Cosmetics are products you apply to your body to clean it, make it more attractive, or change the way it looks. They include

• Hair dyes
• Makeup
• Perfumes
• Skin-care creams

Cosmetics that treat or prevent diseases are also drugs. Products such as dandruff shampoo, fluoride toothpaste, and antiperspirant deodorant are both cosmetics and drugs. A good way to tell if you're buying a cosmetic that is also 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. The manufacturer must have proof that it's safe for its intended use.

Cosmetics can cause allergic reactions. The first sign is often red and irritated skin. Fragrances and preservatives are the most common causes of skin problems.

To find out all the ingredients in a cosmetic you use, check the container. Manufacturers are required to list them. Labels such as "natural" and "hypoallergenic" have no official meaning. Companies can use them to mean whatever they want.

Americans spend a lot of money on creams, lotions and other cosmetics that promise to improve their skin, hair, and even eyelashes.

But sometimes those promises go too far.

The Food and Drug Administration (FDA) warns cosmetics companies when they make claims about their products that classify them as drugs, not cosmetics. FDA has issued warning letters citing drug claims associated with topical skin care, hair care, and eyelash/eyebrow preparations, noted on both product labeling and Web sites. Some examples of the drug claims cited are acne treatment, dandruff treatment and hair restoration.

These letters state that the products are being marketed with drug claims—indicating that they are intended to treat or prevent disease, or change the body’s structure or functions. The agency tells companies that they need to remove any drug claims from their products’ labeling or seek FDA approval to market these products as drugs.

“Consumers need to know that these drug claims have not been proven to FDA when they are making a decision to purchase one of these products,” says Linda M. Katz, M.D., MPH, director of FDA’s Office of Cosmetics and Colors. “These products must be evaluated by FDA as drugs before the companies can make claims about changing the skin or treating disease.”

Some of the drug claims have included promises to increase production of collagen and elastin, resulting in skin that is more elastic and firmer, with fewer wrinkles.

Some get even more specific, such as claims that products reduce inflammation, regenerate cells, prevent facial muscle contractions, boost activity of genes, or give you the same results as injections or surgery. Others promise to treat medical conditions, such as acne, rosacea, eczema, and psoriasis.

Cosmetics or Drugs?

Federal law defines a cosmetic, in part, as a product designed for “cleansing, beautifying, promoting attractiveness, or altering the appearance.” The law does not require FDA approval of cosmetics before they go on the market.

A drug is defined, in part, as a product “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease," or “intended to affect the structure or any function of the body.” Drugs generally are subject to FDA review and approval before they can be marketed.

According to Katz, many companies have crossed the line between saying that their products will enhance a person’s appearance to stating that they will make structural changes to the skin, and even prevent or treat certain medical conditions.

Katz adds that FDA has been tracking claims made about cosmetic products for several years and has seen a proliferation of unlawful, claims on the Internet and on product packaging. “You walk into a store and see shelves of wonder products. If they’re going to be making drug claims, the products need to be evaluated as drugs,” she says.

If companies fail to comply, FDA may take additional action beyond a warning letter, which could include removal of a product from the market.

No Simple Answers

Jane Liedtka, M.D., a dermatologist at FDA, explains that the agency regulates many skin creams and lotions as drugs, such as products used to treat acne or psoriasis. These products make specific therapeutic claims that FDA reviews to make sure they are accurate, she says.

So faced with the possibility that some cosmetic skin products might be making drug claims that haven’t been evaluated by FDA, how can a consumer choose the right cream or lotion?

There’s no one-size-fits-all answer, Liedtka says.

But in general,

• Products intended to cleanse or beautify are generally regulated as cosmetics.
• Products intended to treat or prevent disease, or affect the structure or function of the body, are drugs.
• Some products are both cosmetics and drugs. Examples include anti-dandruff shampoos and antiperspirant-deodorants, as well as makeup with SPF (sun protection factor) numbers. They must meet the requirements for both cosmetics and drugs, as applicable.

What if a skin product comes with the suggestion that it can turn back the biological clock? Consumers might think that these products can be used as effectively as, or instead of, more costly procedures, Liedtka says. “If a skin cream says it works better than a facelift … well, people wouldn’t be getting facelifts anymore.”

That’s a sentiment that Katz shares. “If a product seems too good to be true,” she says, “it probably is.”

The Food and Drug Administration (FDA) regulates all cosmetics marketed in the United States, including mascara, eye shadows, eye liner, concealers, and eyebrow pencils.

Safety experts within the Office of Cosmetics and Colors in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) offer consumers the following advice:

Keep everything clean. Dangerous bacteria or fungi can grow in some cosmetic products, as well as their containers. Cleanliness can help prevent eye infections.

Always wash your hands before applying eye cosmetics, and be sure that any instrument you place near your eyes is clean. Be especially careful not to contaminate cosmetics by introducing microorganisms. For example, don’t lay an eyelash wand on a countertop where it can pick up bacteria. Keep containers clean, since these may also be a source of contamination.

Don’t moisten cosmetic products. Don’t add saliva or water to moisten eye cosmetics. Doing so can introduce bacteria. Problems can arise if you overpower a product’s preservative capability.

Don’t share or swap. People can be harmed by others’ germs when they share eye makeup. Keep this in mind when you come across “testers” at retail stores. If you do sample cosmetics at a store, be sure to use single-use applicators, such as clean cotton swabs.

Don’t apply or remove eye makeup in a moving vehicle. Any bump or sudden stop can cause injury to your eye with a mascara wand or other applicator.

Check ingredients, including color additives. As with any cosmetic product sold to consumers, eye cosmetics are required to have an ingredient declaration on the label. If they don’t, they are considered misbranded and illegal.

In the United States, the use of color additives is strictly regulated. Some color additives approved for cosmetic use in general are not approved for areas near the eyes.

If the product is properly labeled, you can check to see whether the color additives declared on the label are in .

Use only cosmetics intended for the eyes on the eyes. Don’t use a lip liner as an eye liner, for example. You may expose eyes either to contamination from your mouth or to color additives that are not approved for use near the eyes.

Say “no” to kohl! Also known as al-kahl, kajal, or surma, kohl is used in some parts of the world for enhancing the appearance of the eyes. But kohl is unapproved for cosmetic use in the United States.

Kohl contains salts of heavy metals such as antimony and lead. Reports have linked the use of kohl to lead poisoning in children.

Some eye cosmetics may be labeled with the word "kohl" only to indicate the shade, not because they contain true kohl.

A product’s “ingredient statement” should not list kohl—this is not an FDA-approved color additive. Check the ingredient statement to make sure that kohl is not present.

Don’t dye eyelashes and eyebrows. No color additives are approved by FDA for permanent dyeing or tinting of eyelashes and eyebrows. Permanent eyelash and eyebrow tints and dyes have been known to cause serious eye injuries.

Use care with false eyelashes or extensions. False eyelashes and extensions, as well as their adhesives, must meet the safety and labeling requirements for cosmetics. Since the eyelids are delicate, an allergic reaction, irritation, or injury in the eye area can occur. Check the ingredients to make sure you are not allergic to the adhesives.

Don’t use eye cosmetics that cause irritation. Stop using a product immediately if irritation occurs. See a doctor if irritation persists.

Avoid using eye cosmetics if you have an eye infection. Discard any eye cosmetics you were using when you got the infection. Also, don’t use eye cosmetics if the skin around the eye is inflamed.

Don’t use old eye cosmetics. Manufacturers usually recommend discarding mascara two to four months after purchase. Discard dried-up mascara.

