HerbalEGram: Volume 3

A new bill was introduced to the United States Senate on June 21 and passed by a Senate committee on June 28 that would amend the Federal Food, Drug, and Cosmetic Act by requiring manufacturers of dietary supplements and over-the-counter (OTC) products to submit serious adverse event reports to the Food and Drug Administration (FDA).¹ The “Dietary Supplement and Nonprescription Drug Consumer Protection Act” has been sponsored by both Democratic and Republican senators who historically have been on both sides of the dietary supplement debate in Congress. It has also been praised by various dietary supplement and pharmaceutical trade groups, as well as consumer groups. The bill (S.3546) was recently approved by the Senate Health, Education, Labor and Pensions (HELP) Committee, meaning that the bill could be brought to the Senate floor for a vote in the near future.²

Under this bill, companies would be required to include contact information on their products’ labels for consumers to use in reporting adverse events. They would further be required to notify the FDA of any serious adverse event reports received within 15 business days. According to the initial draft of the bill, a “serious adverse event” would be defined as any adverse event resulting in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect, as well as any adverse event requiring a medical or surgical intervention to prevent one of the aforementioned conditions, based on reasonable medical judgment.¹

The drafting of this bill brought together legislators with strongly opposing views of the dietary supplement industry.³ The bill was sponsored by Senators Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Dick Durbin (D-Illinois), Michael Enzi (R-Wyoming), and Edward Kennedy (D-Massachusetts).¹ Senators Hatch and Harkin have been longtime supporters of the dietary supplement industry, and they sponsored the Dietary Supplement Health and Education Act of 1994 (DSHEA). Senator Durbin, on the other hand, has been one of the most outspoken opponents of the 1994 law, and he was a key figure in the FDA’s banning of ephedra in 2004.³

Under the bill, any adverse event reports submitted to the FDA would not be construed as an admission from a company that its product caused or contributed to the reported event.¹ The privacy of individuals reporting adverse events would also be protected.

The American Herbal Products Association (AHPA), the leading trade association dealing primarily with herbs and related botanical products, has been a proponent of mandatory adverse event reporting for serious AERs in the dietary supplement industry since 2002.⁴ According to a press release, AHPA worked closely with the senators’ offices to encourage such a bill. “Dietary supplements, as a class, have a remarkable safety record,” said AHPA President Michael McGuffin in a press release.⁴ “The many Americans who use them responsibly can continue to exercise their freedom of choice, knowing that the rare problems that might be reported will generate the signals that are needed to inform FDA. And marketers of these products can be certain that they will be provided with the same kinds of protection that the pharmaceutical industry enjoys, so that this system does not penalize companies that comply.”

The Council for Responsible Nutrition (CRN), a Washington DC-based trade association representing dietary supplement suppliers and manufacturers, likewise expressed support for the bill, which CRN President and CEO Steve Mister said will demonstrate the supplement industry’s commitment to consumers.⁵ “CRN further commends the Senators for their bi-partisan leadership and their willingness to invite the industry, along with consumer groups and regulators, to have input in the process, thereby recognizing that the best way to protect consumers is to set up a system that is workable for everyone,” Mister said.⁵

The National Nutritional Foods Association (NNFA), the nation’s largest trade association dedicated to the natural products industry, stated in a press statement: “NNFA believes that adverse events potentially related to dietary supplements will be minimal and serious adverse events rarer still. Having a reliable and verifiable system that attests to the safety of dietary supplements will end negative speculation by critics of the dietary supplement industry.”⁶

The United Natural Products Alliance (UNPA), a Utah-based trade group representing many leading manufacturers of dietary supplements, explained in a press release that mandatory adverse event reporting for serious AERs would increase consumer confidence in dietary supplements and nonprescription drugs and protect the public from any adulterated or tampered products.⁷ According to the press release, “It will assure consumers that serious adverse events are rare and that problems will be promptly investigated. UNPA commends Senators Hatch, Durbin, Harkin, Enzi, and Kennedy for their leadership and hard work to bring this important bipartisan legislation forward. UNPA is committed to continuing to work with other industry and consumer groups to promote prompt passage of the bill by the Senate and the House of Representatives.”⁷

One key industry figure, Loren Israelsen, founder and executive director of UNPA and one of the primary architects of DSHEA, summed up his group’s position: “We believe dietary supplements are exceptionally safe products and that this legislation will in future years confirm this fact. We also recognize that should a safety problem arise, we as an industry have a responsibility to quickly identify and resolve such situations and to do so in cooperation with FDA in those cases where the adverse event is serious.”⁸ He further stated, “It will also be incumbent on FDA to administer this legislation in such a way that all parties have full confidence that the intent and spirit of this bill is fully respected, which is to work with industry to resolve serious adverse events reports, rare as they may be, quickly and judiciously” (e-mail to M. Blumenthal, June 29, 2006).

