Cosmetic Ingredients: Understanding the Puffery

by Food and Drug Administration (FDA)

The lotion contained bovine albumin and the label claimed it would give a "face lift without surgery." The Food and Drug Administration said the claims caused the product to be a misbranded drug. In 1968, the court said no. "If lifting and firming products are deemed intended to affect the structure of the body, girdles and brassieres must be devices within the meaning of the law."

In 1969 an appellate court overturned this decision, but the issues persist today. "Most cosmetics contain ingredients that are promoted with exaggerated claims of beauty or long-lasting effects to create an image," says John E. Bailey, Ph.D., director of FDA's division of color and cosmetics. "Image is what the cosmetic industry sells through its products, and it's up to the consumer to believe it or not," Bailey says.

In the past, cosmetic manufacturers have depended upon mysterious "gimmick" additives, such as turtle oil to promote skin rejuvenation or tighten chin muscles, shark oil, queen bee royal jelly, chick embryo extract, horse blood serum, and pigskin extracts.

Promotion of these "gimmick" additives, combined with today's more sophisticated cosmetic ingredients, is what Bailey and the cosmetic industry call "puffery."

The argument is sometimes made that while Congress intended to safeguard the health and economic interests of consumers with the Federal Food, Drug, and Cosmetic Act, it also meant to protect a manufacturer's right to market a product free of excessive government regulation. And, in an industry that sells personal image, especially images of beauty and sex appeal, not allowing the puffery claims would certainly hurt the marketing, says Bailey.

But there's hope for credibility in claims for cosmetic ingredients. Some of the more responsible cosmetic firms are rethinking their claims that push believability to its outside edge. Linda Allen Schoen of Neutrogena says that today's more knowledgeable consumer wants "facts versus puffery — products based on skin care realities, promises banked on achievable benefits." Besides, says Schoen, limited recession dollars tend to be spent on products consumers can trust.

Still, with the exception of colors and certain prohibited ingredients, a cosmetic manufacturer may use essentially any raw material in a product and market it without prior FDA approval. The prohibited ingredients are biothionol, hexachlorophene, mercury compounds (except as preservatives in eye cosmetics), vinyl chloride and zirconium salts in aerosol products, halogenated salicylanilides, chloroform, and methylene chloride.

Federal regulations require ingredients to be listed on product labels in descending order by quantity, but often the list is not user-friendly. Because cosmetic ingredients are often complex chemical substances, the list may be incomprehensible to the product's average user. (See "Cosmetic Safety: More Complex Than at First Blush" in the November 1991 FDA Consumer.) However, if the same name is used by all manufacturers, consumers can compare different products and make reasonable value judgments.

Although cosmetic claims, even those considered "puffery," are allowed without scientific substantiation, if a cosmetic makes a medical claim, such as removing dandruff, the product is regulated as an over-the-counter drug for which scientific studies demonstrating safety and effectiveness must be submitted to FDA.

Baffling Names

Because of the unusual and sometimes bewildering nature of some ingredients in cosmetics, consumers often ask FDA for explanations. "My night cream contains liposomes — what is that?" "Why is placenta used in cosmetics — is it human placenta, and could I get a disease from it?" "What are cerebrosides and ceremides?"

FDA cosmetic scientists can explain the nature of an ingredient when it is identified by its chemical name. But when an ingredient is listed by its trade name, FDA usually must consult the manufacturer's trade literature or the International Cosmetic Ingredient Dictionary, published by the Cosmetic, Toiletry, and Fragrance Association, Inc., the industry's major trade association. The dictionary, now in its fourth edition, provides a uniform system for assigning ingredient names. FDA currently recognizes the second edition as a primary reference.

Here is what FDA knows about some currently marketed ingredients:

Liposomes are microscopic sacs, or spheres, manufactured from a variety of fatty substances, including phospholipids. While phospholipids are natural components of cell membranes, the material actually used in cosmetics may be obtained either from natural or synthetic sources. When properly mixed with water, phospholipids form liposome spheres, which can "trap" any substance that will dissolve in water or oil.

Manufacturers say that liposomes act like a delivery system. They claim that, when present in a cream or lotion, liposomes can more easily penetrate the surface skin to underlying layers, "melt," and deposit other ingredients of the product.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.