Don’t store cosmetics at temperatures above 85° F. Preservatives that keep bacteria or fungi from growing can lose their effectiveness, for example, in cosmetics kept for long periods in hot cars.

Report Problems

If you need to contact FDA concerning an eye cosmetic product problem, go to FDA’s MedWatch Web site and click on “Report a Problem,” or fill in and send form FDA 3500B.

Many people may be unaware of the lead poisoning risk, in adults and children, from an avoidable source: traditional eye cosmetics containing kohl, kajal, al-kahal, surma, tiro, tozali, or kwalli.

The following information is intended to answer questions people may ask about these products and their dangers:

What are these products made of?

Kohl, kajal, al-Kahal, surma, tiro, tozali, and kwalli often contain high levels of lead. For example, lead, usually in the form of lead sulfide, sometimes accounts for more than half the weight of kohl products. Kohl products may also contain a variety of other materials, such as aluminum, antimony, carbon, iron, and zinc compounds, as well as camphor and menthol. A tiro product linked to lead poisoning in an infant was found to consist of 82.6% lead.

What are the effects of lead poisoning?

The risks associated with exposure to lead are especially serious for children. Among the effects associated with high levels of lead exposure are anemia, kidney problems, and neurological damage that may include seizures, coma, and death. Even at relatively low levels, chronic exposure to lead may lead to learning and behavior problems. The Centers for Disease Control (CDC) has set a blood lead level of 5 micrograms per deciliter (µg/dL) in children as the reference level at which CDC recommends initiating public health actions.

Are kohl and similar products directly linked to increased levels of lead in children?

Yes. FDA is aware of instances of kohl-related lead poisoning in children in the U.S. A number of studies have shown that children exposed to kohl and similar products have increased levels of lead in their blood.

How are children exposed to kohl and similar products?

In some cultures, it is common for parents to apply these products to the eyes of infants and children. Infants of mothers who use these products sometimes have elevated levels of lead in their blood. Also, some people traditionally paint a newborn's umbilical stump with kohl powder, supposedly for medicinal reasons.

Unlike some sources of exposure to lead, this one is easily avoidable by not using kohl and similar products on your children or yourself, and keeping them out of your home.

If someone in my family has been exposed to one of these products, what should I do?

Here are two important steps to take against exposure to kohl and similar products:

• Stop using the product immediately and be especially careful to protect children from further exposure.
• Ask a healthcare provider to test children as well as pregnant or nursing women for lead poisoning if they have used the product.

You will receive further recommendations based on the results of your laboratory tests.

Are these products legal in the United States?

No. Here’s why:

FDA has identified kohl, kajal, surma, and similar materials as illegal color additives as defined in the law (Federal Food, Drug and Cosmetic Act, section 201(t)). Under this law, color additives must be approved by FDA and listed in the color additive regulations before they are allowed in cosmetics or any other FDA-regulated products. To be FDA-approved, they must be safe for the intended use.

None of these materials have been approved by FDA and listed in the color additive regulations. This means that their use in cosmetics or any other FDA-regulated products is against the law.

FDA has an Import Alert in effect for eye area cosmetics that declare kohl, kajal, or surma on their labels, not only because they appear to contain high levels of lead, but also because of other labeling violations. For example, some of these products have been falsely labeled as having "FDA approval." Such products are subject to detention and refusal of admission at U.S. ports of entry.

Where do these products come from?

These products have been popular in much of the world since ancient times, particularly in parts of Africa, the Middle East, Pakistan, and India. Kohl and similar products now sometimes appear in specialty markets catering to individuals from the above regions. More recently, tiro, tozali, and kwalli products have come from Nigeria. Despite being illegal in the United States, these products may be imported by individual users, for example, in personal luggage. These products also have been sold by mail order on some websites.

Various products have been promoted in the skin care market as thigh and stomach slimmers. Some advertising claims also promise the reduction of "cellulite", waffly looking or orange-peel type skin caused by fatty deposits.

Aminophylline, an approved prescription drug used in the treatment of asthma, is an ingredient used in many of these thigh cream products that marketers claim will dissolve the fat and smooth the skin. Since some individuals suffer from allergic reactions to ethylenediamine, a component of aminophylline, the FDA is concerned about the use of this ingredient in cosmetics.

Consumers need to be aware of this potential for developing an allergic reaction and carefully read product labels and follow directions. Persons who suffer from asthma may wish to avoid these products so that they don't develop a sensitization (become allergic) to aminophylline.

Drugs, unlike cosmetics, alter the structure or function of the body and are subject to an intensive review and approval process by FDA before their release to the public. Thigh creams may more appropriately be classified as drugs under the Food, Drug, and Cosmetic Act since removal or reduction of cellulite affects the "structure or function" of the body.

People are seeking treatments to smooth smile lines and crow’s feet and plump up their lips, cheeks, and hands.

Injecting dermal fillers into the face and hands can improve the appearance of facial lines and volume loss caused by age or certain medical conditions. In studies of dermal fillers approved by the U.S. Food and Drug Administration, people generally report they are satisfied with their treatment results.

However, dermal fillers are not for everyone. Dermal fillers may not be appropriate for people with certain conditions, such as bleeding disorders or some allergies. If your health care provider confirms that dermal fillers are an option for you, know that all medical products have benefits and risks. The FDA advises you work with a licensed health care provider who is experienced in injecting dermal fillers, knowledgeable about fillers, anatomy, managing complications, and most importantly, tells you about the risks and benefits before receiving treatment.

What are dermal fillers?

Dermal fillers are gel-like substances injected under the skin. Dermal fillers are meant to create a smoother or fuller appearance, or both.

The FDA regulates dermal fillers as medical devices. As reported in clinical trials, the effects of most FDA-approved dermal fillers are temporary because they are made from materials that the body eventually breaks down and absorbs. The injection procedure may have to be repeated to maintain the desired effect.

Types of dermal fillers

Temporary fillers include the following materials:

• Hyaluronic acid, a sugar that is naturally found in the body
• Calcium hydroxylapatite, a mineral and a major component of bone
• Poly-L-lactic acid (PLLA), a biodegradable, synthetic material

There’s only one FDA-approved dermal filler that is not absorbed by the body. It is made with polymethylmethacrylate (PMMA) beads suspended in a solution that contains bovine (cow) collagen. PMMA beads are tiny round, smooth, plastic beads.

FDA-approved uses of dermal fillers

Dermal fillers are approved for specific uses in people aged 22 and older. Those uses include:

• Correcting moderate-to-severe facial wrinkles and skin folds
• Increasing fullness of lips, cheeks, chin, under-eye hollows, jawline, and back of the hand
• Restoring facial fat loss in people with human immunodeficiency virus (HIV)
• Correcting acne scars on the cheek

FDA warnings about unapproved fillers

• The FDA has not approved injectable silicone or any injectable fillers for body contouring or enhancement. The FDA has warned against getting filler injected into the breasts, buttocks, or spaces between the muscles. Using injectable filler for large-scale body contouring or body enhancement can lead to serious injury, including long-term pain, infection, permanent scarring or disfigurement, and even death.

• The FDA has not approved needle-free devices for the injection of dermal fillers and warns against using them to inject hyaluronic acid or other lip and facial fillers. The injectors use high pressure and do not provide enough control over where filler will be placed. Serious injuries and in some cases, permanent harm to the skin, lips or eyes have occurred.

