WASHINGTON, Oct. 18, 2016 –The Food and Drug Administration’s proposed voluntary guidance for salt intake drew praise from public health advocates, who said reducing the amount of salt in American’s diets will save lives. The Salt Institute and defenders of sodium say the guidance is unwise.
Both sides gave their opinion in a comment period that closed earlier this week on the proposed guidance. FDA released its draft guidance in June as part of a settlement with the Center for Science in the Public Interest (CSPI), which sued the agency after it failed to respond to CSPI’s 2005 petition to set mandatory limits on the common food additive.
The agency set 3,000 milligrams a day as the two-year target and 2,300 mg/day as the 10-year target. The average American consumes about 3,400 mg/day of salt. Comments on the long-term reduction goal are due Dec. 2.
Salt producers were not thrilled with the short-term guidance. The Salt Institute, for example, said that the “voluntary” guidance will be used as a tool for enforcement.
“FDA appears to be pursuing a ‘back route’ to regulating salt as a food additive, when salt is by law exempt from the definition of a food additive,” the institute said. “It is disingenuous for FDA to assert that the document is simply voluntary when the agency is recommending average sodium levels for 150 different categories of foods, along with ‘upper bound’ targets that represent the maximum level of sodium that FDA recommends for the specific category. Those levels will become the de facto levels of sodium that can be present in foods.”
In its comments, the Salt Institute said the guidance would end up being anything but voluntary. “The practical reality is the guidance would set maximum acceptable levels for sodium. FDA inspectors, non-governmental organizations (NGOs), and class action lawyers would view the upper bound targets as the maximum quantity of sodium that could be present in individual food products.”
The institute also charged FDA with mischaracterizing the findings of a 2013 Institute of Medicine report, omitting the “expert panel’s caution that the ‘evidence in some cases is suggestive … of associations between lower sodium intake (below 2,300 mg/day) and potential increased risk of adverse health outcomes.’”
The institute also said it was concerned that FDA is moving ahead with the guidance despite House Appropriations Committee language that “effectively blocks the agency from issuing draft targets until the Centers for Disease Control and Prevention or the National Academy of Medicine completes a Dietary Reference Intake update report on sodium.” The institute said its understanding is that FDA wants to finalize the guidance by December.
CSPI, however, was pleased with the proposal. “Researchers estimate that reducing current sodium intakes by 1,200 mg a day (which would bring most people close to FDA’s long-term target of 2,300 mg/day) would prevent 60,000 to 120,000 cases of coronary heart disease and 32,000 to 60,000 cases of stroke,” CSPI said in its comments. Reaching the 2,300 mg/day goal would also save an estimated $10 billion to $24 billion in health-care costs and 44,000 to 92,000 lives annually, CSPI said.
FDA laid out suggested sodium levels for specific food categories, but CSPI said about half of all chain restaurants “were excluded from FDA’s baseline and target calculations due to missing serving size weights.” CSPI suggested that FDA set maximum sodium levels FDA per serving of food for sandwiches, mixed ingredient dishes, and other combination foods.
In its comments, the Grocery Manufacturers Association pointed out the various measures its members have taken to reduce sodium in their products. “GMA members have been voluntarily lowering the sodium content of products for decades,” the group said. “Early lessons from these initiatives are that most consumers generally reject low-sodium products due to their perceived inferior taste, but that many consumers will over time accept gradual reductions where the change in taste and texture is not discernible.”
More than two years will be needed, however, to implement the short-term goals, GMA said. “We estimate that the scope of reformulation required to meet the short-term goals will require at least four years,” GMA said. In addition, some of the short-term goals “are unachievable in a four-year period because of a variety of factors.”
New York City’s Department of Health and Mental Hygiene applauded the targets. The city in 2009 launched the National Salt Reduction Initiative, which has had some success, but not enough, according to the city.
“While many companies made substantial changes in a wide array of foods, progress to date is not enough to meaningfully impact sodium intake at the population level,” the city said. “A sodium reduction program coordinated by a federal agency that has regulatory power, such as the FDA, and that levels the playing field by encouraging more companies to participate, has the potential to yield far greater reductions.”