Thursday, November 29, 2007

FDA Hearings On Restricting Salt: Should Health Advocates' Demands for Government Restrictions On Salt Be Taken Cum Grano Salis?

The FDA held public hearings this week over the GRAS (generally regarded as safe) status of salt. The hearings are in response to health advocates who argue that salt should be treated as a food additive. This would allow the FDA to set limits on the amount of salt that could be added to foods. In light of the role that salt and sodium play in the development of high blood pressure and subsequent heart disease, those of us who work in the public health arena may be quick to jump on this bandwagon. But is government regulation that limits consumer choice the proper answer in this case? If so, what does this mean for other GRAS ingredients such as sugar and caffeine?

The FDA’s regulatory strategy for food and food additives looks like this:
1. If the product is a traditional food (example, apples, wheat, corn), it existed before national food safety laws were passed and is presumed to be safe for human consumption based on extensive use and experience. Premarket testing of these traditional foods is not required. If the food product is deemed unsafe for human consumption, the FDA will use its seizure and injunctive powers to remove the product from the market.

2. If the product is a food additive, premarket testing for safety is required.
a. A "food additive" is a substance that becomes a component of food or affects the characteristics of food, unless the substance is generally regarded as safe (GRAS).

i. A substance is considered to be GRAS if there is a general consensus among informed experts that a substance is safe for human consumption; or, if the substance was used in food prior to 1958, it is deemed safe by virtue of common experience. Examples are salt, sugar and caffeine.

b. If a substance added to food is considered to be GRAS, it will not be regulated as a food additive and will not require premarket approval.

3. Once a food additive has been evaluated by the FDA and is considered safe and effective at certain levels, it is placed on a monograph and can be used as an ingredient in any food product, but only at the levels or in the amounts that are considered safe by the FDA for human consumption.
So if salt loses its GRAS status and is designated a food additive, the FDA can set limits on the amounts that food processors can add to food. This means that the salt content of many foods will be slashed, with a resulting impact on flavor. And consumers will no longer have the choice to eat foods that are bad for their health based on salt content.

Thoreau stated that if he was sure that " ... a man was coming to my house with the conscious design of doing me good, I should run for my life ...."
In his essay Persuasion and Coercion for Health: Ethical Issues in Government Efforts to Change Life-Styles, 56 Health and Society, 303-38 (1978) [reprinted in Rolf Sartorius, Paternalism (U. Of Minn. Press 1983)], Daniel Wickler gives some excellent guidance on when governmental interference with individual life-style choices is justified ... and when it is not.

Professor Wickler gives two reasons why our society values autonomy of decision making: first, because we believe we are the best judges of what is good for us and, second, because the right to make the choice is a good in and of itself. This is translated into our common moral concept of a right of non-interference so long as one does not adversely affect the interests of others.

One view is that an individual’s choice of what to eat or not is self-regarding behavior (does not harm third parties). When a choice is self-regarding, it should be protected from interference from others, even if the decision is unwise.

It is true that there may be situations where we lose the capacity for competent self-direction. Then, as Ulysses did when he approached the sirens, we rely on others to protect us from harming ourselves. This is the basis for guardianship of children and the mentally disabled where the guardian makes the rational choices that would have been made if the individual’s autonomy were not compromised by mental disability.

When a consumer chooses a food with a high salt content (think of french fries that are usually loaded with salt) is this a situation of free and voluntary risk taking, or behavior that is not under the consumer’s control? Or could this be a situation where consumers lack the capacity to make an informed choice?

Unlike the situation with nicotine and its addictive properties where health advocates argue that the choice to smoke is not voluntary, health advocates’ position with regard to salt intake is that consumers lack the capacity to make a wise and rational decision because consumers are not well enough informed.

Does this rationale support the intervention of the government to take the choice to consume salty foods away from competent adults? If it is true and there is a capacity problem based on ignorance, isn’t the solution education?

While regulation to limit the use of salt blocks the harm, education corrects the disability and restores the choice and, therefore, autonomy. Based on the strong value that our society places on freedom of choice, should regulators be obligated to use the less restrictive choice of education, if they can?

Phillus Aureolus Theophrastus Bombastus von Hohenheim (1493-1541), a.k.a. Paracelsus, is well-known for the phrase Alle Ding' sind Gift und nichts ohn' Gift; allein die Dosis macht, dass ein Ding kein Gift ist. It translates as All things are poison and nothing is without poison, only the dose permits something not to be poisonous. Now, this phrase is commonly shortened to "the dose makes the poison."
Finally, issues surrounding life style choices raise the subjectivity of the notion of harm. Professor Wickler explains:
The same experience may be seen as as harmful by one person and as beneficial by another: or, even more common, the goodness (or badness) of a given eventuality may be rated very differently by different persons. Although we as individuals are often critical of the importance placed on certain events by others, we nevertheless hesitate to claim special authority in such matters. Most of us subscribe to a pluralistic ethic, for better or worse, that has a central tenant that there are multiple, distinct, but equally valid concepts of what is good and what is the good life. It follows that we must use our personal preferences and tastes to determine whether our health related practices are detrimental.
If the FDA decides to revoke the GRAS status of salt, what does that mean for sugar, which is equally, if not more, harmful? And there are multiple studies that demonstrate that caffeine in excess has significant health effects. What could this mean for those of us who live for that morning cup of coffee or tea?

