There's no question about it, lobbying is under the microscope right now. From the controversy surrounding high-powered former D.C. lobbyist Jack Abramoff to the popular movie "Thank You for Smoking", which satirizes the world of D.C.'s spin-doctors, Washington's K street corridor, the hub of our nation's lobbying world, is currently the focus of intense scrutiny.

But the world of lobbying is not about private planes, lavish vacations and the best seats at sporting events. At its heart, lobbying is about educating and communicating. Lobbying is the process of influencing how laws are made. It's about developing rapport and relationships, which in turn build credibility. And for any regulated industry worth its salt, lobbying is an absolute necessity.

It's often pointed out that the dietary supplement industry, while not the richest or most powerful, has a back-pocket weapon not enjoyed by other industries that are perhaps more flush with funding-our customers. Without a doubt, one of industry's biggest strengths lies in the grassroots support of the people who purchase our products, as was demonstrated by the tens of thousands of letters consumers generated to help pass the Dietary Supplement Health and Education Act (DSHEA) in 1994. But as important as grassroots efforts are, it's equally as important to deploy a complementary tactic-engaging professional lobbyists and government relations experts who understand the nuances of Congress. Wise companies know that whether it is through their individual efforts or under the broad umbrella of a trade association-or both-it makes sense to have an ongoing legislative outreach effort firmly in place, an effort that places professional troops on the ground and that which is in constant communication to ensure the industry message is getting through.

Many individual companies have quite strong lobbying efforts, and all companies should be encouraged to do more in this field. This may include inviting an elected official to visit your plant back home, or creating a work environment in which each employee feels empowered to write the Member of Congress he/she helped elect when the issue affects his/her livelihood.

Up on 'the Hill'

Individual company efforts should be further leveraged by supporting the efforts of trade associations. At the Council for Responsible Nutrition (CRN), for example, there is a multi-pronged ap­proach to its legislative program. Even though the organization has a full-time staff with lobbying expertise, it recognizes the importance of the experts seeking the support of more experts. In other words, CRN works closely with a D.C. lobbying firm that has strong, established bi-partisan relationships on "the Hill," an expertise in policy analysis, and lobbyists who used to work for key legislators on the Health, Education, Labor and Pensions Committee in the Senate and the Energy and Commerce Committee in the House, two important committees of jurisdiction for the dietary supplement industry. Furthermore, CRN has created an ongoing Congressional Education Campaign using a combination of in-person meetings and distributing informative one-pagers on the benefits of some of the most popular dietary supplements, as well as strategically-placed, similarly-themed advertisements in Capitol Hill publications like, Roll Call, Congress Daily and The Hill.

One of the most effective efforts is an annual lobbying day where staff and member company executives participate in a series of meetings with home-town legislators in small groups and one-on-ones, urging support for legislation and voicing concerns when warranted. This year, during CRN's "Day on the Hill," Adverse Event Reporting (AERs) was addressed, along with two pieces of pending legislation: H.R. 1545, which would allow consumers to claim as deductible medical expenses under Health Savings Ac­counts and Flexible Spending Ac­counts those diet­ary supplements and low-fat meal replacements that qualify for ap­proved health claims, and S. 1546, which would permit food stamp recipients to use their benefits to purchase nu­tritional supplements providing vi­tamins and minerals in the same way they are free to make other dietary choices.

Additionally, CRN made clear its strong desire for Congress to help get diet­ary supplement Good Manufacturing Practices (GMPs) back on track by holding the agency accountable for the release of a final rule, which was promised "soon." CRN was pleased with the positive feedback it received from most legislative offices, with the typical reaction, for example, to the food stamp issue being "Yes, of course these products should be included!" It seemed to be just common sense. But, we know it takes more than just common sense to make policy, and so we must continue to work toward the ends that will demonstrate to legislators that this industry's products are well-regulated, safe, and beneficial, and that we take an active role in ensuring those outcomes.

Here Today, Gone Tomorrow

One of the problems facing the nutraceuticals industry is that a majority of elected officials in office don't know much about DSHEA, and quite frankly, may not particularly care. In general, legislators often don't have much interest in legislation once it has passed, particularly if it is not within their purview, and understandably because there is always another issue unfolding that demands their attention.

Today, unfortunately, less than half of Congress was in office when DSHEA was passed. Even more unsettling, 90% of their staffs have turned over. Most of today's lawmakers don't know why DSHEA was needed, or how passionate consumers were about getting it passed. Instead, they only know what they read in the newspapers or hear on the television about how "supplement regulation is non-existent and supplement products are unsafe." It's up to us to explain that regardless of the misperceptions of this industry, FDA has the authority to regulate supplements under DSHEA, and to remind them that during more than one hearing on the Hill, FDA officials have stated just that.

