Cosmetic Safety : What's Natural? Part 2

by Food and Drug Administration (FDA)

(Page 3 of 3)

Wilcox explains that for FDA to approve other methods, those methods will have to produce test results that can be reproduced in other labs. In addition, databases will have to correlate historical animal test results with newer lab results.

"Database development and cooperation [between industry and FDA] is pivotal to the validation process," says Wilcox.

The cosmetics industry has taken one step towards database development — the Cosmetic Ingredient Review. The basic purpose of the review is to gather information from the scientific literature and from company files on the safety of cosmetic ingredients and make that information publicly available.

FDA's division of toxicological review and evaluation is currently evaluating two alternatives for the Draize eye test. One is Eytex, manufactured by Ropak Corp., Irvine, Calif., a chemical assay that produces opacity similar to that of an animal cornea upon exposure to irritants. The other is vertebrate cell cultures from humans and mice.

But until alternatives have been scientifically verified, the option for animal testing must be available for new ingredients and new products, says Wilcox. "No one wants to think of animals being used for anything other than kindness and human companionship," he says. "But it's important that we continue to recognize the risk to human health if unreliable tests are used."

The Meaning of Makeup

Draize test: an animal test used to determine the effects of different substances on the eyes

fragrance: any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product

fragrance-free: products so labeled may still contain small amounts of fragrances to mask the fatty odor of soap or other unpleasant odors

hypoallergenic: cosmetics that are less likely to cause allergic reactions

in vitro: from the Latin meaning "in glass," in vitro tests do not involve the use of living vertebrate animals

lanolin: a natural extract of sheep wool used as a moisturizer, which is a common cause of allergic reactions but is rarely used in pure form

Natural: ingredients extracted directly from plants or animal products as opposed to being produced synthetically

Non-comedogenic: products so labeled do not contain common pore-clogging ingredients that could lead to acne

Parabens: (methyl-, propyl-, and butyl-) the most widely used preservatives in the United States, commonly used in shampoos, foundations, facial masks, hair-grooming aids, nail creams, and permanent wave products

Propylene glycol: the most common moisture-carrying vehicle in cosmetics other than water.

Beauty on the Safe Side

Besides never putting on makeup while driving, consumers should follow other precautions to protect themselves and the quality of their cosmetics:

• Keep makeup containers tightly closed except when in use.
• Keep makeup out of sunlight; light can degrade preservatives.
• Don't use eye cosmetics if you have an eye infection, such as conjunctivitis, and throw away all products you were using when you first discovered the infection.
• Never add any liquid to bring the product back to its original consistency. Adding water or, even worse, saliva could introduce bacteria that could easily grow out of control. "If it has lost its original texture and consistency," says McEwen, "the preservatives have probably broken down."
• Never share.
• Throw makeup away if the color changes or an odor develops. Preservatives can degrade over time and may no longer be able to fight bacteria.

"We don't have a hard and fast rule on [when to throw cosmetics out]," says McEwen. McEwen says makeup can be kept indefinitely as long as it looks and smells all right and the consistency doesn't change. "It would be difficult to have any kind of bacterial growth and not have it be noticeable," he explains.

However, Janice Teal, a microbiologist who heads the product and package safety division of Avon Products, Inc., disagrees. "Even after the preservatives have stopped working, you may not be able to see or smell anything different," she says.

She agrees with McEwen that there is no absolute date for discarding various products, but says Avon recommends that consumers throw mascara away after three months. They can keep other makeup products a few months longer.

"Mascara is our biggest concern because of the wand," she says. "Normally, the eye is a good barrier to bacteria, but one slip and that wand can scratch the cornea and introduce all kinds of bacteria."

Regulating Cosmetics

The Federal Food, Drug, and Cosmetic Act defines cosmetics as "articles other than soap which are applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance."

FDA has classified cosmetics into 13 categories:

• skin care (creams, lotions, powders, and sprays)
• fragrances
• eye makeup
• manicure products
• makeup other than eye (e.g., lipstick, foundation and blush)
• hair coloring preparations
• shampoos, permanent waves, and other hair products
• deodorants
• shaving products
• baby products (e.g., shampoos, lotions and powders)
• bath oils and bubble baths
• mouthwashes
• tanning products

It is against the law to distribute cosmetics that contain poisonous or harmful substances that might injure users under normal conditions. Manufacturing or holding cosmetics under insanitary conditions, using non-permitted colors, or including any filthy, putrid or decomposed substance is also illegal.

Except for color additives and a few prohibited ingredients, a cosmetic manufacturer may use any ingredient or raw material and market the final product without government approval. The prohibited ingredients are:

• biothionol
• hexachlorophene
• mercury compounds (except under certain conditions as preservatives in eye cosmetics)
• vinyl chloride and zirconium salts in aerosol products
• halogenated salicylanilides
• chloroform
• methylene chloride

Manufacturers must test color additives for safety and gain FDA approval for their intended use.

Cosmetic firms may voluntarily register their manufacturing plants with FDA, file cosmetic formulas, and report adverse reactions.

Cosmetics sold to consumers must bear labels that list ingredients in descending order of predominance. Trade secrets (as defined by FDA) and the ingredients of flavors and fragrances do not have to be specifically listed.

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.