Rising to Our Own Standards: The Unmet Challenge of DSHEA
by Scott Bass

There was a time that the dietary supplement industrycoalesced to produce a stunning, if not impossible result: the firstCongressional legislation significantly cutting back on the Food and DrugAdministrations (FDA) powers to regulate an industry. The unity of purpose,the groundswell of popular support and the intense focus of those involved inthe drafting process stand as a proud history for an industry under regulatorysiege for so many decades.

And the Dietary Supplement Health and Education Act (DSHEA) of1994 did indeed deliver. It delivered a freedom to market healthful productswith 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 manyindustry products.

DSHEA even drew in the broader food market, spawning anexponential growth in functional food ingredients. That growth halted abruptlyfive years ago in the wake of FDAs delays in the phytosterol health claimreview and as a consequence of larger players impatience with the slowedconsumer education process that proceeded blockbuster sales. The functional foodmarket has recently been revived, once again with DSHEA as its underpinning.

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

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

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

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

We must realize self-regulatorystandards are within the industrys grasp.

DSHEA made GMPs (good manufacturing practices) precatory.While the National Nutritional Food Association (NNFA) made them putativelymandatory, they are not in practice. Industry cannot afford to continue withoutGMPs and now FDA will lead.

At the core, GMPs are not an industry financial issue, but oneof industry credibility. Consumers are barraged by reports of expensive nutrientsmissing in overpriced multiple formulas and of phony organic designations.Thatsends customers away from the health products that took decades for consumers toaccept. Similarly, some baseline as to safetysubstantiation is criticalto keep the industry afloat. The ephedra debacleexposed companies without adverse event reports (AERs), lying about how manyreports they had received, and labels with dosage misinformation.

The dietary supplement industry has pride in its safetyrecord. Forcing suppliers to stand behind some manufacturing threshold of safetyis a given. And making sure illegal pesticides or prescription drugs are notmixed into herbs should be something industry deals with before the press.

Claims are protected by the First Amendmentif truthful.Infomercials and Web sites dilute the hard work of legitimate manufacturers andretailers who sincerely wish to inform customers about preventive healthmeasures. One possibility to help in the claims arena is the formation of acredible third-party assessment group.

In short, self regulation is necessary for the industryssurvival. Excessive government regulation will mean excessive restraints onproduct innovation.

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

The danger now is dilution and Congressional backlash. Ephedrawas a near miss and pending legislation makes clear the image of the industry onCapital Hill. And lest there be any doubt, the industry is in danger of losingits core identity as consumer outlets proliferate and product quality stilltakes second place.

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

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