Bimbo, industry wait on F.D.A. rulings

by Jeff Gelski
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A ruling on fiber and a finalized date for Nutrition Facts Panel compliance could spur R.&D. efforts.

CHICAGO — Bakers and their ingredient suppliers, eager to put adjustment plans in place, are waiting on new Food and Drug Administration rulings. The F.D.A. has yet to finalize a compliance date for its new Nutrition Facts Panel, and it has yet to rule on whether certain ingredients, including inulin, meet the agency’s definition of dietary fiber.

“The biggest challenge I think that we face, not only at B.B.U. but industry wide, is the indecisiveness of F.D.A,” said Phil Boehm, director of regulatory affairs for Bimbo Bakeries USA, in a panel discussion Feb. 27 in Chicago at the American Society of Baking’s BakingTech 2018.

The lack of clarity around dietary fiber might be the biggest regulatory issue, said Brook Carson, vice-president of product development and marketing for Manildra Group USA, an ingredient supplier based in Leawood, Kas.

“I would say the lack of clarity prevents the opportunity for new fibers to come to the market and the opportunity for new innovation from bakers,” she said.

The F.D.A. in the May 27, 2016, edition 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. The F.D.A. has yet to rule on 12 petitions on 9 different potential fibers.

Phil Boehm, Bimbo Bakeries
Phil Boehm, director of regulatory affairs for Bimbo Bakeries USA

B.B.U., part of Grupo Bimbo S.A.B. de C.V. and based in Horsham, Pa., has taken a wait-and-see approach to product reformulation involving fiber, Mr. Boehm said. Research and development efforts instead are focusing on such areas as clean label and removing high-fructose corn syrup. Research and development centering on fiber could increase “dramatically” whenever the F.D.A. rules on the petitions on potential fibers, he said.

Scott Gottlieb, M.D., commissioner of the F.D.A., addressed fiber in a March 1 statement about the Nutrition Facts Panel.

“The F.D.A. has been evaluating data submitted to us from the food industry in petitions on various non-digestible carbohydrates and will communicate our decisions on these petitions soon,” he said.

The F.D.A. also issued final guidance that contains more evidence the F.D.A. is looking for on various non-digestible carbohydrates when deciding whether they count as fiber. The guidance may be found here. 

The compliance date

The food industry began preparing for the new Nutrition Facts Panel when the F.D.A. unveiled it in May 2016, Mr. Boehm said. The original compliance date was July 26, 2018. Then in September 2017, the F.D.A. proposed to extend the compliance date. Under the proposal, manufacturers with $10 million or more in annual food sales would have until Jan. 1, 2020, to come into compliance, and manufacturers with less than $10 million in annual food sales would have until Jan. 1, 2021.

Now, companies are placing less emphasis on the Nutrition Facts Panel changes since they should have a longer time to comply, Mr. Boehm said.

“It kind of fell by the wayside a little bit,” Mr. Boehm said. “You can take the indecisiveness not only for the compliance date but for the definition of dietary fiber, what we’re doing with added sugar, and the list goes on and on from an F.D.A indecisiveness point of view. So I think the biggest challenge we have is trying to get our head around what’s the dates, what do we need to do and when do we need to do it.”

Dan Herzog, vice-president of corporate compliance and food safety for Gonnella Baking Co., said F.D.A. inaction was creating “turmoil” in the baking industry.

“It’s just amazing at the amount of change that could come through (following F.D.A. rulings),” he said. “One of the biggest challenges that we see out there is the fact that we don’t understand everything that is coming from the F.D.A. We don’t know the dates.”

Schaumburg, Ill.-based Gonnella Baking Co. is keeping its labeling and packaging inventory as low as possible until the F.D.A. finalizes the compliance date for the Nutrition Facts Panel, he said.

Mr. Boehm said B.B.U., like Gonnella Baking, is keeping inventories at a minimum.

“We’ve already converted probably about two-thirds of our packaging right now because we have been working on it since 2016,” Mr. Boehm said.

Dr. Gottlieb in his March 1 statement said the F.D.A. this spring will issue a final rule. 

What’s next in labeling?

The panelists were asked what labeling regulatory issues will become paramount after attention fades on the Nutrition Facts Panel issue.

Mr. Boehm said he expects G.M.O. labeling to come to the forefront. Mr. Herzog said G.M.O. labeling, and he also mentioned possible effects from California’s Proposition 65 situation.

Jacinte Côté, Ph.D., product management director for Montreal-based Lallemand, said regulation on front-of-pack labeling could become a priority. The issue already has affected Brazil, Chile, France and the United Kingdom. She gave sodium content on the front of packaging as an example.

“I don’t think it’s going to be very positive,” Dr. Côté said. “It’s going to be like warnings.” 
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