Clearing Up Cosmetic Confusion 
    
     This article originally appeared in the May-June 1998
      FDA Consumer. The version below is from a reprint of
      the original article and contains revisions made in May 1998.
    
   
    
    by Carol Lewis
    
     Cosmetics run the gamut from eye shadow to deodorant sprays. And
      consumers' concerns and questions are just as varied as the products
      themselves.
    
     "Consumers are so confused by the products out there because they
      all do so many different things," says Lynn Reniers, a licensed
      cosmetologist with Elizabeth Arden. "So it's important to send them
      away with a very clear understanding of product usage."
    
     When FDA surveyed 1,687 consumers ages 14 and older in 1994 about their
      use of cosmetics, many of the responses pertained to consumer perceptions
      about cosmetic labeling claims. For example, many said they expect a
      product to prevent or slow the formation of wrinkles if it makes such a
      claim on its packaging. And nearly half of those surveyed felt that a
      product claiming to be "natural" should contain all natural
      ingredients. But do these products live up to their labeling claims?
    
     Not necessarily. John Bailey, Ph.D., director of FDA's Office of
      Cosmetics and Colors, says, "Image is what the cosmetics industry
      sells through its products, and it's up to the consumer to believe the
      claims or not."
    
     Behind the image, however, are real products, and consumers want to
      know what works and what doesn't.
    
     An understanding of FDA's cosmetic responsibilities can help consumers
      make wise, rational decisions about the cosmetics they buy.
    
     Regulatory Authority
    
     The regulatory requirements governing the sale of cosmetics are not as
      stringent as those that apply to other FDA-regulated products. Under the
      Federal Food, Drug, and Cosmetic (FD&C) Act, cosmetics and their
      ingredients are not required to undergo approval before they are sold to
      the public. Generally, FDA regulates these products after they have been
      released to the marketplace. This means that manufacturers may use any
      ingredient or raw material, except for color additives and a few
      prohibited substances, to market a product without a government review or
      approval.
    
     But some regulations do apply to cosmetics. In addition to the FD&C
      Act, the Fair Packaging and Labeling Act requires an ingredient
      declaration on every cosmetic product offered for sale to consumers. In
      addition, these regulations require that ingredients be listed in
      descending order of quantity. Water, for example, accounts for the bulk of
      most skin-care products, which is why it usually appears first on these
      products.
    
     Although companies are not required to substantiate performance claims
      or conduct safety testing, if safety has not been substantiated, the
      product's label must read "WARNING: The safety of this product has
      not been determined."
    
     "Consumers believe that 'if it's on the market, it can't hurt me,'"
      says Bailey. "And this belief is sometimes wrong."
    
     FDA's challenge comes in proving that a product is harmful under
      conditions of use or that it is improperly labeled. Only then can the
      agency take action to remove adulterated or misbranded products from the
      marketplace.
    
     The Fine Line Between Cosmetics and Drugs
    
     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. This definition includes skin-care creams, lotions, powders and
      sprays, perfumes, lipsticks, fingernail polishes, eye and facial makeup,
      permanent waves, hair colors, deodorants, baby products, bath oils, bubble
      baths, and mouthwashes, as well as any material intended for use  as a
      component of a cosmetic product.
    
     Products that intend to treat or prevent disease, or otherwise affect
      structure or function of the human body are considered drugs. Cosmetics
      that make therapeutic claims are regulated as drugs and cosmetics, and
      must meet the labeling requirements for both. A good way to tell if you're
      buying a cosmetic that is also regulated as a drug is to see if the first
      ingredient listed is an "active ingredient." The active
      ingredient is the chemical that makes the product effective, and the
      manufacturer must have proof that it's safe for its intended use. For
      products that are both drugs and cosmetics, the regulations require that
      active ingredients be listed first on these products, followed by the list
      of cosmetic ingredients in order of decreasing predominance.
    
     Examples of products that are both cosmetics and drugs are dandruff
      shampoos, fluoride toothpastes that fight tooth decay,
      antiperspirants/deodorants, and sunblocking/tanning preparations,
      including foundations that contain sunscreens.
    
     Before products with both a cosmetic and drug classification can be
      marketed, they must be scientifically proven safe and effective for their
      therapeutic claims. If they are not, FDA considers them to be misbranded
      and can take regulatory action.
    
