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| Friday, August 27, 2010 |
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| NPA Advocates for Dietary Supplement Industry to Supreme Court |
Files Brief Urging Proper Role for AERs
WASHINGTON, D.C. – Today the Natural Products Association (NPA) is filing anamicus curiae brief in the U.S. Supreme Court defending the dietary supplement industry against an overreaching and potentially damaging decision by the Ninth Circuit Court of Appeals.
The case, Matrixx Initiatives, Inc. v. Siracusano, presents the critical question of whether mere nondisclosure of adverse event reports (AERs) can give rise to liability under federal securities laws – even when those reports are not statistically significant. In an unprecedented decision, the Ninth Circuit held that the answer is “yes,” and permitted a class action lawsuit to proceed.
“While the case involves an over-the-counter product, there are clear implications for the supplement industry, especially as the reporting requirements for OTCs and supplements were enacted in the same piece of legislation” said John Gay, Executive Director and CEO of the Natural Products Association. “In this brief, we were able to focus on our industry’s perspective, and bring to bear NPA’s experience with the legislative history of the law that created the AER system.”
“The decision is wrong because evaluation of safety signals is a scientific judgment ultimately made by the FDA. Companies cannot possibly guess in advance what will be deemed adequate disclosure years later in collateral litigation,” said Scott Bass, of NPA’s counsel Sidley Austin LLP. “The statute explicitly states that AERs are not proof of causation.”
“The practical consequence of the Ninth Circuit’s decision, if it is not reversed, is that manufacturers of dietary supplements very likely will be forced to disclose all AERs, however insignificant, in order to avoid meritless – but expensive – strike suits against the supplement industry,” said Jonathan Cohn, who authored the brief for Sidley Austin.
“The Ninth Circuit’s action is not good for manufacturers, not good for consumers, and just is not good law. We hope the Supreme Court will agree,” said Gay.
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| Tuesday, August 17, 2010 |
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| NPF Truth in Advertising Progress | Since meeting with federal regulators late last year, the Natural Products Foundation’s Truth in Advertising program has addressed 50 individual cases of non-compliant advertising practices so far in 2010.
Primarily concerned with supplement ads that claim to treat or mitigate disease, NPF continues to take decisive action to eliminate unscrupulous promotions that undermine the good reputation of the natural products industry.
By following the guidelines laid out for the industry under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Dietary Supplement Health and Education Act (DSHEA), the Foundation is helping advertisers, retailers, suppliers, and publishers to present accurate, honest advertising.
You can show your support for truthful advertising right now by signing the NPF Truth in Advertising Pledge: Take the Truth in Advertising Pledge! |
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| Tuesday, August 3, 2010 |
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| NPA Calls Consumer Reports Article ‘An Attack on Supplements’ | Story’s data are questionable
The Natural Products Association (NPA) has issued the following statement concerning the September 2010 issue of Consumer Reports magazine:
- The latest edition of Consumer Reports is an attack on dietary supplements -- including a call for additional regulation of the industry -- that presents a far from balanced and accurate representation of the industry or the laws that regulate it.
- The NPA questions the data Consumer Reports are using to suggest the dietary supplement industry suffers from inadequate quality controls. In actuality, evidence from the government suggests the contrary. Earlier this year, the U.S. Government Accountability Office (GAO) tested a number of products finding only trace amounts of contaminants, leading the FDA to testify before Congress that “we do not believe these levels represent a significant risk to health.” It is curious that Consumers Union, publisher of Consumer Reports and also a witness at that hearing, did not mention this testimony in the article.
- The U.S. supplement industry has an enviable safety record, especially when compared with other FDA-regulated sectors, and the industry has supported and continues to support measures to make supplements even safer.
- NPA supported enactment of the Dietary Supplement Health and Education Act (DSHEA).
- NPA supported enactment of the legislation creating the Adverse Event Reporting system.
- NPA supported implementation by the Food and Drug Administration of Good Manufacturing Practices, even launching our own GMP certification program in 1999.
- NPA supports the full implementation of DSHEA - including providing additional resources for these agencies. To that end, NPA endorses S. 3414, the Dietary Supplement Full Implementation and Enforcement Act of 2010, introduced by Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT).
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| Wednesday, July 21, 2010 |
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| Natural Products Foundation Elects New Officers | July 21, 2010 — (Washington, D. C.) The Natural Products Foundation (NPF) announced today the election of two executive officers from the organization's board of directors. David Matteson has been elected Treasurer of the Foundation, and J.D. Weir has been elected Secretary.
Mr. Matteson has dedicated his career to advancing healthy ideas, services, and products into the marketplace. He is the co-founder of pH Sciences, and focuses his creative energy on his consulting practice, Early-Edge Solutions. Matteson serves on a variety of national advisory boards that strive to ensure consumer access and choice to effective healthcare services and healthy products. He holds academic degrees in biology/engineering, education, public health, and public policy and planning.
Mr. Weir is the President and CEO of Primus Pharmaceuticals. In the past, Weir has led various prescription and OTC drug and medical device businesses for Procter & Gamble (P&G) and later The Kendall Company’s former home healthcare subsidiary, Kendall-Futuro. At Kendall-Futuro, Mr. Weir was the Vice President of Marketing & Product Development. He has extensive experience in entrepreneurial management, marketing, sales, and product development. He graduated from Harvard Business School with an MBA and from Augustana College with a BS in Business and Accounting.
“With the election of David Matteson and J.D. Weir to the executive branch of our board of directors, the Foundation is primed to move forward in the pursuit of our goals," said Derek Hall, Board Chairman of the Natural Products Foundation and CEO of Qivana. "Through their long personal involvement within the industry, Mr. Matteson and Mr. Weir have made major contributions to the public success of natural products. David and J.D. are perfectly suited to help guide our organization to continued growth and improvement over the coming year. Their leadership will be invaluable, and we are very pleased to have them as part of our executive committee." |
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| Friday, June 25, 2010 |
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| Grassroots and FTC Powers Provision | In another victory for Natural Products Association (NPA) members and the industry, early this morning, conferees on the Wall Street Reform bill (S. 3217) decided not to include in the final legislation sweeping new powers for the Federal Trade Commission. Such additional authority very likely would have led to advertising rules on the industry that would have undercut the protections of the Dietary Supplement Health and Education Act (DSHEA).
“This has been one of the top legislative priorities for the NPA for the last six months,” said John Gay, NPA’s executive director and CEO. “I am proud of the way our members responded to our calls to write their senators and representatives, and to urge their customers to do the same. I am also proud of the hard work put in by our staff and lobby team. Good grassroots and good lobbying are a powerful combination.”
In the last two months, over 28,000 messages were sent to Capitol Hill through the association’s web site, NPAinfo.org.
Since identifying this issue as a potential threat to the industry in December, NPA joined together with what eventually became a coalition of over fifty national trade associations. Through the coalition, NPA lobbied members of Congress, and ran ads in Capitol Hill publications. In addition, NPA was by far the leading organization in producing grassroots contacts with senators and representatives. “Some of our members might have gotten tired of hearing from us on this issue, but sometimes in Washington persistence pays off,” said Gay.
“Like any legislative victory involving a broad coalition, this battle was won thanks to a number of factors,” said Gay, “but NPA members can and should claim a large share of the credit. Their response was tremendous.”
Gay urged the industry not to grow complacent. “This is a great victory, but the war isn’t over. Those forces on Capitol Hill that want to overregulate us are still out there, planning their next move. We need to remain vigilant.” |
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