A new regulation requires that instead of generalized names such as animal fat, vegetable oil, and shortening, labels on processed food will have to tell consumers the common or usual name of the fats and oils in the product, such as lard, or coconut oil, or a shortening made of beef fat and soybean oil.

by Harold Hopkins

E

ven if the customer is not always right, he knows what he wants, and that settles the matter. This simple logic was the controlling factor in FDA's final adoption of a regulation to require that the consumer be given more specific information on labels about the kinds of fats and oils in processed foods. The regulation, published in the FEDERAL REGISTER January 6, 1976, effectively rescinds an FDA moratorium on this requirement that has been in effect since 1940.

Some comments from the food industry opposing the newly adopted requirements had argued that the consumer doesn't quite understand the situation, that the additional information FDA contemplates for the label would confuse the purchaser, that fats and oils information is a complex matter better left to doctors, that the consumer might misinterpret

and misuse the information he does get, that the public has been misled by news articles advocating more detailed fat labeling, that much of the new information proposed for labels is immaterial or of no use to the layman, and that providing it would be difficult and cost the consumer money.

FDA didn't turn a deaf ear to these arguments, but merely pointed to the large pile of comments from irked and frustrated consumers, and said it believes the the food business will be able to comply with the new requirements without most of the unhappy consequences predicted by some food industry representatives.

The new label information will be required for all processed foods entering interstate commerce on or after January 1, 1978, but will be permitted on labels at any time before then. The regulation will require the listing on labels of fat or oil ingredients by their common or usual names, such as lard, or coconut oil, or beef fat and soybean oil shortening blend, instead of the more generalized names now permitted, such as animal fat, vegetable oil, or shortening. The more generalized names would still be permitted, but only when accompanied by a parenthetical listing of the common or usual names of the oils or fats.

Consumers and some physicians

who commented held that many persons are allergic to specific fats and oils in processed foods and that label information is needed about these substances. Other comments said information is needed to make it possible to choose foods containing fats or oils known to be high in polyunsaturated or low in saturated fatty acids. Still others who commented said they need the information for religious reasons or personal preference, or that they are entitled to it because of their basic right to know.

In announcing adoption of the regulation, Commissioner of Food and Drugs Alexander M. Schmidt, M.D., said: "Consumers have a basic right to know the source of fats and oils in the foods they eat, and have overwhelmingly requested that the labeling of fats and oils be more specific." He said consumers "will now be better able to follow doctors' orders to restrict certain kinds of fats and oils in the diet. They will also be able to select the fats and oils they wish to consume for health and religious reasons and personal preference."

The regulation will require use of the term "saturated" or "partially saturated," where applicable, instead of "hydrogenated" for labeled descriptions of fats or oils that have been hydrogenated. Hydrogenated means that the fats or oils have been treated

with hydrogen to convert them from a liquid to a solid form. FDA said it believes "saturated" has become a more familiar term to consumers than "hydrogenated." The word "hardened" will be permitted in parentheses after the word "saturated" as an explanation of the processor's reason for the hydrogenation.

Polyunsaturated and saturated refer to the molecular structure of various fats and oils. The terms may be significant to consumers because some doctors have suggested that a diet high in saturated fats tends to cause an increase in the blood's level of cholesterol, a fat soluble substance contained in foods of animal origin and manufactured by nearly all body tissues. This concern has been about a heart disease condition called atherosclerosis, produced by deposits of cholesterol and other fatty substances on the inner walls of arteries, restricting blood flow.

Although factors other than diet are associated with heart disease, some medical authorities believe that many people would receive health benefit by reducing their total consumption of fat and by substituting moderate amounts of polyunsaturated vegetable fat for some of the saturated fats in

their diets. (Polyunsaturated fats are often saturated or hardened in refining processes). FDA takes no position and has made no recommendations on this question but in its nutrition labeling regulations permits manufacturers to provide information on food labels about the calories contributed by fat to a specific food and its content of polyunsaturated and saturated fats and cholesterol. Such information permits individuals to follow a physician's advice to modify their dietary intake of fat and cholesterol.

