HerbalEGram: Volume 4

Industry, Consumer and Bipartisan Groups Voice Their Support of New Consumer Protection Measure

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (the “AER bill”), a bill requiring manufacturers of dietary supplements and over-the-counter (OTC) products to submit serious adverse event reports (SAERs) to the Food and Drug Administration (FDA), was signed into law by President George W. Bush on December 22, 2006 (Law No. 109-462). The Act was passed by the US Senate on December 6, 2006, and by the US House of Representatives on December 9, 2006.¹
 
This bill was the last act passed by the 109^th Congress before it adjourned, winning unanimous consent within the Senate and approved by a two-thirds majority in the House.² The Act was introduced to the Senate (S. 3546) in June and to the House of Representatives (H.R. 6168) in September. It was approved by committees in both legislative bodies, leading to its recent consideration by the full Senate and House.
 
This Act, which amends the Federal Food, Drug, and Cosmetic Act, will become effective within one year of the date it was signed into law. Once effective, companies will be required to include contact information on their products’ labels for consumers to use in reporting adverse events.³ Companies must further notify the FDA of any serious adverse event reports within 15 business days of receiving such reports. Under this Act, 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 Further, any AERs submitted to the FDA will not be considered an admission from a company that its product caused or contributed to the reported event, and the privacy of individuals reporting adverse events will also be protected.
 
In his statement to the Senate floor on December 6, which preceded the Senate’s vote on the Act, Senator Orrin Hatch (R-Utah, one of the bill’s sponsors) stated that “the Dietary Supplement and Nonprescription Drug Consumer Protection Act represents a too-rare-but-productive alliance between Democrats and Republicans and between consumer groups and FDA-regulated products manufacturers. This is a significant consumer protection measure.”⁴ He also said, “Many have unfairly criticized the industry over media reports that supplements are unsafe because there is no pre-market approval. While I can never support any system that requires pre-market approval for supplements, I have become convinced that having a system in place to identify problems quickly can only enhance the authorities we gave the FDA with DSHEA [the Dietary Supplement Health and Education Act of 1994]. It is also good policy. As the industry matures, we need to separate out the good actors from the bad. This is one way to show that this industry is a respectable mainstream industry.”⁴
 
In his “Dear Reader” column in HerbalGram 71, the American Botanical Council’s Founder and Executive Director Mark Blumenthal also noted that the development of this legislation (which had just been introduced at the time of that writing) reflects the maturation of the dietary supplement industry.⁵ Blumenthal also cited an article he co-authored in HerbalGram 60 with Richard Kingston, Pharm D, president of regulatory and scientific affairs at SafetyCall International and clinical professor at the College of Pharmacy at the University of Minnesota: “Collection of spontaneously reported botanical AERs in a systematic and consistent manner is a vital part of product stewardship and safety assurance. Defining and monitoring the safety of dietary supplements is a dynamic process, and cooperation among multiple stakeholders using reliable methods of surveillance and analyzing collected data in proper context will aid in this process.”⁶
   
The bill has been widely supported by dietary supplement and pharmaceutical trade groups, as well as consumer groups, and many of these organizations have applauded the recent decision by Congress to pass the bill. “We have long said passing this legislation is the responsible, right thing to do for both the industry and consumers,” said David Seckman, executive director and CEO of the Natural Products Association (NPA), a trade association representing the natural foods industry, in a press statement.⁷ “We would like to thank our members, who have overwhelmingly supported this legislation. We would also like to thank all those grassroots supporters who sent thousands upon thousands of messages to Congress urging their legislators to pass this bill.”
 
Steven Mister, president and CEO of the trade association the Council for Responsible Nutrition (CRN), a leading dietary supplement trade association, has also expressed his approval of the recent legislative actions. “This law is something responsible industry has supported for a long time and we greatly appreciate the hard work of Congress to make it a reality,” he said in a press statement.⁸ “We are confident that ultimately the AER system will highlight the strong safety record of dietary supplements and allow consumers to feel increased confidence about the choices they make when taking dietary supplements.”
 
Michael McGuffin, president of the American Herbal Products Association (AHPA), the leading trade association in the United States dealing with herbal products, applauded the widespread support of the bill among legislators.² “The bill was passed by unanimous consent in the Senate and by more than a 2 to 1 majority in the House,” he said in an AHPA press release.² “Such broad and bipartisan support for this important legislation is significant.”
 
Loren Israelsen, founder and executive director of the United Natural Products Alliance (UNPA), pointed out that the bill was the result of much consideration and compromise among various groups and politicians. “As a response to critics of the bill, it should be noted that this legislation required 24 months and 21 drafts. All interested parties had opportunities to present their views and to offer proposed amendments to the bill’s language. I expect that criticism of the bill will continue from some quarters of the industry. The democratic process has been respected, opinions were listened to, and the bill reflects a wide range of input and advice. This is an affirmation of how the system is supposed to work,” he said (e-mail to M. Blumenthal, December 12, 2006).
 
