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Food Ingredients Labels: A Primer on Regulations

By Rabbi Gavriel Price, Orthodox Union Ingredients Approval Registry

Originally published in the OU Daf Haskashrus, June & July 2003; reprinted with permission of the Orthodox Union; © 2003 Orthodox Union

Should salmon raised on feed that artificially keeps its flesh pink be labeled as containing “color additives”? That question is the subject of a class action lawsuit in Seattle against major supermarkets there. It is one of a number of lawsuits brewing across the country that center on food labeling, and it brings into focus a question that kosher consumers, and kashrus professionals in particular, often ask: Can I be reasonably sure that what’s not on the label is not in the food?

The first part of this article will try to answer that question from the point of view of the regulations governing food labels. But a review of the regulations is not adequate to answer a kashrus consumer’s questions; it is also necessary to evaluate the extent to which companies adhere to the regulations. The first part of this article will provide some background about regulations and the second part is a brief discussion about compliance.

I. Regulations

The Food and Drug Administration (FDA), as it responds to Congress and writes regulations for food labels, has to balance two separate interests: One is to inform consumers. The more inclusive a label, the better position a consumer is in to make choices. But the FDA also recognizes that it should not force food manufacturers to sacrifice their trade secrets – which often center upon what ingredients are put into foods, and at what proportions. The regulations represent a middle ground, a balance between these two interests. The philosophy behind food labeling-laws, as the FDA’s literature itself states, is to regulate without over-regulating.

The FDA balances these interests by requiring that all ingredients be declared while granting a few narrow, but significant, exemptions. For example, absent on ingredients labels is the proportion, or percentage, of each ingredient. The regulations require only that food labels list the ingredients in descending order of predominance according to weight. That means that the heaviest is first, the lightest is last, and so on.1 (Medicine ingredients labels, it should be noted, are not beholden to this rule. Medicine labels list ingredients in alphabetical order only.)

A second exemption permits collective language for flavors and spices.2 A simple declaration of “natural flavors” is allowed to cover a host of ingredients used in a product. Collective language is a critical exemption for manufacturers that use proprietary ingredients that can be considered “flavors” or “spices”. As a case in point, a chametz ingredient could be hidden behind the pillar of “natural flavors”. If a person wants to know whether a product is subject to chametz sh’ovar alov HaPesach, it would be prudent not to disregard a “natural flavors” declaration.

Any other ingredient has to be specifically identified. But that statement is meaningful only insofar as we know what an “ingredient” is. Although the regulations do not explicitly define “ingredient”, they do discuss a class of “incidental additives” that are not considered ingredients and yet can be present in a food. An “incidental additive” is exempt if, according to the regulations, it is present at “insignificant levels” and has no “technical or functional effect” in a food. “Incidental additives” are discussed in a section called “exemptions”3 and are some of the more open-ended of the regulations. As a result, they permit a broad range of interpretation.

According to the FDA website, the most common way in which an “incidental additive” would be found in foods is as a sub-ingredient. The regulations exempt “substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect.4

An example of a sub-ingredient that would be exempt from labeling is beta-carotene, a yellow/orange coloring agent that is used in margarine. If margarine that contains beta-carotene were used as an ingredient in a strawberry colored cookie, the beta-carotene, a kosher sensitive substance, would not have to be listed as an ingredient. On the other hand, the oil in the margarine, although only a sub-ingredient, does have a technical or functional effect in a cookie. Therefore, it appears, the oil in margarine would be required to be on an ingredients label.5

Some other examples of incidental additives are the following: A release agent, which helps food separate from equipment that it might otherwise stick to, would probably be exempt from an ingredients label because it does not playing any specific role in the food (although from a kashrus perspective its presence may be relevant). Residual product from a previous run is occasionally mixed into a different product in a new run. Such residual product would qualify as “a substance that has no technical or functional effect” in a food. Airborne particles of whey powder, although in per million, can nevertheless be present in a food. Manufacturers of chocolate, for example, have voluntarily made dairy declarations on non-dairy chocolate because of concerns for allergen reactions. Labeling laws do not require such declaration because the whey powder is present at “insignificant levels” and has no “technical or functional effect” in the food. (The dairy or non-kosher status of equipment, important in an evaluation of the kosher or pareve status of a food, is totally outside the FDA’s universe of concern). Exemptions for trace additives such as these are likely driven more by practical considerations than out of a desire to protect food manufacturers’ trade secrets. It is unrealistic to require food manufacturers to include all of these possibilities on a label.

It is difficult to identify other examples of “incidental” additives. Strictly speaking, almost everything added to a food has some “technical or functional effect” in the food. Indeed, food labeling specialists at the FDA were hard-pressed to list more than one or two items – sulfites at less than 10 parts per million, for example -- that are deliberately added to a food, and are not sub-ingredients of other ingredients, that would be excluded. Even an enzyme added to a food and later removed, the FDA specialists asserted, should be declared, as long as the enzyme plays a technical or functional in a food --which they invariably do.