In adopting the requirement for more specific names of oils and fats, FDA noted that in 1940 it granted exemptions permitting the more generalized or class names on labels, but warned then that these names might at some future time no longer be satisfactory. Consumer comments have now shown such dissatisfaction, FDA said, and the 1940 exemptions are being rescinded when the new regulation takes effect.

Fats or oils must be listed in the ingredient statement in descending order of predominance, except where blends of fats or oils are used. In this case, the blend may be listed in its order of predominance, such as “animal fat and vegetable shortening"

or "blend of vegetable oils," followed in parentheses by a listing of the fats or oils in the blend by their common or usual names, such as "lard" or "peanut oil." If the blend of fats or oils is the predominant ingredient in the food, then the parenthetical listing must be in order of predominance. If the blend is not the predominant ingredient, the parenthetical listing need not be in order of predominance and may include fats or oils that are not always present if they are identified by such words as "or" or "and/or" to indicate that they may not be present.

In addition to the new requirements for labeling of fats and oils, the regulation permits class names to be used on ingredient labels to embrace various forms of certain milk or egg products. For instance, fresh whole milk, concentrated milk, reconstituted milk, and dry whole milk may all be declared simply as milk. Similar simplified class terms are permitted for various forms of skim milk, buttermilk, whey, cream, butterfat, eggs, egg whites, and egg yolks.

Harold Hopkins is editorial director of FDA CONSUMER.

osmetics may come in small pack

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ages, but they are big business. Americans spend about $7 billion a year on cosmetics-everything from toothpaste to cuticle softener. Products that are classified as cosmetics include shampoos and suntan lotions, deodorants and douches, night creams and nail polish-and hundreds of others. Though cosmetics used to be thought of as a "woman's world," the market now includes many products promoted strictly for men, and many even for children.

Most consumers use these products without any thought of hazard, and usually there is none. But a study conducted for FDA shows that adverse reactions to cosmetics occur far more frequently than had been assumed in the past. (The study included bath soaps, many of which are not classified as cosmetics under the Food, Drug, and Cosmetic Act and thus are exempt from FDA regulation, and antiperspirants, which are classified by FDA as over-the-counter drugs because their purpose is to alter a bodily function. These products were included in the survey because many consumers consider them cosmetics and advertisements for them often emphasize their cosmetic effects.)

The study, begun in September 1974, was the first attempt by a Federal agency to obtain information directly from consumers and to verify detailed information on the use of cosmetics and injuries associated with their use. FDA usually receives its information about the extent of adverse reactions to cosmetics through consumer complaints, voluntary industry reports, and reports from hospitals. Each of these sources has limitations as a reporting device.

Consumers usually do not report adverse reactions from cosmetics to FDA or to the manufacturer, and neither do the physicians who treat them. Cosmetics manufacturers have been reluctant to pass on information to FDA concerning complaints from consumers about adverse reactions. Although FDA has developed voluntary industry programs in an effort to obtain more complete information on consumer injuries related to use of cosmetics, the response has not been sufficient to provide reliable data. In 1975, only 123 cosmetics manufacturers and distributors, from an industry total of about 4,000 firms, voluntarily supplied to FDA any 1974 consumer reports of adverse reactions. The hospital reports provide informa

tion only on cosmetic-related adverse reactions treated in emergency rooms.

Because of the limitations of these sources and the need for better information to serve as the basis for regulatory policy decisions, FDA undertook a study to collect data on the frequency and types of cosmetic-related adverse reactions experienced by consumers. A panel of consumers was selected for the study. FDA wanted to determine the extent to which adverse reactions reported by these consumers were verified by physicians as being cosmetic-related, and the severity of the reactions. FDA also wanted information on the overall usage patterns of cosmetics, and the incidence of adverse reactions from the various types of cosmetics used.

According to the study, a high percentage of the adverse reactions reported by participants was confirmed by dermatologists as being definitely or most probably caused by use of cosmetics. On the basis of this finding, FDA believes that the reporting by consumers of adverse reactions to cosmetics can be considered by and large reliable. Moreover, the relatively high incidence of confirmed adverse reactions among study participants, when compared to industry-reported data,

suggests that only a small fraction of the adverse reactions actually experienced by consumers are reported to the industry, and by the manufacturers to FDA.

