The Sum of the Parts

Originally Published NO April 2010

By now, it's old news that dietary supplement consumers and manufacturers successfully dodged the bullet that was the Dietary Supplement Safety Act of 2010, or S. 3002. Barely one month after, in February, Senator John McCain (R–AZ) held a press conference to announce the introduction of S. 3002, cosponsored by Senator Byron Dorgan (D–ND), Senator McCain signaled in March that he would withdraw his support from his own legislation.

All of us understand what a positive outcome this was for the industry. What is less understood is how a trifecta of opposition-from grassroots mobilization, face-to-face lobbying, and the unflinching support of this industry's Congressional champions-led to what would become a historic agreement.

What's in the Bill?

S. 3002 was introduced at the request of the United States Anti-Doping Agency with the intent of providing the Food and Drug Administration (FDA) with additional authority to police the contents of dietary supplements and prevent anabolic steroids and other banned substances from getting into supplement products. While these objectives may have been laudable, the specifics of the bill were draconian.

The legislation would have created an "Accepted Dietary Ingredient" list. All dietary supplement ingredients, regardless of how long they had been marketed or their histories of safe use, would have had to be reviewed by FDA and approved for inclusion in the list. Otherwise, the ingredients would have been subject to the New Dietary Ingredient notification provisions that require the submission of evidence of safety to FDA for review-in other words, premarket approval.

The bill would also have imposed a retail certification requirement, mandating supplement retailers to certify the compliance of their distributors and manufacturers with the many facets of regulation imposed by the Federal Food, Drug, and Cosmetic Act. It would also have required annual reporting of all adverse events associated with supplements-a much more burdensome requirement than the serious-adverse-events reporting (AER) mandated by existing law.

Not everything in the bill was antithetical, however. The bill also proposed mandating annual reporting of dietary supplement facilities and providing FDA with mandatory-recall authority. The industry's major trade associations already supported these two provisions as they currently stand in the food-safety legislation currently working its way through Congress.

Also in the bill was a requirement that all supplement labels be provided to FDA-a requirement that would allow FDA to keep better track of which ingredients are marketed by which companies, without providing FDA with any ability to restrict or approve those ingredients. Recently, whenever an ingredient issue has been raised in the press, it seems that FDA has thrown up its proverbial hands with the excuse that it doesn't even know what products are being marketed. Providing FDA with a copy of labels would give FDA more ability to monitor, but not restrict, the industry.

The inclusion of these less-objectionable provisions hardly outweighs the other requirements that would have turned the bedrock principles of the Dietary Supplement Health and Education Act (DSHEA) on their head by allowing FDA to "approve" dietary supplements before they can be marketed.

Consumers Engage

The ink on the bill had barely dried when dietary supplement consumers began making their dissatisfaction known. Groups such as the Alliance for Natural Health U.S. mobilized their members, urging them to write, call, or e-mail their members of Congress. The same constituencies that had so effectively displayed their collective strength in the grassroots efforts that led to the passage of DSHEA in 1994 quickly responded. Thousands of constituent opinions soon reached the ears of Congress.

These phone calls and e-mails achieved a critical purpose of raising the visibility of this issue to members of Congress and staff, proving that regardless of what Washington insiders might accomplish, only the raw power of grassroots mobilization tenderizes Congress to the concerns of their own constituents. Within a couple of weeks, Congressional offices were buzzing with the requests they were receiving: "Don't support this bill called S. 3002."

The only problem with grassroots activities of this kind is that they are inherently truncated messages. For instance, there isn't time or opportunity in a 100-word e-mail to fully explain the repercussions of a bill, especially one as nuanced as S. 3002. Grassroots movements could deliver a bottom-line message to Congress that the bill would limit consumer access to popular supplements. However, they couldn't explain how something like retailer certification, which doesn't technically remove products from the market, would nonetheless have the de facto effect of discouraging chain drugstores, natural health stores, supermarkets, and club warehouses from stocking products carrying that kind of liability-thus leaving an unavoidable hole on store shelves. Nor could the calls that generate thousands of constituent letters explain the subtleties of an annual AER requirement versus a 14-day requirement (both unnecessarily burdensome to manufacturers).