• The FDA also warns against buying or using lip or facial fillers that are sold directly to the public. They are not FDA approved and may be contaminated with chemicals and infectious organisms. The only FDA-approved dermal fillers are supplied by a prescription for injection by a licensed health care professional using a syringe with a needle or a cannula (a small flexible tubing with a blunt tip that is inserted under the skin).

Risks of FDA-approved fillers

As with any medical procedure, there are risks involved with the use of dermal fillers. Most side effects reported in clinical trials and post-market surveillance occur shortly after injection and go away within a few weeks. In some cases, side effects may emerge weeks, months, or years later.

Common risks include:

• Bruising
• Redness
• Swelling
• Pain
• Tenderness
• Itching
• Rash
• Difficulty in performing activities (only observed when injected into the back of the hand)

People should be tested for allergies before receiving dermal fillers made with certain materials, especially materials derived from animals, such as collagen.

Unintended injection into blood vessels
The most serious risk associated with dermal fillers is accidental injection into a blood vessel. Filler that enters a blood vessel can cause skin necrosis (death of tissue), stroke, or blindness. While the chances of this happening are low, if it does happen, the resulting complications can be serious and may be permanent.

Removing Dermal Fillers
If you want to have fillers removed or reduced because of side effects, you may need additional procedures to reduce the filler or surgery to remove it. These procedures carry their own risks. Be aware that it may be difficult or impossible to remove some filler materials.

6 Tips for Consumers About Injectable Dermal Fillers

1. Do work with a licensed health care provider who has experience in the fields of dermatology or plastic surgery and is trained to inject dermal fillers. The provider should use properly labeled, sealed vials or pre-filled syringes of FDA-approved filler.
2. Do request and read the patient labeling information on FDA-approved injectable dermal fillers from your licensed health care provider.
3. Do know the type of product to be injected and the possible risks. Know where each product you will be receiving is to be injected. Talk to your licensed health care provider if you have any questions.
4. Do not buy dermal fillers that are sold directly to the public. They may be fake, contaminated, or not approved for use in the U.S. FDA-approved dermal fillers are indicated for prescription use only.
5. Do not inject yourself with dermal fillers or with needle-free injection “pens.”
6. Do not get any type of filler or liquid silicone injected for body contouring.

Dermal Fillers and Botulinum Toxin Products

The FDA also has approved botulinum toxin products such as Botox, Dysport, Xeomin and Jeuveau to treat facial wrinkles. These products are not dermal fillers. They are injectable drugs that work by keeping muscles from tightening, so the wrinkles don’t show as much. The safe use of dermal fillers in combination with Botox and other treatments has not been evaluated in clinical studies.

Although botulinum toxin products are derived from the same bacteria that cause botulism, the amounts used for cosmetic purposes are purified and many orders of magnitude smaller.

The FDA has approved these injectable drugs for the temporary improvement in the appearance of one, or perhaps several types of facial lines, including frown lines, forehead lines, and crow’s feet.

Side effects reported in clinical trials include facial weakness, eyelid drooping, and brow drooping. Other adverse events included localized pain, swelling, reddening, and bruising at the injection site. In rare cases, injections have resulted in double vision, dry eyes, or difficulty swallowing or breathing. The injection of botulinum toxin products for cosmetic purposes is not recommended for use while pregnant or lactating.

Many products we use every day contain fragrances. Some of these products are regulated as cosmetics by FDA. Some belong to other product categories and are regulated differently, depending on how the product is intended to be used. Here is information about fragrances that people often ask about:

How to Know If a Fragrance Product Is Regulated as a Cosmetic

If a product is intended to be applied to a person’s body to make the person more attractive, it’s a cosmetic under the law. Here are some examples of fragrance products that are regulated as cosmetics:

• Perfume
• Cologne
• Aftershave

Fragrance ingredients are also commonly used in other products, such as shampoos, shower gels, shaving creams, and body lotions. Even some products labeled “unscented” may contain fragrance ingredients. This is because the manufacturer may add just enough fragrance to mask the unpleasant smell of other ingredients, without giving the product a noticeable scent.

Some fragrance products that are applied to the body are intended for therapeutic uses, such as treating or preventing disease, or affecting the structure or function of the body. Products intended for this type of use are treated as drugs under the law, or sometimes as both cosmetics and drugs. Here are some examples of labeling statements that will cause a product containing fragrances to be treated as a drug:

• Easing muscle aches
• Soothing headaches
• Helping people sleep
• Treating colic

Many other products that may contain fragrance ingredients, but are not applied to the body, are regulated by the Consumer Product Safety Commission. Here are some examples:

• Laundry detergents
• Fabric softeners
• Dryer sheets
• Room fresheners
• Carpet fresheners

Statements on labels, marketing claims, consumer expectations, and even some ingredients may determine a product’s intended use.

“Essential Oils” and “Aromatherapy”

There is no regulatory definition for “essential oils,” although people commonly use the term to refer to certain oils extracted from plants. The law treats Ingredients from plants the same as those from any other source.

For example, “essential oils” are commonly used in so-called “aromatherapy” products. If an “aromatherapy” product is intended to treat or prevent disease, or to affect the structure or function of the body, it’s a drug.

Similarly, a massage oil intended to lubricate the skin is a cosmetic. But if claims are made that a massage oil relieves aches or relaxes muscles, apart from the action of the massage itself, it’s a drug, or possibly both a cosmetic and a drug.

Safety Requirements

Fragrance ingredients in cosmetics must meet the same requirement for safety as other cosmetic ingredients. The law does not require FDA approval before they go on the market, but they must be safe for consumers when they are used according to labeled directions, or as people customarily use them. Companies and individuals who manufacture or market cosmetics have a legal responsibility for ensuring that their products are safe and properly labeled.

Labeling of Fragrance Ingredients

If a cosmetic is marketed on a retail basis to consumers, such as in stores, on the Internet, or person-to-person, it must have a list of ingredients. In most cases, each ingredient must be listed individually. But under U.S. regulations, fragrance and flavor ingredients can be listed simply as “Fragrance” or “Flavor.”

Here’s why: FDA requires the list of ingredients under the Fair Packaging and Labeling Act (FPLA). This law is not allowed to be used to force a company to tell “trade secrets.” Fragrance and flavor formulas are complex mixtures of many different natural and synthetic chemical ingredients, and they are the kinds of cosmetic components that are most likely to be “trade secrets.”

Fragrance Allergies and Sensitivities

Some individuals may be allergic or sensitive to certain ingredients in cosmetics, food, or other products, even if those ingredients are safe for most people. Some components of fragrance formulas may have a potential to cause allergic reactions or sensitivities for some people.

FDA does not have the same legal authority to require allergen labeling for cosmetics as for food. So, if you are concerned about fragrance sensitivities, you may want to choose products that are fragrance free, and check the ingredient list carefully. If consumers have questions, they may choose to contact the manufacturer directly.

Phthalates as Fragrance Ingredients

Phthalates are a group of chemicals used in hundreds of products. The phthalate commonly used in fragrance products is diethyl phthalate, or DEP. DEP does not pose known risks for human health as it is currently used in cosmetics and fragrances.

Although many people report being adversely affected by fragrances, the issue remains controversial.

While some individuals may dislike a particular fragrance and may experience physical reactions from exposure to them, others exposed to the same fragrance may appreciate the smell or attribute health benefits to the exposure (e.g., aromatherapy).

There is also controversy among scientists as to whether the odor causing ingredients of some fragranced products actually ‘cause’ the adverse physical impact (e.g., triggering asthma episodes) experienced by some individuals or whether the adverse impact is caused by physiological, physical, chemical or emotional factors not directly related to the odor.

