Chronic under-regulation

Readable Research | ByAbby Ferla | Health, Regulation

September 7, 2011 — Regulatory failures are often reported in isolation from one another. In one news cycle, it is the Minerals Management Service that takes "a lax attitude toward overseeing [oil drilling] operations." In another news cycle, it is the Securities and Exchange Commission that, almost without exception, refuses to prosecute those individuals and entities in the financial services industry who were apparently engaged in mortgage-securities fraud.

putting regulatory failures in context

Remapping Debate’s specialty is original reporting. But in this case, we thought that it would be useful to build on the work of others. By compiling previous reporting that has been done on individual instances of regulatory failure, a picture quickly emerges that is very different from the bogeyman of overregulation: an unmistakable, systemic pattern of under-regulation.

Beginning with this edition’s feature on the strikingly limited extent to which the Food and Drug Administration has regulated the cosmetics industry, each installment of our series will look at one regulatory agency and examine the ways in which the agency has failed to fulfill its promise of robust public protection consistently over time.

The series will conclude later this fall with original reporting that explores further the key reasons for the failures that have continued to recur, looking both at agencies that have themselves been unwilling to exercise their powers and at the external hurdles that are placed in the path of agencies that seek to regulate more aggressively.

Editor

But when one steps back from individual stories, it is apparent that, over at least the last 30 years, a series of similar problems has undermined the ability of agencies to protect the public. These problems include a lack of statutory authority, a failure to write appropriate regulations even where necessary statutory authority exists, a lack of willingness to enforce the regulations that are on the books, and deep and chronic underfunding.

These obstacles are sometimes fueled by an administration’s or a political party’s hostility to an agency’s mission, sometimes by Congressional indifference, and, almost always, by resistance from industries seeking to evade effective oversight. These roadblocks to effective regulation — singly and in combination — recur again and again, both across administrations and across agencies.

The Food and Drug Administration (FDA) is a good case in point, and, while there are a host of areas in which agency performance has been criticized, this article limits its scope to matters related to cosmetics safety.

The agency is authorized by the Food, Drug, and Cosmetic Act of 1938 to regulate cosmetic products — in interstate commerce — that are adulterated either through false labeling, toxic contents, or damage.

The agency, however, is still not authorized to test cosmetics before they are put on the market or to mandate recalls of dangerous products. It also still cannot require cosmetic manufacturers to register with the FDA, file information on their ingredients, or report any cosmetic-related injuries. Since the creation of the Food, Drug, and Cosmetic Act, Congress has updated laws relating to labeling regulation (1967) and given the FDA authority to regulate color additives in cosmetics (1962). Otherwise, the cosmetics-related provisions have remained largely unchanged since 1938.

For more than 30 years now, questions have been raised about the efficacy of federal efforts to assure consumers that the cosmetics they use are safe. This story recounts some of those questions, including those regarding the FDA’s vigor in utilizing the statutory authority it does have in the area of cosmetics safety, those about its interest in pushing to expand that authority further, and those about Congressional receptivity to changing the status quo.

To read the full article, go to page 2, and then click through page-by-page. If you wish to jump directly to a particular year, just click that year on the timeline below.

When sources are available online, we link to them. When not available online, we use cite them in note form. To view the note online, place your cursor over the superscript number. To view the full article with end notes, click "Download a PDF" on the upper right of this page.

Big industry with a history of limited oversight:

Some highlights of the research

1978: General Accounting Office study highlights limiations on FDA authority to regulate cosmetics industry and criticizes FDA for failing to use existing authority robustly.

1984: Advocacy group report finds that beauticians who use hair dyes regularly in their work have above-average cancer rates.

1988: Subcommittee of House Committee on Small Business holds hearing on safety of cosmetics. Emergency rooms said to have treated 47,000 cosmetics-related injuries in previous year. FDA and other regulatory entities called "toothless pit bulls," with press coverage identifying major limitations in government oversight of cosmetics industry.

1990: GAO report is critical of both the existing voluntary cosmetic regulation program and of FDA enforcement.

1997: Study finds dyes for darkening gray hair may leave harmful lead residue that can be ingested, which is especially threatening to children. FDA overhaul bill that would, among other things, establish standardized labeling and warning requirements for cosmetics introduced in Congress.

2001: University of Southern California study finds above-average bladder cancer rates in beauticians that work with hair dyes. European Union conducts follow-up study, and, in response, strengthens cosmetics regulation in the EU.

2005: California requires manufacturers to report carcinogens in their products, including those in cosmetics, to the state and authorizes regulation of such products.

2007: Consumer group finds that 61 percent of tested lipstick samples contain lead above levels allowed in food.

2009: Legislation that would increase FDA authority to regulate cosmetics dies in committee.

2010: California and Oregon each find high levels of formaldehyde in hair straightening product. The proposed federal Safe Cosmetic Act of 2010 dies in committee.

2011: Revised version of 2010 proposed legislation, the Safe Cosmetic Act of 2011, is introduced.

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