FDA
REMAINS ASLEEP AT THE WHEEL ON THE DANGERS OF SUNSCREENS, BESIDES OTHER
COSMETICS AND PERSONAL CARE PRODUCTS
CHICAGO, IL, August 7, 2008 --/WORLD-WIRE/-- Since
1978, sunscreens have been regulated and labeled by the Food and Drug
Administration (FDA) on the basis of their SPF (Skin Protection Factor).
On August 23, 2007, the FDA proposed new regulations for more informative
labeling of sunscreens. However, almost a year later, they still remain pending.
In response to FDA’s inaction, and mounting concerns on the unreliability of the
SPF, Connecticut Attorney General Richard Blumenthal wrote to the FDA on July 24
criticizing its failure to regulate the sunscreen industry, and prevent it from
making “dangerously misleading claims” on the safety and effectiveness of its
products.
A week later, Senator Jack Reed (D-Ri) and Christopher Dodd (D-Ct) introduced
the “Sunscreen Labeling Act of 2008.” This gave the FDA six more months to
finalize comprehensive rules, otherwise the Act would become law.
Sunscreens pose scientifically well documented risks. While well known for over
a decade, they remain unregulated by the FDA, and ignored by the industry.
Sunscreens are based on six ingredients, some of which actively penetrate the
skin, accumulate in the body, and have been identified in urine and breast milk.
More ominously, these ingredients have toxic hormonal effects, known technically
as “endocrine disruptive.” Evidence for these effects has been well documented
over the last decade. This includes stimulation of human breast cancer cells in
test tube experiments, and increased uterine growth in immature female rats
following skin painting or feeding.
Sunscreens block short wave ultraviolet light (UVB), which is responsible for
sunburn. This encourages prolonged exposure, particularly of children. Moreover,
sunscreens are ineffective against long wave ultraviolet light (UVA), which is
responsible for malignant melanoma, the fastest growing known cancer. As a
result, its incidence has increased by 130%, and its mortality has increased by
26% since 1975. FDA’s continuing regulatory failure in this regard reflects the
reckless indifference to consumer product safety of its Commissioner Dr. Andrew
von Eschenbach, former director of the National Cancer Institute.
Of major concern, and still ignored by the FDA, is the increasing addition to
sunscreens of unlabeled atom or molecule size zinc oxide or titanium dioxide
particles. Technically known as nanoparticles, they increase the durability and
effectiveness of these products. However, as reported in over two dozen
scientific publications since 2003, including those by an Environmental
Protection Agency research team and the International Center for Technology
Assessment, nanoparticles can penetrate the skin, invade blood vessels, and
produce devastating distant toxic effects.
FDA’s regulatory failure extends from sunscreens to a wide range of other
dangerous ingredients in cosmetics and personal care products. Of illustrative
concern is FDA’s reckless failure to respond to November 1994 and May 2008
Citizen Petitions, by the Cancer Prevention Coalition, “Seeking a Cancer Warning
on Cosmetic Talc Products,” used for feminine hygiene. As detailed in these
Petitions, talc is a major avoidable cause of ovarian cancer, a relatively rare
cancer at any age, whose incidence has escalated dramatically by 12% for white
and 32% for black women, with about 15,000 deaths annually. This makes it the
fourth most common fatal cancer after breast, colon and lung.
The “Sunscreen Labeling Act” should be the first step to developing a
comprehensive “Cosmetics and Personal Care Products Labeling Act.” This could be
modeled along the lines of California’s precedential 2007 Safe Cosmetics Act.
As warned by Senator Edward Kennedy (D-Ma) at September 10, 1997 Hearings on the
FDA Reform Bill, “The cosmetics industry has borrowed a page from the playbook
of the tobacco industry by putting profits ahead of public health.” This warning
remains recklessly unheeded by the FDA.
Samuel S. Epstein, MD
Professor emeritus Environmental & Occupational Medicine
University of Illinois at Chicago School of Public Health
Chairman, Cancer Prevention Coalition
Chicago, Illinois
www.preventcancer.com
epstein@uic.edu
