FDLI Conference In Brief

Law professor dubs Zicam AER case one to watch in 2012; Cargill draws legal line between customers’ food and supplement products.

Zicam AER case dubbed one to watch

A law professor says the class-action investor lawsuit against [Matrixx Initiatives Inc.], remanded from the Supreme Court, is a case to watch in 2012 based on what it will say about disclosure of adverse event reports. Speaking at the Food & Drug Law Institute annual conference April 25, William Janssen said the Supreme Court, in its unanimous 2011 decision on Siracusano v. Matrixx Initiatives, left questions unanswered on what would obligate a firm to disclose AERs to shareholders, as Matrixx failed to do with consumers’ reports of anosmia linked to Zicam products (Also see "Matrixx Decision Raises More Disclosure Questions – Law Professor" - Pink Sheet, 11 Apr, 2011.). “If statistical significance isn’t the thing we’re supposed to look at to determine whether or not undisclosed [adverse drug events] create liability, what are we supposed to look at?” asked Janssen, an associate professor at the Charleston School of Law. The U.S. District Court for the District of Arizona has certified the plaintiffs’ motion for class-action status and is expected to weigh dispositive motions in the fourth quarter this year.

Cargill draws line between foods, supplements

Agribusiness firm and ingredient supplier Cargill Inc. weighs many aspects of its customers’ products to avoid a “disconnect” over whether a product will be marketed as a conventional food or dietary supplement, says Cargill food law attorney Joshua Kim. He noted at the FDLI event April 25 that some finished product firms attempt to skirt the rules by labeling a beverage or bar as a supplement because it contains ingredients not generally recognized as safe, but marketing the product as a food. “It’s important to have these types of conversations with the customer to acknowledge that there are different assumptions out there as to how to define a certain product,” Kim said. He added Cargill looks at the customer’s planned labeling and marketing materials for the product, where it will be positioned at retail and how it will be delivered to the consumer, to determine whether it would be more appropriate as a food or supplement. Sen. Dick Durbin has called on FDA to enforce the division between conventional foods and supplements, in light of concerns about energy drinks labeled as supplements containing high levels of caffeine and other ingredients (Also see "In Brief" - Pink Sheet, 9 Apr, 2012.).