FDA Says No Decision Reached Yet On Oxybenzone/Octinoxate Ban Petition

According to industry, available scientific evidence regarding oxybenzone’s and octinoxate’s effects on coral does not support their removal from the OTC sunscreen drug monograph’s list of permitted UV filters, and FDA is fully compliant with federal environmental laws, contrary to the Center for Biological Diversity’s suggestions. FDA says the petition raises complex issues requiring extensive review.

The Center for Biological Diversity will have to continue waiting for FDA’s decision on its petition seeking a ban on oxybenzone and octinoxate use in sunscreens, a request that drew strong opposition from industry groups.

According to FDA, the petition – submitted by CBD in late May – “raises complex issues requiring extensive review and analysis.”

The agency provided the interim response to CBD in November. Regulations require FDA to respond to citizen petitions within 180 days, though it has the option of issuing a tentative response, as exercised in this case.

CBD’s petition focuses on the sunscreen ingredients’ potential link to coral bleaching, among other adverse environmental effects, but also suggests that they pose human health risks, including genotoxic and endocrine-disrupting concerns.

“The use of the toxic pollutants oxybenzone and octinoxate in sunscreen and other personal care products poses an unnecessary and avoidable risk to human health and the marine environment. Alternatives are available and effective,” the nonprofit says.

It adds, “As we introduce more and more of this needless chemical into the aquatic environment, the more irreparable damage it causes.”

Short of a ban, FDA is obligated by Section 7 of the Endangered Species Act to consult with the National Marine Fisheries Service to ensure that oxybenzone and octinoxate are not harming any listed endangered or threatened species, according to CBD.

Further, the agency should conduct an environmental analysis on the impacts of oxybenzone and octinoxate on marine life and the human environment pursuant to the National Environmental Policy Act, the group says. (Also see "Petition Suggests Environmental Laws Compel FDA To Ban Oxybenzone, Octinoxate In Sunscreens" - HBW Insight, 31 May, 2018.)

Oxybenzone and octinoxate figure among the most commonly used sunscreen ingredients on the US market, featuring in an estimated 3,500 products. 

CBD and the Personal Care Products Council, which submitted comments to FDA on the petition, interpret those environmental statutes differently.

From PCPC’s standpoint, the consultation required by ESA must be triggered by an agency action. In this case, the trade group says, the relevant agency action is the final sunscreen rule it issued in 1999, which enumerated the active ingredients (including oxybenzone and octinoxate) permitted for use in OTC sunscreen drug products.

A subsequent rulemaking in 2011 established sunscreen labeling and testing requirements, but FDA stressed that it did not address issues related to sunscreen active ingredients or their GRASE statuses.

PCPC goes on to argue that obligations under the ESA only arise if there is a listed species at issue at the time the relevant agency action was taken. In 1999, the threatened coral species cited by CBD were not yet identified as such under the law.

Further, the 1999 sunscreen rule was decades before any research linking UV filters to coral health problems, the trade group says.

CBD does not read the ESA so narrowly, maintaining that new environmental health information can trigger the responsibility to consult with NMFS, and “ongoing” agency activity can be subject to the law’s terms. In other words, the NMFS meeting shouldn’t have to wait until FDA’s next formal rulemaking related to sunscreen ingredients.

The organization points to case history in the courts that it says support its interpretation.

PCPC: More Recent Studies Show Milder Coral Impact

With regard to oxybenzone’s and octinoxate’s alleged environmental toxicity, PCPC accuses CBD of placing too much emphasis on a single in situ study – the same that drove Hawaii to ban the sale of sunscreen products containing the ingredients via legislation signed into law in July. (Also see "Hawaii’s Sunscreen Ingredient Ban Is On The Books; To Industry, An Affront To Science" - HBW Insight, 7 Jul, 2018.)

Led by C.A. Downs of the Haereticus Environmental Laboratory in Clifford, Va., the study documented striking transformations in coral exposed to the UV filters, including "encasing [of] the entire planula in its own skeleton,” but PCPC takes issue with aspects of the study that limit its applicability to the real world, according to the group. (Also see "Hawaiian Sunscreen Ban On Brink Of Passage; Lawmakers Hashing Out Final Details" - HBW Insight, 19 Apr, 2018.)

The trade association highlights more recent research that found substantially weaker associations between oxybenzone exposure and coral degradation, leading PCPC to believe “it is safe to say that all life stages of the Indo-Pacific hard coral species S. damicornis are relatively insensitive to oxybenzone exposure.”  

PCPC notes there is no published study linking the ingredients in question to adverse effects on coral in a native setting.

Emerging research does show that the UV filters are barely detectable in oceans – in the parts-per-trillion range – while evidence increasingly indicates that climate change and rising water temperatures are the real culprits in coral bleaching.

“Restricting the use of oxybenzone and octinoxate based on a very limited number of reports from which concrete conclusions cannot be drawn would be contrary to the existing scientific weight of evidence and set a precedent for poor policy decisions,” PCPC asserts.

The Consumer Healthcare Products Association similarly finds fault with CBD’s evidence, contending in its comments to FDA that the lab studies cited in the petition “are insufficient to define what, if any, effect these safe and effective sunscreen active ingredients have on the health of native coral reef populations.”

Both CHPA and PCPC warn against shrinking sunscreen formulators’ active ingredient palette, already limited compared with options overseas, without more compelling environmental risk data. (Also see "Could Gottlieb Bring Red-Tape Scissors To FDA Sunscreen Review?" - HBW Insight, 17 Mar, 2017.)

The latter notes that oxybenzone is one of the few approved UV filters in the US that offer broad-spectrum protection.

In its comments to the agency, the Public Access to SunScreens (PASS) Coalition expresses similar concern about the prospect of sunscreen ingredient prohibitions at a time of escalating cancer rates.

Oxybenzone and octinoxate figure among the most commonly used sunscreen ingredients on the US market, featuring in an estimated 3,500 products. According to PASS, 70% of sunscreens chosen by US consumers contain oxybenzone.