Congressional Allies Move to Save DSHEA
Published: Thursday, November 01, 2001
by frank lampe
WASHINGTON—Recent action taken by the industry’s Capitol Hill stalwarts, Sens. Orrin Hatch, R-Utah, and Tom Harkin, D-Iowa, to encourage FDA to enforce provisions of the Dietary Supplement Health and Education Act (DSHEA); (see “Opinion,” pg. 2), is a good first step to ensure that the law has a viable future, but more needs to be done from within the industry that stands to benefit, say industry observers.
Amendment 2013 to the Senate’s version of the farm bill calls for $1 million in funding for FDA to make enforcement of DSHEA a “top priority,” according to Harkin.
The Hatch/Harkin bill may be an attempt to counteract two pieces of legislation submitted in the House a week earlier by Rep. Susan A. Davis, D-Calif., to modify the legal framework for dietary supplements: HR 3065, The Dietary Supplement Education Act; and HR 3066, The Ephedrine Alkaloid Consumer Protection Act (see Weekly News Update, Oct. 17).
In response to the bills, the Washington-based Council for Responsible Nutrition (CRN) issued a statement that the introduction of any legislation changing the basic framework of existing dietary supplements regulation should be closely monitored and warned that it must “solve real problems, and the use of scarce resources—people and dollars—must be consistent with the highest priority for enforcement action that ensures consumers’ continued access to safe products made to quality standards, and to useful science-based information.”
Regardless of any pending legislation, the task of strengthening DSHEA should include the following, according to industry insiders interviewed for this story:
Extended funding for FDA, beyond what is called for in Amendment 2013, and for the National Institutes of Health: There is general agreement that FDA needs the proper funding to enable it to enforce DSHEA, including the establishment of good manufacturing practices. In fact, this effort has been a primary focus of the Washington-based Consumer Health Care Association (CHPA), which is actively lobbying in both houses of Congress at the committee and subcommittee level for adequate funding for FDA, according to Kevin Kraushaar, VP and director of government relations.
More scientific validation of the efficacy of supplements to mitigate health conditions and support optimal health: CHPA is also looking at funding for NIH, to “make sure that the validated-methods piece of the research picture is put together,” Kraushaar says. “Another of our efforts involves funding for the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS), to make sure that they can protect consumer interests by making the science credible and by doing the research.
“Without [product] patents, the research is not built into the process—there just aren’t the financial incentives to do so. However, NIH can do that research. It’s uniquely positioned to do peer-reviewed, scientifically sound research on these products,” Kraushaar says, adding that NCCAM last year was funded at just under $100 million and ODS at $10 million. “We’d like to see NCCAM at $110 million and ODS at not less than $15 million.”
Voluntary registration with FDA of manufacturers and products: One of the key components of Rep. Davis’ proposed legislation is mandatory registration with FDA of all supplements companies, products and labels.
Attorney Anthony Young, a partner in Piper, Marbury, Rudnick & Wolfe LLP, who also serves as legal counsel for the American Herbal Products Association, says the cosmetics industry can teach the supplements trade a few things about voluntary registration, which he believes will “fill in the holes that the public and elected representatives may see with respect to DSHEA—at no cost to the government” (see Natural Business, October 2001, pg. 8).
He points out that the cosmetics industry is regulated much the way the foods industry is, yet its products are more exotic. “When it became aware of a movement among consumer advocates to ask for more regulation of cosmetics, the industry took some of its hard-earned dollars and came up with voluntary registration of manufacturers to address concerns that FDA didn’t know who they were. The industry also came up with a system of voluntary filing of cosmetic products and ingredients statements, and outside of FDA, established cosmetic-ingredients review and old-ingredients review if there were any problems. It has served the public interest.
“These are remedies that do not require a lot of brainpower or money,” Young adds. “It’s the kind of thing that we need to think about doing here.”
Quality-certification programs administered privately or by the government: The industry has already instituted a number of quality-certification programs. In addition to its good manufacturing practices program that involves third-party site inspections and comprehensive audits, the National Nutritional Foods Association (NNFA) currently lists more than 17,000 labels from member-supplier companies that have been certified through its TruLabel program. The association recently announced that it will publish the results of random testing on its website, www.nnfa.org.
Additionally, at least three independent companies are also currently testing products to ensure that labels accurately reflect what’s in the bottle. The Ann Arbor, Mich.-based NSF Inc.; ConsumerLab.com in White Plains, N.Y.; and most recently, the U.S. Pharmacopeia, all conduct fee-based testing and certification of supplements products.
“We have to continue to self-police,” notes David Seckman, executive director and CEO of NNFA. “Certification programs and quality are the main concerns of the industry, and the industry does get that. Either the industry can do it, or government will do it.”
A broad-based education program to inform Congress, the media and consumers about the benefits of supplements: While the industry has struggled in the past to mount an effective public relations campaign, a new effort by the Dietary Supplement Education Alliance (DSEA) is bearing fruit, and the organization hopes to play a role in providing the educational component that has been missing from the DSHEA equation.
DSEA, in its short history, has launched a national public relations campaign, constructed a website and a supplements information bureau (www.supplementinfo.org), and plans to begin a testimonials-based advertising campaign to extol the virtues of the products. The group hopes to raise $5 million to complete its multiyear, multilevel plan, according to DSEA Chairman Elliott Balbert, who also serves as CEO of supplements manufacturer Natrol Inc. (NTOL).
“If this is an opportunity for our industry to rise up, what we’re talking about is educating the public about benefits and the good-news stories that help the quality of life,” Balbert says.
“But we need funding. It would be irresponsible for any company to not participate if they derive any income from this industry,” he adds. “DSEA can be a catalyst to help get information to Congress and a catalyst for the trade groups to work together. It can also serve as a catalyst for some of the self-regulations that we need.”
Increased financial support of proindustry trade and consumer groups: Seckman notes that all of the trade associations have gotten involved with DSEA and agrees with Balbert that DSEA can serve as a catalyst to create support of the trade groups, too. “We need to pull together and work as one collective team,” he says. “It’s more important now than ever to enhance the industry.”
Consumer group Citizens For Health, which was instrumental in rallying citizen support for DSHEA but subsequently suffered from decreased funding from the industry, has emerged once again and could play a crucial role in protecting the law from wholesale changes (see story, pg. 1).
“To the extent that consumer trust is compromised, we must isolate the reasons and promptly resolve those issues. This may mean strict labeling guidelines, the restriction of the sale of some products in stores and dosage and potency limits,” says Loren Israelsen, executive director of the Utah Natural Products Alliance. “Inherent in that is a commitment to quality—if the consumer questions the quality or safety of our products, we have work to do. We need look no farther than the tire and aviation industries to see that. If anyone thinks this is not his or her problem and not an industry problem, that deeply concerns me. Bad news about anything is bad news for all of us.”