For those who love salt, adding an extra dash with a personal salt shaker provides a partial remedy. But for those of us who love coffee and tea, finding a way to exercise personal choice could be a bit harder.

When it comes down to an individual life style choices, should the FDA take the views of health advocates cum grano salis? After all, any substance in excess can become a poison.



Blogger Darren said...

Limiting my salt content is one of my top priorities when shopping at the grocery store. Canned food often has exorbitant amounts of salt within it, and eating a whole can of vegetables like green beans can result in meeting your daily salt quota as prescribed by the labels on the back of cans.

Any discussion of the free choice must recognize that the vast majority of the processed foods in the supermarket aisle contains a great deal of sodium.

'So if salt loses its GRAS status and is designated a food additive, the FDA can set limits on the amounts that food processors can add to food.'

The CSPI petition itself:

According to the petition, 75% of Americans' salt intake comes from processed foods/foods consumed outside the home. Furthermore, 77% of the salt in processed foods has been added onto the existing levels.

Free choice is an important right, but it has been recognized that too many choices can be a burden. When presented with too many choices, consumers can become overwhelmed. And the supermarket as it is can be quite overwhelming. Often, in the search for a low-fat diet that incorporates healthy and delicious foods, one has to compromise. The result is a high-salt diet which is otherwise healthy. Trying to get the best of both worlds can cause hypertension on its own!

12/02/2007 12:14 AM  
Blogger Marielle said...

Yes, many products contain a great deal of sodium. This is because many people buy them, which is an expression of their free choice.

In addition, there are a wide variety of low sodium products out there; I even buy low sodium saltines.

And, failing that, would it kill you to eat fresh vegetables instead of canned ones? They're better for you to begin with.

The simple matter is you can't blame other people for your salt consumption. It's your responsibility, and yours only. Should the rest of us suffer because you happen to be lazy?

12/03/2007 9:43 AM  
Blogger former law student said...

Yes, many products contain a great deal of sodium. This is because many people buy them, which is an expression of their free choice.

Uniformly high sodium levels in processed foods is an example of consumers' lack of choice. Sodium levels in canned foods have not changed since at least the 1950s. Few products besides canned foods could remain unresponsive to consumer demands for so long.

Claiming consumers are exercising their free choice by continuing to buy high sodium foods is like saying Cubans are exercising their free choice by continuing to drive 1950s Chevrolets.

12/03/2007 4:54 PM  
Blogger Ross said...

Excess dietary sodium is spilled into the urine by your kidneys, as long as you don't have high levels of insulin (as caused by eating too much sugar and starches). If you do have high levels of insulin, your kidneys will retain more sodium (and water) than they should.

By cutting almost all sodium from your diet, you can reduce your blood pressure by as much as 4-6%! Which may help a small amount in getting someone's high blood pressure from >140mmHg to <120mmHg.

Lowering your insulin levels (by reducing sugars and starches) will only reduce blood pressure by a measly 20-30% which would solve the whole problem and leave your body able to deal with as much salt as you can cram down. A lot less drama there.

The whole argument that salt is the primary vector of high blood pressure and therefore heart disease is misguided advocacy piled high on top of bad science.

As for the person concerned about the sodium in processed food... Processed food products are considered toxic waste in my household. IMNSHO, any human beings reading this would do well to avoid processed food completely. No need to legislate what's in a product if there's no market for that product.

12/08/2007 11:25 AM  
Anonymous Anonymous said...

Realize that the harmfulness of salt is by no means a settled matter. The journal Science ran this article by Gary Taubes:

The (Political) Science of Salt

Three decades of controversy over the putative benefits of salt reduction show how the demands of good science clash with the pressures of public health policy

12/08/2007 5:15 PM  
Anonymous circlenatural said...

Salt is among the most important minerals supporting our lives and health!

The importance of salt in our lives cannot be overstated. Without salt, our bodies cannot perform some of the vital functions like regulating blood and body fluids and maintaining nerve signals. Salt deficiency leads to muscular weakness, cramps and exhaustion.

Severe salt deprivation can even prove fatal.

Salt sets off an osmosis movement in the body and adjusts the amount of fluids within and outside the cells. A healthy body processes the amount of salt it needs, and expels the rest through the kidneys.

The two elements of salt – sodium and chloride – play a vital role in body functions.

Sodium helps in sending messages to and from the brain, regulates the body fluids and helps our muscles including those of the heart to contract.

Chloride preserves the acid-base balance of the body, absorbs potassium and helps the blood to carry carbon dioxide from respiratory tissues to the lungs.

To read more go to

4/21/2010 12:27 PM  

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