Despite their limitations, grassroots campaigns serve their own purpose, and, as discussed ahead, certainly play an important part in a larger movement.

Trade Associations Mobilize

Immediately following the introduction of S. 3002, Washington-based trade associations and their lobbyists also began an intense analysis of the legislation. The lobbyists earned their namesake: wearing down shoe leather in the "lobbies" and halls of Congress with face-to-face meetings. And this is where the real impact of the grassroots campaigns had its effect. Now that constituents had gotten the attention of Congressional staffers, the lobbyists were welcomed into offices looking for, if nothing else, an understanding of what had triggered this outpouring, and, quite frankly, how to make this flood of communication stop.

Industry-supported trade groups such as the Council for Responsible Nutrition (CRN), the Natural Products Association, and the Coalition to Preserve DSHEA dispatched their lobbyists to explain the bill and reiterate the broader opposition to the bill. Thanks to CRN's efforts, the association was granted a meeting with three senior staffers of Senator McCain himself, who now stood dead center in the middle of the firestorm.

No doubt, other Congressional offices were at the same time contacting Senator McCain's office asking why he had introduced a bill that had created such a groundswell. In fact, CRN learned from McCain's staff that while his office was feeling the heat, it couldn't identify the source of the flames. McCain had been operating under the impression that the bill did not impact legitimate products.

In our meeting with the Senator's office, CRN was able to summarize particular provisions, illustrate how they would play out to negatively impact the industry, and "connect the dots" between the truncated consumer outrage and the specific provisions of the bill-giving Senator McCain more reasons to likely pull back on his bill.

Other meetings with Congressional offices were also conducted to determine if a companion bill in the House of Representatives would materialize, as well as to ensure that members of the Senate Health, Education, Labor, and Pension (HELP) Committee (the likely place the bill would be referred to for a hearing) would oppose the bill. These meetings also reinforced the grassroots message with additional information about the impact of S. 3002. Thus, the grassroots campaign and in-person initiatives synergized each other.

With the Table Set, the Senators Can Dine

With both grassroots and high-level interaction occurring, the time was ripe for a compromise. The dietary supplement industry's longtime champions Senators Orrin Hatch (R–UT) and Tom Harkin (D–IA) stepped in.

Because Senators McCain and Hatch share the same party and had a long-standing relationship, Hatch was best positioned to offer McCain a way out that would still allow him to pursue his objectives.

With assurances from Senator Hatch that he understood and sympathized with McCain's legitimate concerns about anabolic steroids in supplements, Hatch was able to ensure that mandates such as facility registration and mandatory FDA recall stayed where they were in the existing food-safety bill. The senators also worked together to add amendments to that bill to call for increased coordination between FDA and the Drug Enforcement Administration. Senator Hatch also announced that he would introduce additional legislation of his own to strengthen the ability and resources of FDA to enforce existing laws that already make illegal the inclusion of anabolic steroids in a dietary supplement.

Neither industry nor consumers could have orchestrated that kind of deal. Only a trusted Senate colleague of Senators McCain and Dorgan could have forged the agreement. However, the resolution probably would not have moved so swiftly if not for the letters, e-mails, and meetings that primed the pump for compromise.

What this industry, as well as political observers, should take away from this is that all three components of the strategy are necessary and dependent on one another. Without skilled and professional lobbyists, a grassroots movement could have caused Senator McCain to entrench himself even more solidly behind his original bill, unconvinced of the rationale for the opposition. Similarly, without the political pressure created by the grassroots campaign, well-heeled lobbyists would still be cooling their tassel-toed loafers outside Congressional offices, waiting to get in. And neither effort, without the finesse of an industry advocate within the halls of the Senate itself, could strike the deal that ultimately led Senators McCain and Dorgan to back away from their own legislation.

As is the saying, the whole is often greater than the sum of its parts.