FDA: We are eveloping draft voluntary targets for sodium reduction
CSPI sues FDA for dragging its feet over sodium reduction; FDA still working on voluntary targets
In its complaint*, filed in a federal court in Washington DC, the CSPI says the agency has been “dragging its feet” on sodium reduction, and that despite industry efforts, average intakes (3,650mg/day) remain stubbornly higher than federal recommendations (2,300mg/day or 1,500mg for some at-risk groups), proof that voluntary approaches are not delivering.
The petition also urges the FDA to require manufacturers to gradually reduce the amount of sodium in different categories of processed food, and post health messages on table salt sold in grocery stores.
In the complaint, the CSPI alleges that the FDA's failure to respond to its petition violates the Administrative Procedure Act, which requires federal agencies to approve or deny petitions in a timely manner.
If salt is deemed a food additive, the FDA would have to adopt a regulation “prescribing the conditions under which it may be safely used", it says, whereas at the moment, manufacturers add as much as they like.
Has sodium reduction fallen down the food policy agenda?
Five years ago, notes the CSPI, sodium reduction was a hot topic in food policy. The Institute of Medicine (IOM) called for the FDA to modify the GRAS status of salt and slash the daily value for sodium to 1,500mg/day; the FDA opened up a docket asking for comments and advice on sodium reduction strategies; and the food industry was on high alert.
Today, however, sugar is the new bogeyman, and while sodium intakes remain stubbornly high in the US, the FDA has not issued any new guidance since opening the docket in 2011, although a spokeswoman today confirmed that the FDA is committed to "developing draft voluntary targets for sodium reduction in various foods [but isn't saying when they might be released]".
Is salt generally recognized as safe?
According to the CSPI, the FDA presumptively classified salt as GRAS based on its common use in food before 1958. However, it also committed to revisit the GRAS status of various food ingredients, including salt, in light of new data, and stated in 1982 that “if no significant progress” was made on sodium reduction via voluntary industry efforts, it would “consider additional regulatory actions".
In 2011, following the publication of an IOM report urging bold action to cut sodium intakes, the FDA opened a docket to request comments, data, and information on approaches to reducing sodium consumption, but has made no recommendations since.
FDA: We are developing draft voluntary targets for sodium reduction
She told FoodNavigator-USA: "We will continue to work closely with all stakeholders on sodium reduction targets, which have the potential for major public health gains. The FDA’s goal is to encourage industry to gradually lower sodium in the foods that are available to consumers so that they will have more options available to them. The FDA is committed to moving forward on strategies to reduce sodium consumption in the United States."
Asked about the CSPI's petition, she said: "The FDA will continue to consider the citizen petition as it develops its sodium reduction strategies."
CSPI: Excess sodium is killing just about as many people this year as four years ago
Speaking to us last year about whether sodium reduction was falling down the food policy agenda, CSPI executive director Dr Michael Jacobson said: “Yes, the issue has lost momentum, though excess sodium is killing just about as many people this year as four years ago.”
He added: “FDA officials gave up more than half the ballgame when they dismissed the IOM’s 2010 advice to set limits on sodium and instead said they would issue voluntary guidelines."
While voluntary limits might be better than nothing, the problem with voluntary approaches is that “companies that want to lower sodium will likely fear that some competitors won't lower sodium”, added Dr Jacobson, noting that “mandatory limits create a level playing field.”
2013 IOM report muddied the waters
Meanwhile, a 2013 IOM report set back the debate by focusing narrowly on whether the daily intake should be 1500mg or 2300mg, while the core message (somehow buried in the 200-page report), that excess sodium is bad for your heart, was completely lost, he said.
Indeed, within hours, the internet was swamped with a flurry of media reports that can be paraphrased as follows: ‘Boffins backpedal on sodium reduction, admit that eating less salt could do us more harm than good’.
While three members of the IOM committee behind the report subsequently penned a viewpoint article in JAMA complaining that much of the media coverage “misses the larger conclusion” of their report, the damage was done, said Jacobson.
Sodium: How much is enough?
A 2013 report from the IOM muddied the waters over sodium reduction by prompting a confusing academic argument about data on intakes between 1,500mg/day and 2,300mg/day (click HERE ) when the wider message - that excessive sodium consumption is bad for your heart, and all Americans need to eat a lot less - was lost, argues the CSPI.
What is the industry doing?
When it comes to reformulation, all of the major food companies have made great strides in trying to reduce sodium, although the foodservice market has been slower to act, said Jacobson, who singled out Walmart, Unilever, and Cargill for praise.
However, he said, "the lack of FDA action means population-wide reductions necessary to reduce sodium-related diseases have not been achieved."
As for measuring progress, it’s hard to tell how much is going on just from looking at label claims, as sodium reduction is frequently conducted by stealth (in other words, firms might be reducing sodium, but they are not flagging it up on front of pack).
Consumer research, meanwhile, suggests that shoppers aren’t as bothered about sodium reduction as they are about other food-related issues, observed Tom Vierhile, innovation insights director at Datamonitor Consumer in an interview with FoodNavigator-USA late last year.
Waning interest in sodium reduction may also reflect fatigue with ‘health minus’ claims, with consumer more interested in what is in the product rather than what isn’t, he said.
The merits of population-wide sodium reduction are discussed at length in submissions to the 2011 FDA/FSIS probe into sodium reduction strategies, with the American Heart Association arguing that there is “overwhelming evidence” to support it, and the Grocery Manufacturers Association arguing that new data challenges “the conventional wisdom that sodium reduction will universally lead to health-promoting outcomes”.
*The case is The Center for Science in the Public Interest v US Food and Drug Administration, 1:15-cv-01651 filed in the US District Court for the District of Columbia