SAN DIEGO – People in the food industry are keeping a close watch on the Food and Drug Administration’s rule-making on fiber definition and claims. Another group might be equally interested in the new regulations. Lawyers may be looking for reasons to bring class-action lawsuits against food companies that get sloppy in their fiber claims.
The Food Lawyers, Los Angeles, defends food companies involved in class-action lawsuits. George Salmas, managing principal, spoke about ways to avoid such legal action on Oct. 10 in San Diego at Cereals 17, the annual meeting of AACC International.
The F.D.A. in the May 27, 2016, issue of the Federal Register defined fiber for the first time. Ingredients may qualify as fiber if they are non-digestible carbohydrates (with three or more monomeric units) and lignin that are intrinsic and intact in plants. Isolated and synthetic non-digestible carbohydrates (with three or more monomeric units) also may qualify if they are the subject of an authorized health claim or if the F.D.A. rules in favor of a citizen petition.
Companies determine whether a non-digestible carbohydrate is intrinsic and intact, Mr. Salmas said. A wrong determination may lead to a visit from the F.D.A., or worse, a lawsuit. To manage legal risk, companies could have a panel of outside experts determine if the ingredient is intrinsic and intact, he said.
|George Salmas, managing principal of The Food Lawyers|
“If you ask somebody inside your company whether something is intrinsic and intact fiber, everybody knows what answer you want,” Mr. Salmas said. “You want the answer to be yes, and that puts tremendous pressure on that person to give you a yes, and if he doesn’t have a lifetime of experience to get you a yes the right way, you’re going to have a worthless answer.”
The findings from a panel of outside experts, in contrast, could be a “bullet-proof shield,” he said. A law firm threating to file a lawsuit may see known and respected names on the panel.
“And all of a sudden the case is not so attractive, and (they) are going to move on to softer targets,” Mr. Salmas said.
When working with potential fibers that are isolated or synthetic, companies may need to file a citizen petition with the F.D.A., which in November 2016 explained what information it looks for in a petition. The F.D.A. decides when to rule on a citizen petition.
“When you file that petition with the government, you’ve lost control of your timeline,” Mr. Salmas said. “It’s completely out of your hands.”
The F.D.A. has proposed its new rules on Nutrition Facts Panel labeling, including the labeling of fiber, go into effect Jan. 1, 2020, for companies with $10 million or more in annual sales and Jan. 1, 2021, for companies with less than $10 million in annual sales. Companies may believe they have a great deal of time, about 26 months, to work on fiber labeling, Mr. Salmas said.
“What could go wrong?” he asked. “Plenty.”
Researching and writing a petition could take two months, and four to six months might be a more likely timeline. An F.D.A. ruling on the petition will take some time, too. Some citizen petitions on fiber were filed 18 months ago, and the F.D.A. has yet to rule on those, Mr. Salmas said. Other factors for food companies to consider are label designs, legal reviews and print orders, which all together could take four to six months.
“So here’s your takeaway: Get started today, or get started yesterday,” Mr. Salmas said.
Mr. Salmas said he once defended a company accused of overstating the amount of dietary fiber on a food label in a class-action lawsuit.
“Don’t think that if you mess up on your label with dietary fiber, nobody is going to notice,” he said. “I guarantee you these guys (class-action lawyers) will notice.”
Food companies should hire professionals outside the company to analyze the information on the labels, he said.“A lot of the cases we get, the regulatory people inside the company said the label was OK, and they don’t understand the class-action risk,” Mr. Salmas said. “You’re in much worse position if you get hit with a class-action (lawsuit) than you do with the F.D.A. knocking on your door over fiber. I can negotiate with the F.D.A. With the class-action guys, they’re going to file a lawsuit.”