Monday, June 23, 2008

The Profitability of Regulatory Loopholes:
Inside the $35 Billion Personal Care Biz


-- trends + business + politics--

"EWG's research shows that nearly 90% of ingredients in personal care products have not been assessed for safety and many contain ingredients that are known toxins like mercury and lead that are linked to very serious health problems. Cosmetics in the U.S do not have to be approved as safe by the FDA before they are sold. As a result, they can contain dozens of hazardous ingredients banned in other countries."

This sentiment was one part of a long and heated public statement made by the Vice President of Research for the Environmental Working Group, Jane Houlihan. The statement came last week just following a public meeting held at the FDA which called on the government to include public health, consumer and environmental organizations in upcoming industry-regulatory meetings set for July 28th. The event is set to bring together representatives from nations including U.S, Canada, Europe and Asia with the cosmetics industry for the International Cooperation on Cosmetic Regulation (ICCR). The meeting is anticipated to confront efforts to further "remove regulatory obstacles" from the already lax U.S regulations.

Currently, cosmetics, or personal care products, are essentially unregulated under the Federal Food, Drug, and Cosmetics Act (FFDCA). The Act includes 112 pages of standards for food and drugs, but just a single page for cosmetics. This single page provides the Food and Drug Administration (FDA) with virtually no power to perform even the most rudimentary functions needed to ensure the safety of an estimated $35 billion of personal care products purchased by consumers annually. Under federal law and regulation:

  • Cannot require companies to test cosmetic products for safety before marketing.
  • Does not review or approve cosmetic products and cosmetic ingredients before they are sold to the public.
  • Cannot regulate cosmetic products until after they are released to the marketplace, and even then the process is extremely cumbersome.
  • Cannot require product recalls. The agency must to go to court to remove misbranded and adulterated products from the market.
  • Cannot require manufacturers to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries. Instead, FDA relies on voluntary reporting of ingredients, injuries and establishments.


“The cosmetics industry enjoys a largely unwatched and unregulated status in the U.S. that raises serious concerns for public health, and closed-door meetings between regulators and the industry may well widen these significant gaps, This process is inherently biased, conflicted, and unacceptable." said Houlihan,

The EWG has earlier put forth certain suggestions to remedy the regulatory challenge. These include;

  • Mandatory registration of facilities. FDA needs to know who is making personal care products, and what products they are making, as a basic first step to protecting the public health.
  • Mandatory, public injury reports (adverse event reporting). FDA needs to know exactly which products may be endangering public health so that they can take the appropriate actions.
  • Registration of products and ingredients must be mandatory. FDA must know what is in products if it is to protect the public from ingredients that may pose health risks.
  • Meaningful and proven labeling. Product claims and marketing terms must be backed up by tests and must meet explicit definitions set by FDA.
  • Safety standards for cosmetics and FDA enforcement authority. FDA's safety standard for cosmetics and its authority over cosmetic safety must be brought up to par with the agency's authority over pesticides and food and color additives under the Federal Food, Drug, & Cosmetic Act (FFDCA). FDA must have the mandate to ensure that ingredients are safe and the authority to demand the studies that it needs to make this finding. Cosmetic ingredients have been found in cord blood and they pollute the bodies of nearly everyone in the population; they should be as safe as pesticides, and food and color additives that meet safety standards under FFDCA.
  • Lastly, the ICCR meetings must be open to the public to ensure that a broad range of stakeholders are included, so that the interests of more than just the regulated industry are represented.

To this date, no word has been released on weather the July meeting will be open to public health, environmental or consumer interest stakeholders.



(Via: EWG)

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