FOrmed in 1973, at a time when most of the organizations speaking on the subject of dietary supplement issues tended to be somewhat extreme, the Council for Responsible Nutrition’s (CRN) philosophical goal was to establish a moderate, rational, scientifically based voice on dietary supplement issues.

“Practically, the group’s mission was to bring some high-caliber legal and public relations talent into the effort to prevent the Food and Drug Administration (FDA) from limiting the amounts and combinations of vitamins and minerals that could be marketed as dietary supplements,” said Steve Mister, the organization’s current president and CEO.

The founding members were William

T. Thompson, II, president of the W.T. Thompson Company; George Crawford, vice president of Archon
Pure Products Corporation; and Nolan Draney, executive vice president of Plus Products Corporation.

CRN was established to:

• Educate and inform the public about scientific discoveries in human nutrition and the governmental regulation of nutritional practices;

• Inform its members about relevant legislative and administrative developments at the national, state or local level;

• Provide a forum for its members to examine and review governmental actions;

• Represent the interests of its members on the subject of vitamin and mineral regulations; and

• Develop legislative and administrative proposals for submission to appropriate branches and agencies of government concerning responsible nutritional regulation.

As director of Washington affairs, CRN’s first and sole employee, Annette Dickinson, PhD began arranging meetings with various regulators and legislators to introduce the organization and to express its willingness to explore reasonable solutions to the issues at hand.

Top Events Since then, “CRN has been involved throughout the evolution of the dietary supplement industry, doing our best to influence many of these changes, with the end goal of ensuring that consumers have access to safe, beneficial dietary supplements,” said Mister.

He pointed out that the 1990s were a particularly eventful decade for the sup
Plement industry—a time with the highest percentage growth in sales and a large body of epidemiological research in favor of vitamin and mineral supplements.

Following a great deal of emerging science showing that folic acid could greatly reduce the risk of having a baby born with a neural tube birth defect (NTD), the US Public Health Service recommended in September 1992 that all women of childbearing age consume 400mcg of folic acid daily to reduce their risk of having a pregnancy affected with spina bifida or other NTDs.

In the meantime, 1994 was a watershed year for the supplement industry.

That year, Durk Pearson, Sandy Shaw and the American Preventive Medical Association (APMA) first filed comments asking the FDA to authorize a folic acid health claim, which would later lead to the landmark Pearson v. Shalala case on the marketing of conventional foods and dietary supplements.

The Dietary Supplement Health and Education Act (DSHEA), was enacted in 1994, with efforts led by many in the dietary supplement industry, including CRN. A flood of new products entered the marketplace and consumers were eager to try them. With the passage of DSHEA, which expressly authorized good manufacturing practices (GMPs) specific to dietary supplements, the supplement industry began to push for these GMP regulations, which would take 13 years for FDA to publish in final form.

In 1996, FDA’s final rule requiring that folic acid be added to specific flour, breads and other grains was published.

On January 15, 1999, the DC Circuit Court of Appeals handed down its decision in Pearson v. Shalala, and in October 2000, the FDA announced several significant decisions concerning its regulation of health claims for dietary supplements.

Specifically, FDA announced that it would permit the marketing of certain health claims even though they do not meet the “significant scientific agreement” standard. Rather than denying all petitions that do not meet the significant scientific agreement standard, FDA advised that it would exercise its discretion, in appropriate circumstances, to permit the use of a claim where there was substantial evidence of health benefits.

As a result, an unqualified health claim for folic acid and NTDs, as well as a qualified health claim for omega-3 fatty acids and cardiovascular disease were permitted.

As science continued to evolve, there was a growing concern over certain supplement ingredients, namely ephedra and anabolic steroid pre-cursors, like androstendione. With the support of CRN and the dietary supplement industry, ephedra was banned in 2004, followed by the move of andro to the Controlled Substances List in 2005.

In 2006, CRN led the industry in passage of a serious adverse event reporting (AER) law, which requires that companies submit all serious adverse event reports to FDA. And then in June 2007, the final good manufacturing practices (GMPs) rules specific to dietary supplements (for which CRN and the dietary supplement industry had pushed hard for more than 13 years) were finally published, amidst the food safety concerns for other industries, and helped to give consumers further peace of mind that supplements are manufactured to safe, high-quality standards.

