Rising to Our Own Standards: The Unmet Challenge of DSHEA

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 “dietary supplements” 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 industry’s 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.