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FDA may soon make call on whether to add new dietary fibers

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After months of deliberations, FDA officials should be getting close to releasing a determination on whether 26 commonly used food ingredients – including inulin, soluble corn fiber and sugarcane fiber – would be classified as dietary fibers under the new Nutrition Facts panels next year. 

That is the belief of at least one former FDA official, who says that unless the agency decides to follow requests from some in industry to revoke or alter its new definition of dietary fiber, it should soon be releasing the results from a long-awaited review of scientific evidence, suggesting that certain isolated and non-digestible synthetic carbohydrates have a beneficial effect on human health and should therefore count as dietary fiber.

“It’s been long enough, that if they are going to do it, they’ve had enough time to do it,” said Elizabeth Campbell, a former director of the agency’s Office of Food Labeling.

“I am going to guess that the staff is finished or nearly finished with their evaluation, and then it would go up the line for review and approval and then senior management at FDA and then [Department of Health and Human Services] will probably have to approve it,” said Campbell, who has 35 years of experience at FDA and now works as an independent advisor at Virginia-based EAS Consulting. 

“Ordinarily, it’s a guidance document and, ordinarily, FDA would be enough,” Campbell added. “But this is controversial enough, that it may have to go to the departments.”

The issue of what substances can be defined as dietary fibers on food labels has been a sore subject for many in industry, as food producers have been waiting to see if FDA would be willing to add more ingredients to its new, narrower definition of added fiber. That could prevent some businesses from having to invest both time and resources into reformulating products to meet the new labeling requirements on dietary fiber.

Industry did receive some relief this summer, when FDA announced that is extending compliance dates for the updated Nutrition Facts label from the original July 28, 2017 deadline for large food producers to Jan. 1, 2020, giving food manufacturers about a year and a half more to prepare for the change.

However, the agency has remained tight-lipped on a number of questions that would ultimately determine how industry will handle dietary fiber in product labels in the future.

For one, FDA has yet to decide whether it will extend its new definition of dietary fiber to cover 26 additional substances that manufacturers often use to boost the fiber content of processed foods. The agency is considering the list now, but has released no timeline for the final decision, leaving companies uncertain on whether they should wait for a decision or begin reformulating their products – a drawn and complex process that requires a considerable amount of time, money and resources.

While a number of food producers have asked the agency to consider various plant-based or synthetic ingredients as dietary fibers, industry is particularly concerned about inulin – a widely used ingredient derived from chicory root that is also used as sugar substitute.

And it also remains unclear how FDA would rule on an April 27 petition from the American Bakers Association (ABA), which asked the agency to revoke the new definition of dietary fiber. The 29-page petition stated that FDA lacks authority to set definitions of fiber based on physiological benefits, that the agency unfairly applies different standards for intrinsic and intact fibers, and that it violated the Administrative Procedure Act by failing to provide a complete and clear definition of dietary fiber.

As the agency has been unwilling to provide answers, industry has been left in the dark and even food experts like Campbell are finding it hard to make informed predictions on how the dietary fiber issue will end up playing out eventually.

“It is going to depend on how strongly FDA feels about this new definition of dietary fiber,” Campbell told IEG Policy. “I really don’t know what the thoughts on this are, but apparently the staff felt very strongly about that [new definition].”

'It would be a political decision'

So, if FDA does end up honoring the petition and going back to its old dietary fiber definition, that would not be a decision that comes from within the agency, Campbell said.

“It would be a political decision,” she said. “I am speculating that the staff would not do that on their own, that they would be overruled on the political level.”

And if high-level officials in the current administration decide that the agency needs to reverse the new dietary fiber definition, they will likely do the same with the agency’s mandates on added sugars, which has been another “big, hairy deal for the food industry,” Campbell said. Just like the new fiber definition the new FDA mandate on added sugars has placed industry in a tough spot and forced many companies to start reformulating products, so that added sugars would be eliminated or reduced.

While Campbell said she has not heard of anyone on a political level making a push for a reversal of the FDA new dietary fiber definition, that does not mean it may not happen in the future, she noted.

“It would be the administration getting involved in the nutrition label and telling FDA to be nice,” she said. “And the industry thinks FDA is not being nice.”

The FDA’s new take on dietary fiber has become a major headache for the food industry, ever since the agency on May 27, 2016 released a final rule on the new Nutrition Facts labels. The rule for a first time defined dietary fibers in food labels not by chemical composition, but based on whether they might have physiological benefits for human health.