The limited number of additives that would qualify as “incidental” underscores how comprehensive and pervasive the regulations are. In fact, besides selected use of collective language for flavors and spices, and the exemption for incidental additives, nearly everything else must be declared.

An illustration of how exacting the regulations can be is the case of the farmed salmon and the Seattle lawsuit. Farmed salmon are fed astaxanthin, an anti-oxidant that has the effect of making their flesh pink (more on the kashrus ramifications of that subject can be found in an excellent article by Rabbi Chaim Goldberg in the previous issue of the Daf). Astaxanthan is part of the feed given to farmed salmon, and it is a vitamin that wild salmon would anyway absorb as part of their natural diet. Nevertheless the regulations consider astaxantan to be a “color additive”. A color additive, the regulations state, “includes an ingredient of an animal feed whose intended function is to impart, through biological processes of the animal, a color to the meat, milk, or eggs of the animal.”6

Finally, the reader will note that no mention has been made of an exemption of an ingredient that is less than two per cent of the food. Entrenched, somehow, in the public mind is a notion that anything less than two per cent need not be labeled. That idea is at loggerheads with the regulations. So where did the idea come from? Actually, there is a source for a two per cent rule in the regulations. But it’s very different from what people think it is.

The two per cent rule plays a role in the following: all ingredients must be labeled in order of predominance, by weight. The heaviest is first, and so on. All ingredients that are less than two percent of the weight of the product are freed from being placed in a specific order – that is, order of predominance by weight. As long as the ingredients label writes: “the following ingredients are present at less than 2%” or “1.5%” or so on, the ingredients can be in any order that the manufacturer chooses.7 (Please refer to the ingredient statement on the “French Dressing”).

II. Compliance

Besides illustrating how strict the regulations can be, the case of the farmed salmon brings up another question. If the letter of the law says that farmed salmon raised on feed that artificially keeps their skin pink should be labeled as containing “color additives”, why is it that packages of farmed salmon do not actually bear that declaration? That is the basis of the Seattle lawsuit. Now, without getting into the details of that particular case – the supermarkets that sell farmed salmon without such a declaration may have a compelling counterargument -- the question does arise: how much of a relationship is there between the regulations and reality? A very brief history of the regulations may help to answer the question.

In 1990 Congress enacted a law called the Nutritional Labeling Education Act (NLEA). The NLEA is best known for introducing the Nutrition Facts box that we see on our products. But it was also responsible for re-writing many of the regulations governing the food ingredients label.

While the FDA is responsible for writing the regulations, it does not generally police food manufacturers vis a vis adherence to food ingredients labels. That responsibility falls to state agencies. However, according to a specialist from the State of Utah Department of Agriculture and Food, Congress, while it enacted the NLEA in 1990, did not supply funding to the states to guarantee compliance with what had become more stringent rules (this is a version of the pharonic decree: produce more bricks without supplying additional straw).

As a result, many states have no means of guaranteeing compliance. At least one state has a program educating manufacturers, but few states have inspectors. One exception is California, which apparently funds its own policing by fining companies found in violation of ingredients label laws.

Government, however, is not the only entity monitoring compliance. “Self-regulation” is the way many industries claim to police themselves. A representative of the FDA readily acknowledged that self-regulation of industries is the principal form in which the FDA assumes that labeling regulations are being obeyed. Similarly, states may rely on the efforts of competitors to whistle blow if a competitor is violating a regulation. But that type of policing is more likely to take place when a product makes a declaration that is not true – if a product calls itself low in fat, for example, when it is actually quite high in fact. Crimes of omission are more difficult to identify. Indeed, according to the Utah specialist, only a small percentage of products on the supermarket shelves adhere to the regulations.

So even though an enzyme may have to be identified, it is a good bet that if the enzyme is a trade secret, or if a company is not aware of the niceties

of the regulations, or for some other good or not so good reason, there is basis for doubting whether a company really would declare it.

Certainly, labels can be helpful and informative. The Federal Government, by requiring food labels and in particular by enacting a set of intelligent and thorough regulations, provides a great benefit to American consumers. But the regulations were not written with the Jewish consumer in mind. Areas of interest in halacha are not the areas that are covered by the regulations. And where the regulations do tend to provide helpful information, it is not a guarantee that the regulations are being followed. Kosher consumers and kashrus professionals should keep these considerations in mind when looking at food ingredients labels. Remember – don’t judge a product (solely) by its label!


1) See Code of Federal Regulations 101.4(a)1 The Code of Federal Regulations (CFR) is a public government document and can be found, among other places, on the Internet. Go to http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

Section 21 of the CFR is the section that governs the food industry, and several articles within that section relate to the issue of food labeling. In general, 21 CFR is a helpful document for mashgichim to be familiar with because it provides details for the ingredients and processes pertinent to the types of manufacture that mashigichim see every day.

2) CFR 101.4b(1)

3) CFR 101.100

4) CFR 101.100(3) i

5) CFR 101.4b(2)

6) CFR 21.70(3)

7) CFR 101.4a(2)


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