It was early winter 1993, and Loren Israelsen was coming into my windowless office in GNC’s Pittsburgh headquarters to give me an update. “It’s not going to happen this year,” he said.
We had just been trying to pass legislation that year to proactively clarify the legal status of a new category of drugs now called dietary supplements. The 1993 legislative session ended without a bill being introduced in Congress.
The U.S. Food and Drug Administration has been working to develop its own standards for dietary supplements since the passage of the Nutrition Labeling and Education Act (NLEA) in 1990. The FDA’s approach could effectively ban amino acids, botanicals, and even vitamins and minerals that exceed RDA (Recommended Dietary Intake) levels from the market. This was an existential issue for our industry, and we had to act.
Although the setbacks in 1993 were disappointing, there was also reason for hope: the groundwork we established in lobbying and preparing a regulatory framework laid the groundwork for potential success in 1994. Although it would have cost much more to fund the lobbying, drafting, and consumer communications efforts, it was worth it to gain regulatory clarity for a business segment that had (and still has) great potential to change health for the better.
Vitamins, minerals, amino acids, and botanicals existed in the no man’s land between food and drug. There were no proven standards for efficacy, no clear manufacturing standards, and no way to safely make the most innocuous claims on labels without risking enforcement action. If this industry was to reach its full potential, it needed clear legislation. And fast!
Lauren and I talked about the 1994 campaign, and it was clear that we needed to step up our lobbying and negotiations, especially with Senators Orrin Hatch of Utah and Tom Harkin of Iowa, who supported our efforts. This was still a time when the two parties could actually talk to each other and agree on some things. Hatch was a Republican and Harkin was a Democrat, and they were the driving force behind the bill.
Importantly, we also needed some serious marketing muscle to motivate consumers to take action — something to pressure Congress to act in 1994 when it had failed to do so in 1993. That’s when the Save Our Supplements (SOS) campaign was born.
The idea was simple: launch the largest letter-writing campaign to Congress since the Vietnam War. The message: “Supplements help millions of people stay healthy every day, and how dare the FDA deny consumers this right.” SOS was the first national grassroots campaign to generate a major movement against the industry from consumers shopping in the specialty retail and natural food store distribution channels (the only two channels that made sense for supplements at the time).
As the only company with the size and resources to pull it off at the time, GNC conceived and funded roughly half of the industry-wide multimillion-dollar effort to pass the Dietary Supplement Health and Education Act of 1994. [DSHEA]) and ran this integration program.
We printed freestanding letter-writing stations that folded up and sat on small desks in our stores. We provided preprinted form letters so consumers only had to sign. We shipped these kits to both GNC stores and independent grocers, who saw us as formidable competitors. We monitored store employees to make sure they were telling all their customers that they needed a large volume of letters to make an impact on Capitol Hill.
In the end, the SOS campaign 2.5 million letters to Congress A time when there was no internet or email communication.
The following year we were successful, and DSHEA was passed, which still defines and governs the regulatory framework for the dietary supplement industry today. We didn’t get everything we wanted: we wanted stronger claims beyond limited structure-function statements, and a herbal medicine category modeled after the approach of some European countries.
However, this compromise allowed supplements to make limited claims and be sold legally, setting the stage for consumer branding and innovation that continues to this day. DSHEA will drive the U.S. dietary supplement industry through 2024, More than six times the number in 1994.
DSHEA’s success had many fathers and mothers: talented lawyers, lobbyists and policy influencers coordinated by the dynamic Lauren Israelsen, president of the United Natural Products Alliance (UNPA), passionate GNC and natural food store owners who conducted the largest letter-writing campaign in U.S. history, VMS (vitamin, mineral and supplement) manufacturers who contributed time, money and best practice manufacturing standards to the effort, and 2.5 million consumers whose voices were heard.
The passage of DSHEA was a rare moment for our industry when we had to come together and act as an industry, and that’s exactly what we did.
While DSHEA is not perfect, it did avoid a downward spiral that was fatal to the VMS industry. The risk of downsides and unintended consequences of tinkering with the regulatory framework is a key issue in the current discussion of a revised “DSHEA 2.0” and is worth considering in terms of risks and benefits as DSHEA enters its 40th year.
Happy Birthday, Dshea!
thank you for reading.
