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Gottlieb announces commitment to advance sodium reduction, defining 'healthy' and 'natural'

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To the delight of public health advocates, FDA Commissioner Scott Gottlieb on Thursday (March 29) charted a course of action for FDA nutrition-related activities that appears very similar to the path the agency followed under the Obama administration.

Speaking at the Consumer Federation of America’s (CFA) 41st Annual National Food Policy Conference in Washington D.C., Gottlieb said FDA intends to stay on track with a number of nutrition-related initiatives that began under the previous administration, including the new menu labeling mandates, the Nutrition Facts panel modernization and efforts to reduce sodium.

As part of a comprehensive, multi-year plan aimed at reducing obesity rates and preventing the incidence of chronic conditions, such as heart disease and diabetes, FDA will also try to define the term “healthy,” and may even consider the use of a symbol that could make it easier for busy consumers to improve their diet.

Additionally, the agency will also look at ways to modernize label claims, ingredient labels, and standards of identity.

The goal of all these efforts, Gottlieb stressed, is to empower consumers with information, and also to facilitate industry innovation toward healthier foods that consumers want.

Just like reducing smoking rates can help improve public health and reduce the risk of chronic disease, improvements in diet and nutrition offer a great opportunity to make a “profound and generational” impact on public health, Gottlieb said, noting that FDA is committed to making the most of this opportunity.

“The public health gains of such efforts would almost certainly dwarf any single medical innovation or intervention we could discover,” he said.

Chronic diseases are the leading causes of death and disability in the U.S., and both chronic diseases and weight-related conditions raise health care costs, reduce productivity, and shorten lifespans, Gottlieb said.

At the same time, the typical American’s eating habits are also “far from perfect,” he said. While three-quarters of the population does not eat enough healthy foods, most Americans exceed the recommended intake of added sugars, saturated fats and sodium, and only 17% of parents consider their children’s diet to be healthful, Gottlieb noted.

“As a parent of three young girls, I share in the challenges busy, stressed families encounter daily in encouraging healthy eating. I know that among the reasons for a poor diet are the challenges in accessing healthy foods and in knowing which foods offer more health benefits,” he said.

“And I feel strongly that FDA can do more to assist the American public with creating healthier diets for themselves and their families,” Gottlieb added.

Sodium reduction

As he sketched the broad ideas for the new FDA strategy, Gottlieb stressed that reducing sodium should be one of the agency’s priorities.

“There remains no single more effective public health action related to nutrition than the reduction of sodium in the diet,” Gottlieb said, noting that reducing sodium intake by one-half teaspoon a day could prevent nearly 100,000 premature deaths a year.

That may come as a surprise for those in industry who had opposed the Obama administration’s 2016 draft voluntary sodium reduction targets. Arguing that salt is an important ingredient in foods that not only improves flavor, but also helps preserve foods, industry has fought back against the sodium reduction effort. Some in industry – including the Salt Institute – had argued that the idea of reducing sodium does not reflect the most recent science on sodium intake and had hoped that Trump’s FDA would freeze the effort.

Pressure from industry also resulted in language being added in the latest appropriations bill that urged FDA to halt work on sodium reduction until the National Academy of Medicine releases its analysis of the latest studies on sodium intake – which is expected to happen in January 2019.

“To provide guidance to industry, FDA proposed short-term, voluntary, draft targets for sodium reduction in foods that support reducing sodium intake to 3,000 milligrams per day from the current average intake of over 3,400 milligrams,” he said, adding that the agency does intend to align its approach with the Dietary Reference Intake (DRI) that’s being conducted by the National Academies.

Gottlieb said he expects the agency to release updated short-term sodium reduction targets in 2019, and then to continue a dialogue on longer-term reduction efforts.

“I believe we can build broad support for our approach,” he said, noting that FDA is reviewing more than 150 public comments (including important technical information) that should enable the agency to “improve on the targets to make them more practical and meaningful.”

Gottlieb’s remarks on sodium reduction immediately caught the attention of Center for Science in the Public Interest (CSPI) – a group that has been asking FDA since 1978 to set limits on sodium use in foods. Margo Wootan, CSPI’s vice president for nutrition, asked Gottlieb to elaborate on the agency’s planned timeline for the short-term sodium reduction.

