In addition, regulations prohibit or restrict the use of several ingredients in cosmetic products and require warning statements on the labels of certain types of cosmetics. Recalls of cosmetics are voluntary actions taken by manufacturers or distributors to remove from the marketplace products that represent a hazard or gross deception, or that are somehow defective 21 CFR 7.
FDA is not authorized to order recalls of cosmetics, but we do monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request. FDA may take regulatory action if we have reliable information indicating that a cosmetic is adulterated or misbranded. For example, FDA can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market.
To prevent further shipment of an adulterated or misbranded product, FDA may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Cosmetics that are not in compliance with the law may be subject to seizure. FDA also may initiate criminal action against a person violating the law.
In addition, FDA works closely with U. Customs and Border Protection to monitor imports. Products that do not comply with FDA laws and regulations are subject to refusal of admission into the United States. They must be brought into compliance if possible , destroyed, or re-exported.
FDA does not inspect every shipment of cosmetics that comes into this country, but imported cosmetics are still subject to the laws we enforce, even if they are not inspected upon entry.
However, breast cancer tumours do not originate in the lymph nodes, they start in the breast, and travel to the lymph nodes later.
Another study found no difference in the concentration of aluminium between the cancer and the surrounding tissue. Currently there is no clear link between the use of under-arm products containing aluminium and breast cancer.
Every day, humans are exposed to aluminium through food, packaging, pots and pans, medicine and even air and water. Despite these findings, some manufacturers have begun producing aluminium-free products for consumers who still hold concerns. Triclosan was originally developed as an anti-bacterial agent for use in hospitals, primarily as a surgical scrub. However its usefulness has seen it increasingly added to a wide range of consumer products including deodorant, soap, toothpaste, cosmetics and general house-hold cleaning products.
Triclosan is also used as a pesticide and can, under certain circumstances, break down into potentially toxic chemicals such as dioxins. Triclosan hit the news in after findings published by the National Academy of Sciences US noted rising levels of the chemical being detected in the environment and its increasingly broad use in everyday products as concerns.
Studies conducted by scientists at the University of California found that prolonged exposure to triclosan causes liver fibrosis and cancer in laboratory mice. Other studies have suggested triclosan can disrupt hormones, impair muscle contraction and reduce bacterial resistance. Whilst the over-use of triclosan in products warrants further study, Australian experts have highlighted its value and importance when used correctly and in moderation.
Laurie Walsh, noted that the chemical has been proven to fight various conditions such as gingivitis, inflammation and bleeding gums. In Australia, a full risk assessment conducted by NICNAS found no cause for public concern in general, though did recommend controls for maximum concentrations of triclosan 0.
At present, cosmetic products containing more than 0. The American Food and Drug Administration FDA is planning to release an updated report on Triclosan in , though in the interim consumers may look for triclosan-free products if they wish. Formaldehyde is an organic compound with a wide variety of uses.
Although commonly associated with embalming, it is also used in the manufacture of building materials, textiles, household cleaning products, plastics, cosmetics and personal care products.
It also occurs naturally in a wide range of foods , for example the humble egg. Formaldehyde is not typically used in its pure form, but altered slightly and listed under the name formalin. It works as a preservative to protect products from contamination.
Formaldehyde is classified as a Group 1 carcinogen known to cause cancer in humans by the World Health Organization International Agency for Research on Cancer. It can also cause skin and sensory irritation and breathing difficulties in people when inhaled, ingested or if it comes into contact with skin.
So why is it still used in everyday products? As with other chemicals, it is the concentration present in a product that is important. Oral products such as toothpastes may only contain up to 0. All other cosmetic products such as shampoos and straightening solutions can have up to 0.
At these low levels, the use of formaldehyde is deemed to be safe. NICNAS has noted that people with particularly sensitive skin may still experience irritation even at these low concentrations. In , the Australian Competition and Consumer Commission ACCC conducted a survey of the formaldehyde concentrations of several cosmetic products that resulted in the voluntary recall of two products that contained unacceptably high concentrations of the chemical.
Phthalates pronounced THAL-ates are another group of chemicals found in some cosmetics that have been red-flagged by environmental groups. They are generally used to make plastic products soft and flexible but can also be found in cosmetics like nail polish, hair spray to make the products less brittle or stiff and perfumes.
