FDA issues draft voluntary sodium reduction targets

By Daniel Enoch

© Copyright Agri-Pulse Communications, Inc.



WASHINGTON, June 1, 2016 - The Food and Drug Administration today issued draft guidance for voluntary sodium reduction targets for the food industry.

FDA says the targets are aimed at helping the public gradually cut sodium intake to 2,300 milligrams (mg) per day, a level recommended by the leading experts and the overwhelming body of scientific evidence. The average sodium intake in the U.S. is about 3,400 mg per day.

“The Obama administration has led many public health initiatives that will improve the way Americans eat for many years to come,” said Michael F. Jacobson, president of the Center for Science in the Public Interest, which in 2005 filed a petition asking FDA to set mandatory, not voluntary, reduction targets. “If industry takes these targets seriously, this initiative could have the biggest impact.”

In a release, FDA said the science supporting the relationship between sodium reduction and health is clear: “When sodium intake increases, blood pressure increases, and high blood pressure is a major risk factor for heart disease and stroke - two leading causes of death in the U.S.”

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FDA noted that one in three individuals has high blood pressure. That number climbs to one in two African Americans and even includes one in 10 children aged 8-17. The majority of sodium intake comes from processed and prepared foods, not the salt shaker, it said.

Researchers in some of the studies cited by FDA estimate that lowering U.S. sodium intake by about 40 percent over the next decade could save 500,000 lives and nearly $100 billion in healthcare costs, the agency says.

“Many Americans want to reduce sodium in their diets, but that's hard to do when much of it is in everyday products we buy in stores and restaurants,” Health and Human Services Secretary Sylvia Burwell said in the FDA release. “Today's announcement is about putting power back in the hands of consumers, so that they can better control how much salt is in the food they eat and improve their health.”

While he would rather have seen a mandatory approach, the CSPI's Jacobson said the FDA's draft guidance provides clear goals by which food companies can be held accountable. He said it also “levels the playing field for those companies that are already trying to use less salt in their foods.”

The Salt Institute, a trade association that represents salt producers, condemned FDA's action.

“The issuance today of new ‘voluntary' sodium reduction mandates by the FDA is tantamount to malpractice and inexcusable in the face of years of scientific evidence showing that population-wide sodium reduction strategies are unnecessary and could be harmful,” it said in a lengthy release. “This effort will limit the food choices of Americans, not increase them as the FDA claims. It will make our food less safe and endanger public health.” 

The FDA's guidance to industry calls for appropriate sodium levels in 150 categories of processed and restaurant foods from bakery products to soups. Once finalized, interim levels would be met in two years and more ambitious levels in 10 years.

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The agency says its draft targets factor in data on consumer preferences, as well as current industry efforts to reduce sodium. FDA said it is confident that the short-term targets, which seek to decrease sodium intake to about 3,000 mg per day, are readily achievable. In fact, many foods, such as top-selling pretzel products, have already met the short-term target, it said.

The two-year sodium-reduction targets will now be subject to 90 days of public comment and the 10-year targets to 150 days of public comment.  FDA will then consider those comments before issuing final guidance, which even then will be voluntary.

The targets are part of the FDA's response to a lawsuit that CSPI had filed against the FDA last October seeking action on its 2005 petition. In addition to the draft guidance, CSPI said FDA today formally denied its petition asking for mandatory standards.

Leon Bruner, the chief science officer of the Grocery Manufacturers Association, said GMA is looking forward to working with FDA “to ensure the best and most recent science is taken into account” when determining sodium intake levels.

“Like others inside and outside of government, we believe additional work is needed to determine the acceptable range of sodium intake for optimal health,” Bruner said in a release. “This evaluation should include research that indicates health risks for people who consume too much sodium as well as health risks from consuming too little sodium.”

Bruner pointed out that GMA members have been improving the nutritional profile of their products for years. Between 2002 and 2013, he said, member companies made more than 30,000 healthier product choices available to consumers by reducing sodium, calories, sugar and saturated fat while increasing whole grains fruits and vegetables. He cited a 2014 study indicating between 2008 and 2013, the food and beverage industry reduced sodium in products purchased by consumers by 16 percent, for a total of 28 million pounds, or the equivalent of over 100 mg of sodium per person per day.

“GMA and its member companies are committed to continue our efforts to provide consumers with healthful choices,” he said.

Dr. Benard P. Dreyer, president of the American Academy of Pediatrics, said AAP welcomes the FDA action, calling the draft guidance a “practical step to improve the quality of Americans' diets and ultimately the health of children.” He said the Academy is urging industry to work to achieve the proposed reductions in the draft guidance without delay.

“Almost 80 percent of the salt content in our diets comes from processed foods like bread, soups, salty snacks, fast food, canned food, or processed meats,” Dreyer said. “Given how prevalent these foods are in the diets of millions of children and their parents, today's announcement will empower parents who want to take steps to reduce the amount of sodium they and their children consume.”

The Salt Institute disagreed, accusing FDA's Dietary Guidelines Committee of repeatedly ignoring “a loud chorus of researchers who advise that population-wide sodium reduction is unnecessary and/or potentially harmful, and “completely ignoring their own CDC-sponsored 2013 Institute of Medicine report that specifically did not support sodium reduction.”


“Contrary to the government's recommendations, evidence indicates people on low sodium diets place themselves at risk. The government disregarded peer-reviewed research showing that low-salt diets can lead to insulin resistance, congestive heart failure, cardiovascular events, iodine deficiency, loss of cognition, low birth weights, and higher rates of death. Studies show dangerous side effects from lowering sodium below 3,000 milligrams a day.

The Institute also pointed to what it called the “abject failure” of government-issued voluntary reduction targets in other countries.

“Food producers are placed under intense pressure to abide by the arbitrary limits despite the use of the term ‘voluntary,' and even when food producers do manage to safely lower the sodium in their foods they almost never meet the targets. Even when they do, this does not in fact reduce population-wide sodium consumption as the body naturally craves a certain amount of sodium to maintain optimum health. Consumers simply add in more of their own table salt or consume more food to make up the sodium deficiency, worsening the obesity epidemic.”

(This story was updated at 4:38 p.m. to include comment from the Salt Institute.)


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