Yesterday, GAO reported the findings of its investigation into, among other things, mechanisms available to FDA to decrease the likelihood of unnecessary food recalls.  In an unusual twist to the food safety debate, GAO looked at possible ways to compensate manufacturers in the event of an erroneously ordered food recall or an erroneous food advisory.  

One option that GAO considered is government-subsidized insurance against erroneous food recalls.  Another is one-time acts of Congress, or private laws, to address specific events.  Other potential solutions are government-funded loans for producers affected by an erroneous recall, and non-monetary methods "such as a government promotional campaign or a public statement acknowledging an error recalling a product."

GAO notes that any compensation system faces the threshold challenge of determining what constitutes an "error."  GAO cites the recent spinach recall, in which the contagion was ultimately traced to a specific farm but the recall covered all bagged spinach, as one example of a recall that industry thought was over-broad but that FDA thought was prudent.  GAO also cites the tomato e.coli outbreak, in which epidemiologists identified tomatos but later confirmed that serrano and jalapeno peppers could also be a source, as an example of an "error."

GAO's report comes as food advocates complain that the Obama Administration is holding up regulations to implement the Food Safety Modernization Act, particularly the provisions regarding foreign importers and recall procedures.  

Read the full report here.

Contributed by Kimberly K. Egan and Rebecca Jones McKnight as part of our Food Matters series.

Today, May 5, 2011, the United States Food & Drug Administration reminded Americans that "each year about 48 million people (1 in 6 Americans) are sickened, 128,000 are hospitalized, and 3,000 die from food borne diseases."

Yesterday, May 4, 2011, FDA issued the first rules to be promulgated under the controversial Food Safety Modernization Act that Congress passed on January 4, 2011.  The two new rules expand powers FDA had originally received under the Bioterrorism Preparedness and Response Act of 2002. 

Continue Reading

Kimberly K. Egan and Michelle L. Schaefer

The Institute of Medicine (IOM) last week asked FDA to regulate salt in America’s food supply. In a report titled Strategies to Reduce Sodium Intake in the United States, IOM urged FDA to modify sodium’s status as a food ingredient that is Generally Recognized As Safe (GRAS) and to limit how much salt may be added to processed and menu foods. IOM says salt added to processed and menu food items accounts for 80 percent of sodium in the American diet.

Pressure has been building on FDA to engage in the public health debate about salt. The Center for Science in the Public Interest has called salt “the single greatest problem in the American diet.” The American Heart Association believes a population-wide decrease in salt intake is needed. And Mayor Michael Bloomberg recently announced that the New York City health department would set recommended salt levels for manufactured and restaurant food and would encourage the nationwide food industry to meet the targets.

IOM’s rationale: The USDA Dietary Guidelines set a recommended target of 2,300 mg salt, the equivalent of one teaspoon, per day. The average American consumes twice that amount of salt on a daily basis. According to IOM, Americans consume unhealthy amounts of salt, which increases the risk of high blood pressure. High blood pressure is associated with heart disease and other preventable health problems. IOM believes that changing salt’s GRAS status would lower the amount of salt in the American food supply to healthier levels.

IOM’s strategy: IOM proposed an “innovative and unprecedented” approach to reduce Americans’ salt intake to the levels recommended in the Dietary Guidelines. IOM recommends a coordinated, gradual and stepwise reduction of salt to allow consumer’s to adjust their salt-taste preferences to lower-sodium foods and to create a level playing field for all industry stakeholders.

What did IOM propose?

IOM’s April 20, 2010 Strategies to Reduce Sodium Intake in the United States was in response to Congress’s 2008 request that IOM recommend strategies for reducing salt intake. Very little of the salt in foods is naturally occurring; most dietary salt is added to food to enhance flavor, texture and shelf life. IOM proposed that FDA implement regulations to reduce the amount of salt added to foods gradually so that that consumers’ palates can adjust to lower salt levels.

The specific proposals include:

• “[A] coordinated effort to reduce sodium in foods across the board by manufacturers and restaurants” 
• A “level playing field for the food industry” where “[a]ll segments of the food industry would be carrying out the same reductions and none would be at a disadvantage”

How has FDA responded?

FDA responded to the report by saying it will review IOM’s recommendations and work with stakeholders including other federal agencies, public health and consumer groups and the food industry to support the reduction. FDA said that “[t]oday’s average sodium intake is several times what the body requires, and its long-term effect on our health is very serious. Hypertension, or high blood pressure, affects one in three US adults – nearly 75 million people aged 20 or older.” It also acknowledged that “coordinated national action” is necessary.

FDA also said that it has not determined how it will implement IOM’s recommendations and that “FDA is not currently working on regulations, nor has it made a decision to regulate sodium content in foods at this time.” The Department of Health and Human Services will, however, convene an interagency working group to address policy approaches to dietary salt.

How have legislators reacted?

Lawmakers and other stakeholders are already calling upon FDA to expedite mandatory reduction of salt in prepared foods. Senator Tom Harkin (D-IA), for example, called the Report “ground breaking” and said it will “help the federal government prevent hundreds of thousands of unnecessary sodium-related deaths.” Senator Harkin plans to hold hearings on reducing salt in prepared food.

In addition, Congress’s recent health care reform legislation includes some changes for restaurant operators. The law requires FDA to, within one year, propose regulations to require calorie labeling on menus and menu boards in any restaurant with 20 or more locations that operate under the same name. The legislation does not currently cover salt content, but FDA may combine any rulemaking it institutes on salt intake with the required rulemaking on calorie labeling.