In spite of the controversy, EPA’s Indoor Environments Division (IED) understands that exposure to fragrances can cause some sensitive individuals to experience asthma episodes and other adverse health impacts and therefore notes this potential in several of their indoor air quality publications.

In addition, IED continues to monitor the research and works with our federal, state and local partners to provide up-to-date science-based information to the public on this and other indoor air quality issues.

Whatever your complexion, it’s important to use products that will help your skin and not damage it. But as you wade through the beauty aisles, the U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions that contain mercury.

How will you know if mercury is in the cosmetic, especially one that’s marketed as “anti-aging” or “skin lightening”? Check the label. If the words “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury” are listed on the label, mercury’ is in it—and you should stop using the product immediately.

The products are usually marketed as skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes, and wrinkles. Adolescents may use these products as acne treatments.

These products usually are manufactured abroad and sold illegally in the United States, often in shops catering to the Latino, Asian, African, or Middle Eastern communities. They are promoted online on social media sites and sold through mobile apps. Consumers may also have bought them in another country and brought them back to the U.S. for personal use.

If the ingredients aren’t listed and there is no product label, don’t assume it’s fine. Federal law requires that ingredients be listed on the label of any cosmetic or nonprescription drug, so do not use a product that doesn’t have a label. In addition, don’t use drugs or cosmetics labeled in languages other than English unless English labeling is also provided. That’s also a sign that the product may be marketed illegally.

Even though these products are often promoted as cosmetics, they also may be unapproved new drugs under the law. FDA does not allow mercury in drugs or in cosmetics, except under very specific conditions where there are no other safe and effective preservatives available – conditions that these products do not meet.

Sellers and distributors who market mercury-containing skin whitening or lightening creams in the U.S. may be subject to enforcement action, including seizure of products, injunctions, and, in some situations, criminal prosecution.

Dangers of Mercury

Exposure to mercury can have serious health consequences. The danger isn’t just to people who use mercury-containing products but also to their families. When you use these products your family might breathe mercury vapors or might become exposed by using things like washcloths or towels contaminated with mercury.

Some people – including pregnant women, nursing babies and young children – are especially vulnerable to mercury toxicity. Babies may be particularly sensitive to the harm mercury can cause to their developing brains and nervous systems. Newborns who nurse are vulnerable because mercury is passed into breast milk.

Signs and Symptoms of Mercury Poisoning

• irritability
• shyness
• tremors
• changes in vision or hearing
• memory problems
• depression
• numbness and tingling in hands, feet or around mouth

Source: Agency for Toxic Substances and Disease Registry

Tracking Skin Products Containing Mercury

In the past few years, FDA and state health officials have discovered numerous products that contain mercury, and there have been cases in which people exposed to such products have had mercury poisoning or elevated levels of mercury in their bodies. FDA has an import alert in place that lets our field staff know that the agency has enough evidence or other information to refuse admission of shipments of mercury-containing skin products.

But this is only a partial solution.

Many of these products are coming into the country through illegal channels. That’s why it’s so important for consumers and sellers to know about the dangers of possible mercury poisoning associated with the use of these skin products.

How to Protect Yourself

Thoroughly wash your hands and other parts of your body that have come in contact with products that contain mercury.

Contact your health care professional or a medical care clinic for advice. If you have questions, call your health care professional or the Poison Center at 1-800-222-1222; it is open 24 hours a day.

Before throwing out a product that may contain mercury, seal it in a plastic bag or leak-proof container. Check with your local environmental, health, or solid waste agency for disposal instructions. Some communities have special collections or other options for disposing of hazardous household waste.

Manicures and pedicures can be pretty. The cosmetic products used, such as nail polishes and nail polish removers, also must be safe—and are regulated by the U.S. Food and Drug Administration.

The FDA also regulates devices used to dry (or “cure”) artificial nails or gel nail polish as electronic products because they emit radiation.

You can do your part to stay safe (and look polished, too) by following all labeled directions and paying attention to any warning statements listed on these products.

Cosmetic Nail Care Products: Ingredients and Warnings

Cosmetic ingredients (except most color additives) and products, including nail products, do not need FDA approval before they go on the market.

But these products are required to be safe when used as intended. (Note that nail products intended to treat medical problems are classified as drugs and do require FDA approval.)

Cosmetic nail care products also must include any instructions or warnings needed to use them safely. For example:

• Some nail products can catch fire easily so you should not expose them to flames (such as from a lit cigarette) or heat sources (such as a curling iron).
• Some can injure your eyes, so you should avoid this exposure.
• Some should only be used in areas with good air circulation (ventilation).
• Some ingredients can be harmful if swallowed, so these products should never be consumed by any person or pet.

Also know that retail cosmetics such as those sold in stores or online must list ingredients in the order of decreasing amounts. If you’re concerned about certain ingredients, you can check the label and avoid using products with those ingredients.

For example, some nail hardeners and nail polishes may contain formaldehyde, which can cause skin irritation or an allergic reaction. And acrylics, used in some artificial nails and sometimes in nail polishes, can cause allergic reactions. (To learn more about ingredients, visit the FDA’s nail care products webpage.)

The bottom line? Read the labels of cosmetic products and follow all instructions. And if you go to a salon for a manicure or pedicure, make sure the space has good ventilation.

Note: Nail salon practices are regulated by the states, and not the FDA. If you’re a nail salon owner or employee, you can find information on maintaining safe salons on the webpage of the U.S. Department of Labor’s Occupational and Health Safety Administration.

If you have questions about whether certain nail products are right for you, talk to your health care provider.

About Nail Drying and Curing Lamps—and UV Exposure

Ultraviolet (UV) nail curing lamps are table-top size units used to dry or “cure” acrylic or gel nails and gel nail polish. These devices are used in salons and sold online. They feature lamps or LEDs that emit UV (ultraviolet) radiation. (Nail curing lamps are different than sunlamps, which are sometimes called “tanning beds.” You can learn more about the risks of sunlamps on the FDA’s website.)

Exposure to UV radiation can cause damage to your skin, especially if you’re exposed over time. For example, it can lead to premature wrinkles, age spots, and even skin cancer.

But the FDA views nail curing lamps as low risk when used as directed by the label. For example, a 2013 published study indicated that—even for the worst case lamp that was evaluated—30 minutes of daily exposure to this lamp was below the occupational exposure limits for UV radiation. (Note that these limits only apply to normal, healthy people and not to people who may have a condition that makes them extra sensitive to UV radiation.)

To date, the FDA has not received any reports of burns or skin cancer attributed to these lamps.

That said, if you’re concerned about potential risks from UV exposure, you can avoid using these lamps.

You may particularly want to avoid these lamps if you’re using certain medications or supplements that make you more sensitive to UV rays. These medications include some antibiotics, oral contraceptives, and estrogens—and supplements can include St. John’s Wort. See an extended list of medications that can cause sun sensitivity on the FDA’s website.

Also remove cosmetics, fragrances, and skin care products (except sunscreen!) before using these lamps, as some of these products can make you more sensitive to UV rays.

If you have questions about using nail drying or curing lamps, consult a health care professional.

And if you do choose to use these devices, you can reduce UV exposure by:

• Wearing UV-absorbing gloves that expose only your nails.
• Wearing a broad-spectrum sunscreen with an SPF of 15 or higher. (Since nail treatments can include exposure to water, follow the sunscreen’s labeled directions for use in these situations.)

Finally, nail curing lamps usually come with instructions for exposure time. The shorter your exposure, the less risky the exposure, in general. So always follow labeled directions when available. In general, you should not use these devices for more than 10 minutes per hand, per session.

