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Posted on Nov 22, 2010
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How are the FDA and cosmetics manufacturers working together to ensure consumer safety?

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The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market. However, cosmetics must not be adulterated or misbranded.
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  • Posted on Nov 22, 2010
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Consumer safety is the number one priority for cosmetic and personal care products companies, and manufacturers are committed to upholding strict FDA regulations as required by the U.S. Food, Drug, and Cosmetic Act (FD&C Act). The law requires that every cosmetic and personal care product and its ingredients be substantiated for safety before going to market, and that they contain no prohibited ingredients. Cosmetic companies take their safety responsibility very seriously and often surpass the requirements of the law with additional consumer safety measures.

Consumers must have confidence in the products they buy and use each day. Toward that end, cosmetic and personal care products companies invest substantial resources in scientific research and safety processes to ensure the safety of their products. Companies work with and employ thousands of chemists, toxicologists, biologists, environmental scientists and other experts to evaluate the safety of cosmetic products before they go to market.
As a result, of the more than 11 billion personal care products sold each year in the United States, there are very few adverse experiences reported to the FDA in a typical year, and of those reported, most are related to rashes or allergies. Cosmetic companies' strong commitment to safety has made cosmetic and personal care products the safest product category regulated by the FDA.

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Related Questions:

0helpful
1answer

Who tests the content of the supplements?

The supplement companies are required to test their own products and make sure that the supplement facts and ingredient list are correct. The FDA does not evaluate supplements and it is under the sole responsibility of the supplement companies to make sure that their supplements are safe.

0helpful
1answer

Does maybelline use lead in their product???

Maybelline is owned by L'Oreal.And yes they do use lead . Cosmetics are not subject to pre-market approval by FDA. However, pre-market approval is required for the color additives used in cosmetics (including those in lipsticks) and other FDA-regulated products (with the exception of coal-tar hair dyes). To learn more on this subject, please refer to FDA Authority Over Cosmetics1.
0helpful
1answer

Is the safety of a cosmetic product evaluated once it hits the market?

Cosmetic safety reassurance does not end once a product is placed in the marketplace. Companies engage in ongoing, active monitoring of consumer experience to confirm cosmetic product safety.

Cosmetic and personal care product manufacturers have established post-market surveillance processes for the identification of potential safety issues related to their products. Such systems help to identify consumer use patterns, such as alternate uses or product combinations that may contribute to adverse events. These processes include regular surveys of consumer contacts received by a marketer or manufacturer either through toll-free 1-800 numbers on packages or direct correspondence.

Trend analyses of contact data, including evaluations of frequency and severity of adverse events, as well as comparison of these trends with historical information for other comparable products, also represent valuable mechanisms for identification of safety-related concerns. Although adverse reactions that are both serious and unexpected are extremely rare for cosmetic and personal care products, manufacturers must report knowledge of any instances of serious product reactions to the U.S. Food and Drug Administration.
0helpful
1answer

What actions can the FDA take against manufacturers that produce and market unsafe cosmetics?

Consumer safety is the number one priority for cosmetic and personal care products companies, and manufacturers are committed to upholding strict FDA regulations as required by the U.S. Food, Drug, and Cosmetic Act (FD&C Act). The law requires that every cosmetic and personal care product and its ingredients be substantiated for safety before going to market, and that they contain no prohibited ingredients. Cosmetic companies take their safety responsibility very seriously and often surpass the requirements of the law with additional consumer safety measures.

Consumers must have confidence in the products they buy and use each day. Toward that end, cosmetic and personal care products companies invest substantial resources in scientific research and safety processes to ensure the safety of their products. Companies work with and employ thousands of chemists, toxicologists, biologists, environmental scientists and other experts to evaluate the safety of cosmetic products before they go to market.

As a result, of the more than 11 billion personal care products sold each year in the United States, there are very few adverse experiences reported to the FDA in a typical year, and of those reported, most are related to rashes or allergies. Cosmetic companies' strong commitment to safety has made cosmetic and personal care products the safest product category regulated by the FDA.
0helpful
2answers

Doesn’t the government certify that personal care products are safe and healthy before they can be sold to consumers?

