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Regulation of Cosmetics

This is a little a tricky, and it's going to feel Kafka-esque, but stick with us.  It's important. And if you think this systems is crazy (like we do), and you want to do something about it, we encourage you to Take Action and support The Safe Cosmetics and Personal Products Act of 2013.

How Are Cosmetics Regulated?

The most important laws relating to cosmetics are the Federal Food, Drug, and Cosmetics Act (FD&C Act), which grants the U.S. Food and Drug Administration (FDA) limited authority over cosmetics manufacturers, and the Fair Packaging and Labeling Act, which requires labels to list quantities, not ingredients. 

What are "cosmetics"?

Under the FD&C Act, cosmetic are defined by their intended use, not their ingredients.  A cosmetic is something that's "intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance."[1] This includes lipstick, eye and facial makeup, shampoos, conditioners, perms, hair dyes, deodorants, and substances that are intended to be components of cosmetic products. It does not include soap or items intended for any therapeutic use (which are regulated by FDA as "drugs"). "Soap" is only traditional soap made from fats and an alkali, and are regulated by the Consumer Products Safety Commission, not FDA; most products we actually use to clean ourselves are synthetic "cleansers," which are considered to be cosmetics.  Makes sense, right?

Who Ensures Product Safety?

In short, cosmetics are among the most unregulated products you can buy. The FDA does not regulate or check the safety of cosmetics ingredients. It can only bring an enforcement action if a cosmetic is contaminated or something is mislabeled. It cannot recall a dangerous product once it is on the shelves; it can only ask a manufacturer to do so voluntarily. Sounds safe, right?

Does the FDA Regulate Cosmetics BEFORE People Can Buy Them? NO!

Neither the FDA - nor any other agency - regulates the ingredients in cosmetics. There is no premarket oversight or approval process for cosmetics, with the exception of color additives. The FDA can only bring enforcement actions AFTER a product has entered the market, because the FD&C Act prohibits the marketing of "adulterated" or "misbranded" cosmetics in interstate commerce. Under the FD&C Act, Section 601, a cosmetic is "adulterated" if it contains anything poisonous  or injurious under conditions of "normal use," anything "filthy, putrid, or decomposed," if it's been prepared, packed or stored in unsanitary conditions, or if its container is made from any poisonous substances that could render the cosmic contents injurious to health.  Under Section 602, a cosmetic is "misbranded" if its labeling is "false or misleading in any particular," or if it fails to have any required instructions for use. It's important to note that while cosmetics sold on a retail basis to consumers are required to list ingredients, those distributed for professional use, institutional use (including to schools or in the workplace), or as free samples are not required to label ingredients.

Manufacturers cannot put anything into cosmetics, but the list of regulated or banned substances in the US is completely outdated. Federal regulation prohibit use of nine ingredients: bithionol, chlorofluorocarbon propellants, chloroform, halogenated salicylanilides, methyls chloride, vinyl chloride, zirconium-containing complexes, and prohibited cattle materials. Use of three substances are restricted: hexachlorophene, mercury compounds, and "sunscreen"ingredients used in cosmetics.[2] 

You can see the complete list of prohibited and restricted ingredients on the FDA website. In contrast, Canada and the EU ban or regulated hundreds of ingredients. Links to those lists are available in the resource information below.

So, Who DOES Check Cosmetics for Safety BEFORE People Can Buy Them? The Cosmetics Industry!

Ensuring that cosmetics are "safe" is left entirely to a voluntary, industry-led process. There is no law or regulation that requires manufacturers to conduct specific tests to ensure the safety of their products or ingredients. No law requires cosmetics firms to be registered with the FDA; nor is there any mandate requiring companies to share product formulations or their safety data with the FDA. FDA states that "the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information."[3] 

So, here's what happens voluntarily. The FDA encourages cosmetics companies to participate in the Voluntary Cosmetics Registration Program. The Cosmetic Ingredient Review (CIR) is an industry-based “safety” panel, whose overall funding comes from the cosmetics industry’s main trade association, the Personal Care Products Council (PCPC).  In over 30 years, the CIR has reviewed only less than 20% of ingredients used in cosmetics,[4] and as of May 2013, has found only 11 chemicals to be "unsafe for use in cosmetics."[5] In addition, the PCPC admits that it does NOT “keep a record of products that have been reformulated or removed from the market as a result of a CIR review.” 

According to the Campaign for Safe Cosmetics, CIR does NOT look at:
  • chemicals linked to negative health impacts;

  • cumulative effect of exposures over a lifetime;

  • the timing of exposure, which can magnify the harm for the very young and other at-risk populations; or

  • worker exposures, in both beauty salons and manufacturing plants.

  • Scientific research has made us aware that even low-dose exposure to hazardous chemicals, when repeated, can have negative long-term health effects.[6]

    Is there Anything Else that The FDA Can do?

    While the FDA cannot regulate product ingredients or require specific safety tests, under FD&C Act, Section 704, it can inspect cosmetic manufacturing facilities to make sure they are sanitary. The FDA can also collect samples for analysis as part of its inspection process, to determine if a product has been adulterated, and to follow up on any complaints received from the public. 

    If the FDA has "reliable evidence" that a cosmetic is adulterated or misbranded, it can bring an enforcement action and the federal courts can issue a restraining order to prevent further shipment of the harmful product. The FDA cannot order a product recall, even if people have been harmed. It can only ask a manufacturer to recall the harmful product voluntarily.

    Learn More

    U.S. Federal Drug Administration - The FDA website provides links to laws, regulations, and guidance materials explaining cosmetics regulation.

    Personal Care Product Council - This industry trade group provides voluntary oversight of cosmetics in the United States.

    California Department of Public Health - To see where the US should be headed, check out the California Safe Cosmetics Act and the California Safe Cosmetics Program.

    European Commission - For an eye-opening look at the protections available in the European Union, check out the website.  It posts law, regulations, and access to a database of cosmetic ingredients, and list of banned ingredients that have been banned because they are classified as carcinogenic, mutagenic, or toxic to reproduction.

    Health Canada - Like the European Union, Canada has taken a proactive stance and banned hundreds of chemicals from use in cosmetics. Canada requires stringent labeling of ingredients, and keeps a Hotlist of banned ingredients.

    1. Federal Food, Drug and Cosmetics Act, Sec. 201(i). 
    2. 21 CFR, Parts 250.250 and 700-11-700-35.
    3. U.S. Food & Drug Administration (FDA), FDA Authority Over Cosmetics, (last updated Aug. 3, 2013).
    4. The Campaign for Safe Cosmetics, FDA Regulations.
    5. Environmental Working Group, Myths on Cosmetic SafetyWasik, John F. "Beauty Tips for the FDA." Washington Monthly (May / June 2013).
    6. Environmental Working Group, Low-Dose Exposures.

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