New York Times on regulating herbal remedies


#1

The excerpt below appeared in the 23 February 2003 New York Times Sports section.

http://www.nytimes.com/2003/02/23/sports/23DRUG.html

Its focus is the deadly herbal drug ephedra, but the comments sum up the consumer issues behind herbal “hair inhibitors” as well:

</font><blockquote><font size="1" face="Verdana, Helvetica, sans-serif">quote:</font><hr /><font size="2" face="Verdana, Helvetica, sans-serif">Herbal products are primarily used as medicines and should be regulated as over-the-counter drugs. Their designation as dietary supplements is a legal fiction. Manufacturers of over-the-counter products are required to take responsibility for the potency and purity of their products, base health claims on scientific evidence, provide appropriate warnings about possible adverse effects and immediately report adverse effects to the F.D.A. Why should manufacturers of herbal products be held to lesser standards?

According to a recent survey, the American public overwhelmingly supports the idea of new regulations that would require the F.D.A. to review the safety of new dietary supplements before their sale. That would give increased authority to the F.D.A. to remove unsafe products from the market, and that would regulate advertising claims about the health benefits of dietary supplements.

Continued delay by the federal government is costing lives. </font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>

[ February 23, 2003, 08:53 AM: Message edited by: Andrea ]


#2

This is one of those things that worries me because some regulation needs to be done, but the U.S. government seems to have no mode between ‘no regulation’ and ‘over-regulation’.

The problem with ephedra is that it does work, for some people. It kills others. If it isn’t pulled from the market entirely, or made prescription-only, it at least needs a big huge warning label. (And possibly a liability waiver on purchase.)

But for hair-removal/inhibition kind of stuff? Alas, all it’d mean is a slight change of wording like all the herbal dietary supplements use now, and that wouldn’t really change much.


#3

I feel the hair inhibitors claim to change structures in the body, which makes them drugs. I also feel they are making health claims when they say they can regulate hirsutism. Both of thiese reasons should make them subject to FDA regulation. Right now they get away with claims they are cosmetics, but that will probably change in upcoming years as FDA deals with preparations that straddle the fence.

I am pushing for FDA to require the same thing they require on dietary supplements: “The FDA has not evaluated these claims and this product has not be cleared to treat any symptom or disease.”

These hair inhibitors are probably safe; it’s the unregulated health claims that need to be addressed.