FDA Hearing on Sodium Follow up:

I am pleased to share that I had the opportunity to travel to Washington D.C. to attend and testify at the U.S. Food and Drug Administration (FDA) hearing on sodium held November 29, 2007 (please see the November 13 entry for details about the hearing).

Overall, the majority of scheduled presenters and those providing public comment were in favor of a sodium reduction in processed, packaged and restaurant foods; they only differed on the amount of the reduction and how it should be implemented (i.e. all at once or in a stepwise fashion). Many of the presenters also stated that a change in package labeling is needed to help consumers make better choices. A discussion of whether to change the daily recommended values for sodium will take place at another time.

An historic event occurred in the month prior to this hearing when Dr. Michael Jacobson of the Centers for Science in the Public Interest (CSPI) met with representatives from the Grocery Manufacturers Association / Food Products Association (GMA/FPA)and other stakeholders to work collaboratively on finding solutions to the problem of excess sodium in the American diet.

The representative from the American Diabetes Association, Dr. Richard Kahn, gave an excellent analogy of one pill that is taken which creates optimal health, however when twenty pills are taken creates a toxic situation that is harmful to health; he then asked the FDA panel if this were the case, wouldn’t the FDA step in to regulate the drug? He stated that this is what is happening with sodium and the FDA should step in to regulate it.

When someone questioned why sodium was being singled out, another presenter, Dr. Larry Appel who is a professor of Medicine, Epidemiology and International Health at Johns Hopkins Medical Institutions, made the point that sodium is the only nutrient/food additive that you can ask for, add yourself and have available at every table.

Dr. Stephen Havas represented the American Medical Association and spoke of his organization's strong, unanimous support and recommendations for reducing the sodium in our foods:

1. reducing sodium content by 50% using a stepwise approach

2. revoking the "generally regarded as safe" (GRAS) status of salt

3. working together to educate the public

4. revising food labeling

Dr. Havas stated that currently consumers have no idea how much sodium they currently eat in a day. In countries like Finland, who began focusing efforts on reducing sodium 30 years ago, cardiovascular disease mortality has been reduced by 80%. The United Kingdom uses innovative color coded labeling for sodium in their public health efforts.

There were a few dissenting opinions regarding lowering sodium in processed, packaged and restaurant foods. Several of those presenters, when questioned by the FDA panelists were unable to provide supportive evidence for their positions other than to say, "Americans won't eat food without salt added to it".

My presentation wove a "real life" story about a patient named Bob who ends up in the hospital over and over again for fluid build up in his lungs since he cannot cook, has no family nearby and doesn't know HOW to keep track of his salt intake. I also included the scientific evidence from my many years of reviewing sodium related studies. My Masters' thesis which was a review of the measures of the behaviors of salt/sodium eating was completed in 2005; the current manuscript, co-authored by Dr. Stergios Roussos of San Diego State University, has been accepted for publication by the American Journal of Health Promotion (AJHP) and should be published in late 2008. The journal graciously gave permission to submit a draft copy of the article to the FDA committee that is reviewing all submissions regarding sodium.

The journal article entitled, "Measuring Salt Consumption to Guide Behavior Change in Applied Settings: A Critical Review" is the first comprehensive review to summarize and outline the potential errors in past research primarily because research has relied on indirect measures as opposed to direct measures of salt eating behavior.

I made the point that eating sodium is a long-standing, hard to change habit that is largely considered "personal preference" and is essentially invisible. Furthermore, I stated that measuring the sodium that someone excretes in urine or through asking them to recall foods they ate is like measuring the safety of a car by asking someone if it feels safe to ride in it rather than conducting crash tests.

Addressing possible solutions, I stated that one way to improve accuracy is to use a direct measure of the behavior as the behavior occurs, stressing the importance of policies that guide food labeling as a critical strategy to produce behavioral changes. I emphasized the need to develop strategies and tools to directly measure and impact behavior change; further stating that when we teach people to observe their own behavior using a direct measure such as a tracking tool, we actually change the behaviors that matter most to the problem of excess dietary sodium intake.

If anyone would like to read my entire presentation to the FDA committee, please e-mail me at srpark@saltrax.com or feel free to post a comment or question here.

If you have an opinion regarding this important issue, please consider submitting comments to the FDA (you have until March 28, 2008 to submit comments).

*Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 

*Submit electronic comments to http://www.fda.gov/dockets/ecomments

The FDA panelists mentioned to the attendees during the meeting and to me afterwards that they are very interested in hearing the consumer opinions regarding sodium. The more opinions they hear, the better their decision about this issue will be. Remember - Your voice counts!!