CRN led the GMP effort almost singlehandedly from writing original comments, negotiating with other trade groups, encouraging Congress to inter-
Cede when GMPs were “stuck” at Office of Management and Budget (OMB), and educating industry about how to comply with GMPs, “Throughout the past 15 years, the dietary supplement industry has matured from being viewed as ‘fringe’ or ‘alternative’ to being mainstream healthcare with over $23 billion in sales in the US alone—world-class companies turning out quality supplements that make a positive difference in the lives of over 150 million Americans who take supplements annually,” Mister said. “This industry has grown up. No longer an adolescent, resistant to any regulation and responsibility, but a mature industry ready to promote on a world stage the safety and many health benefits of our products, and CRN has been a part of all of this.” Its Place in the Industry CRN has played an instrumental role in helping define the responsible dietary supplement industry that has consumers’ best interests at heart. Every program that comes out of CRN— whether it is its lobbying efforts to help pass reasonable regulation that does not restrict consumer access to dietary supplements or “Life…supplemented” program, which encourages a wellness regimen incorporating the three pillars of health (healthy diet + supplements + exercise, or its paradigm of prevention initiative, which questions the current scientific research paradigm for dietary supplements and whether it’s the right way to study nutrition—is responsible and focused on well-balanced, sciencebased information. More than 150 million Americans use dietary supplements each year, and CRN and its members are committed to ensuring that consumers continue to have confidence in the safety and efficacy of the products they are taking. One of the ways that CRN continues to instill this consumer confidence is by being the responsible and leading voice of the dietary supplement industry and doing everything it can to get the bad actors out of the industry.

Work in Washington CRN supports legislation and Congressional activities that encourage and promote responsible use of dietary supplements by consumers. CRN also defends against any legislative efforts that place unnecessary or burdensome requirements on dietary supplements.

The council works with key Congressional organizations like the Dietary Supplement Caucus in the House of Representatives to educate members of Congress and staff providing information on the benefits, quality and safety of dietary supplement products. CRN and its members have been directly involved in leading the industry during difficult and complicated legislative endeavors since its inception, and have been instrumental in pushing landmark legislation: DSHEA and the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 (commonly known as the AER bill within the industry) to name a few. CRN has been successful in resolving legislative conflicts and concerns with misguided legislation.

“Like other mainstream industry regulated by the FDA, CRN’s leadership and credibility on Capitol Hill is wellknown by members of Congress and staff alike. It is what makes CRN, CRN,” said Mike Greene, vice president of government relations.

Life…Supplemented CRN has long been known for its rapid response efforts with the media, particularly when it comes to putting into perspective results of the ‘study du jour,’ said Judy Blatman, CRN’s senior vice president of communications. “But several of CRN’s members thought it was equally important that CRN take responsibility for being proactive about
Working with the media,” she added.

With the encouragement and support of CRN’s Board of Directors, the Council found a public relations partner in CRT/tanaka, and raised funds for a multi-million dollar, multi-year communications initiative designed to give voice to the more than 150 million Americans who take supplements each year.

Launched in the fall of 2007, the campaign known as “Life…supplemented” was a first for the industry—bringing together 25 companies to proactively execute a lifestyle public relations effort that combined science-backed information with a platform for incorporating dietary supplements as one of the smart choices for a healthy lifestyle.

The program features a consumerfriendly interactive website with the popular health assessment tool, My Wellness Scorecard. The “Life…supplemented Healthcare Professionals Impact Study” surveyed nine healthcare professional populations over three years (including physicians, physician specialties, nurses and nurse practitioners, registered dietitians and pharmacists), the results of which have been communicated in print, broadcast and social media outlets. The campaign most recently added a Social Media Advisory Board and has expanded its social media communities through Twitter (@wannaBwell) and on Facebook.

Proactive Messaging CRN has a science-based approach for how it responds to various studies and issues in the media. Drs. Andrew Shao, John Hathcock and Douglas MacKay are constantly reviewing scientific studies published in peer-reviewed publications, examining the details such as the duration of the study, the type of study that was conducted, the questions addressed by the study, the population being studied and how the results fit in the context of the overall body of research on that particular subject.

How that science is communicated is an issue, according to Blatman. “CRN makes a concerted effort to correct misinformation and to put the science into perspective, regardless of whether the misinformation appears in the scientific literature or in the consumer media,” she said. “CRN’s communications and science teams work closely together to rapidly respond to this misinformation and to set the record straight.” Particularly in more recent years, CRN has committed to a proactive approach to controversial studies on dietary supplements published in high profile medical journals—an approach which not only involves well thought out and measured responses to research studies, but also an attempt to shape the research paradigm on which nutrition and dietary supplement policy are based, said Shao.

This proactive approach has paid dividends, with CRN now playing a prominent role in the agenda of important scientific meetings, such as the Institute of Food Technologists annual meeting, Experimental Biology annual meeting and industry sponsored meetings, such as Nutracon. CRN has also been effective in planning its own scientific event, the Day of Science, securing the participation of some of the world’s most respected experts and thought leaders in nutrition and dietary supplement research.

Moving Forward While CRN is discussing the many benefits of dietary supplements with consumers, it is also working behind the scenes to level the playing field for responsibility within the dietary supplement industry itself. In 2007, the council reached agreement on a new initiative with the National Advertising Division (NAD) of the Council of Better Business Bureaus, under which CRN will provide funding for expanded activities in monitoring dietary supplement advertising and challenging ads believed to be false or misleading.

“This is an exciting time for the dietary supplement industry,” said Mister. “Despite the economic downturn, sales of dietary supplements have increased over the past year, with consumers realizing that they can’t afford to not be well and recognizing that dietary supplements play a critical role in overall health and wellness.”