State actions, FSMA, election changes among concerns for in-house lawyers

Stuart Pape, shareholder at Polsenelli, moderated a roundtable discussion at FDLI’s Food Advertising, Labeling, and Litigation Conference on a stack of regulatory issues that keep general counsels up at night. The panel included: John Packman, senior counsel, Coca-Cola Company; Meredith Olearchik, vice president and associate general counsel, Campbell Soup Company, and Megan Olsen, senior counsel at Walgreen Co.

Packman said a letter from a state attorney general is always unsettling because it’s usually followed by a class action lawsuit. When Packman started his job, he lived in a “FDA-centric” world, but that has changed in recent years.

And while California’s Proposition 65 may be the “biggest and the baddest” state regulation, Vermont’s GMO legislation and subsequent litigation got more of the attention of management this year, he said.

The in-house lawyers discussed implementation of the Food Safety Modernization Act (FSMA), with Olearchik stressing the need for everyone to use the proper records technology when FDA investigators come to food plants. “I’m anxiously awaiting the mid-September inspections,” she said.

Olsen said there’s concern FSMA’s expanded record access means companies must be able to retrieve the information FDA said it needs quickly, which will demand suppliers are more transparent.

Pape said he sees the relationship between food manufacturers and suppliers evolving into the integrated relationship FDA expects in the pharmaceutical industry. Passive reviews will be “in the rear window very quickly” on the food side under FSMA, he added.

But making suppliers more transparent in post-FSMA will be a challenge and will demand a “continued conversation,” Olsen said.

Election predictions

The panel also discussed what the regulatory agenda might look like after the upcoming election.

Pape said he expected a new Clinton administration to look more like an Obama administration. But if GOP nominee Donald Trump wins the White House, he expects a new FDA commissioner with ties to the drug side of FDA’s mission. The “F” in FDA is not likely to be a priority, and this may give rise to more activist states, he suggested. “State AGs may assert their own authority,” he said.

States will feel the need to step in if they perceive the federal government is not doing enough, agreed Packman.

If Hillary Clinton wins, Pape asked, would front-of-package labeling may be an issue at FDA?

The panel said it is unlikely.

Food companies are juggling a dramatically shifting landscape between GMOs, FSMA and the new Nutrition Facts panel changes, said Olsen, who hoped FDA would see how these new rules play out first.

And the role of consumer groups in the new administration? The panelists agreed they will be pressing for more disclosure on food ingredients.

“No matter how much we disclose, there will always by a NGO that wants more,” Olearchik said.