     Reading Is Believing 
    
     The ingredient list on a cosmetic container is the only place where a
      consumer can readily find out the truth about what he or she is buying.
      Consumers can check the listing to identify substances they wish to avoid.
      And becoming familiar with what cosmetics contain can help counter some of
      the alluring appeal showcased elsewhere on the product.
    
     "Our best friend is the ingredient label," says beauty
      consultant and 14-year veteran consumer reporter Paula Begoun. "And
      spending the time to read it may be all that is needed to protect
      ourselves from hurting our skin."
    
     But the ingredient list, although a mandatory requirement on cosmetics,
      is also the most difficult part of the label to understand. Bailey admits
      that most of us don't recognize the names of the ingredients listed
      because there are thousands available to chemists creating a wide variety
      of products. But there's no way to change that, he says, and still
      accurately identify the substances that are used.
    
     Consumers can, however, obtain specific information about a cosmetic
      ingredient in various references, such as the International Cosmetic
      Ingredient Dictionary and Handbook, published by the Cosmetic, Toiletry,
      and Fragrance Association, available at most public libraries or at the
      Office of the Federal Register, 1100 L St., N.W., Washington, DC 20408.
      FDA recognizes the association as a reliable source of substances that
      have been identified as cosmetic ingredients, as well as their definitions
      and trade names.
    
     Cosmetic ingredient declaration regulations apply only to retail
      products intended for home use. Cosmetic samples and products used
      exclusively by beauticians in salons and labeled "For Professional
      Use Only" are not required to include the ingredient declaration.
      However, these products must state the distributor, list the content's
      quantity, and include all necessary warning statements.
    
     They Can Be Irritating
    
     Almost all cosmetics can cause allergic reactions in certain
      individuals. Often the first sign of a reaction is a mild redness and
      irritation. There is no list of ingredients that can be guaranteed not to
      cause allergic reactions, so consumers who are prone to allergies should
      pay careful attention to what they use on their skin.
    
     Nearly one-quarter of the people questioned in FDA's 1994 cosmetics
      survey responded "yes" to having suffered an allergic reaction
      to personal care products, including moisturizers, foundations, and eye
      shadows.
    
     "Because of the almost limitless combinations in all sorts of
      mixtures and formulations, it is virtually impossible to know if, when, or
      how anyone's skin will react to any cosmetic," Begoun says. She
      advises consumers to "buy with a healthy dose of skepticism,"
      and to stop using an offending product and return it to the place of
      purchase. "Returning the product gives the cosmetics company
      essential information about how these formulas are working."
    
     What Lies Behind the Meaning
    
     FDA has tried to establish official definitions for the use of certain
      terms such as "natural" and "hypoallergenic," but its
      regulations were overturned in court. So companies can use them on
      cosmetic labels to mean anything or nothing at all. Most of the terms have
      considerable market value in promoting cosmetic products to consumers, but
      dermatologists say they have very little medical meaning.
    
     Some of the more common terms that consumers should be aware of
      include:
    
       Natural: implies that ingredients are extracted directly from plants
        or animal products as opposed to being produced synthetically. There is
        no basis in fact or scientific legitimacy to the notion that products
        containing natural ingredients are good for the skin. 
       Hypoallergenic: implies that products making this claim are less
        likely to cause allergic reactions. There are no prescribed scientific
        studies required to substantiate this claim. Likewise, the terms "dermatologist-tested,"
        "sensitivity tested," "allergy tested," or "nonirritating"
        carry no guarantee that they won't cause skin reactions.
       Alcohol Free: traditionally meant that certain cosmetic products do
        not contain ethyl alcohol (or grain alcohol). Cosmetic products,
        however, may contain other alcohols, such as cetyl, stearyl, cetearyl,
        or lanolin, which are known as fatty alcohols. 
       Fragrance Free: implies that a cosmetic product so labeled has no
        perceptible odor. Fragrance ingredients may be added to a fragrance-free
        cosmetic to mask any offensive odor originating from the raw materials
        used, but in a smaller amount than is needed to impart a noticeable
        scent. 
       Noncomodogenic: suggests that products do not contain common
        pore-clogging ingredients that could lead to acne. 
       Shelf Life (Expiration Date): the amount of time for which a
        cosmetic product is good under normal conditions of storage and use,
        depending on the product's composition, packaging, preservation, etc.
        Expiration dates are, for practical purposes, a rule of thumb, and a
        product may expire long before that date if it has not been stored and
        properly handled. 
       Cruelty Free: implies that products have not been tested on animals.
        Most ingredients used in cosmetics have at some point been tested on
        animals so consumers may want to look for "no new animal testing,"
        to get a more accurate indication.
    