The agency drew a line between intrinsic fibers, or those that occur naturally in fruits, vegetables or grains and those fibers that manufacturers can add to foods – either by isolating or synthesizing them. Intrinsic fibers have been proven to have a health benefit for health, so manufacturers do not need to demonstrate evidence for their positive effect on health. But in the case of fibers that have been added to foods, manufacturers have to demonstrate at least one beneficial physiological effect on human health if they want to list those fibers on the new food labels.

An exception to that are seven isolated fibers that FDA has already identified as meeting the dietary fiber definition – beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose.

The agency now is in the process of conducting an in-depth scientific review aimed to determine whether 26 additional types of added isolated or synthetic non-digestible carbohydrates may also have a beneficial effect on health and could therefore be declared as dietary fibers on Nutrition Facts labels.

The agency gave industry stakeholders extended period of time (until Feb. 13, 2017) to submit comments and contribute their own scientific evidence for review and stated that companies may also use a citizen petition process to have additional fibers being added to the list for consideration.

However, a spokesperson for FDA told IEG Policy last week, that the agency is still not ready to comment on when the final evaluation would be complete or whether the agency may have a decision by the end of the year.

In addition to ABA, the Natural Products Association (NPA) has also raised concerns about fibers and in February attacked FDA’s Nov. 23, 2016 draft guide, Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition. The group said FDA’s definition of dietary fiber and its citizen petition process amounts to a new “pre-approval process for isolated or synthetic non-digestible carbohydrates” that is not authorized by any statute. FDA only has premarket review of food additives, color additives and health/nutrition content claims.

Companies in limbo

In the meantime, however, industry has been left to find its own way to handle the uncertainty on the matter.

“The companies remain in limbo,” said Riete van Laack, an attorney and a director at Hyman, Phelps and McNamara, who provides regulatory counsel on food and supplements.

“Companies can wait a bit longer before they determine if they have to reformulate the product(s),” van Laack said in an Oct. 25 email. “However, the companies remain in limbo when it comes to dietary fiber (that is if they use isolated or synthetic non-digestible carbohydrates).”

The problem is that companies require time and resources to track approved dietary fibers, as well as more calculations to ensure accuracy of reported fiber values and caloric content, and most foods with nutrient content claims or specific fiber goals would have to be reformulated.

While conducting new trials takes time, the cost of proving physiological benefits of fiber is also significant, with the cost of proving laxation benefits per fiber type running as high as $300,000.

Food industry giant General Mills has been among those in industry that have complained about the problem, and in September petitioned FDA to get three additional years to come into compliance with the new dietary fiber requirements. The problem the company said was with the primary isolated fibers used in the Fiber One snack products, which are extracted from chicory root, soluble corn fiber and sugar-case fiber, and were among the 26 substances still under consideration by the agency.

General Mills officials in September estimated that even if reformulation were possible, researching and developing reformulated versions of nearly 30 individual products would be an expensive endeavor and it could take between two and a half to three and a half years to bring 30 reformulations into the market.

However, the company is at least optimistic about FDA’s possible stance on inulin, General Mills spokesperson Bridget Christenson told IEG Policy on Monday (Oct. 30).

“FDA has received ample scientific support for inulin's health benefits to finalize their fiber evaluation, so we do not anticipate the need for recipe changes,” Christenson wrote in an email.

Consumer advocates however, oppose the idea of FDA adding the 26 ingredients on their list to the new definition of dietary fiber.

Bonnie Liebman, director of nutrition at the Center for Science in the Public Interest (CSPI) said the problem is that food companies tend to add these isolated fibers to unhealthy, processed products, which then end up competing on the market with fresh fruits and vegetables that are truly the best source of getting dietary fiber.

People who consume diets rich in fruits, vegetables, whole grains and other foods rich in intrinsic fibers, have a lower risk of cardiovascular disease, Liebman said.

“Those are foods with intact fibers, not isolated fibers,” she explained. CSPI has tried unsuccessfully to convince FDA to only count fibers that are naturally contained in foods, Liebman said.

“Companies don’t have to reformulate, it’s not as though they can’t use the fibers that have not been approved, they just can’t declare them as fiber on the label. That matters to companies in the particular because they can subtract some of the calories from the fiber, because they are essentially poorly absorbed carbohydrates ... . So, that’s an incentive for companies to use these fibers,” Liebman explained.

The problem is that companies add fibers to junk food like brownies, chocolate bars or other sweets, so consumers who may otherwise ignore those items, pick them up thinking that they may be good for their health, Liebman explained.

“People know that a fresh fruit is better than a brownie,” she said. “But this gives them enough of an excuse to go with the brownie.” 

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