Phthalates are produced from oil and there are more than 20 types in common use. As the various phthalates have different chemical structures, toxicity profiles and uses, their safety should not be generalised as a group, but looked at on an individual basis. Some studies have indicated that at high, recurring concentrations different phthalates can act as endocrine disruptors—this means they upset the hormonal balance in the body and can lead to developmental problems, particularly in males.
Other studies have indicated there may be a link between phthalates and type 2 diabetes. In response, the European Union and the United States have imposed bans on some types of phthalates for use in cosmetics. News reports detailing levels of lead and other metals in lipsticks are persistent and recurring, but should consumers be worried? A study by the University of California Berkley examined the metal content of 32 different lipsticks.
Researchers found traces of aluminium, manganese which can cause neurological problems and titanium in all the products they tested, while three-quarters of the products contained lead which affects the nervous system, and can cause learning disabilities in children. Many of the lipsticks and lip glosses also contained nickel and cobalt, as well as cadmium and chromium—both known carcinogens. Why would manufacturers add these ingredients to their products?
Because of the persistent nature of these substances and the fact they occur in the natural environment, including in water, it is almost impossible to remove all traces of them. The presence of these naturally-occurring elements in lipsticks is not necessarily a problem—the important issue is the level or concentration. Are the the levels high enough to be considered toxic, or are they low enough to be deemed safe?
Remember, sunlight is also a proven carcinogen skin cancer —but you still go outside and you might even sunbathe. It all comes down to dose. Basically, you will consume more lead from drinking water than you will from applying lipstick. However, the study did conclude that further research into the metal content of cosmetic products is necessary, particularly with respect to chromium.
While sun creams are not officially cosmetics they are considered to be therapeutics , we will include them here as their use is so common, particularly in Australia. Their use has been proven to help prevent certain skin cancers including melanomas and basal cell carcinomas.
In recent years there has been some concern about nanoparticles NP in sunscreens. The position of the Therapeutic Goods Administration TGA , based on several published papers up to May as well as reviews of international authorities, is that nano-particles are safe. This suggests that systemic absorption is unlikely. A further study published in found that when exposed to zinc oxide nanoparticles, human immune cells called macrophages effectively absorbed the nanoparticles and broke them down.
Based on current evidence, neither TiO 2 nor ZnO nanoparticles are likely to cause harm when used as ingredients in sunscreens. There are more risks associated with avoiding suncreams sunburn, skin cancers than there are posed by nanoparticles.
Source: RiAus on YouTube. View video details and transcript. While the current scientific thinking on many of these chemicals is that they are safe to use, it is up to each consumer to make their own decision as to whether they purchase and use a product containing certain ingredients or not.
Consumers should also try to purchase reputable brands from established sellers—cheap imports or copies bought online may not have been through the proper testing and assessment process and may not contain what they claim to. In our pursuit of beauty, it is wise to remember that cosmetics can be complex combinations of chemicals. Achieving even a basic understanding of the long chemical names on a product ingredient list—what they are and what they do—can go a long way to helping consumers make informed decisions about the products they choose to use—certainly helpful when putting on your best face.
Common cosmetics and their ingredients Lipsticks Lipsticks are generally made by combining a water-insoluble dye with wax and a non-volatile oil. The wax provides a stable base for the lipstick and the oil alters the texture and makes it easy to apply, while providing a shiny finish. Common waxes include beeswax, carnauba wax and candelilla wax, while popular oils include castor, olive and mineral oils, cocoa butter, lanolin, and petrolatum. Lip glosses, with their higher shine, contain more oils and less wax.
This results in a substance that is stiff, but will spread easily on your lips. Mascara is one of the most popular cosmetic products on the market. The main ingredients of mascara are pigment, such as carbon or iron oxide to create the colour, polymer to create a film that coats the lashes, preservatives to extend the life of the product, and a thickening agent such as wax or oil.
Mascara can come in a water-free formula, which makes it waterproof and smudge proof, but more difficult to remove. Oil-water emulsion formulas are also used, which can smudge and run more readily, but are easier to wash off. The basic ingredient of eye shadow is base filler or diluent, like mica, talc or sometimes kaolin clay.