“Since those will be aligned with the 3,000 mg sodium intake, and the question before the DRI is should you go lower than 2,300 mg, will you be able to go forward with the short-term sodium targets right away and then wait for the DRI for the longer-term reduction?” she asked.

Gottlieb said FDA will likely wait to get the information from the DRI and then see how that aligns with what the agency wants to do.

“I don’t want to commit today that we are going to fully align with that process,” Gottlieb said. “I think we need to see what comes out of it… What I am saying today, is that we are committed to taking a hard look at how we both implement what we’ve committed to continue to implement and taking a look at how we make further reductions in sodium, consistent with where the trend is heading.”

The agency will likely decide down the road, whether it will choose to fully align with the DRI process, or possibly incorporate the findings into its own science-based assessment of where the target should end up, Gottlieb added.

“I think that’s going to be part of the process,” he said. “The important message is that we are committed to continuing to move that process forward and committed to trying to reduce that target amount.”

FDA to modernize claims, work on defining “healthy,” “natural”

Another step that FDA will take as a result of its new strategy on nutrition, is to modernize claims on food products and look for ways to tackle the definitions of terms such as “healthy” and “natural,” Gottlieb suggested on Thursday.

Claims on foods are important, not just as a tool to help consumers understand what benefits a food might have, but also for industry, as they can encourage food companies to introduce new, healthier products or to reformulate existing products making them healthier, he said.

“I believe there’s more room for competition in the marketplace when it comes to the healthfulness of different foods people eat, he said. “And we’re pursuing new ways to incentivize that competition.”

Health claims are one such tool, but FDA needs to modernize its approach in this area in order to ensure that such claims are employed effectively, Gottlieb said.

“These claims can show that a food component may reduce the risk of a health-related condition, such as the relationship between folate and the reduction in risk of a child being born with certain birth defects,” he said.

Qualified health claims, which are claims supported by some scientific evidence, but don’t meet the significant scientific agreement standard, are another example, Gottlieb said.

“It’s in everyone’s interest to have meaningful claims that consumers can understand and trust,” he said.

He said FDA also plans to streamline its process for reviewing health claims that it receives from industry and find new ways to make the process more efficient. The change will allow the agency to triage requests based on their public health significance, so that priority can be given to requests that are the most meaningful and science-based.

Another surprise in Gottlieb’s announcement was the commitment to tackle the definition of the term “natural” – a move that experts had not expected FDA to make any time soon, if ever.

The difficult-to-define concept, “natural” has been the focus on numerous lawsuits, as well as a wave of conflicting petitions from the Consumers Union, the Grocery Manufacturers Association (GMA), the Sugar Association and Sara Lee. FDA in 2015 announced its intent to define the term and collected more than 11,800 comments, but until now the agency has not indicated how it would proceed.

Gottlieb on Thursday recognized that defining “natural” will be hard, but promised that FDA will soon “have more to say on the issue.”

“It’s clear that consumers increasingly want to know what is in the food they eat and whether it is ‘natural,’” he said. “We recognize that consumers are trusting in products labeled as “natural” without clarity around the term. Just like other claims made on products regulated by FDA, we believe the “natural” claim must be true and based in science. At the same time, we know that there are wide differences in beliefs regarding what criteria should apply for products termed “natural” -- and some of those criteria aren’t based on public health concerns.”

Just like he promised in January, Gottlieb also indicated that FDA will also use the public input that it collected last year to also tackle the definition of the term  “healthy.”

“'Healthy’ is one claim that we believe is ripe for change,” Gottlieb said on Thursday. “Having a one-word claim such as “healthy” that’s based on current science would make it even easier for busy consumers, including me, to make choices that can help build more healthful diets.”

In determining what food is “healthy” FDA has traditionally focused on the nutrients in that food. However, “people eat foods, not nutrients,” Gottlieb said.

“This is why we’re asking the important question of whether a modernized definition of ‘healthy’ should go beyond nutrients to better reflect dietary patterns and food groups, like whole grains, low fat dairy, fruits and vegetables and healthy oils,” he said.

“As we broaden our message, we can’t undermine the importance of nutrients,” he added. “Availability of information about nutrients – both those that we need to limit, such as added sugars and sodium, and those that consumers aren’t getting enough of, like potassium, remains a core aspect of our role and nutrition strategy…. We’re keeping all these considerations in mind as we pursue rulemaking to update the definition of “healthy” so it’s based on nutrition criteria and food considerations that are more up-to-date than those being used for the current definition.”

