NEWS BRIEFS: December 1997

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 Service 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.

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. . .

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.

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