The Obama administration is teeing up one of its last fights with Big Food — this time over salt.
Voluntary targets for how much sodium should be in processed foods, from soup to potato chips, are expected to be released as early as this summer, current and former administration officials tell POLITICO.
Reducing salt consumption has long been part of the administration’s push to get Americans to eat healthier. But a plan to nudge food companies to take steps to voluntarily reduce sodium in their products, launched seven years ago, has been stalled amid concerns about political blowback and new studies questioning whether salt is actually a pressing health threat. Most of the sodium Americans consume comes from processed foods.
One former top FDA official said he believes a lawsuit brought by a consumer advocacy group will finally shake loose the voluntary targets that were completed two years ago but have never been released. The FDA agreed in February to respond by June 1 to the petition from the Center for Science in the Public Interest.
That timetable “is the reason for my optimism,” said Michael Landa, former director of the FDA’s Center for Food Safety and Applied Nutrition and an advocate of government action to reduce sodium.
"It remains a priority and it will come out this year," said another former administration official who asked not to be named.
FDA spokeswoman Megan McSeveney confirmed the agency is working on voluntary targets for sodium reduction, "which has the potential for major public health gains,” but declined to say when they would be released.
The government’s reduction targets wouldn’t be mandatory — and the industry would likely have a decade to meet them — assuming the draft guidance is completed by the end of President Barack Obama’s term and embraced by succeeding administrations. Still, the idea stirs dread among some food manufacturers that would be under pressure to reduce an ingredient that gives their breads, crackers and sauces their trademark taste.
“We have concerns that the science that would be the basis for the new sodium targets is outdated and something of this magnitude and long-term impact should also include more current research,” said Roger Lowe, a spokesman for the Grocery Manufacturers Association.
The industry cites recent studies suggesting that high-sodium diets do not increase disease risks, even as most public health officials stand behind another body of research linking excessive salt consumption with high blood pressure and cardiovascular disease.
“For more than 35 years, FDA has dragged its feet and refused to do anything to protect Americans from excess sodium in the food supply,” Michael Jacobson, president of CSPI, said last October when the group sued FDA. The group alleges the agency violated the law by not responding to the group’s 2005 petition seeking strict regulation of salt and warning labels on high-sodium products. “The government’s inaction condemns hundreds of thousands of Americans to early deaths due to preventable strokes and heart attacks,” Jacobson said then.
In February, CSPI agreed to give FDA until June 1 to respond to the petition, promising to update the court by June 15. Jacobson says the group took on the legal fight “with the hope that the lawsuit would give the agency an excuse to do something.”
The food industry, meanwhile, appears poised to go into battle over the targets after repeated clashes with the administration over its efforts to reduce salt and fat in school lunches, label foods with added sugar and rid food of trans fats.
“We don’t think this is justified,” said Morton Satin, the vice president of science and research at The Salt Institute, an industry group representing salt producers. “What is the impact? We’re going to have salt replaced by a cocktail of chemicals. They can’t just take out salt. They have to make the food tasty.”
The shifting science on sodium
In 2009, it seemed almost a foregone conclusion that the Obama administration would set targets to reduce sodium in processed foods.
Less than a month after being confirmed in May 2009, FDA Commissioner Margaret Hamburg and Deputy Commissioner Josh Sharfstein said the agency needed to make greater progress on nutrition in an article for the New England Journal of Medicine. The Washington Post ran a story in April 2010 claiming that a big salt crackdown would be launched later that year and “would eventually lead to the first legal limits on the amount of salt allowed in food products.”
That same month, the Institute of Medicine urged the federal government to do more to reduce sodium. It recommended that FDA set mandatory standards for sodium levels in processed foods, but that it go slowly so that consumers’ taste buds could adjust. The IOM pointed to estimates indicating more than 100,000 lives could be saved if the whole country cut back.
Not long after that report, however, the scientific consensus on sodium began to crack.
In 2011, a large study published in the Journal of the American Medical Association found that going below 3,000 milligrams of sodium per day — which the government recommends — was actually associated with an increased risk of death. Though previous studies had found a similar connection, none had used such a large sample size.
“There is absolutely no evidence to support the current recommendations,” said Andrew Mente, a researcher at McMaster University in Ontario who has published a significant body of research, including the JAMA study, questioning the long-held advice that people should reduce salt consumption to boost health.
Since then, prominent journals, including the New England Journal of Medicine, have continued to publish science suggesting that dramatically lowering salt intake might actually increase health risks. In 2013, the IOM concluded there wasn’t enough evidence to support sodium reduction below 2,300 milligrams — even though the government had been recommending everyone stay under that level, while urging about half the population to stay below 1,500 milligrams.
By 2014, Mente and others had published data on nearly 400,000 people finding a U-shape relationship between sodium intake and cardiovascular disease outcomes, with increased risks found below 3,000 milligrams and above 6,000 milligrams. This emerging body of research suggests the vast majority of Americans are in the safe zone. It also raised questions about the government’s recommendation that African-Americans, those with hypertension and adults over 50 years old stay below 1,500 milligrams of sodium per day.