Linda A. Suydam, president of the Consumer Healthcare Products Association (CHPA), an association that represents the leading manufacturers and distributors of nonprescription (OTC) medicines and dietary supplements, released the following statement: “Despite the industry’s strong safety record, the Association has always believed that more can be done to further enhance consumer confidence in OTCs and supplements. As a strong and consistent supporter of mandatory reporting of all serious adverse events associated with dietary supplements and OTCs, CHPA was pleased to see recent progress made on the bill, and looks forward to seeing mandatory adverse event reporting for all OTC medicines and nutritional supplements become a reality. In addition to bolstering public confidence, the establishment of a mandatory system also will benefit manufacturers by standardizing the scope and extent of reporting to FDA.”⁹
 
The Center for Science in the Public Interest (CSPI), a consumer-based nonprofit organization that has been a longtime critic of many dietary supplements and the supplement industry, was likewise supportive of the bill and the recent decision by Congress.¹⁰ “Making it simple for consumers to report adverse reactions and requiring companies to turn those reports over to the FDA will make it easier for the FDA to protect the public from hazards,” said Bruce Silverglade, CSPI’s director of legal affairs, in a press statement.¹⁰ “Under the previous voluntary system, the FDA received less than 1% of all reports of adverse reactions to dietary supplements.”
 
James S. Turner, an attorney and the chairman of the board of the consumer advocacy group Citizens for Health, described the Act as “a very important piece of legislation that advances consumer interests within a safe, credible dietary supplement marketplace.”¹¹
 
Dr. Rick Kingston has been a longtime advocate for post market surveillance in the dietary supplement industry. Dr. Kingston encouraged companies to begin the process of assessing their ability to comply with the legislation. “Fortunately there are very few serious AERs in this industry, but companies will need systems in place to monitor all AERs to insure that incidents meeting the appropriate criteria are identified, screened (using reasonable medical judgment), and reported to FDA within the prescribed 15 day reporting period. There is a lot at stake for companies here and critics will be watching to make sure the legislation works as intended. If done right, AE reporting will result in a tremendous boost in consumer, and health professional, confidence in this industry” (e-mail to M. Blumenthal, December 12, 2006).
 
The bill was originally sponsored by Senators Orrin Hatch (R-Utah), Tom Harkin (D-Iowa), Dick Durbin (D-Illinois), Michael Enzi (R-Wyoming), and Edward Kennedy (D-Massachusetts), thus bringing together legislators who historically had voiced opposing views of the dietary supplement industry.³ Senators Hatch and Harkin have been longtime supporters of the dietary supplement industry, and they sponsored DSHEA in 1994. 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 the controversial herb ephedra (Ephedra sinica Stapf, Ephedraceae) in 2004.

-Courtney Cavaliere

References

1. Dietary Supplement and Nonprescription Drug Consumer Protection Act. S.3546, H.R.6168 (2006). Available at: http://www.govtrack.us/congress/billtext.xpd?bill=s109-3546. Accessed December 12, 2006.
2. SAER bill passed by US Congress; awaits president’s signature [press release]. Silver Spring, MD: American Herbal Products Association; December 11, 2006.
3. Senate introduces bill to require reporting of serious AERs of dietary supplements and nonprescription drugs. HerbalEGram. July 2006;3(7). Available at: http://www.herbalgram.org/default.asp?c=AERbill. Accessed December 11, 2006.
4. Dietary Supplement and Nonprescription Drug Consumer Protection Act: Senate Floor Statement, 109^th Cong, 2^nd Sess (2006) (statement of Orrin Hatch, senator).
5. Blumenthal M. Dear reader: new AER bill for supplements and OTC drugs. HerbalGram. 2006;71:6.
6. 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.
7. Adverse event reporting bill passes Congress; Natural Products Association applauds passage [press release]. Washington DC: Natural Products Association; December 11, 2006.
8. CRN celebrates passage of AER bill; commends Congress on this important milestone for industry, consumers [press release]. Washington DC: Council for Responsible Nutrition; December 9, 2006.
9. U.S. Congress underlines importance of mandatory adverse event reporting [press release]. Washington DC: Consumer Healthcare Products Association; December 11, 2006.
10. Congress requires dietary supplement companies to report adverse reactions to FDA [press release]. Washington DC: Center for Science in the Public Interest; December 11, 2006.
11. AER bill passes congress-a victory for consumers and the natural products community [press release]. Washington DC: Citizens for Health; December 9, 2006.