Caving to Industry, FDA Delays Safety Standards For Decades
[Rachel's Introduction: A new study by the U.S. Centers for Disease Control (CDC) reveals that 97% of Americans are contaminated with a sunscreen ingredient called oxybenzone linked to allergies, hormone disruption, and cell damage. At the request of industry lobbyists such as Supreme Court Chief Justice John Roberts, who represented the Cosmetic Toiletry and Fragrance Association, the agency has delayed sunscreen safety standards for nearly 30 years.]
A companion study published just one day earlier revealed that this chemical is linked to low birth weight in baby girls whose mothers are exposed during pregnancy. Oxybenzone is also a penetration enhancer, a chemical that helps other chemicals penetrate the skin.
Although oxybenzone is most common in sunscreen, companies also use the chemical in at least 567 other personal care products.
Environmental Working Group identified nearly 600 sunscreens sold in the U.S. that contain oxybenzone, including products by Hawaiian Tropic, Coppertone, and Banana Boat (see the full list of 588 sunscreens here) as well as 172 facial moisturizers, 111 lip balms, and 81 different types of lipstick.
The Food and Drug Administration has failed miserably in its duty to protect the public from toxic chemicals like oxybenzone in personal care products. At the request of industry lobbyists, including Supreme Court Chief Justice John Roberts, who represented the Cosmetic Toiletry and Fragrance Association, the agency has delayed final sunscreen safety standards for nearly 30 years. FDA issued a new draft of the standards last October under pressure from EWG, but continues to delay finalizing them at the behest of the regulated industry.
EWG research shows that 84% of 910 name-brand sunscreen products offer inadequate protection from the sun, or contain ingredients, like oxybenzone, with significant safety concerns.
The last safety review for oxybenzone was done in the 1970s, and does not reflect a wealth of information developed since that time indicating increased toxicity concerns and widespread human exposure. A recent review in the European Union found that sufficient data were not available to assess if oxybenzone in sunscreen was safe for consumers.
Environmental Working Group again calls on FDA to review the safety of oxybenzone, given this new data on widespread contamination of the U.S. population, and to finalize its sunscreen safety standards so that consumers can be certain that sunscreen products they purchase are safe and effective.
CDC study of oxybenzone signals concern
Top scientists from CDC published results March 21, 2008 from a national survey of 2,500 Americans, age 6 and up, showing that oxybenzone readily absorbs into the body and is present in 97% of Americans tested (Calafat 2008). Oxybenzone, also known as benzophenone-3, was detected in the urine of nearly every study participant. Typically, women and girls had higher levels of oxybenzone in their bodies than men and boys, likely a result of differences in use of body care products including sunscreens.
A companion study released a day earlier revealed that mothers with high levels of oxybenzone in their bodies were more likely to give birth to underweight baby girls (Wolff 2008). Low birth weight is a critical risk factor linked to coronary heart disease, hypertension, type 2 diabetes, and other diseases in adulthood (Lau 2004).
Oxybenzone damages and penetrates the skin
Among common sunscreen chemicals, oxybenzone is most likely to be associated with allergic reactions triggered by sun exposure. In a study of 82 patients with photoallergic contact dermatitis, over one quarter showed photoallergic reactions to oxybenzone (Rodriguez 2006); another study reported 1 in 5 allergic reactions to photopatch tests resulted from exposure to oxybenzone (Bryden 2006).
Sunlight also causes oxybenzone to form free radical chemicals that may be linked to cell damage, according to 2 of 3 studies (Allen 1996; Serpone 2002; Hanson 2006).
A less visible but more alarming concern, this chemical absorbs through the skin in significant amounts, as indicated by the CDC study. A previous biomonitoring study reported that 96% of 6 to 8 year old girls had detectable amounts of oxybenzone in their urine (Wolff 2007). An earlier study detected oxybenzone in the urine of all 30 adult participants (Ye 2005).
Studies on human volunteers indicate a wide variation in the level of oxybenzone absorbed into the body, with some individuals absorbing at least 9% of the applied dose, as measured in excretions in urine (Hayden 1997; Janjua 2004; Sarveiya 2004; Gonzalez 2006). Volunteers continued to excrete oxybenzone many days after the last application of the chemical, an indication of its tendency to accumulate in fatty tissues in the body (Gonzalez 2006).
In addition to its ability to absorb into the body, oxybenzone is also a penetration enhancer, a chemical that helps other chemicals penetrate the skin (Pont 2004).
