Bad Stuff in Food: Risk Analysis and Political Commentary: June 2015

The No Postcaution Is Necessary Principle

The Food Additive Amendment of 1958 was precautionary. But, many chemicals and substances were routinely added to food long before the act was passed. Consequently, the act was written so additives already in use were exempted from requiring FDA approval. The legal mechanism for doing this was to create a new class of substances that are “Generally Recognized As Safe” that, even though they are intentionally added to food, they are not legally considered to be “Food Additives”. The original rationale for GRAS substances was pretty simple – the GRAS list functions as a grandfather clause that allowed substances already in use to continue to be used.

The original act contained a list of over 700 substances that were considered to be GRAS. However, because processes have been instituted for adding and removing substances that are considered to be GRAS, the current list is somewhat different. But still, there is a long list of substances that includes:

· Spices and other natural seasonings and flavorings
· Multiple Purpose GRAS Food Substances
· Anticaking Agents
· Chemical Preservatives
· Sequestrants
· Nutrients

The main point is this: There are many chemicals and substances intentionally added to food that have never been through the premarket approval process required for new food additives.

History of Safe Use

The 1954 Pesticide Amendments and the 1958 Food Additive Amendments created a new standard for food safety. Those same amendments also exempted many substances, including unintentional contaminants, GRAS substances, and food itself from having to meet that standard. It didn’t take more than a few years for that fact to be noticed, which gave rise to measures intended to make GRAS substances safer. The first effort involved the creation of the Select Committee on GRAS Substances (SCOGS) to review the safety of some GRAS substances. Between 1970 and 1982, this resulted in the review of 370 substances (FDA, 2015). The SCOGS reviews have scant resemblance to premarket approval reviews. The data reviewed did not follow established testing regimens, and there is no mention of safety factors.

Even though they had no legal force, the reviews conducted by SCOGS make it clear that the safety demonstrated by History of Use is quite different from that provided through premarket approval and the Safety Assessment Paradigm. On the plus side, instead of the usual battery of laboratory animal testing that typically underlies the Safety Assessment Paradigm, History of Use provides some semblance of demonstrated safety after human exposure. But, as safety often depends on how hard one looks, many GRAS substances have not passed with flying colors. Excerpts from two SCOGS reviews make this point quite well:

Caffeine. “the Select Committee views with concern the continued addition of caffeine to cola-type beverages, representing as it does a unique addition to food of a pharmacologically active central nervous system stimulant. The amount of caffeine consumed as cola type beverages borders on the dose known to produce central nervous system stimulation in animals and man. Whether such stimulation constitutes an adverse effect or whether a potential hazard may exist for the segment of the population, particularly children, that is exposed chronically to stimulating doses of caffeine, cannot be answered on the basis of the evidence now available. Despite the long history of use and absence of definitive evidence of toxicity in mammalian in vivo test systems, there is a possibility that behavioral effects in children from the consumption of caffeine from infancy through adolescence exist, even though these potential effects are neither adequately documents nor are their consequences clear. The Select Committee is well aware that caffeine in cola-type beverages is not the only dietary source of this substance. However, based on the evidence available in May 1978, the Committee believes it is not appropriate to continue to consider caffeine as a generally recognized as safe substance for addition to cola-type beverages.”
Sodium Chloride. “Sodium chloride, an essential constituent of the body and present in many foods, exhibits acute and chronic toxic effects when ingested in excessive amounts. Excess sodium chloride may induce hypertension in rats. There is a strong genetic component in the hypertensive response, and by selective breeding, strains of "spontaneusly" hypertensive rats have been developed. Hypertension has been evoked by excess sodium chloride in the food or drinking water of dogs but the effects were reversible and related to osmotic factors. Salt appetite is an important expression of personal preference in relation to diet, and salt contributes to palatabiity of foods. For some, saltcontaining foods have important cultural values. Foods in which salt is important for preparation or preservation are a prominent component of many diets. The causes of hypertension in man are related to genetic and environmental factors: race, family history, variations in endocrine and kidney function, degree of obesity, and life-style. Although the findings of epidemiological studies suggest a relationship between salt intake and onset of hypertension, the evidence that salt consumption is a major factor in causing hypertension is not conclusive. However, available data suggest that 10 to 30 percent of the U.S. population is genetically predisposed to hypertension and is exposed to a higher risk by ingestion of sodium at current levels. The Select Committee believes that a reduction of sodium chloride consumption by the population will reduce the requency of hypertension.”

GRAS Affirmation and GRAS Notification

Even in 1958, it was recognized that the list of substances was incomplete. Therefore, the FDA created a separate review process for establishing substances that would be considered to be GRAS. Even though that was not the original intent of the GRAS provision, this essentially provided an alternative mechanism for the approval of at least some food additives, with many notable differences:

· While initial GRAS petitions were reviewed by the FDA, since 1997 GRAS “self-affirmation” is carried out by experts hired by the food industry. The FDA is then notified when a GRAS determination is made, with an opportunity to object. As a result, the FDA has far less responsibility and oversight for GRAS substances than for food additives that go through the normal review process.
· While the premarket approval process is highly standardized, the GRAS review process is not.
· GRAS reviews typically use history of use as part of the justification. Premarket approval reviews never do that.

In short, even though the GRAS concept was originally developed as a grandfather clause, it has developed into a kindler, gentler approval process for substances added to food than the one introduced in 1958.

Rewriting History

It doesn’t happen very often, but the FDA can revoke GRAS status. In particular, the FDA recent proposed to remove Partially Hydrogenated Oils (“trans-fat”) from the GRAS list (USFDA, 2013). If trans-fat is delisted, then the food industry could presumably go through the premarket approval process. But, that will never happen; if it isn’t safe enough to be GRAS, then it almost certainly would never survive the Safety Assessment Paradigm.