This is why it's crucial that dietary supplement industry lobbyists go to the Hill to educate Congress and staff about why and how DSHEA passed, and discuss the very delicate balance between the need for reasonable regulation and the importance of consumer access to pro­ducts and choice. While legislators' detailed understanding of the nuts and bolts of DSHEA should not necessarily be the supplement industry lobbyist's goal, Congress does need to know that there is a responsible industry looking out not only for its business, but also the best interests of consumers. Congress needs to know that this is an industry subject to myriad regulatory requirements under DSHEA, and that a mature industry understands the necessity of embracing enforcement actions in order to level the competitive playing field and protect consumers.

Start with the Basics

Sometimes, the conversation needs to begin with the basics. For example, many on the Hill are under the impression that dietary supplements are only diet products for weight loss. Thus the first step in the education process is to ensure that our Congressional audiences know that the multivitamin mom told them to take each morning, the folic acid that the March of Dimes recommends to all women of child-bearing age, the glucosamine and chondroitin that are helping their constituents cope with osteo­arthritis pain, and the calcium that helps prevent osteoporosis-just to name a few-are among the safe and beneficial products that comprise the broad category of dietary supplements.

But once past the basics, there are some very important issues our industry needs to address with legislators.

Perhaps the most controversial is the potential for proposed legislation to mandate reporting of serious adverse events for dietary supplements and OTC products. With rumors flying, no one but the legislators themselves actually know what kind of a bill might be introduced. But CRN along with other major trade associations have taken an active role in working with legislators to share the kinds of concerns that industry has about how this type of bill might work. Thankfully, the industry has been welcomed to the table, as have other consumer groups, in an effort by legislators to create a transparent process resulting in a bill that will provide consumers with confidence that our industry stands behind the safety of its products, while at the same time ensuring that this bill won't place unnecessary burdens on an industry trying to do the right thing.

The fact is, we are supporting mandatory reporting of serious adverse events because it's the right thing to do for consumers. They have a right to expect that if they have a serious problem they believe is associated with a product, then the government agency regulating that product should know about it.

Yes, there are some concerns about how this kind of legislation could negatively impact the industry, but the trade associations would not support a bill preventing access to safe dietary supplement products, nor would they support a bill that threatened a responsible company's ability to do business by handing plaintiffs' attorneys fodder for litigation or eliminating the ability to get liability insurance.

Other Things to Think About

There's a lot on this industry's legislative plate. It's not just federal legislation, but we also must be continually vigilant in the states where sessions are short, bills move fast and there is great potential for unwelcome surprises. The impetus for state legislation is often a perceived lack of action at the federal level. A seasoned lobbyist can sometimes defuse an emotional situation where legislation is being introduced for all the wrong reasons by providing facts that put the situation in perspective or assurances FDA is already acting. And the subtle variations of lobbying state-to-state are apparent to those professional lobbyists who understand how cultural politics on a local level are often quite different than on a federal level, requiring tactics that fit a specific situation, rather than a rehash of what worked somewhere else.

We've already seen proposed legislation for mandatory adverse event reporting, state-imposed labeling re­quirements, performance-enhancing substance restrictions, and restricted sales popping up in a number of states, as well as many copycat bills passed on from one state to the next. Often these proposed bills are laden with misinformation about dietary supplements, inaccurately blurring the line between safe and beneficial products and illegal steroids, and failing to recognize the extensive federal framework already in place for supplements.

Additionally, the return of ephedra to the marketplace while the court sorts out the legal issues poses a threat to the perception of FDA's regulation of our industry that cannot be ignored. More than ever, trust needs to be established and maintained with state legislators, and industry needs to provide substantive assurance that the industry's products are defensible and that industry wants to work in earnest with legislators and regulators to ensure the safety of their constituents.

For the Future

Putting GMPs in place, establishing an AER system, and building a larger consensus that dietary supplements are appropriately regulated will create an environment in which it will be much easier to convince legislators to proceed with policies that will highlight the importance of dietary supplements in preventative healthcare as part of the culture of wellness. The nuanced, day-to-day relationship-building facet of lobbying is more important than ever to the dietary supplement industry as it grows.

As our industry develops, we are moving into a different phase in which we are being observed with more and more scrutiny, but also in which there is more and more promise. Yes, we understand the importance of DSHEA, but lobbying now is not only about making sure legislators know about DSHEA and the power it gives FDA to regulate our industry, it's about building for the future and what comes next. Emerging science will provide more information about the ways dietary supplements im­prove consumers' health and quality of life. We need to lobby in support of the science, which means funneling more money toward research. We need to lobby in support of regulatory bodies like FDA and FTC and make sure they are adequately funded. It is time to demonstrate that DSHEA got it right.NW


About the authors: Steven Mister is the president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C., and Mike Greene is the association's director of government relations. They can be reached at 202-776-7929.