflect that they're
intended for the same use as the anti-obesity drugs, fenfluramine and
phentermine. The agency is warning consumers that these unapproved
drugs have not been shown to be safe or effective and may contain
ingredients that have been associated with injuries.
TWO ANTI-OBESITY DRUGS WERE WITHDRAWN DUE TO SAFETY CONCERNS
Two anti-obesity drugs, fenfluramine (brand name Pondimin) and
dexfenfluramine (brand name Redux), have been withdrawn from the
marketplace because of safety concerns. FDA believes the use of
unapproved alternative products may increase as a result of the
withdrawal. Herbal fen-phen products contain none of these prescription
drugs.
The main ingredient of most herbal fen-phen products is ephedra,
commonly known as Ma Huang. Ephedra is an amphetamine-like compound
with potentially powerful stimulant effects on the nervous system and
heart. FDA has received and investigated more than 800 reports of
adverse events associated with the use of ephedrine alkaloid-containing
products since 1994. These events ranged from episodes of high blood
pressure, heart rate irregularities, insomnia, nervousness, tremors and
headaches to seizures, heart attacks, strokes and death, according to
FDA.
Many ephedra-containing herbal fen-phen products also contain Hypericum perforatum, an herb commonly known as St. John's Wort and sometimes referred to as "herbal Prozac." The actions and possible side effects of St. John's Wort have not been studied under carefully controlled
trials either alone or in combination with ephedra.
Other herbal fen-phen products contain 5-hydroxy-tryptophan, a compound
closely related to L-tryptophan, a dietary supplement widely used in
the U.S. until 1990. Used primarily as a sleep aid, L-tryptophan was
pulled from the market after it was found to be linked to more than
1,500 cases, including about 38 deaths, of a rare blood disorder known
as eosinophilia myalgia syndrome.
FDA REGARDS OTC PRODUCT COMMERCIALLY PROMOTED AS ALTERNATIVE TO
PRESCRIPTION ANTI-OBESITY DRUGS AS DRUG
FDA regards any over-the-counter product commercially promoted as an
alternative to prescription anti-obesity drugs (such as phentermine and
fenfluramine) to be a drug. FDA is currently taking regulatory action
to remove these products from the market.
FTC'S EXPECTED ROLE; LAWSUITS PENDING
In addition to any possible action by FDA against Internet advertisers
of fen phen, you can expect FTC to join the fray soon. Moreover, there
are a host of legal actions involving fen phen (though not necessarily
involving advertising), including: . . .
WHAT THIS SHOWS
As the fen-phen controversy illustrates, there are still numerous
outdated fen-phen-related Web pages on the Internet that could be
costly to their web page owners and/or creators. . .
WEB PAGE OWNERS AND CREATORS: WATCH OUT!
If you own, create or maintain a web site, the Fen/Phen controversy
highlights this point: . . .
[Editor's Note: This article will appear in its entirety in Advertising Compliance ServiceÔ on December 1, 1997. A limited number of this issue will be made available to the first interested parties. For your free sample copy,
.]
LAWYER'S REFERENCE SERVICE
FDA Talk Paper T97-56: "FDA Warns Against Drug Promotion of `Herbal
Fen-Phen'", November 6, 1997.
NOTE: FDA Talk Papers are prepared by the Press Office to guide
FDA personnel in responding with consistency and accuracy to
questions from the public on subjects of current interest. Talk
Papers are subject to change as more information becomes
available.
See also:
. . .
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December 1997 Advertising Law News...
From: Advertising Compliance ServiceÔ.