Mente characterizes the sodium debate in personal and political terms. Scientists and policymakers who have staked their reputations on the need to lower salt consumption are standing firm, or “basically their entire legacy would be questioned,” he said.
“It’s pretty much a club,” Mente said. “Now the new data is questioning the dogma of this particular club and now they wanted to defend it.”
Other top scientists think the methodology underlying many of the newer studies is deeply flawed, largely because they say they do not accurately measure sodium intake. They point out the studies don’t use an average of multiple 24-hour urine collections, which is considered the “gold standard” for estimating how much sodium a person has consumed.
They think the 2013 IOM report questioning federal sodium advice was also problematic because it relied on these studies.
“There are a lot people who don’t like that report and it’s not just me,” said Lawrence Appel, a leading researcher and proponent of sodium reduction at the Johns Hopkins University School of Medicine.
Appel is skeptical of the large studies finding associations between low sodium intake and an increased risk of disease or death, in part, because it is unclear whether the low sodium consumption is real — and if the association is real, whether there isn’t another factor at play. Appel believes that people eating a low sodium diet might be doing so because they are already sick, making it impossible to attribute low sodium intake as a cause of their poor health outcomes.
Appel and others in the anti-salt camp put much more weight in highly controlled clinical trials and other studies that have found reducing sodium intake lowers blood pressure.
Ideally, he said, scientists would conduct highly controlled clinical trials looking at clinical outcomes like heart attacks and stroke in a broad population, but doing so is prohibitively expensive.
While the scientific debate has raged on, top administration officials pressed forward on a goal that still animated most of the public health community.
In June 2014, Hamburg told The Associated Press that voluntary sodium reduction targets would be released “relatively soon.” But when she stepped down in February 2015 after leading the agency for nearly six years, they still had not come out.
There are competing theories about what, exactly, delayed the targets. Some former FDA officials blamed their counterparts at Health and Human Services. “It was at HHS for ages,” one source said. Some said the increasing debate about the state of sodium science dampened the White House’s appetite to move on the issue. Others said the administration worried about stoking too many debates about “nanny state” nutrition policies at once.
By the time Landa, former director of the food division within FDA, left the agency in January 2015, he’d grown tired of waiting. In March 2015, he wrote to HHS Secretary Sylvia Mathews Burwell urging swift action.
“There should be no further delay in issuing draft voluntary sodium reduction targets, whether to help set a ‘level playing field’ to facilitate industry reduction efforts or to lay the groundwork for mandatory limits, should the targets fail,” he wrote in a letter obtained by POLITICO.
In another letter to FDA last October, Landa called it “incomprehensible” that the agency hadn’t already responded to the CSPI sodium petition after more than a decade of consideration. He cited statistics indicating sodium reduction could save as many or more lives as eliminating gun deaths.
Almost everyone POLITICO spoke with for this story, including Jacobson, thinks the guidance document is now under review at the White House Office of Management and Budget, but since such documents are not logged in the public tracking system, it’s impossible to confirm the review or how long the document has been there.
A looming fight
While it’s not clear exactly what FDA’s policy may look like, Canada’s reduction targets offer clues. Several years ago, Health Canada set voluntary benchmarks for where it wanted average sodium levels to be for dozens of product categories, ranging from toaster pastries to chicken wings.
Jacobson’s expectation is that FDA will propose draft reduction targets for dozens of food categories, then take comments for a number of months and perhaps tweak the levels based on the feedback.
He thinks it’s likely the agency will set a three-year benchmark that is easier to meet and then set another more ambitious target for 10 years out.
“We’re looking at a very, long slow process,” Jacobson said. “I think voluntary targets would put pressure on many companies to lower sodium levels significantly. I think there will be continuing progress, and that’s the most important thing, is continuous progress.”
Still, the targets will likely have a very long phase-in after being finalized, which could take years — well past the start of the next presidential administration which might choose to oversee or abandon the process.
Almost without question, any FDA action on sodium would precipitate a fight on Capitol Hill.
The Grocery Manufacturers Association points out that its members — under enormous pressure from advocacy groups and changing consumer preferences — have been working to reduce sodium without any government nudges. Between 2008 and 2013, food and beverage manufacturers cut sodium overall by about 16 percent — or a total of 28 million pounds — according to GMA.
Industry leaders say they would be particularly unhappy about going down a path that will later need to be reversed if the scientific consensus changes. Everyone recalls the missteps with trans fats: For a long time, the federal government and consumer groups urged reduced saturated fat consumption, so much of the processed food world switched to trans fats by using partially hydrogenated oils — which the FDA is now essentially trying to ban because it’s believed to be even more problematic for heart health.
“What we can’t do is make all these changes and then have the government turn around and say actually this was wrong — oh and all the substitutes you’re using are worse,” said one industry leader who asked not to be named.