Senate Supplements Hearing Marks New Direction in Congress
Published: Monday, October 01, 2001
Fortunately, the chair of the hearing, Sen. John Breaux, D-La., recognized that “the vast majority of manufacturers and marketers of dietary supplements are reputable and law abiding.” And he and Sen. Ron Wyden, D-Ore., repeated that mantra throughout a hearing that was otherwise critical from the first to the last word. The hearing was broadcast live over the Internet and ran later that evening on CSPAN. The submitted testimony of the witnesses can be found on the committee’s website (http://aging.senate.gov/hr73.htm) and the transcript will be there soon.
The world was turned upside down the next morning by the attacks on the World Trade Center and the Pentagon, and those events make the dietary supplements industry and so many other things in our lives seem small indeed. But the future of the dietary supplements business is important to those who make their livings by it and those who make its products part of their lives.
Industry’s Capital Devalued
This Senate hearing, and the fact that it was held without a nod to any of those who champion and defend the industry, demonstrates how the industry’s political capital has devalued since the triumph of the Dietary Supplement Health and Education Act (DSHEA) of 1994. The hearing focused on the some rather prominent law enforcement targets. But every industry has its bad actors. There will be counterpoints to the hearing. In fact, one of those testifying against the industry is said by one Congressional staffer to have inflated his resume. And Rep. Dan Burton, R-Ind., will hold hearings in the spring that will focus on industry bright spots. But the Senate hearing has provided a new point of departure for those on Capitol Hill who have chaffed all these years since DSHEA became law.
At the hearing, FDA was represented by John Taylor, director of the Office of Enforcement, Office of Regulatory Affairs, and, when pressed, he expressed concerns about DSHEA, including the fact that manufacturers are not required to register with FDA, so that the agency finds it “difficult to identify all of the sources” of dietary supplements products; that adverse event reporting is voluntary; and the fact that, in Taylor’s view, DSHEA’s placement of the burden of proof on FDA to prove its case “makes it much more challenging to bring enforcement action” against supplements companies. His testimony directly contradicted that of FDA’s last commissioner, Jane Henney, who testified in 1999 that she believed that “DSHEA provides FDA with the necessary legal authority to protect the public health.” But Dr. Henney, and apparently her views, are history.
Obviously, DSHEA’s mandate that the government bear the burden of proof in determining whether a product is adulterated is not novel, challenging or disabling. FTC has no objection to proving its cases, and it does—so why should FDA object to doing so? Our judicial system does not declare the accused guilty and then require the accused to prove innocence. Meeting a burden of proof in court is not extraordinarily difficult or unique. It is done in federal courts on a daily basis. FDA has simply stopped bringing cases and has forgotten how to do so. There is a challenge in meeting a burden of proof if you have never gone to court to do it. FDA’s lack of enforcement encourages lawbreakers to use the dietary supplements industry as a platform for fraud and deceit.
When the new Secretary of Health and Human Services (HHS), former Wisconsin Governor Tommy Thompson, came to office earlier this year, his first view of the dietary supplements industry was a report by his department’s Office of Inspector General. That report concluded that FDA’s adverse event reporting system did not work because of failures in DSHEA. The report never investigated FDA’s operation of the system, and many see the report as a cover-up of FDA’s failure to make even the most rudimentary reporting system work. But the secretary’s attitude toward this industry was fixed.
Accordingly, the dietary supplements industry has no champion in HHS, and FDA appears to have taken no steps to make its adverse event reporting system work.
Voluntary ID System Needed
The time has come for the industry to move itself forward. At the Senate hearing and in the Inspector General’s report, FDA stated that it has difficulty identifying dietary supplements products and the manufacturers of those products. This is an issue that could be addressed by the industry with a voluntary manufacturer, distributor and product registration system. The National Nutritional Foods Association, the oldest trade association devoted exclusively to this industry, has such a system in place—the TruLabel program, which already has 15,000 SKUs entered.
Would it not be worth the effort for the industry to take these simple steps voluntarily? The cosmetics industry did exactly this in the early 1970s, and the system has been made into a voluntary federal regulation, where it works in the public interest and in the interests of that industry. Moreover, many states, such as California and Texas, require all foods manufacturers, including dietary supplements companies, to be registered or licensed by the state. The time has come for the industry and its associations to seriously consider developing a database of products, manufacturers and distributors and to voluntarily make this information available to state and federal agencies. This is not an industry in hiding and no one should believe that it is.
The dietary supplements industry needs to take tangible steps to support itself. No one else is going to lift the industry’s bootstraps except those who wear its boots.
Anthony L. Young is a partner in Piper, Marbury, Rudnick & Wolfe LLP and also serves as general counsel for the American Herbal Products Association.