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The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Soap products consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law.

The principal display panel, i.e., the part of the label most likely displayed or examined under customary conditions of display for sale (21 CFR 701.10), must state the name of the product, identify by descriptive name or illustration the nature or use of the product, and bear an accurate statement of the net quantity of contents of the cosmetic in the package in terms of weight, measure, numerical count, or a combination of numerical count and weight or measure.

The name and place of business of the firm marketing the product must be stated on an information panel of the label (21 CFR 701.12). The address must state the street address, city, state, and zip code. If a firm is listed in a current city or telephone directory, the street address may be omitted. If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase "Manufactured for ......" or "Distributed by ......" or similar, appropriate wording.

Cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration (21 CFR 701.3). Cosmetics not customarily distributed for retail sale, e.g., hair preparations or make-up products used by professionals on customers at their establishments and skin cleansing or emollient creams used by persons at their places of work, are exempt from this requirement provided these products are not also sold to consumers at professional establishments or workplaces for their consumption at home.

The ingredient declaration must be conspicuous so that it is likely to be read at the time of purchase. It may appear on any information panel of the package, i.e., the folding carton, box wrapping if the immediate container is so packaged, and may also appear on a firmly affixed tag, tape or card. The letters must not be less than 1/16 of an inch in height (21 CFR 701.3 (b)). If the total package surface available to bear labeling is less than 12 square inches, the letters must not be less than 1/32 of an inch in height (21 CFR 701.3(p)). Off-package ingredient labeling is permitted if the cosmetic is held in tightly compartmented trays or racks, it is not enclosed in a folding carton, and the package surface area is less than 12 square inches (21 CFR 701.3(i)).

The ingredients must be declared in descending order of predominance. Color additives (21 CFR 701.3(f)(3)) and ingredients present at one percent or less (21 CFR 701.3(f)(2)) may be declared without regard for predominance. The ingredients must be identified by the names established or adopted by regulation (21 CFR 701.3©); those accepted by the FDA as exempt from public disclosure may be stated as "and other ingredients" (21 CFR 701.3(a)).

Cosmetics which are also drugs must first identify the drug ingredient(s) as "active ingredient(s)" before listing the cosmetic ingredients (21 CFR 701.3(d)).

FDA is only able to regulate cosmetics after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by FDA before they are sold to the public.

FDA cannot require companies to do safety testing of their cosmetic products before marketing. If, however, the safety of a cosmetic product has not been substantiated, the product's label must read

"WARNING: The safety of this product has not been determined."

FDA does not have the authority to require manufacturers to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries. To keep abreast of such information, FDA maintains a voluntary data collection program. Cosmetic companies that wish to participate in the program forward data to FDA.

Recalls are voluntary actions taken by the cosmetic industry to call back products that present a hazard or that are somehow defective. FDA is not permitted to require recalls of cosmetics but does monitor companies that conduct a product recall. If FDA wishes to remove a cosmetic product from the market, it must first prove in a court of law that the product may be injurious to users, improperly labeled, or otherwise violates the law.

FDA collects cosmetic product samples as part of its plant inspections, import inspections, and follow-ups to complaints of adverse reactions. The agency does not, however, function as a private testing laboratory. FDA is prohibited from recommending private laboratories to consumers for sample analysis. Consumers may consult their local phone directory for testing laboratories.

FDA can inspect cosmetics manufacturing facilities, collect samples for examination, and take action through the Department of Justice to remove adulterated and misbranded cosmetics from the market. Domestic and foreign manufacturers must follow the same regulations. Foreign products that appear to be adulterated or misbranded may be refused entry into the United States.

Products that intend to treat or prevent disease, or otherwise affect the structure or functions of the human body, are considered drugs. Over-the-counter drugs are drugs that can be purchased without a doctor's prescription. Examples of products that are over-the-counter drugs are fluoride toothpastes, hormone creams, sunscreen preparations, antiperspirants, and antidandruff shampoos.

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.

Hypoallergenic cosmetics are products that manufacturers claim produce fewer allergic reactions than other cosmetic products. Consumers with hypersensitive skin, and even those with "normal" skin, may be led to believe that these products will be gentler to their skin than non-hypoallergenic cosmetics.

There are no Federal standards or definitions that govern the use of the term "hypoallergenic." The term means whatever a particular company wants it to mean. Manufacturers of cosmetics labeled as hypoallergenic are not required to submit substantiation of their hypoallergenicity claims to FDA.

The term "hypoallergenic" may have considerable market value in promoting cosmetic products to consumers on a retail basis, but dermatologists say it has very little meaning.

Since 1989, the Food and Drug Administration (FDA) has received more than 100 reports of adverse reactions in people using AHA products. Their complaints included severe redness, swelling (especially in the area of the eyes), burning, blistering, bleeding, rash, itching, and skin discoloration.

Considering the question of safety, FDA and dermatologists advise consumers who use AHA products to follow these precautions:

* Always protect your skin before going out during the day. Use a sunscreen product with a SPF (Sun Protection Factor) of at least 15. Wear a hat with a brim of at least 4 inches (about 10 centimeters). Cover up with lightweight, loose-fitting, long-sleeved shirts and pants.

* Buy products with adequate label information: for example, a list of ingredients to see which AHA or other chemical acids are in the product; the name and address of the manufacturer or distributor; and a statement about the product's AHA concentration and pH level. The first two pieces of information are mandatory; the third is optional. Consumers can call or write the manufacturer, however, to get information about a product's AHA concentration and pH level.

* Buy only products with an AHA concentration of 10 percent or less and a pH of 3.5 or greater.

* Do a skin-sensitivity test on a patch of skin if you are a first-time user of any AHA product or are using a different brand or a product with a different concentration or pH than you are use to.

* Stop using the product immediately if you experience adverse reactions (i.e. mild irritation, stinging, redness, itching, burning, pain, and bleeding or change in sun sensitivity).

* If you have an adverse reaction, see a dermatologist. You also can report your adverse reaction yourself to FDA. Reports can be made to local FDA offices, listed in the Blue Pages of the phone book or to the CFSAN Adverse Event Reporting System (CAERS) by phone at 301-436-2405 or email at [email protected].gov.

and this one

During the 1970's medical reports and complaints received from consumers by the Food Drug Administration (FDA) demonstrated that the use of children's bubble bath products was frequently associated with skin irritation and urinary tract infections; therefore, the FDA promulgated a regulation which requires that the label of children's foaming detergent bath products (bubble baths) bear the following warning statement.

"CAUTION: Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness, or itching occurs. Consult your physician if irritation persists".

Currently marketed children's bubble bath products should be safe under conditions of intended use; however, occasionally a sensitive individual may experience an adverse reaction. The purpose of the required warning statement is to advise the user who may experience such a reaction.

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