PHOs: Illegal Food Additives Since 2005

In the Middle Ages when meat was scarce, con men were known to sell suckling pigs in a bag but substitute a cat. The lesson came down to us as, “Never buy a pig in a poke.” Similarly, in Europe buying a “cat in a sack” means to be fooled.

GRAS (generally recognized as safe) is a pig in the poke. Consumers buy and eat food without ever seeing inside the “poke” of GRAS status. GRAS, general recognition of safety by experts in the field, does not require FDA approval, acquiescence, or even knowledge. 

Recently, concerns about the GRAS exemption have been raised from many sides. An overlooked and troubling facet is that GRAS has become a cat in a sack for not just the public but also the food industry. The lack of transparency on GRAS status, the lack of regulatory review, and arcane wording in the law have muddled understanding by the public and professionals alike.

A clear manifestation of this confusion is seen in responses to FDA’s recognition that partially hydrogenated oils (PHOs) are not GRAS. For instance, critics of FDA point to naturally occurring trans fat in whole foods like butter and meat as a reason to allow synthetic trans fat. However, GRAS applies to additives not whole foods. U.S. law holds added substances to a higher standard than the natural components of foods. 

Opposition to the “de-GRASing” of PHOs includes arguments designed to cast doubt on the science behind the risk assessments for trans fat. This demonstrates a misconstruing of the GRAS exemption as an FDA approval. No amount of criticism of FDA or their science is sufficient to stop a de-GRASing. One must produce a public body of safety evidence sufficient to create a strong consensus among all scientific experts.

How did a simple concept get so confusing? GRAS is simple on its face, and that is a big part of the problem. The simple wording of the law lends itself to colloquial interpretation, but the colloquial sense masks a complicated and convoluted meaning.

For example, the lack of formal regulatory review fosters a common misperception that GRAS is a relaxed, seat-of-the-pants matter. After all, proof of safety can be based on long history of use in food before 1958. However, the history is not sufficient for GRAS status. Nitrates, for example, have a long history of use before 1958, but you cannot add them to soda pop. It is the recognition of the experts that confers GRAS status. No substance is granted GRAS status merely based on use before 1958.

The informal nature of GRAS also leads to failure to recognize that GRAS status is often limited by narrow conditions. For instance, caffeine is GRAS in colas up to 0.02%, but no quantity is GRAS in beer. The level of safety required for GRAS substances is also widely perceived as lower than for food additives; however, there is no difference under the law.

In some ways, the GRAS standard is more stringent than the standard for FDA food additive approvals because GRAS requires a public body of evidence that has convinced the experts all across the country. “General recognition” means a strong consensus among experts in the field. Although unanimity is not necessary, any genuine difference of opinion among the experts is enough to preclude GRAS status.

The accumulation of these misperceptions and more are why food industry professionals are holding a cat in a sack with PHOs.

By 2005 a strong consensus had developed among experts that trans fats are unsafe at any level. Several panels of experts from independent scientific organizations have found that trans fat is associated with changes in lipid metabolism and inflammatory effects that lead to dose-dependent increases in coronary heart disease. Certainly by 2005, when the Institute of Medicine found no tolerable threshold intake level of trans fat, PHOs with trans fat could no longer be considered GRAS.

Yet, PHOs with trans fat have remained in the food supply for 10 years after losing GRAS status.

GRAS status is self-executing both for recognition of safety and for loss of recognition. Just as achieving GRAS status does not wait for FDA affirmation, the loss of GRAS status does not wait for FDA confirmation. GRAS status is self-executing notwithstanding FDA affirmation, recognition, or even knowledge.

Once GRAS status is lost, that substance is regulated as a food additive, and an unapproved food additive is automatically an adulterant. Thus, for a decade PHOs have been illegal food additives yet widely used in foods.

This is not a regulatory scheme that inspires confidence. After more than 50 years of service, it is time to retire GRAS. Every approved food additive use should be listed on a government positive list. The scientific data supporting each approval should be available for public review.

It is time to “let the cat out of the bag.”

Neal D. Fortin,
a professional member of IFT,
is Professor, Dept. of Food Science and Human Nutrition,
and Director, Institute for Food Laws and Regulations, Michigan State University
([email protected]).