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Collagen (from young cows) is the protein substance found in connective tissue. (Connective tissue binds together and supports organs and other body structures.) A great deal of research has been done on the different types and uses for collagen. In cosmetics, collagen has a moisturizing effect. It is not water soluble, but it holds water. FDA says there is no convincing evidence that collagen can penetrate the skin and have an effect below the surface.

Cerebrosides (from animals or plants) are a type of glycolipid (a chemically combined form of fatty substance and carbohydrate) produced naturally in basal epidermal cells — the deepest layer of skin. After cerebrosides are formed, they are secreted to the outside of the cells and serve as a protective coating. As new cells form in lower layers of skin, the older skin cells move closer to surface layers and start to dry out. During this process, the cerebrosides are chemically changed and form ceramides, part of a network of membranes between cells. Skin moisture and suppleness comes from this network.

The raw material for cerebrosides in cosmetics comes from cattle, oxen or swine brain cells or other nervous system tissues. Alternatively, the raw material may be isolated from plant sources. Industry cosmetic scientists claim that the use of cerebrosides in skin products results in a smoother skin surface and better moisture retention, effects that translate into marketing claims such as luminosity and ever-improving hydration. FDA has not evaluated the studies on which these claims are based.

Industry Self-Regulation

"The cosmetic industry is sensitive to the image of an uncontrolled market where anything goes," says Bailey. "They counter this image with well-established self-regulation programs. Part of the incentive for such industry policy is to avoid increased regulatory authority."

The most well-known of industry-sponsored self-regulation is the Cosmetic Ingredient Review, sponsored by the Cosmetic Toiletry and Fragrance Association. The CIR is accomplished by a panel of scientific and medical experts who evaluate cosmetic ingredients for safety and publish detailed reviews of available safety data. "A finding of safety by the CIR provides a degree of confidence that the ingredient can safely be used in cosmetics," Bailey says. "In the absence of the CIR program, there would be no systematic examination of the safety of individual cosmetic ingredients." FDA has no statutory authority to require that the data be submitted to the agency.

FDA encourages industry cooperation through its cosmetic voluntary reporting program. Cosmetic firms registered in the program voluntarily report manufacturing and formulation information, along with product experience data, to FDA. Adverse reactions such as skin irritations are also reported. Using this information, FDA can determine a baseline reaction rate for specific product categories such as hair coloring or eye makeup preparations. The agency gives participating companies this baseline information so they can compare their own adverse reaction rates to the FDA-established baseline.

"Registration in this voluntary program does not mean that FDA approves or endorses a firm, raw material, or product," says Mary Waleski, chief of the cosmetic registration program. "But it does provide for an interaction between the industry and government for exchange of information."

FDA would like to see wider industry participation. "Based on the number of companies we think are eligible to participate, only about 35 percent do," Waleski says. There are also other problems. "Sometimes the information a firm submits is incomplete," Waleski says. "And if a firm does not update its submissions with additions or deletions, the information in the registration files could accumulate as inaccurate information."

FDA continues to explore ways to make the program more useful for both industry and government, says Bailey. "We compare product information available to the agency with registered data, and now we're considering periodic field surveys of products on the shelves. Such a review would include comparison of label ingredient declarations with information reported to FDA."

The quest for sustained youth and beauty that sells cosmetics is age-old, though ingredients used to achieve that image may change. Shakespeare noted the same concern that keeps the cosmetic industry going when he said,

Time doth transfix the flourish set on youth
And delves the parallels in beauty's brow.

But he gave voice to another standard when he wrote,

To me, fair friend, you never can be old,
For as you were when first your eye I eyed,
Such seems your beauty still.

Tags: Skin Care

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.