February 23, 2011
California health officials in the San Francisco Bay Area sent out a medical alert earlier this month after tracing the mercury poisoning of a 39-year-old Alameda County woman to a skin-lightening cream. (I'm glossing over the obvious sociological issue of why people are taking a risk using black market mixtures to whiten their skin to begin with; that's a subject for another blogger. I'll stick to the chemical engineering and regulatory side of the issue.)
The skin cream in question was unlabeled, smuggled into the US from Mexico. Lead in brand name lipstick is one thing, but what can be done about mercury in unmarked vials smuggled over the border without traceability? In fact, there's not much the U.S. Food and Drug Administration (FDA) can do about it, whether the cosmetic product is marked, labeled, branded or not.
While health investigators are currently going undercover in some San Francisco Bay Area ethnic communities to root out this month's mercury-laden foreign-made products, after a case of mercury poisoning from an illegally imported skin-whitening cream occurs, the FDA can warn against using such products but is largely unable to take further legal action.
FDA banned and restricted chemicals in cosmetics The EU has banned over 1300 chemicals in cosmetics; the Food and Drug Administration in America has banned ten. The online news agency ecosalon notes that Cover Girl waterproof mascara contains the same ingredient (petroleum distillates, an oil by-product) as Dr. Scholl’s Wart Remover -- which is illegal in Europe, as are any petroleum based ingredients in cosmetics.
As of February 2011, the United States FDA has banned or restricted 10 chemicals (if "mercury compounds" can be called a "chemical") from use in cosmetics. Regulations specifically prohibit the use of the following ingredients in cosmetics:
- Bithionol The use of bithionol is prohibited because it may cause photo-contact sensitization (21 CFR 700.11).
- Chlorofluorocarbon propellants The use of chlorofluorocarbon propellants (fully halogenated chlorofluoroalkanes) in cosmetic aerosol products intended for domestic consumption is prohibited (21 CFR 700.23).
- Chloroform The use of chloroform in cosmetic products is prohibited because of its animal carcinogenicity and likely hazard to human health. The regulation makes an exception for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient (21 CFR 700.18).
- Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide). These are prohibited in cosmetic products because they may cause photocontact sensitization (21 CFR 700.15).
- Methylene chloride The use of this substance in cosmetic products is prohibited because of its animal carcinogenicity and likely hazard to human health (21 CFR 700.19).
- Vinyl chloride The use of vinyl chloride is prohibited as an ingredient of aerosol products, because of its carcinogenicity [21 CFR 700.14].
- Zirconium-containing complexes The use of zirconium-containing complexes in aerosol cosmetic products is prohibited because of their toxic effect on lungs, including the formation of granulomas [21 CFR 700.16].
- Prohibited cattle materials To protect against bovine spongiform encephalopathy (BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed with, or otherwise contain, prohibited cattle materials. These materials include specified risk materials*, material from nonambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef. Prohibited cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities, tallow derivatives, and hides and hide-derived products, and milk and milk products.** [21 CFR 700.27, as amended].
(For more, review the regulation: 21 CFR, Parts 250.250 and 700.11 through 700.35).
Certain other ingredients may be used in cosmetics, but only under restrictions. Those restrictions are stated in the regulations and apply to the following chemicals / mixtures:
- Hexachlorophene Because of its toxic effect and ability to penetrate human skin, hexachlorophene (HCP) may be used only when an alternative preservative has not been shown to be as effective. The HCP concentration of the cosmetic may not exceed 0.1 percent. HCP may not be used in cosmetics that in normal use may be applied to mucous membranes, such as the lips [21 CFR 250.250].
- Mercury compounds Mercury compounds are readily absorbed through the skin on topical application and tend to accumulate in the body. They may cause allergic reactions, skin irritation, or neurotoxic manifestations. The use of mercury compounds as cosmetic ingredients is limited to eye area cosmetics at concentrations not exceeding 65 parts per million (0.0065 percent) of mercury calculated as the metal (about 100 ppm or 0.01 percent phenylmercuric acetate or nitrate) and is permitted only if no other effective and safe preservative is available for use. All other cosmetics containing mercury are adulterated and subject to regulatory action unless it occurs in a trace amount of less than 1 part per million (0.0001 percent) calculated as the metal and its presence is unavoidable under conditions of good manufacturing practice [21 CFR 700.13].
- Sunscreens in cosmetics Use of the term "sunscreen" or similar sun protection terminology in a product's labeling generally causes the product to be subject to regulation as a drug. However, sunscreen ingredients may also be used in some products for nontherapeutic, nonphysiologic uses (for example, as a color additive or to protect the color of the product). To avoid consumer misunderstanding, if a cosmetic product contains a sunscreen ingredient and uses the term "sunscreen" or similar sun protection terminology anywhere in its labeling, the term must be qualified, in accordance with 21 CFR 700.35(b), by describing the benefit to the cosmetic product provided by the sunscreen ingredient (for example, "Contains a sunscreen to protect product color."). Otherwise, the product may be subject to regulation as a drug [21 CFR 700.35]. For further information on sunscreens, refer to guidance on tanning products. In fact, there is an entire list of tanning products that are regulated by the US government.
The names may seems like "obvious" restricted chemicals to most of us, but these chemicals were available in aerosol hairsprays, shampoos, face creams, deodorants and more until just a few decades ago.
FDA regulatory authority < = 0 Unlike with food and drug additives, the FDA has no authority to do any of the following:
- test chemicals in cosmetics
- require safety testing before cosmetics hit shelves
- recall cosmetic products
Cosmetic manufacturers are responsible for the safety of their own products. They are responsible for making sure they adhere to the FDA’s guidelines. Companies are not at this time required to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries to FDA.
The FDA announced intentions recently to enhance the agency’s and industry’s ability to trace the supply chain of all food related products. While there's no crystal ball, it would be fair to say that the next three years should be interesting in terms of chemical regulation activity in cosmetics and related products.