How to Report Problems with Nail Care Products

If you ever have a bad reaction to a cosmetic nail product or nail curing lamp, please consult your health care provider and then tell the FDA.

You can call an FDA Consumer Complaint Coordinator (phone numbers for your area are online) or report the problem via MedWatch, the FDA Safety Information and Adverse Event Reporting program.

July 6, 2017

FDA often receives questions from soap makers about how their products are regulated. Here is information to help small-scale soap producers understand the laws and regulations they need to know about.

How are traditional soaps and synthetic detergents different?

Ordinary soap is made by combining fats or oils and an alkali, such as lye. The fats and oils, which may be from animal, vegetable, or mineral sources, are degraded into free fatty acids, which then combine with the alkali to form crude soap. The lye reacts with the oils, turning what starts out as liquid into blocks of soap. When made properly, no lye remains in the finished product. In the past, people commonly made their own soap using animal fats and lye that had been extracted from wood ashes.

Today there are very few true soaps on the market. Most body cleansers, both liquid and solid, are actually synthetic detergent products. Detergent cleansers are popular because they make suds easily in water and don't form gummy deposits. Some of these detergent products are actually marketed as "soap" but are not true soap according to the regulatory definition of the word.

What’s the regulatory definition of soap?

Whether a product is a “soap” in the traditional sense, or is really a synthetic detergent, helps determine how the product is regulated. So, let’s take a look at how “soap” is defined in FDA’s regulations;

To meet the definition of soap in FDA’s regulations, a product has to meet three conditions:

1. What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
2. What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word “soap” on the label.
3. How it's intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. You still can use the word “soap” on the label.

How are different “soap” products regulated?

• If your product meets the regulatory definition of soap, it’s regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about requirements for these products to CPSC.

• If it’s a cosmetic, it’s regulated by FDA. Neither the product nor its ingredients need approval by FDA, except for any color additives it contains. It is your responsibility to make sure your product is safe for consumers when it is used as intended, and to make sure it is properly labeled.

• If it’s a drug, it’s regulated by FDA. It must comply with the regulations (called “monographs”) for certain categories of non-prescription drugs or requirements for new drug approval or. You will need to register your firm and list your products with FDA.

• If it’s both a cosmetic and a drug, it must meet the requirements for both cosmetics and drugs.

What if my ingredients are “natural” or “organic”?

The laws and regulations that FDA enforces do not have definitions for “natural” or “organic.” The same requirements apply to your product no matter whether the ingredients are plant, animal, mineral, or synthetic. It’s important not to assume that using only ingredients from plants will make your products safe.

A number of cosmetic products are marketed for consumers to achieve a tanned appearance without having to go out in the sun or use artificial sources of ultraviolet radiation. FDA has received questions about some of these products. The following information is provided in response to these questions.

What are "sunless tanners"?

Neither the laws nor the regulations enforced by FDA define the term "sunless tanner." It typically refers to products that provide a tanned appearance without exposure to the sun or other sources of ultraviolet radiation. One commonly used ingredient in these products is dihydroxyacetone (DHA), a color additive that darkens the skin by reacting with amino acids in the skin's surface.

What are "bronzers"?

Like the term "sunless tanner," "bronzer" is not defined in either the laws or the regulations enforced by FDA. It is often used to describe a variety of products intended to achieve a temporary tanned appearance. For example, among the products marketed as bronzers are tinted moisturizers and brush-on powders. These produce a temporary effect, similar to other types of makeup, and wash off over time. Some products are marketed with other ingredients in addition to DHA in order to provide a tanned appearance.

What does the law say about color additives, and DHA in particular?

The Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 721 authorizes the regulation of color additives (other than coal-tar hair dyes), including their uses and restrictions. These regulations are found in Title 21, Code of Federal Regulations (21 CFR), beginning at Part 70. If a color additive is not permitted by regulation or is used in a way that does not comply with the specific regulation(s) authorizing its use, it is considered unsafe under the law. Such misuse of color additives causes a cosmetic to be adulterated.

DHA is listed in the regulations as a color additive for use in imparting color to the human body. However, its use in cosmetics--including sunless "tanning" products--is restricted to external application (21 CFR 73.2150). According to the CFR, "externally applied" cosmetics are those "applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane" (21 CFR 70.3v). The industry has not provided safety data to FDA in order for the agency to consider approving it for use on these exposure routes, including "misting" from tanning booths.

In addition, no color additive may be used in cosmetics intended for use in the area of the eye unless the color additive is permitted specifically for such use DHA is not permitted for use in the area of the eye. The CFR defines "area of the eye" as follows:

"the area enclosed within the circumference of the supra-orbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge." (21 CFR 70.3s)

As with the lips and other areas covered by mucous membrane, the industry has not provided safety data to FDA in order for the agency to consider approving it for use in the area of the eye.

The regulations listing DHA as a color additive also require it to meet tight specifications, with strict limitations on impurities. For example, volatile matter must not exceed 0.5 percent when measured at 34.6 degrees centigrade for three hours at a pressure of not more than 30 mm. mercury. (Please note that the reference to "millimeters of mercury" is a measure of atmospheric pressure, not an indication that DHA contains mercury.) Certain minerals are restricted to miniscule amounts, measured in parts per million (21 CFR 73.1150 and 73.2150).

What does this mean for DHA spray "tanning" booths?

As noted above, the use of DHA in "tanning" booths as an all-over spray has not been approved by the FDA, since safety data to support this use has not been submitted to the Agency for review and evaluation, When using DHA-containing products as an all-over spray or mist in a commercial spray "tanning" booth, it may be difficult to avoid exposure in a manner for which DHA is not approved, including the area of the eyes, lips, or mucous membrane, or even internally.

Consequently, FDA advises asking the following questions when considering commercial facilities where DHA is applied by spraying or misting:

• Are consumers protected from exposure in the entire area of the eyes, in addition to the eyes themselves?
• Are consumers protected from exposure on the lips and all parts of the body covered by mucous membrane?
• Are consumers protected from internal exposure caused by inhaling or ingesting the product?

If the answer to any of these questions is "no," the consumer is not protected from the unapproved use of this color additive. Consumers should request measures to protect their eyes and mucous membranes and prevent inhalation.

What about sunless tanning products sold in retail stores, such as creams and lotions?

DHA is approved for external application to the human body, which is the way these products are intended to be used. Consumers can easily avoid inhaling them or applying them to the area of the eye or mucous membrane.

Who is responsible for the safety of spray tanning booths?

The FD&C Act does not authorize FDA to approve cosmetic products or ingredients, with the exception of color additives that are not coal-tar hair dyes. Firms and individuals who market cosmetics are responsible for assuring that the products they market are safe when used under labeled or customary conditions of use and properly labeled. FDA can take action against firms and individuals who violate the law. The practice of administering such products by professionals, such as in salons, is generally the responsibility of local and state health authorities.

Do sunless tanners and bronzers provide protection from the sun?

Sunless tanners and bronzers may or may not provide protection from the sun. Only those sunless tanners that contain sunscreen ingredients and are labeled with sun protection factor ("SPF") numbers may provide protection. Consumers are advised to read the labeling carefully to determine whether or not these products provide protection from the sun.

All suntanning preparations that do not contain sunscreen ingredients are required to carry the following warning statement on the label:

"Warning--This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin even if you do not burn." (21 CFR 740.19)

Sunscreens are regulated as over-the-counter drugs unless they are used in the product for reasons other than protecting the consumer from the sun, such as protecting the product itself from fading. Cosmetic products that are marketed with sun-protection claims, such as makeup labeled with SPF numbers, are regulated as both drugs and cosmetics.