When considering the study's findings, it should be noted that the participating consumers were not selected at random, but were a carefully chosen panel of people who had demonstrated in previous consumer behavior studies that they would be dependable reporters, and who indicated a willingness to supply information on their use of cosmetics. The makeup of the panel, however, closely resembled the 1970 Census in regard to the socio-economic characteristics of the U.S. population as a whole.

The findings are based on cosmetics use and adverse reactions reported for a period covering September through November 1974. Since the panel was not randomly selected and the study covered a specific three-month period,

the findings cannot be statistically projected to the entire population, or to annual usage of cosmetics. Nevertheless, because of the similarity of the panel structure to the population as a whole, the findings do provide overall perspective on the nature and extent of cosmetic-related injuries.

A consumer panel of 10,050 families located throughout the United States was recruited for the study. The total number of individual family members in the study was 35,490.

The 35,490 study participants reported 703 adverse reactions that they believed resulted from the use of cosmetics. Of this number, 589 or 84 percent were confirmed by dermatologists as definitely or most probably caused by cosmetic products. Virtually all of the adverse reactions involved skin irritations or related problems.

Of the 589 confirmed adverse reactions, the vast majority, about 86 percent, were considered mild; about 11

percent were classified as moderate; and less than 3 percent as severe.

For purposes of the study, a mild adverse reaction was defined as a minor irritation that would not require medication or a physician's attention; a moderate reaction was defined as one that persisted for a prolonged period and could cause loss of time from normal activities; and a severe reaction was defined as being painful and severe enough to ordinarily require a physician's evaluation and which would result in a loss of time from normal activities.

The type of cosmetic product that caused the largest number of adverse reactions reported by study participants and confirmed by physicians was the deodorant/antiperspirant group, with 182 incidents. Soap was the category showing the second highest number of reactions, with 74 confirmed incidents. Hair spray/lacquer ranked third, with 29 confirmed ad

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verse reactions reported. It should be noted that soap was used by more study participants than any other type of cosmetic and the deodorant/antiperspirant group ranked third in terms

of use.

When the rate of adverse reactions is measured, however, the picture is somewhat different. The rate is based on the number of adverse reactions caused by a certain type of product in relation to the number of people using it. The ten categories showing the highest rate of adverse reactions were: deodorant/antiperspirants; depilatories (chemical hair removers); moisturizer/lotion; hair spray/lacquer; mascara; bubble bath; eye cream; hair color/dye lightener; facial skin cream/ cleaner; and nail polish.

The overall average rate of 6.9 confirmed adverse reactions per 10,000 users of cosmetic products for a onemonth period constitute a substantially higher rate of adverse reactions to cos

metics than any data in the past have suggested. Two new FDA regulations should help consumers use cosmetics with a greater degree of safety. One of these requires that cosmetics manufactured after November 30, 1976, must carry a list of their ingredients on the product label. If a consumer knows a certain substance has caused a problem in the past, he or she can avoid products that contain it.

The second regulation deals with socalled hypoallergenic cosmetics. Many cosmetic products claim to be "hypoallergenic," implying they are safer to use by people who have had allergic reactions to cosmetics. In the past, however, the term has had no uniform meaning and usually no proof was available demonstrating the implied lower potential for adverse reactions of products calling themselves hypoallergenic. The FDA regulation, originally scheduled to become effective in June 1975, would require proof before

a manufacturer can label a cosmetic "hypoallergenic." The effective date has been delayed, however, because two cosmetic manufacturers have entered suit in a U.S. district court against the FDA and this regulation.

Meanwhile, consumers should realize that while most cosmetics are safe when used properly, there is a potential for adverse reactions, even from products that they have used many times before. The best precaution is to read the label on cosmetic products and carefully follow the directions for use, including making a "patch test" if one is recommended or if the user has a history of allergic reactions. And if adverse reactions do occur, they should be reported to FDA and to the cosmetic firm whose name is noted on the label of the product.

Margaret Morrison is a staff writer with FDA's Office of Public Affairs.