From: http://www.naturalproductsinsider.com/articles/5c1governupdate01.html

Copyright © 2005 by Virgo Publishing.

Posted : 12/05/2005

Rising to Our Own Standards: The Unmet Challenge of DSHEA

by Scott Bass

There was a time that the dietary supplement industry coalesced to produce a
stunning, if not impossible result: the first Congressional legislation
significantly cutting back on the Food and Drug Administration's (FDA)
powers to regulate an industry. The unity of purpose, the groundswell of
popular support and the intense focus of those involved in the drafting
process stand as a proud history for an industry under regulatory siege for
so many decades.

And the Dietary Supplement Health and Education Act (DSHEA) of 1994 did
indeed deliver. It delivered a freedom to market healthful products with
claims. It defined a new regulatory category of ³dietary supplements² that
burgeoned in the decade that followed. And it legitimized the preventive
health focus of so many industry products.

DSHEA even drew in the broader food market, spawning an exponential growth
in functional food ingredients. That growth halted abruptly five years ago
in the wake of FDA's delays in the phytosterol health claim review and as a
consequence of larger players' impatience with the slowed consumer education
process that proceeded blockbuster sales. The functional food market has
recently been revived, once again with DSHEA as its underpinning.

But, in conferring legitimacy, DSHEA did something more: it brought
self-regulatory responsibility. The movement that eschewed over-regulation
has now failed to regulate itself.

While nobody involved in drafting DSHEA foresaw the effect of the Internet,
we did understand that consumers would not long tolerate under-potent or
unsafe products. As the industry multiplied post- DSHEA, many cashed out,
but few put money into raising product quality, ensuring potency, setting
safety standards or putting in place a process for the evaluation of claims
substantiation.

While some efforts have been begun, they are lacking teeth. And without
teeth, most of the industry chose either to fight such standards or stand by
until all were forced to comply.

The net result has been an industry with a small group of principled leaders
and a larger group of suppliers and Internet marketers willing to supply
whatever sells. And even if the responsible industry players hold their nose
when talking about Internet fraud, the public is not as quick to draw that
distinction.

We must realize self-regulatory standards are within the industry's grasp.
DSHEA made GMPs (good manufacturing practices) precatory. While the National
Nutritional Food Association (NNFA) made them putatively mandatory, they are
not in practice. Industry cannot afford to continue without GMPs and now FDA
will lead.

At the core, GMPs are not an industry financial issue, but one of industry
credibility. Consumers are barraged by reports of expensive nutrients
missing in overpriced multiple formulas and of phony organic
designations.That sends customers away from the health products that took
decades for consumers to accept. Similarly, some baseline as to
safetysubstantiation is critical to keep the industry afloat. The ephedra
debacle exposed companies without adverse event reports (AERs), lying about
how many reports they had received, and labels with dosage misinformation.
The dietary supplement industry has pride in its safety record. Forcing
suppliers to stand behind some manufacturing threshold of safety is a given.
And making sure illegal pesticides or prescription drugs are not mixed into
herbs should be something industry deals with before the press.

Claims are protected by the First Amendment - if truthful. Infomercials and
Web sites dilute the hard work of legitimate manufacturers and retailers who
sincerely wish to inform customers about preventive health measures. One
possibility to help in the claims arena is the formation of a credible
third-party assessment group.

In short, self regulation is necessary for the industry¹s survival.
Excessive government regulation will mean excessive restraints on product
innovation.

History is clear that the dietary supplement industry has always risen to
the challenge when survival was at stake. Years of acquisitions, public
offerings and company sales have yielded a sense of entitlement and
decreased the sense of danger or feeling of responsibility to a bigger
cause.

The danger now is dilution and Congressional backlash. Ephedra was a near
miss and pending legislation makes clear the image of the industry on
Capital Hill. And lest there be any doubt, the industry is in danger of
losing its core identity as consumer outlets proliferate and product quality
still takes second place.

The call to arms this time is to stand tall and assure the weight of our
responsibilities.

Scott Bass heads the International Food and Drug Law Practice at Sidley
Austin Brown & Wood LLP, and has authored two books on the Dietary
Supplement Health and Education Act (DSHEA). He also serves as legal counsel
to the National Nutritional Foods Assocation.