April 21, 2010 (Washington, DC) — As widely expected, the US Institute of Medicine (IOM) is advising the FDA that it should set stricter federal standards for the amount of salt that food manufacturers, restaurants, and food-service companies can add to their products . In its new report, issued today, the IOM explains that such a strategy would make it easier for American consumers to consume less sodium, because the vast majority of salt intake comes from prepared meals and processed foods.
As discussed in detail in a recent heartwire feature, a number of other countries have instituted policies to try to reduce the amount of salt in the diet of their whole populations, and many experts have been calling for the US to institute similar initiatives.
Asked to comment on the news for heartwire , incoming president of the American Society of Hypertension (ASH) Dr George Bakris (University of Chicago Pritzker School of Medicine, IL) said: "I take my hat off to the IOM. ASH, along with the AHA and other societies, has been actively campaigning against high salt in the diet, but there needs to be a partnership with the government in doing this; otherwise physicians will fail."
I take my hat off to the IOM. . . . There is absolutely no reason we should not do this.
The report says the FDA has the authority to regulate salt as a food additive and is recommending that the agency should gradually reduce the maximum amount of salt that can be added to foods, drinks, and meals, so that consumers are unlikely to notice the change in taste. Previously, salt has been treated as "generally recognized as safe," and there have been no regulatory limits on its use as an additive, the report explains.
The report was due to be released today but was made public yesterday following a front-page story in the print edition of the Washington Post, which is believed to have broken the embargo. The Post report contained erroneous information, giving the "mistaken impression" that the FDA has already begun the process of regulating the amount of sodium in foods, the agency said in a statement yesterday .
"The FDA is not currently working on regulations, nor have they made a decision to regulate sodium content in foods at this time. Over the coming weeks, the FDA will more thoroughly review the recommendations of the IOM report and build plans for how the FDA can continue to work with other federal agencies, public-health and consumer groups, and the food industry to support the reduction of sodium levels in the food supply," it states.
No Success for 40 Years, But Should Government Get Involved?
The chair of the IOM committee that compiled the report, Dr Jane E Henney (University of Cincinnati College of Medicine, Cincinnati, OH), said: "For 40 years we have known about the relationship between sodium and the development of hypertension and other life-threatening diseases, but we have had virtually no success in cutting back the salt in our diets." This report "outlines strategies that will enable all of us to effectively lower our sodium consumption to healthy levels," she notes in a statement .
Henney says the best way to accomplish this is to provide companies with "the level playing field they need so they are able to work across the board to reduce salt in the food supply." But the committee appreciates that the FDA will need time to gather and assess sufficient data to determine what limits to set and what the incremental decreases should be.
Taking this into account, she says that the committee is recommending that restaurants, food-service firms, and food and beverage manufacturers should pursue voluntary sodium-reduction efforts in the meantime.
Asked to address the concerns of naysayers--who argue that there is little proof that reducing salt in the diet will have an effect on health outcomes and who say that the administration should not get involved in "nanny-state" activities like regulating the amount of sodium people consume--Bakris said that government-backed salt-reduction campaigns "have been very effective in the UK, in Finland--with a dramatic improvement in mortality--and in Japan--same story--and there is absolutely no reason we should not do this.
"The reality is that there needs to be some guidance to the general public about this--most people do not read labels, most people don't pay attention, and they don't know how much salt is too much--so the availability needs to be regulated. Clearly, the FDA does have a role as a regulatory body to adjust sodium standards in foods so that they are in keeping with the current guidelines," he told heartwire .
"It's certainly true that people who are in their 20s and teens don't need salt restriction for blood-pressure control," he acknowledges, "but it is an acquired taste. And so if you don't learn from a young age, it's going to catch up with you in your 40s, 50s, and 60s, when you actually will need some salt restriction, so it is a lifestyle issue."
Common Sense Must Prevail
In response to what Bakris calls the "outcomes mafia, who say that unless we have an outcomes study it's impossible to make any conclusions," he remarked, "While there is some truth to this, common sense has to prevail. The FDA as a regulatory body has accepted the notion that lowering of blood pressure is a validated surrogate for a reduction in cardiovascular mortality and morbidity. "To do an [outcomes] clinical trial as is being requested, you would need well over 100 000 people, so it's not feasible. Let's be reasonable.
Many of the people who are saying this are also consultants to the Salt Institute. . . . They spin the data . . . to suit what their needs are.
"If you are telling me that reducing BP by 5 to 7 mm Hg, which is what most of these salt restrictions will do, is not going to translate into a benefit, then I think we have to throw out all the clinical trials we have to date," he adds. "There is no meta-analysis of any clinical trials that fails to show that a reasonable reduction in blood pressure has not been associated with a benefit, certainly on stroke and to a lesser degree on coronary events, but nevertheless the data are very consistent.
"I think the conflict of interest here needs to be established," he points out. "With all due respect, many of the people who are saying this are also consultants to the Salt Institute; they are lobbyists in their own right. They spin the data to make it suit what their needs are."
The IOM report was requested by Congress and sponsored by the US Centers for Disease Control and Prevention; the FDA; the National Heart, Lung, and Blood Institute; and the Office of Disease Prevention and Health Promotion of the US Department of Health and Human Services.
No conflict-of-interest disclosures were noted. Other than being the incoming president of ASH, Bakris reports no other conflicts of interest.
Heartwire from Medscape © 2010 Medscape, LLC
Cite this: IOM Recommends FDA Set New Standards for Salt in Foods - Medscape - Apr 20, 2010.