September 1, 2010
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 NPA. “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,” added Jonathan Cohn, who authored the brief for Sidley Austin.
In addition, CHPA (Consumer Healthcare Products Association) and CRN (Council for Responsible Nutrition) jointly filed an amicus brief regarding the case.
“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.
Straus Family Creamery seeks out partnerships with family-owned and operated organic dairies like the Correias to meet the increasing popularity of its organic milk and dairy products. These partnerships, which help save small, local family farms and promote sustainable organic farming, are critical to the mission of Straus Family Creamery, said the company.
“Our vision of sustainability includes not only the land and animals, but also the community,” said Albert Straus, president of Straus Family Creamery. “Partnering with local family farms helps us meet increasing demand for our products while preserving the family farming culture and protecting the jobs it creates.”
The Correia’s dairy, consisting of 235 cows on 148 acres in Petaluma, CA, recognized the changing economics of the dairy business and converted their farm to organic production in 2007, hoping to create a more sustainable business for itself. The relationship with Straus Family Creamery enables the Correias to continue to produce superior quality milk and work with a local creamery.
Straus Family Creamery has existing relationships with the 100-cow, 200-acre Hughes Family Dairy in Bodega, CA, and the Tresch Family Farms in Petaluma, which comprises two dairies with a combined 900 cows on 2,100 acres.
“This is wonderful news, particularly given the current economic climate. With this extension, the US organic sector can expect uninterrupted trade with Korea equaling about $55 million in US organic exports to Korea per year,” said Christine Bushway, OTA’s executive director and CEO, adding, “Equally important, this extended time frame gives the US organic industry the confidence to expand its product lines and sales strategies for the first time since 2008.” She noted that the decision also contributes to the goals of President Obama’s initiative to increase US agricultural exports.
The organic industry, through OTA, and US Department of Agriculture (USDA) officials had requested the extension of the labeling requirement provided under Korea’s Food Sanitation Act that had been scheduled to be withdrawn at the end of 2010.
MIFAFF is continuing to tighten its domestic organic regulations to integrate its certification programs for agricultural products and processed foods into one unified program, and to apply ISO Guide 65 to the accreditation of certification agencies.
The Korean decision came about as a result of public-private efforts by USDA’s Foreign Agricultural Service (FAS), US Embassy staff and OTA representatives in concert with the Korean organic industry and Korean organic regulators. FAS officials have noted that the extension allows for negotiation of MIFAFF recognition of the National Organic Program as equivalent to the Korean Organic Regulation while keeping the Korean market open for US organic exports.
Verdure Sciences (Noblesville, IN), a US based ingredient manufacturer, has announced the launch of its newly designed website located at www.vs-corp.com.
The new corporate website offers visitors comprehensive insight into company news, products, research and quality assurance. The site also includes an overview of Verdures’ Guiding Principles, which include research, traceability and sustainability. Additionally, site visitors have access to Verdure’s ingredient offerings and can enjoy new graphics and navigation tools.
According to Noah Herron, the company’s marketing coordinator, “Our aim is for our customers to experience a seamless view of Verdure Sciences and our ingredients. The new design was specifically created for our B2B customers to have a 24-hour snapshot of our ingredients and research.”
“The outcome does not question the current authoritative dietary recommendations and advices for omega-3 intakes on which our products are based,” said Flip Dotsch, Unilever’s media relations manager.
The ALPHA-OMEGA trial saw almost 5,000, 60-80 year old male and female heart attack survivors consuming varying levels of EPA, DHA and ALA via Unilever omega-3 spreads for 40 months.
One group consumed 376mg of marine sourced DHA and EPA; another had 1.9g of soy and walnut sourced ALA; a third group had a spread fortified with all three fatty acids and a fourth was placebo.
After the 40 months, 13.9 percent of the participants, who were 75 percent male and 24 percent obese, had suffered another cardiac event among all the groups.
Unilever said it found the results surprising, especially when the body of EPA/DHA scientific literature was considered.
“The study outcome for EPA and DHA is surprising considering the weight of evidence published to date,” Unilever said in a statement. “This could be the result of methodological issues such as the relatively low daily dosage compared to previous studies or the fact that in this study serious cardiovascular events were much lower than in studies performed in the past. This is probably due to extensive drug treatment that is nowadays applied.”
It said its “science experts” were looking at the paper in greater detail. The European Food Safety Authority has issued opinion on ALA, saying it supports lowering of blood cholesterol, but EPA/DHA were not backed for the same effect in an opinion published in October 2009.
Lead researcher, Daan Kromhout, PhD, of Wageningen University in the Netherlands, said that while the study found omega-3 fatty acid-enriched margarines “had no effect on the rate of major cardiovascular events,” improvements in medical treatment could have been a factor.
The EPA-DHA daily dose of 400mg was half that recommended by the American Heart Association.
The findings were presented at the European Society of Cardiology Congress and simultaneously published in the New England Journal of Medicine.