NGOs Food & Water Watch and Friends of the Earth seek a moratorium on cosmetics containing nanomaterials until the science is better understood and sufficient testing technology is available to affirm safety, the groups say in response to a recent FDA guidance.

In its July 24 comments, F&WW lauds the agency’s April guidance – titled “Safety of Nanomaterials in Cosmetic Products” – for what it says are “very good suggestions to industry about the kinds of evaluations needed to establish the safety of nano-embedded cosmetics.”

However, the guidance in itself “fails to protect the public from possible dangerous uses of nanomaterials in cosmetics,” the group asserts.

In the document, FDA says its expectations for cosmetics manufacturers using nanomaterials generally are the same as its expectations for firms working with conventional materials – i.e., product safety must be substantiated prior to market launch Also see "Clinical Studies May Be Needed For Cosmetics With Nanomaterials – FDA" - HBW Insight, 30 April, 2012..

FDA notes, however, that testing methods may have to be modified to account for the unique properties of nano-ingredients measured in billionths of a meter, which often behave differently compared with their macro-sized counterparts.

FDA encourages companies to consult with its Office of Cosmetics and Colors to discuss test methods and data needed to substantiate a nanotech-containing product’s safety.

F&WW believes this approach is inadequate. “The agency leaves it up to manufacturers whether they should pursue a rigorous safety assessment or not,” the organization says. “This leaves a gaping gray area in regulations in which industry can self-determine the safety of their products and the acceptability of using nanomaterials in cosmetics.”

The group calls it “a step forward” that FDA has identified areas where data is needed in safety assessments of cosmetics featuring nano-scale particles, including a nanomaterial’s physico-chemical characteristics, agglomeration and size distribution in conditions simulating final-product use, and impurities.

At the same time, “the public deserves a formal process in which the FDA makes specific and strict requirements of industry regarding risk assessment,” F&WW says.

The group recognizes that the development of such a protocol may be difficult given that existing test methods are in some cases unsuitable for evaluating nanomaterials and the science surrounding nanotechnology is so young, lacking “standards and precision in instrumentation,” among other fundamentals.

F&WW concludes: “FDA should not simply allow industry to move forward with marketing nano-embedded cosmetics. Nor should the FDA depend on a weak ‘post-market surveilllance’ regime.”

The group proposes a moratorium on the use of nanomaterials in cosmetics in the absence of a “rigorous regulatory review process.” Such a move would not be greatly detrimental to the functionality of cosmetics or a blow to industry’s economic power, F&WW asserts.

Concerns Include Penetration In Damaged Skin

In their comments, F&WW and Friends of the Earth Australia cite concerns regarding nanomaterial use that they say have yet to be addressed.

Both cite findings suggesting that nano-sized zinc oxide and titanium dioxide used in sunscreen products are photoreactive and can release free radicals that accelerate aging and pose a cancer risk.

Industry and experts have dismissed such concerns, maintaining that manufacturers have developed technologies to suppress the formation of free radicals and that particles do not penetrate deeply enough in skin to represent a significant threat Also see "Friends Of The Earth Less Chummy With Nanotech; Sunscreen Concerns Linger" - HBW Insight, 24 August, 2009..

FOE isn’t convinced. In particular, the group questions the safety of sunscreens and cosmetics containing nanomaterials when applied to damaged skin.

Such products are not subject to new safety-assessment requirements or mandatory labeling, FOE notes. “This is especially a problem for people with skin conditions such as eczema that may make them more vulnerable to skin penetration,” it says.

In its guidance to industry, FDA stated: “For exposure via dermal absorption, studies should be conducted for intact skin and impaired skin (e.g., sunburned, atopic, eczematous, psoriatic skin) to address the possibility of an increased rate of penetration and ability of the ingredient to become systemically absorbed.”

The Personal Care Products Council has been generally optimistic about the direction regulators are taking with regard to nanotechnology oversight, and the growing consensus between them Also see "U.S., EU Nanotech Guidances Demonstrate “Growing Consensus” – PCPC" - HBW Insight, 23 July, 2012..

However, “we do not believe that compromised skin should be routinely used in the assessment of cosmetics,” the trade association says in its comments.

The group notes that testing on damaged skin poses challenges for nano-sized and conventional materials alike, and international guidelines and scientific standards dictate that absorption studies should use healthy animals or intact, healthy skin for in vitro analysis.

Standardization is critical “to ensure reproducibility and comparison of results across studies and between laboratories,” the Council says, adding that “impaired skin models generally do not provide the kind of reproducible conditions necessary.”

The American Chemistry Council is of a similar mind, pointing out that “reproducible models of compromised skin are not available. This makes their use inappropriate for regulatory safety studies,” the group says.

ACC also says it “appreciates” FDA’s open-door policy inviting manufacturers to meet with the agency to get clarification on nanotech regulatory points; however, the organization “is concerned it may result in an unnecessary drain on FDA resources and set unwarranted expectations for industry to request meetings with FDA every time a nanomaterials is used in a cosmetic product.”

NGOs Call For Moratorium On Nanotech-Enabled Cosmetics

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