Having had allergic reactions to several cosmetics, it was intriguing for me to review general literature regarding cosmetics. General physicians see several patients with allergies to cosmetics, but the real dilemma of the cosmetic world may not be clear to the general physician. I am certain that it is more than ever confusing to the general public.

In an article published from U.S. Food and Drug Administration "FDA-Consumer" of May-June 1998, with revisions made in May 1998 and August 2000¹, under the Federal food, drug and cosmetics (FD&C) act, cosmetics and their ingredients are not required to undergo approval before they are sold to the public. FDA is said to regulate these products after they have been released to the market. The manufacturers could use any raw material ingredient, except for color additives and a few prohibited substances, without being approved or reviewed by the government.

The Fair Packaging and Labeling Act requires the declaration of ingredients on every cosmetic product, and that the ingredients be listed in descending order of quantity (this being the reason why water is first on the list of moisturizers). Companies are not required to substantiate claims of performance or conduct safety testing. If the latter has not been substantiated, the product label must read "WARNING: the safety of this product has not been determined". The Cosmetic ingredient declaration regulations are said to apply to retail products, which are intended for home use but not to cosmetic samples, and products used exclusively by beauticians in salons, except that the product must state the name of the distributor, list the content's quantity and the required warning statements.

Cosmetics that make claims of therapeutic effects are regulated as drugs and cosmetics and have to meet the labeling requirements of both, where the "active ingredient" has to be listed as the first ingredient, e.g. medicated shampoos. It is required by the FDA that such products be proved to be scientifically safe and effective for the therapeutic claim. The list of ingredients prohibited, as published in publication no. (FDA) 98-5017², applies to these products.

An independent panel of scientific experts named Cosmetic Ingredient Review (CIR) Expert Panel regularly assesses the safety of many cosmetic ingredients and publishes the findings. The Cosmetic, Toiletry and Fragrance Association establish this panel. The report may be obtained on www.cir-safety.org. Familiarity of the list of such substances would enable the physicians and the public to review the presence of prohibited chemicals on the list of ingredients written on the labels of cosmetics. Color additives are strictly regulated to protect the consumers from harmful contaminants.

Although the FDA had tried to establish definitions for the terms used by the manufacturers of cosmetics, the court overturned it in 1977. Most cosmetics have terms such as natural, hypo allergenic, etc. on the labels, this could mean anything or nothing. They have very little medical meaning according to dermatologists. Terms such as dermatologist tested and allergy tested carry no guarantee that skin reactions will not occur.

An average adult uses at least seven different skincare products each day. The estimate of side effects from these products is reported as 0.021% of all people, as published in the article, "Cosmetics and Skin Care Products", on the American Academy of Dermatology 1999 Net online services³.

It has been reported that more than 5000 different fragrances are used in skincare products. Those labeled as unscented may contain fragrances to mask the odors of the chemicals used. The culprit of most allergic reactions is the fragrances and preservatives.

Since skin of the eyelids is the most sensitive skin of the body, most allergic reactions are seen in this region. Water-soluble eye cosmetics will reduce irritation rather than the waterproof counterpart. Although many companies label their products indicating that animals have not been used in testing, it has been found that the chemicals may be those which have been previously tested on animals and found to be safe.

As the previously used "Draize eye test" on animals has to be replaced, it would take a combination of alternative tests. The FDA is considering the following tests. One test is named EYTEX manufactured by Ropak Corporation of Irvine, California. This is a chemical assay test that produces opacity similar to that of an animal cornea exposed to irritants. The other test signifies the reactions of cosmetics on vertebrate cell cultures from humans and mice.

Most stringent rules may need to be applied on the cosmetics manufacturing industry, as it is important to establish the clear understanding of the nomenclature and the ingredients in cosmetics used so extensively by the public.

Wineetha S. Fernando, M. D.
Editor-In-Chief

References

1. Lewis, Carol Clearing up Cosmetic Confusion; Consumer FDA May-June 1998 Revisions May 1998, August 2000.
2. Prohibited Ingredients FDA Publication No. 98-5017.
3. Cosmetics and Skin Care Products American Academy of Dermatology 1999 Net On-Line Services.

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About the Editor
Wineetha S. Fernando, M. D., Editor in Chief, is an Associate Professor of Medicine of the American College of General Medicine.

This editorial represents the opinion of the Editor in Chief and does not reflect the official policy of the American Academy of General Physicians nor the institutions with which the Editor is affiliated.