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.
Source: Samuel S. Epstein,
MD
Posted August 8th, 2008
