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

By Jim Chen et al.

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.

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?

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.

Full post as published by Biolaw Blog on November 29, 2007 (boomark / email).