Has FDA received reports of adverse reactions associated with sunless tanners?

FDA has received reports from consumers stating that they have experienced adverse events associated with sunless tanning, including rashes and, primarily in the case of spray tanning booths, coughing, dizziness, and fainting. It is uncertain what, if any, ingredient or combination of ingredients in the sunless tanning products might have caused these adverse events, whether an individual's allergic reaction might have played a part, or whether factors unrelated to the sunless tanning products may have been involved, such as pre-existing medical conditions.

Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires ingredient declarations on cosmetics sold on a retail basis to consumers. In this way, consumers can know what ingredients are contained in the products they purchase and avoid ingredients to which they may be sensitive. However, the FPLA does not apply to products used exclusively by professionals, such as those used in spray tanning booths.

The following information is intended to answer questions about alpha hydroxy acids, also known as AHAs, which are often used as ingredients in cosmetic and drug products applied to the skin.

Why are AHAs used in some cosmetics?

Products containing AHAs are marketed for a variety of purposes, such as smoothing fine lines and surface wrinkles, improving skin texture and tone, unblocking and cleansing pores, and improving skin condition in general. Sometimes AHAs are used in cosmetics for other purposes, such as to adjust the pH (the degree of acidity or alkalinity).

How do AHAs work?

AHA-containing products cause exfoliation, or shedding of the surface skin. The extent of exfoliation depends on the type and concentration of the AHA, its pH, and other ingredients in the product.

What about products that contain AHAs and are marketed with therapeutic claims?

Some products containing AHAs have been marketed for uses such as treating acne, removing scars, and lightening discolorations. Among these are some products marketed as "skin peelers," which may contain relatively high concentrations of AHAs or other acids and are designed to remove the outer layer of the skin. Products that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body are drugs under the law (Federal Food, Drug, and Cosmetic Act, Sec. 201(g)). For example, products intended for use as acne treatments or skin lighteners are considered drugs.

Has FDA received reports of adverse events related to AHAs?

FDA received a total of 114 adverse dermatologic experience reports for AHA-containing skin care products between 1992 and February 2004, with the maximum number in 1994. The reported adverse experiences included burning (45), dermatitis or rash (35), swelling (29), pigmentary changes (15), blisters or welts (14), skin peeling (13), itching (12), irritation or tenderness (8), chemical burns (6), and increased sunburn (3). The frequency of such reports for skin exfoliating products that contain AHAs has been considerably lower in subsequent years. The more serious adverse reactions appear to occur most often with products that cause the greatest degree of exfoliation, such as "skin peelers."

Has FDA conducted research on the safety of AHAs?

Yes. These studies (1) compared the effect of AHAs, topically applied in a cream, on the sensitivity of human skin to ultraviolet (UV) radiation with the effect of the same cream containing no AHAs, (2) measured how fast the skin returns to normal after use of the AHA-containing cream is discontinued, and (3) investigated whether AHAs enhance UV-induced damage to DNA in the skin (Kays Kaidbey, Betsy Sutherland, Paula Bennett, Wayne G. Wamer, Curtis Barton, Donna Dennis, and Andrija Kornhauser, Topical glycolic acid enhances photodamage by ultraviolet light, Photodermatology, Photoimmunology and Photomedicine, vol. 19 (2003), issue 1, pages 21-27).

These studies confirmed previous industry studies indicating that applying AHAs to the skin results in increased UV sensitivity. After four weeks of AHA application, volunteers' sensitivity to skin reddening produced by UV increased by 18 percent. Similarly, the volunteers' sensitivity to UV-induced cellular damage doubled, on average, with considerable differences among individuals.

However, the studies also indicated that this increase in sensitivity is reversible and does not last long after discontinuing use of the AHA cream. One week after the treatments were halted, researchers found no significant differences in UV sensitivity among the various skin sites.

The studies did not identify exactly how AHAs bring about the increased UV sensitivity, although the effects did not appear to involve dramatic increases in UV-induced damage to DNA in the skin.

Previous FDA studies have indicated that a cosmetic-type cream base caused an AHA to penetrate more deeply into the skin when compared to an AHA solution without the usual cosmetic ingredients. However, further studies will be needed to learn how much, if at all, those cosmetic-type ingredients influence the AHA-related effects on UV sensitivity.

FDA also has collaborated with the National Toxicology Program (NTP) to assess the safety of the long-term use of AHAs. This study determined that glycolic acid did not affect photocarcinogenesis (the development of cancer cells associated with exposure to light) in mice, and that salicyclic acid had a photoprotective effect (protected against the effects of light) in mice. The complete results of this study are available in the NTP Technical Report on the Photocarcinogenesis Study of Glycolic Acid and Salicylic Acid (CAS Nos. 79-14-1 and 69-72-7) in SKH-1 Mice.

FDA continues to review available data on AHAs to address the potential for this increased skin sensitivity to the sun.

How can AHAs be used safely?

It is important to follow directions carefully and heed any warning statements on the label when using any cosmetic product. If you are using AHAs, it is advisable to use sun protection.

In January 2005, FDA issued Guidance for Industry: Labeling of Cosmetics Containing Alpha Hydroxy Acids as Ingredients. The purpose of this guidance is to educate consumers about the potential for increased skin sensitivity to the sun from the topical use of cosmetics containing AHAs and to educate manufacturers to help ensure that their labeling for these products is not false or misleading.

FDA recommends that the labeling of a cosmetic product that contains an AHA as an ingredient and that is topically applied to the skin or mucous membrane, such as the lips, bear a statement that conveys the following information:

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Based on industry-sponsored studies, the Cosmetic Ingredient Review (CIR) Expert Panel — the industry's self-regulatory body for reviewing the safety of cosmetic ingredients — concluded that products containing the AHAs glycolic and lactic acid are safe for use by consumers if:

• The AHA concentration is 10 percent or less.
• The final product has a pH of 3.5 or greater.
• The final product is formulated in such a way that it protects the skin from increased sun sensitivity or its package directions tell consumers to use daily protection from the sun.

How can I know if a cosmetic product contains AHAs?

Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires an ingredient declaration on cosmetic products sold at the retail level to consumers.

However, because the FPLA does not apply to products used exclusively by professionals — for example, in salons — the requirement for an ingredient declaration does not apply to these products.

The most common AHAs in cosmetic products are glycolic acid and lactic acid. Among others are citric acid, hydroxycaprylic acid, and hydroxycapric acid.

Throughout the last decade, alpha hydroxy acids (AHAs) have increasingly appeared as ingredients in cosmetics intended to reduce the signs of aging in the skin. More recently, beta hydroxy acids (BHAs), or a combination of AHAs and BHAs, have appeared as ingredients in these skin care products. While both AHAs and BHAs act as exfoliants, it has been claimed that BHAs are effective in reducing the appearance of fine lines and wrinkles, and improving overall skin texture, without the occasional irritation associated with the use of AHAs.

BHA ingredients may be listed as -

• salicylic acid (or related substances, such as salicylate, sodium salicylate, and willow extract)*
• beta hydroxybutanoic acid
• tropic acid
• trethocanic acid

Currently, the BHA most commonly used in cosmetics is salicylic acid. On rare occasions, citric acid is also cited as a BHA in cosmetic formulations. More commonly, citric acid is referred to as an AHA.