    
     The list of ingredients, once again, can help consumers determine if
      there is any significant difference between products labeled similar to
      the above, and competing brands that don't make these claims.
    
     Since the cosmetics industry often produces new, reworked versions of
      old ingredients, a wise consumer will take the time to read the labels to
      know what's in a product and how to use it safely. After all, consumers
      are likely to try other products with the same recognizable names. Once
      you have all the information, you can begin to make your own decisions
      about what products work best for you.
    
     "There is really very little that's new under the sun,"
      Bailey concludes, "and that certainly applies to cosmetics."
    
     Carol Lewis is on assignment with FDA's Office of Public
      Affairs.
    
     
    
    
    Beauty on the Safe Side
    
    Serious injury from makeup is a rare occurrence, according to John
      Bailey, director of FDA's Office of Cosmetics and Colors. But it does
      happen. Good common sense and a few precautions can help consumers protect
      themselves against hazards associated with the misuse of cosmetics.
    
       Never drive and apply makeup. Not only does it make for dangerous
        driving, but hitting a bump in the road and scratching your eyeball can
        cause bacteria to contaminate the cut and could result in serious
        injury, including blindness. 
       Never share makeup. Always use a new disposable applicator when
        sampling products at a cosmetics counter. Insist that salespersons clean
        container openings with alcohol before applying their contents to your
        skin. 
       Never add liquid to a product to bring back its original
        consistency. Adding other liquids could introduce bacteria that can
        easily grow out of control. 
       Stop using any product that causes an allergic reaction. 
       Throw away makeup if the color changes or an odor develops.
        Preservatives degrade over time and may no longer be able to fight
        bacteria. 
       Do not use eye makeup if you have an eye infection. Throw away all
        products you were using when you discovered the infection. 
       Keep makeup out of sunlight. Light and heat can degrade
        preservatives. 
       Keep makeup containers tightly closed when not in use. 
       Never use aerosol beauty products near heat or while smoking because
        they can ignite. Hairsprays and powders may cause lung damage if inhaled
        regularly.
    
    
    --C.L.
    
     
    
    
    Helping the Buyer Beware
    
    Despite many questions about their safety, alpha hydroxy acids (AHAs)
      and beta hydroxy acids (BHAs) have become widely used in recent years.
      AHAs are derived from fruit and milk sugars, and are among the popular
      ingredients that attract customers with their claims to reduce wrinkles
      and age spots, and help repair sun-damaged skin. (See "Alpha Hydroxy
      Acids" in the March-April 1998 FDA Consumer.)
    
     FDA recommends that consumers take precautions with AHA and BHA
      products:
    
       Test any AHA/BHA-containing product on a small area of skin before
        applying to a larger area. 
       Avoid the sun when possible. 
       Use an effective sunscreen when using an AHA-containing product,
        even if you haven't used the product that day. 
       Follow use instructions on the label. 
       Do not exceed recommended applications. 
       Do not use on infants and children. 
    
    
    --C.L.
    
     
    
    
    Prohibited Ingredients
    
    The following ingredients, because of the dangers they impose, are
      either restricted or prohibited by regulation for use in cosmetics:
    
       bithionol 
       mercury compounds 
       vinyl chloride 
       halogenated salicylanilides 
       zirconium complexes in aerosol cosmetics 
       chloroform 
       methylene chloride 
       chlorofluorocarbon propellants 
       hexachlorophene 
       methyl methacrylate monomer in nail products 
    
    
    --C.L.
    
      Consumers should report cosmetic adverse reactions by calling their
      local FDA office, listed in the Blue Pages of the telephone book, or FDA's
      Office of Consumer Affairs at 1-800-532-4440. More information on
      cosmetics is available by calling the Office of Cosmetics and Colors'
      automated information line at 1-800-270-8869 or by visiting FDA's Website
      (www.fda.gov). 
    
     Publication No. (FDA) 98-5017