No. Major loopholes in federal law allow the $50 billion cosmetics industry to put unlimited amounts of chemicals into personal care products with no required testing, no required monitoring of health effects, and inadequate labeling requirements.

Neither cosmetic products nor cosmetic ingredients are reviewed or approved by the Food and Drug Administration (FDA) before they are sold to the public. FDA cannot require companies to do safety testing of their cosmetic products before marketing
0helpful
1answer

Who regulates cosmetics in the U.S. and under what laws?

The marketing of cosmetics in the U.S. is regulated by the Office of Cosmetics and Colors within the
Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition pursuant to the
Federal Food, Drug, and Cosmetic Act (FFDCA)2 and the Fair Packaging and Labeling Act.
0helpful
1answer

Are cosmetics safe?

Yes, for the most part. Serious problems from cosmetics are rare. But sometimes problems can happen.

The most common injury from cosmetics is from scratching the eye with a mascara wand. Eye infections can result if the scratches go untreated. These infections can lead to ulcers on the cornea (clear covering of the eye), loss of lashes, or even blindness. To play it safe, never try to apply mascara while riding in a car, bus, train, or plane.

Sharing make-up can also lead to serious problems. Cosmetic brushes and sponges pick up bacteria from the skin. And if you moisten brushes with saliva, the problem can be worse. Washing your hands before using make-up will help prevent this problem.

Sleeping while wearing eye make-up can cause problems too. If mascara flakes into your eyes while you sleep, you might wake up with itching, bloodshot eyes, infections, or eye scratches. So be sure to remove all make-up before going to bed.

Cosmetic products that come in aerosol containers also can be a hazard. For example, it is dangerous to use aerosol hairspray near heat, fire, or while smoking. Until hairspray is fully dry, it can catch on fire and cause serious burns. Fires related to hairsprays have caused injuries and death. Aerosol sprays or powders also can cause lung damage if they are deeply inhaled into the lungs.

To find out more about cosmetic safety, please visit FDA's cosmetics safety section at http://www.fda.gov/Cosmetics/ProductandIngredientSafety/default.htm.
0helpful
1answer

What is the shelf life of cosmetics?

The shelf life for eye-area cosmetics is more limited than for other products. Because of repeated microbial exposure during use by the consumer and the risk of eye infections, some industry experts recommend replacing mascara 3 months after purchase. If mascara becomes dry, discard it. Do not add water or, even worse, saliva to moisten it, because that will introduce bacteria into the product. If you have an eye infection, consult a physician immediately, stop using all eye-area cosmetics, and discard those you were using when the infection occurred.

Among other cosmetics that are likely to have an unusually short shelf life are certain "all natural" products that may contain plant-derived substances conducive to microbial growth. It also is important for consumers and manufacturers to consider the increased risk of contamination in products that contain non-traditional preservatives, or no preservatives at all.

Consumers should be aware that expiration dates are simply "rules of thumb," and that a product's safety may expire long before the expiration date if the product has not been properly stored. Cosmetics that have been improperly stored - for example, exposed to high temperatures or sunlight, or opened and examined by consumers prior to final sale - may deteriorate substantially before the expiration date. On the other hand, products stored under ideal conditions may be acceptable long after the expiration date has been reached.

Sharing makeup increases the risk of contamination. "Testers" commonly found at department store cosmetic counters are even more likely to become contaminated than the same products in an individual's home. If you feel you must test a cosmetic before purchasing it, apply it with a new, unused applicator, such as a fresh cotton swab.
0helpful
1answer

Does FDA specifically require that cosmetics or their ingredients be tested on animals?

No. In contrast to most other products regulated by FDA, cosmetics and their ingredients are not subject to specific testing requirements or pre-market approval by the agency. However, the FFDCA broadly prohibits the marketing of "adulterated" or "misbranded" cosmetics, including any product
(other than a hair dye) that "bears or contains any poisonous or deleterious substance which may render it injurious to users...."4-5 In other words, cosmetic manufacturers are responsible for assuring the safety of their products and the ingredients they use, but are not required to use animal tests to do so.
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