The safety of salicylic acid used as a cosmetic ingredient has been evaluated by both the cosmetic industry and FDA. At a meeting in February 2000, the Cosmetic Ingredient Review (CIR) Expert Panel, the cosmetic industry's independent body for reviewing the safety of cosmetic ingredients, reached the tentative conclusion that the use of salicylic acid related substances in cosmetics is "safe as used when formulated to avoid irritation and when formulated to avoid increased sun sensitivity." CIR added that "when sun sensitivity would be expected, directions for use [should] include the daily use of sun protection."

In other words, according to CIR Director Alan Andersen, products containing salicylic acid should either contain a sunscreen or bear directions advising consumers to use other sun protection. In order to comply with the CIR recommendations, cosmetic manufacturers should test their products to determine whether or not they cause an increase in sensitivity to the harmful ultraviolet radiation in sunlight.

The long-term safety of salicylic acid in cosmetics also is being evaluated in studies initiated by FDA and sponsored by the National Toxicology Program. These government-sponsored studies are examining the long-term effects of both glycolic acid (an AHA) and salicylic acid on the skin's response to ultraviolet (UV) light. These studies have determined that applying glycolic acid to the skin can make people more susceptible to the damaging effects of the sun, including sunburn.

Until these safety assessments are completed, FDA advises that similar precautions be taken for the use of cosmetics containing AHAs and BHAs. These precautions are:

• Test any product that contains a BHA on a small area of skin before applying it to a large area. If you use cosmetics with BHAs and experience skin irritation or prolonged stinging, stop using the product and consult your physician.
• Follow the use instructions on the label. Do not exceed the recommended applications.
• Avoid using BHA-containing products on infants and children.
• Use sun protection if you use a BHA product.

*From a chemist's perspective, salicylic acid is not a true BHA. However, cosmetic companies often refer to it as a BHA and, consequently, many consumers think of it as one.

Parabens are commonly used as preservatives in cosmetics. Here are answers to questions that consumers often ask about the safety and use of these ingredients.

What are parabens, and why are they used in cosmetics?

Parabens are a family of related chemicals that are commonly used as preservatives in cosmetic products. Preservatives may be used in cosmetics to prevent the growth of harmful bacteria and mold, in order to protect both the products and consumers.

The parabens used most commonly in cosmetics are methylparaben, propylparaben, butylparaben, and ethylparaben.

Product ingredient labels typically list more than one paraben in a product, and parabens are often used in combination with other types of preservatives to better protect against a broad range of microorganisms.

What kinds of products contain parabens?

Parabens are used in a wide variety of cosmetics, as well as in foods and drugs. Cosmetics that may contain parabens include makeup, moisturizers, hair care products, and shaving products, among others. Many major brands of deodorants do not currently contain parabens, although some may.

Cosmetics sold to consumers in stores or online must have a list of ingredients, each listed by its common or usual name. This is important information for consumers who want to find out whether a product contains an ingredient they wish to avoid. Parabens are usually easy to identify by their name, such as methylparaben, propylparaben, butylparaben, or ethylparaben.

Does FDA regulate the use of preservatives in cosmetics?

FDA doesn’t have special rules that apply only to preservatives in cosmetics. The law treats preservatives in cosmetics the same as other cosmetic ingredients.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetic products and ingredients, other than color additives, do not need FDA approval before they go on the market.

However, it is against the law to market a cosmetic in interstate commerce if it is adulterated or misbranded. This means, for example, that cosmetics must be safe for consumers when used according to directions on the label or in the customary way, and they must be properly labeled.

FDA can take action against a cosmetic on the market that does not comply with the laws we enforce. However, to take action against a cosmetic for safety reasons, we must have reliable scientific information showing that the product is harmful when consumers use it according to directions on the label or in the customary way.

Are parabens safe as they’re used in cosmetics? Are they linked to breast cancer or other health problems?

FDA scientists continue to review published studies on the safety of parabens. At this time, we do not have information showing that parabens as they are used in cosmetics have an effect on human health. Here are some of the questions we are considering:

• What do published studies show about the possible hazards of parabens, and on the effects of parabens on human health? For example, do experimental findings with various parabens also happen in real life?
• What are the hazards and risks of not using parabens? If we stop using parabens to protect cosmetics and consumers from harmful bacteria, are there safer alternatives for preservatives?
• If there are paraben-related health effects that are scientifically supported and documented, how do these effects relate to the use of parabens in cosmetics?
• Do the different kinds of parabens act the same or differently in our bodies?

FDA will continue to evaluate new data in this area. If we determine that a health hazard exists, we will advise the industry and the public, and will consider the agency’s legal options under the authority of the FD&C Act to protect the health and welfare of consumers.

FDA has received a number of inquiries on the safety of phthalates, which are used in a variety of cosmetics as well as other consumer products. Here are answers to questions consumers often ask about these ingredients.

What are phthalates?

Phthalates are a group of chemicals used in hundreds of products, such as toys, vinyl flooring and wall covering, detergents, lubricating oils, food packaging, pharmaceuticals, blood bags and tubing, and personal care products, such as nail polish, hair sprays, aftershave lotions, soaps, shampoos, perfumes and other fragrance preparations.

How phthalates have been used in cosmetics

Historically, the primary phthalates used in cosmetic products have been dibutylphthalate (DBP), used as a plasticizer in products such as nail polishes (to reduce cracking by making them less brittle); dimethylphthalate (DMP), used in hair sprays (to help avoid stiffness by allowing them to form a flexible film on the hair); and diethylphthalate (DEP), used as a solvent and fixative in fragrances. According to FDA's latest survey of cosmetics, conducted in 2010, however, DBP and DMP are now used rarely. DEP is the only phthalate still commonly used in cosmetics.

Phthalates and human health

It's not clear what effect, if any, phthalates have on human health. An expert panel convened from 1998 to 2000 by the National Toxicology Program (NTP), part of the National Institute for Environmental Safety and Health, concluded that reproductive risks from exposure to phthalates were minimal to negligible in most cases.

The Centers for Disease Control and Prevention (CDC) released a report on March 21, 2001, titled "National Report on Human Exposure to Environmental Chemicals." The report described a survey of a small segment of the U.S. population for environmental chemicals in urine. One group of chemicals surveyed was phthalates. However, the CDC survey was not intended to make an association between the presence of environmental chemicals in human urine and disease, but rather to learn more about the extent of human exposure to industrial chemicals.

In 2002, the Cosmetic Ingredient Review (CIR) Expert Panel reaffirmed its original conclusion (reached in 1985), finding that DBP, DMP, and DEP were safe as used in cosmetic products. (See “Annual Review of Cosmetic Ingredient Safety Assessments 2002/2003,” International Journal of Toxicology (Supplement 1), 1-102, 2005.) Looking at maximum known concentrations of these ingredients in cosmetics, the panel evaluated phthalate exposure and toxicity data, and conducted a safety assessment for dibutylphthalate in cosmetic products. The panel found that exposures to phthalates from cosmetics were low compared to levels that would cause adverse effects in animals. (The CIR is an industry-sponsored organization that reviews cosmetic ingredient safety and publishes its results in open, peer-reviewed literature. FDA participates in CIR on a non-voting basis and may or may not accept CIR findings.)

FDA reviewed the safety and toxicity data for phthalates, including the CDC data from 2001, as well as the CIR conclusions based on reviews in 1985 and 2002. While the CDC report noted elevated levels of phthalates excreted by women of child-bearing age, neither this report nor the other data reviewed by FDA established an association between the use of phthalates in cosmetic products and a health risk. Based on this information, FDA determined that there wasn’t a sound, scientific basis to support taking regulatory action against cosmetics containing phthalates.