FDA is also interested in making it easier for consumers to see the healthy claim and has discussed the possibility of adopting a symbol or a standard icon that could stand for the word “healthy” on food packages and could be easily understood by everyone, Gottlieb said.

“We’ll be soliciting stakeholder input on whether this would be useful,” he said on Thursday. “We also plan to seek input on other possible changes to our nutrient content claims and other types of claims that could facilitate innovation to promote healthful eating patterns.”

Modernizing ingredient labels

As part of its new strategy, FDA also plans to re-evaluate the ingredients list on food packages and consider ways to make ingredient information more consumer-friendly. Specifically, the agency will consider, whether replacing complex-sounding ingredients with simpler terms (vitamin B6 instead of pyridoxine or vitamin B12 instead of cyanocobalamin) might help consumers better understand what’s in their food.

“Consumers want “clean labels” that are readable and understandable,” Gottlieb said, noting that “public health implications will be included” into such consideration.

The agency, he noted, is already looking at one specific example for such a change in a petition requesting that FDA allow the use of “salt” instead “potassium chloride,” in order to avoid negative connotations among consumers, Gottlieb said.

“The petitioner argued that some consumers associate the term “chloride” with chlorine bleach and consequently avoid foods that have “potassium chloride” in the ingredient list,” he noted.

Updating standards of identity

FDA also will look into updating food standards of identity, the first of which were set into place in 1939 and may not reflect the latest nutritional science.

“For example, the standards of identity for certain cheeses don’t always permit the use of salt substitutes, which could be used to lower the sodium content of cheese,” he said.

FDA has also been asked to modernize the standard of identity for yogurt “to support the many innovations occurring in this food category,” he noted. 

“Our priority, again, is public health, and flexibility is key,” he said. “We want to maintain the basic nature and nutritional integrity of products while allowing industry flexibility for innovation. … But we also see a need for flexibility in standards that allow better public health outcomes by encouraging manufacturers to produce more healthful foods that are still affordable.”

FDA committed to push forward with menu labeling, Nutrition Facts updates

Last but not least, Gottlieb also reaffirmed the agency’s commitment to moving forward with the new menu labeling requirements and the efforts to update the Nutrition Facts labels.

FDA is now working to finalize the guidance it issued on menu labeling in November, so that industry can meet the new menu labeling mandates in May, Gottlieb said to the relief of public health advocates who have feared that the mandate may end up being delayed yet again. 

“And beginning on May 7, 2018, consumers can walk into these covered eating establishments across the country and know at a glance how many calories are in the foods they order for themselves and their kids,” Gottlieb said.

The original menu labeling rule was initially set to go into effect before the end of 2015, but FDA has delayed enforcement twice – first until May 2017 and then until May 2018. The latest delay came after non-restaurant businesses (supermarkets, convenience stores and pizza deliveries) complained that the mandate applies a “one-size-fits-all” approach that makes their businesses vulnerable to legal and even criminal penalties. 

Additionally, Gottlieb suggested that FDA’s work on updating the Nutrition Facts labels will also remain on track.

While Gottlieb on Thursday said the agency will ensure robust public engagement as the process continues, he also stressed the need to provide clear expectations, “so that industry can meet them.”

“It’s a priority to make sure we’re communicating with stakeholders to ensure the standards they need to meet and guidance as to how to meet them can be utilized,” he said.

Health advocates commend FDA’s new nutrition strategy

Some public advocates on Thursday commended Gottlieb and FDA on their plan of action and particularly on the decision to push forward with initiatives that can make a difference for public health.

“It is really good to hear the Commissioner of FDA in the Trump administration talking about the importance of nutrition to health,” CSPI’s Wootan told IEG Policy after Gottlieb’s presentation on Thursday.

“It sounds like the agency is very committed to implementing menu labeling on time,” she said.

Gottlieb’s presentation does suggest that FDA will delay the new Nutrition Facts labels by a year and a half, to 2020, which was disappointing but not unexpected, Wootan noted.

“We are disappointed that Nutrition Facts will be delayed because we see so many companies going forward with the new label. That makes for a confusing marketplace,” Wootan said. “But we are also relieved that they are not talking about weakening Nutrition Facts in any way. There was a lot of industry pushback, especially about added sugars and we are thrilled to see they are committed to going forward with that.” 

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