Greg Horn’s Nutrition Business: DSHEA turns 30

It was the early winter of 1993, and Loren Israelsen was in my windowless office at GNC headquarters in Pittsburgh, giving me updates. “It won’t happen this year,” he said.

We have just spent a year trying to pass legislation that would proactively clarify the legal status of a new category now called dietary supplements. The 1993 session of Congress ended without legislation being brought to a vote.

The U.S. Food and Drug Administration has been working to create its own criteria for dietary supplements since the passage of the Nutrition Labeling and Education Act (NLEA) in 1990. Following the FDA’s approach, amino acids, botanicals, and even vitamins and minerals exceed the RDA. (recommended diet) could be effectively banned from the market. This was an existential problem for our industry and we had to act.

While the 1993 setback was disappointing, there was reason for hope. The lobbying and regulatory preparation game we developed set the stage for potential success in 1994. Funding lobbying, drafting and consumer communications efforts will cost significantly more, but it would be useful for regulators to be clear about the segment of business that had – and still has – so much potential to change health for the better.

Vitamins, minerals, amino acids, and botanicals find themselves in a no man’s land between food and drugs – with no evidence to support efficacy standards, no clear manufacturing standards, and no safe way to make even the most innocuous claims on a label without the risk of enforcement action. If this industry was ever to reach its full potential, we needed clear regulations and fast!

Loren and I talked about the 1994 campaign, and it was clear that we needed to increase our lobbying and negotiation efforts, especially with key U.S. senators who supported our cause: Orrin Hatch of Utah and Tom Harkin of Iowa. This was still an era in which both sides of the political aisle could actually discuss and agree on some issues. Hatch was our Republican and Harkin was our Democratic leader in the legislative process.

Most importantly, we also needed serious marketing power to galvanize consumers into action. Something that was intended to put pressure on Congress to take action in 1994 that it had not done in 1993. That’s when the Save Our Supplements (SOS) campaign was born.

The idea was simple: create the largest letter-writing campaign to Congress since the Vietnam War. Message: Supplements have helped millions of people stay healthy every day, and how dare the FDA try to deny consumers that right? SOS was a first-of-its-kind national grassroots campaign designed to generate a wave of action for our industry from consumers purchasing through the distribution channels of specialty retailers and health food stores (the only two significant supplement distribution channels at the time).

As the only company with the scale and resources to do so at the time, GNC conceived and financed it (along with only half of the multi-million-dollar industry-wide effort to pass the Dietary Supplement Health and Education Act of 1994 (DSHEA)). and performed this integrated program.

We printed free-standing letter writing stations that can be folded out of cardboard into small desks in the store. We provided a pre-printed form letter so consumers only needed to sign it. We shipped these kits to both GNC stores and independent grocery stores that otherwise viewed us as a formidable competitor. We monitored our store employees to make sure they informed every customer that we needed letters coming in to influence Capitol Hill.

Ultimately, the SOS campaign generated approx 2.5 million letters to Congress in the days before internet and e-mail communication.

The following year ended successfully with the passage of DSHEA, which continues to define and regulate the regulatory framework for the dietary supplement industry. We didn’t get everything we wanted. We wanted stronger claims beyond limited statements about structure and function and a category of herbal medicines modeled on the approach used in some European countries.

However, compromise legislation allowed supplements to make limited claims, be sold legally, and set the stage for consumer branding and innovation that continues to this day. DSHEA Powers the US Dietary Supplement Industry in 2024 more than six times greater than in 1994.

The success of DSHEA had many fathers and mothers: skilled lawyers, lobbyists and policy makers, coordinated by the tireless Loren Israelsen, president of the United Natural Products Alliance (UNPA); to the passionate owners of natural food stores and GNC who organized one of the largest letter-writing campaigns in the history of our country; VMS (vitamins, minerals and supplements) manufacturers who have invested time, money and best-practice manufacturing standards in this effort; and 2.5 million consumers whose voices were heard.

The passing of DSHEA was a rare moment in our industry when we had to come together as an industry, and that’s exactly what we did.

DSHEA is not perfect, but it has avoided a potentially deadly death spiral for the VMS industry. The risk of flaws and unintended consequences of tinkering with the regulatory framework is a key issue in current discussions about a revised “DSHEA 2.0” and is worth weighing on a risk-benefit basis as DSHEA enters its fourth decade.

Happy birthday DSHEA!

Thank you for reading.