What we know about infant exposure to phthalates

Infants, like all consumers, are exposed daily to phthalates from a number of sources, including air, drugs, food, plastics, water, and cosmetics.

The American Academy of Pediatrics has published an article stating that infants exposed to infant care products, specifically baby shampoos, baby lotions, and baby powder, showed increased levels of phthalate metabolites in their urine.

Like the CDC report, this study did not establish an association between these findings and any health effects. In addition, levels of phthalates, if any, in the infant care products were not determined.

FDA included 24 children’s products intended for infants and children in the survey we completed in 2006, and nearly 50 products for infants and children in the survey we completed in 2010. What we learned was that the use of phthalates in cosmetics intended for people of all ages, including infants and children, has decreased considerably since our surveys began in 2004.

How to know if there are phthalates in the cosmetics you use

Under the authority of the Fair Packaging and Labeling Act (FPLA), FDA requires an ingredient declaration on cosmetic products sold at the retail level to consumers. Consumers can tell whether some products contain phthalates by reading the ingredient declaration on the labels of such products.

However, the regulations do not require the listing of the individual fragrance ingredients; therefore, the consumer will not be able to determine from the ingredient declaration if phthalates are present in a fragrance. Also, because the FPLA does not apply to products used exclusively by professionals--for example, in salons--the requirement for an ingredient declaration does not apply to these products. Based on available safety information, DEP does not pose known risks for human health as it is currently used in cosmetics and fragrances. Consumers who nevertheless do not want to purchase cosmetics containing DEP may wish to choose products that do not include "Fragrance" in the ingredient listing.

Most people use cosmetic products containing latex without adverse effects. However, some people may have had allergic reactions to latex-containing products. Because of this the FDA is concerned that consumers might not be aware that some cosmetic products contain natural rubber latex.

What We Know about Latex Allergy

Roughly 1-6% of the general population is allergic to natural rubber latex. Natural rubber latex is a milky fluid that contains extremely small particles of rubber that comes from plants, principally from the H. brasiliensis rubber tree. Natural rubber latex also contains a variety of naturally occurring substances, including the polymer cis-1,4-polyisoprene and various plant proteins, including what are called antigenic proteins that may trigger an immune response. Some of these antigenic proteins may also be allergenic: that is, they can cause a latex-sensitive person to have an allergic reaction. Sensitivity to latex may develop over time, especially for people who are often exposed to it.

From January 2015 to September 2017, the FDA received 30 reports of allergic reactions involving cosmetic products that typically contain natural rubber latex, including hair bonding adhesives, face and body paints, eyeliner, and eyelash adhesives. Allergic reactions can range from skin irritations or rashes to respiratory problems and even to a more severe reaction called anaphylactic shock. Four of these reports appeared to be of anaphylactic reactions. Because reporting is not required, the actual number of cases is likely to be higher than what is reported to the FDA. The only way that the FDA learns about incidents like these is when consumers, physicians or companies voluntarily report them. The current laws regulating cosmetics do not require companies to submit reports about cosmetic-related adverse events to the FDA.

How to Know if a Cosmetic Contains Natural Rubber Latex

Read the label
Although cosmetic products are not required to include a latex allergy warning, the FDA does require that the labels of cosmetics include a list of ingredients, in order of decreasing amount. Consumers should review labeling information prior to purchase. Usually the ingredient list is on the package, where the consumer can easily find it. If the product is sold by mail order, including online, the list may be on the package directly or consumers may be directed to a product catalog or a website, or there may be specific information about how to request a copy of the ingredient list. FDA regulations requires that mail-order distributors respond promptly to your request.

Here are some ingredient names to watch for, all of which indicate the presence of latex:

• Natural Rubber Latex
• Natural Latex Rubber
• Rubber Latex
• Natural Latex
• Latex Rubber
• Natural Centrifuged Latex
• Natural Liquid Latex
• Aqueous Latex Adhesive
• Latex

Manufacturers can change their products' ingredients at any time, so it's a good idea to check the ingredient list every time you buy the product - even if you have used it before.

Consumers who are concerned about natural rubber latex allergy may want to take more precautions, such as:

• Avoiding all products that commonly contain natural rubber latex ingredients (body paints, theatrical cosmetics, hair bonding adhesives, and eyelash adhesives), even if latex isn't listed as an ingredient, or
• Contacting the manufacturer to learn more about the ingredients in the product.
• Speaking with your healthcare professional or dermatologist about your concerns.
• Telling your salon professional if you have or suspect that you have a latex allergy, to avoid possible exposure.

Products marketed only to professionals may not have a list of ingredients. That's because the Fair Packaging and Labeling Act doesn't apply to those cosmetic products sold for professional use. Salon professionals may need to contact the manufacturer to find out what's in these products.

What should I do if I think that I may have a problem with latex?

If you are allergic to natural rubber latex and you have reaction to a cosmetic product, stop using the product and contact your healthcare professional. Please inform the FDA by using our adverse events reporting tools (see below how to report a problem).

How to Report a Problem

If you are a consumer, health professional, attorney, or member of the cosmetics industry who wants to report a complaint or an adverse event (such as an allergic reaction) related to a cosmetic, you have three choices:

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

When you report a reaction, be sure to include as much information as possible. It is helpful for FDA to know the precise product name, place, and time of purchase, lot number, labeling, and ingredients, especially if you believe you have experienced a reaction to latex. It is also important to let us know if you have a latex allergy or sensitivity.

The law does not require cosmetic companies to report problems to the FDA. Therefore, your report is very important in order to help the FDA monitor the cosmetics market.

Talc is an ingredient used in many cosmetics, from baby powder to blush. From time to time, FDA has received questions about its safety and whether talc contains harmful contaminants, such as asbestos.

FDA's authority over cosmetic safety

Under the Federal Food, Drug and Cosmetic Act (FD&C Act), cosmetic products and ingredients, with the exception of color additives, do not have to undergo FDA review or approval before they go on the market. Cosmetics must be properly labeled, and they must be safe for use by consumers under labeled or customary conditions of use. Cosmetic companies have a legal responsibility for the safety and labeling of their products and ingredients, but the law does not require them to share their safety information with FDA.

FDA monitors for potential safety problems with cosmetic products on the market and takes action when needed to protect public health. Before we can take such action against a cosmetic, we need sound scientific data to show that it is harmful under its intended use.

Talc: What it is and how it is used in cosmetics

Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen. Chemically, talc is a hydrous magnesium silicate with a chemical formula of Mg₃Si₄O₁₀(OH)₂.

Talc has many uses in cosmetics and other personal care products; in food, such as rice and chewing gum; and in the manufacture of tablets. For example, it may be used to absorb moisture, to prevent caking, to make facial makeup opaque, or to improve the feel of a product.

Asbestos: What it is, why it’s a concern, and how to prevent its occurrence in cosmetics

Asbestos is also a naturally occurring silicate mineral, but with a different crystal structure. Both talc and asbestos are naturally occurring minerals that may be found in close proximity in the earth. Unlike talc, however, asbestos is a known carcinogen.

Published scientific literature going back to the 1960s has suggested a possible association between the use of powders containing talc and the incidence of ovarian cancer. However, these studies have not conclusively demonstrated such a link, or if such a link existed, what risk factors might be involved. Nevertheless, questions about the potential contamination of talc with asbestos have been raised since the 1970s.

To prevent contamination of talc with asbestos, it is essential to select talc mining sites carefully and take steps to purify the ore sufficiently.