The Center for Science in the Public Interest (CSPI), a long-time critic of many dietary supplements and the supplement industry, has also responded favorably to the bill. “Under the current voluntary system, the FDA receives less than 1% of all reports of adverse reactions to dietary supplements,” said CSPI Legal Affairs Director Bruce Silverglade in a press statement.⁹ We urge the Senate to approve this legislation promptly and hope that the House can pass a companion bill before the end of the current session. We also encourage Congress to provide sufficient funding to the FDA so that the agency can timely respond to reports of adverse reactions and protect the public from any hazardous products.”

The Consumer Healthcare Products Association (CHPA), a trade association representing U.S. manufacturers and distributors of OTC medicines and dietary supplements, released the following statement: “CHPA has long been an advocate of mandatory reporting of serious adverse events to FDA for all OTC medicines and nutritional supplements. Manufacturers of many OTC drugs are already required to report serious adverse events to the Agency. This legislation would codify this procedure for all drugs and extend the practice to dietary supplements. The legislation, if passed, will ensure FDA has the tools it needs to fulfill its public health mission to more aggressively monitor the medicines and nutritional supplements it regulates.”¹⁰

Rick Kingston, PharmD, Professor of Pharmacy at the University of Minnesota’s College of Pharmacy, and an expert on pharmacovigilance and adverse event reporting for conventional drugs and dietary supplements, cautioned that the adverse event reporting system that is established by this new bill, i.e., if it is eventually passed into law, would require some safeguards so that the data from the reports is interpreted accurately. “Discussing allegations of adverse effects for dietary supplements will undoubtedly be challenging for an industry that has not had a formal process in place for receiving, managing, and documenting these types of incidents in the past. We need to do everything we can to insure that the AERs are objectively analyzed in a scientific and credible manner” (e-mail, June 30, 2006). Dr. Kingston is also the founder of the Center for Dietary Supplement Safety at the University of Minnesota and a senior partner at SafetyCall International, a medical practice that helps major companies in the food, drug, dietary supplement and household products industry manage and document adverse events, as well as assist in reporting of incidents to regulatory bodies when necessary. Dr. Kingston has recently co-authored a peer-reviewed article showing some of the weaknesses and inconsistencies in current adverse event reporting systems.¹¹

It is not certain at this time who will sponsor a corresponding bill in the House of Representatives.

References

1. Dietary Supplement and Nonprescription Drug Consumer Protection Act [bill]. S.3546 (2006).
2. HELP committee approves bill to improve dietary supplement and non-prescription drug safety reporting [press release]. Washington DC: Senate Committee on Health, Education, Labor and Pensions; June 28, 2006.
3. Rovner J. Lawmakers come together on supplement bill. National Public Radio Web site. Available at: http://www.npr.org/templates/story/story.php?storyId=5502822. Accessed June 22, 2006.
4. Introduction of AER bill in US Senate announced [press release]. Silver Spring, MD: American Herbal Products Association; June 21, 2006.
5. CRN applauds senators on AER bill introduction [press release]. Washington DC: Council for Responsible Nutrition; June 21, 2006.
6. NNFA statement on adverse event reporting legislation [press release]. Washington DC: National Nutritional Foods Association; June 21, 2006.
7. Introduction of S.3546 the dietary supplement and non-prescription drug consumer protection act [press release]. Salt Lake City, UT: United Natural Products Alliance; June 21, 2006.
8. Mandatory AER bill emerges. Natural Products Industry Insider Web page. Available at: http://www.naturalproductsinsider.com/hotnews/66h21133923.html. Accessed June 28, 2006.
9. Dietary supplement bill would require companies to report adverse reactions to FDA [press release]. Washington DC: Center for Science in the Public Interest; June 21, 2006.
10. CHPA statement in support of the introduction of S.3546, the dietary supplement and nonprescription drug consumer protection act [press release]. Washington DC: Consumer Healthcare Products Association; June 21, 2006.
11. Kingston R, Blumenthal M. A rational perspective on adverse events reports on herbs: misinterpretation of adverse reactions tabulated in the TESS annual report of the American Association of Poison Control Centers as they relate to ephedra dietary supplements. HerbalGram. 2003;60:48-53.