Oxybenzone may disrupt the human hormone system
Studies on cells and laboratory animals indicate that oxybenzone and its metabolites, the chemicals the body makes from oxybenzone in an attempt to detoxify and excrete it, may disrupt the hormone system. Under study conditions, oxybenzone and its metabolites cause weak estrogenic (Nakagawa 2002; Schlumpf 2001, 2004; Kunz 2006; van Liempd 2007) and anti-androgenic (Ma 2003) effects. Oxybenzone displays additive hormonal effects when tested with other sunscreen chemicals (Heneweer 2005). Laboratory study also suggests that oxybenzone may affect the adrenal hormone system (Ziolkowska 2006).
One human study coapplying 3 sunscreen active ingredients (oxybenzone, 4-MBC, and octinoxate) suggested a minor, intermittent, but statistically significant drop in testosterone levels in men during a one-week application period (Janjua 2004). Researchers also detected statistically significant declines in estradiol levels in men; other hormonal differences detected could not be linked to sunscreen use due to differences in baseline hormone levels before and during treatment.
Outdated health protections do not take into account these and other adverse effects
A 2006 European Union review concluded that a rigorous exposure assessment of oxybenzone was impossible, due to lack of information about the levels of absorption into the body (SCCP 2006). The levels of contamination reported in this latest CDC study indicate that absorption may be significant, consistent with previous, small-scale biomonitoring reports. A decades-old evaluation by FDA, as well as more recent review by the cosmetics industry's own safety panel, do not consider concerns regarding hormone disruption, nor the implications of the ability of oxybenzone to penetrate the skin (FDA 1978; CIR 1983, 2002). At present, no health-based standards exist for safe levels of oxybenzone in the body.
Additional cautions must be employed when considering the effects of oxybenzone on children. The surface area of a child's skin relative to body weight is greater than adults. As a result, the potential dose of a chemical following dermal exposure is likely to be about 1.4 times greater in children than in adults (SCCNFP 2001). In addition, children are less able than adults to detoxify and excrete chemicals, and children's developing organ systems are more vulnerable to damage from chemical exposures, and more sensitive to low levels of hormonally active compounds (NAS 1993; Janjua 2004). Children also have more years of future life in which to develop disease triggered by early exposure to chemicals (NAS 1993). Despite these well- documented concerns regarding children's sensitivity to harmful substances, no special protections exist regarding ingredients in personal care products marketed for babies and children.
The fraction of oxybenzone that is not absorbed into the human body often contaminates water, washed from the skin during swimming and water play or while bathing (Lambropolou 2002; Danovaro 2008). Wastewater treatment removes only a fraction of this sunscreen chemical (Li 2007), resulting in detection of oxybenzone in treated wastewater, in lake and sea waters due to recreational use or to discharges from water treatment facilities, and even in fish (Balmer 2005; Cuderman 2007; Li 2007). Studies show oxybenzone can trigger outbreaks of viral infection in coral reefs (Danovaro 2008), and can cause feminization of male fish (Kunz 2006). Despite significant ecological concerns, there are no measures in place to protect sensitive ecosystems from damage caused by this contaminant.
EWG to FDA: Oxybenzone investigation is long overdue
FDA last reviewed the safety of oxybenzone in the 1970s, publishing its evaluation in 1978, at the same time it announced plans to develop comprehensive standards for sunscreen safety and effectiveness (FDA 1978). 30 years later, the Agency has yet to issue final regulations. Instead, it encourages manufacturers to follow draft guidelines that the Agency has delayed finalizing at the behest of the sunscreen industry. As a result, sunscreen manufacturers in the U.S. are free to market products containing ingredients like oxybenzone that have not been proven safe for people.
Found in over half of the 910 name-brand sunscreen products we reviewed, oxybenzone is tied to significant health concerns that must be scrutinized. Instead, FDA's refusal to re-examine this ingredient keeps sunscreens containing oxybenzone on the market. Petitions for review of newly developed sunscreen ingredients approved for use in other countries, and with far fewer health concerns, have been met with similar inattention, blocking Americans' access to better products.
FDA foot-dragging has left the U.S. without enforceable standards for sunscreen safety and effectiveness for decades. EWG demands that FDA finalize the latest version of its monograph on sunscreen products immediately, and launch an investigation into the safety of the sunscreen ingredient oxybenzone.
More EWG comments on FDA's sunscreen monograph
EWG report on sunscreen safety
View name-brand products that contain oxybenzone:
Sunscreens (588 products)
other products with SPF
fragrance for women
Although oxybenzone is most common in sunscreen, companies also use the chemical in at least 567 other personal care products.
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