20 Years of DSHEA: Focusing on the Future

Daniel Fabricant, PhD, CEO and Executive Director, Natural Products Association
Daniel Fabricant, PhD, CEO and Executive Director, Natural Products Association

Related tags Dietary supplements Dietary supplement Food and drug administration

While we should certainly take a second to pause and reflect in honor of the 20th anniversary of the passage of the Dietary Supplement Health and Education Act (DSHEA), it’s important to keep in mind that the industry as a beacon of growth must focus forward, not backward. There’s still a lot of work to be done.

DSHEA was a monumental piece of legislation for the dietary supplement industry, as it gave consumers wide access to dietary supplements, as well as demonstrated the power of consumer demand and grassroots action, demonstrating to the government that we are a powerful, consumer-driven industry.

By classifying dietary supplements as a category of food, DSHEA set essential boundaries for what the Food and Drug Administration (FDA) could and couldn’t do regarding regulation, and stopped the agency from grouping dietary supplements with pharmaceuticals. This was imperative for the industry because, as we know, ingredient safety is different in dietary supplements as a category of foods versus pharmaceuticals.

The combination of consumer power and correct categorization has helped the industry to flourish over the past 20 years. Recent cases have shown that the clauses and regulatory tools put forth in DSHEA can work, and work quite well. I believe that the number of injunctions for firms not following current Good Manufacturing Practices (cGMPs) led all commodities regulated by the FDA in 2012 and 2013. While, the regulations are in place, it’s up to the agency to develop a strong and clear enforcement strategy to create a consistent deterrent effect that will rid the market of criminals who give our industry a bad name and endanger consumers.

Another challenge for the industry has been the value placed on product claims by the Federal Trade Commission (FTC). As we have seen with increased cases against the marketing of dietary supplements, many of these cases, are concerning as precedent as binding norms. Such as a possible requirement to require two double-blind placebo controlled trials, to meet the competent and reliable scientific standard to substantiate claims, which is neither present in regulation or in the statute.

As we move forward from DSHEA’s 20th anniversary, we will continue to see these issues and many more to come. History has shown us that when these battles are contested we must be prepared on all fronts of government: Legislatively, judicially and with the regulators (Executive Branch). So, what can we do to protect our industry?

One pivotal part of that preparation is to foster new champions on Capitol Hill. In the days of DSHEA, Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, led the charge for legislation to be created and passed, responding to consumer demand and regulation from the agencies. As they and other industry champions approach retirement, we will soon lose their influential voices where it counts.

We need to seek out new representatives who will be just as passionate about our industry as Sens. Harkin and Hatch and send out the message when the agencies that regulate dietary supplements overstep their boundaries. Grassroots action is certainly essential for our industry, to support and create change, but a foot in the door on the congressional side will only further advance our cause. Politics are very different now than they were in 1994. If we want the next 20 years to go well, we have to play in modern politics, especially at the campaign and contribution parts of the equation.

The past 20 years will continue to shape the next 20, and suppliers, manufacturers and retailers in the dietary supplement industry need to keep in mind that the future is in our hands. How well we adapt to the new realities of politics will greatly affect our success as an industry.


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