To make the eye shadow stick to your skin, binders such as magnesium or zinc compounds are added. Silica, nylon, dimethicone, boron nitride or bismuth oxychloride can be included to make the eye shadow easier to apply to the eyelids. Preservatives, such as glycol or tocopherol are also added.
Then, of course, there is the pigment — eye shadow comes in a huge variety of colours. Foundation can come as a loose powder, pressed powder or liquid. Whichever type you use it will generally contain a moisturiser, a colourant and a filler, which dilutes the pigment and also is supposed to fill in any fine lines or wrinkles.
Various chemicals such as iron oxide, and titanium dioxide are used as pigments. Talc, a soft mineral made from magnesium, silicon and oxygen, is a commonly used filler.
Bismuth oxychloride is another common ingredient in foundation, used for the shimmering glow it gives to the wearer. Talc can also cause skin irritation, and there has been some concern that it is also a carcinogen. This is however, regarded as a myth albeit one with a foundation pardon the pun in truth; prior to the regulation of talcum powder in , talc could contain asbestos which might have contributed to an increased cancer risk.
Some doctors advise checking to see if diazolidinyl urea or imidazolidinyl urea has been used as a preservative in foundations, as this can give off formaldehyde, which can irritate the skin of some people. The typical Western ideal of beauty includes glowing, rosy cheeks. In the Victorian era the mid and late s make-up was frowned upon and so women resorted to biting their lips and pinching their cheeks to get a bit of colour. These days, rouge, or blush is commonplace, and can come in many different forms—powder, gel, cream or liquid.
A typical blush will contain a filler such as talc or stearic acid, and of course different pigments to provide the rosy complexion. Other concealing pigments can also be added to the mix to block the natural skin colour so the blush will appear stronger.
These additives can include mica, zinc oxide or titanium oxide. Fake tans change colour on contact with skin. Under this law, cosmetics must not be adulterated or misbranded. For example, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled.
Packaging and labeling must not be deceptive. If you manufacture or market cosmetics, you have a legal responsibility for the safety and labeling of your products. If your cosmetics are marketed to consumers on a retail basis, such as in stores, or by mail order including online , or by personal sales representatives for example, door-to-door sales , they also must meet ingredient labeling requirements under the Fair Packaging and Labeling Act.
The law does not require cosmetic products and ingredients, except for color additives , to be approved by FDA before they go on the market. However, cosmetics must not be adulterated or misbranded. This means that they must be safe for consumers when used according to the labeling, or as people customarily use them, and they must be properly labeled. With the exception of color additives and ingredients that are prohibited or restricted by FDA regulations , you may use any ingredient in your cosmetic, as long as it does not cause the product to be adulterated in any way.
You are legally responsible for making sure your cosmetics are safe and properly labeled, in compliance with all the laws and regulations that apply to them.
For example, some are regulated as drugs. If your product is a drug under U. Here are some examples of products marketed as cosmetics:. Drugs must meet different requirements. Here are some resources to help you learn more:. A color additive, other than coloring materials intended for use as coal-tar hair dyes, must be approved by FDA for the intended use. FDA encourages both domestic and foreign cosmetic firms to register their establishments and file their product formulations with our Voluntary Cosmetic Registration Program VCRP , but participation in this program is voluntary.
In fact, the VCRP will only accept information on cosmetics that are already on the market in this country. If, however, your products are drugs, or both cosmetics and drugs, they must meet the requirements for drug registration. Similarly, importers of cosmetic ingredients that are also classified as food products must meet the registration requirements of the Bioterrorism Act of We have posted this list of GMP guidelines to alert firms to some factors to keep in mind when planning their manufacturing conditions and procedures.
Even if you are manufacturing your products in your home or salon, these guidelines will help you keep your process and your products safe. The same requirements for safety and labeling apply to all cosmetics, no matter what their source. This includes, for example, making sure that all your labeling is truthful and not misleading. FDA also does not have regulations for the term "organic" for cosmetics. The U. You are still responsible for making sure your ingredients are safe when used according to the labeling, or as they are customarily used, no matter what kinds of ingredients you use.
FDA does not have a list of tests required for any particular cosmetic product or ingredient, but you are responsible for ensuring that your product is safe when it is used according to labeled directions, or in the way it is customarily used.
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