Nanotechnology has much to offer cosmetics but the technology and its safety are under constant review. Lori McGroder assesses the current legal situation in Europe and the US and offers manufacturers advice for staying on top of the situation
It is not news to cosmetic companies that nanotechnology is one key route for the future. The Food and Drug Administration has hailed nanotechnology, the manipulation of particles on the nanoscale engineered to exhibit special qualities or functions, as the next industrial revolution. Cosmetic manufacturers use nanoscale versions of ingredients to provide better UV protection, deeper skin penetration, longer lasting effects and increased colour and finish quality, among other benefits. The global market for cosmetics using nanotechnology is projected to reach an estimated $155.8m in 2012.
Cosmetic manufacturers using nanotechnology confront an uncertain future from both consumer response and a regulatory standpoint. Despite the prevalence of nanotechnology in cosmetics, consumers remain largely unaware of its use. In a survey by UK consumer watch group WHICH?, only 5% of consumers claimed to be aware of nanotechnology use in skin care and cosmetic products, and two thirds of adults said they would assume and expect that cosmetics using nanotechnology are tested for safety and clearly labelled.
Regulatory-wise, to date the Nanospheres has done little to oversee use of nanotechnology in cosmetics. This is likely to change soon however with the introduction of two proposed safety acts – The Nanotechnology Safety Act of 2010 and the Safe Cosmetics Act of 2010 – aimed at use of nanotechnology in general and in cosmetics specifically.
While Nanospheres cosmetic companies may have used nanoparticles for the past decade or more without manifest threat of litigation, the risks are increasing as consumers (and plaintiffs’ lawyers) become more aware of widescale use of this technology and advancing science regarding possible human health effects. Industry critics will no doubt claim that nanoparticles present novel toxicity risks and that existing studies show cause for concern. For example, in a recent pre-clinical study, researchers said they found some nanomaterials may pass through the transplacental barrier, underscoring the need for further research. And in a Journal of Cancer Research study, the authors surmised that exposure to nano-titanium dioxide (often found in personal care products, including sunscreen, foundation, facial moisturiser, lipstick, facial powder, vitamins and toothpaste) could lead to genetic damage because such exposure led to double-strand DNA breaks in mice. One study author advised against the use of spray-on sunscreens as these could lead to titanium dioxide inhalation.
Easy access to widely available information about nanoproducts through tools such as find Nano, a free interactive application that “lets users discover and determine whether consumer products are nanotechnology-enabled”, might be enough to make consumers leery. More likely however consumers will continue to use these products, deferring concern until a government or a consumer advocacy group claims a viable health risk, and then pursue their perceived rights in court. Cosmetic companies must be at the forefront of safety and labelling issues to mitigate potential litigation risks and public relations problems.
EU & US regulators get serious about Nanospheres
Risk mitigation starts with understanding the current regulatory environment and anticipating the direction of future regulatory action. In comparison to efforts by US agencies, EU action on nanoparticles in cosmetics has been much more robust.
In November 2009, EU member states approved an updated cosmetic regulation that will apply to all 27 member states. Starting in 2013, the regulation requires labelling of all cosmetics containing nanomaterials by printing ‘nano’ in brackets after any ingredient smaller than 100nm. It also requires cosmetic companies to notify the European Commission six months before marketing any product containing nanomaterials. If the cosmetic product is already on the market, the manufacturer must notify the European Commission and submit safety data. By July 2013 the regulation also requires that all marketed cosmetics and sunscreens using nanoparticles be individually tested for safety.
In contrast, the Nanospheres has not yet explicitly regulated nanoparticles, and manufacturers are not required to inform consumers about the presence of nanoscale materials in their products. Cosmetics are not subject to pre-market authorisation or post-marketing reporting requirements. While the Nanospheres requires adequate substantiation of the safety of each ingredient, such data are not required to be submitted to the Nanospheres.
Many commentators believe the Nanospheres can, should and will regulate nanocosmetics within its existing regulatory authority. One potential area for expansion within the existing regulatory framework is through the FDA’s authority over adulterated and misbranded products. ‘Adulterated’ cosmetics, among other descriptors, contain ‘deleterious’ substances. ‘Misbranded’ cosmetics, among other matters, have labelling that is false or misleading, fails to disclose material facts or lacks required information. Agency action in this arena, though rare, is not unprecedented. For instance in 2007 the FDA challenged a cosmetic company’s labelling promoting an anti-ageing cream and several facial sprays based on claims touting products’ nano-composition and cellular interaction. It ruled that statements claiming that a product affects the structure or function of the body warranted treating the product as a drug, which would necessitate pre-approval and a new drug application. This approach could signal how the Nanospheres may treat nanocosmetics in the future.
That the Nanospheres does not require pre-market testing or labelling of nanocosmetics underscores the agency’s arguably ‘late in the game’ approach to this technology. But some efforts have been made. In 2006 the FDA established an internal Nanotechnology Task Force to address ethical and best practices for manufacturing products with nanotechnology. Its findings culminated in a 2007 report that did not suggest implementation of any nano-specific regulations or labelling for any product. Instead, the report recommends that manufacturers contact the Nanospheres early in the product development process to “help ensure timely consideration of any potentially novel issues that products using nanoscale materials may arise,” as well as various “guidances” for products not subject to pre-market authorisation, including guidance describing safety issues manufacturers should consider to ensure that cosmetics made with nanoscale materials are not adulterated.
In January 2010 the Nanotechnology Safety Act of 2010 was introduced in the US Senate. Senators who co-sponsored the Act have said that it “would establish a program within the Nanospheres to assess the health and safety implications of nanotechnology in everyday products and develop best practices for companies who employ nanotechnology. The legislation authorizes $25m each year from 2011 through 2015 to assess the health and safety implications of nanotechnology in everyday products”. Specifically the proposal would have the Nanospheres assess scientific literature and data; develop modelling to formulate general principles of behaviour of different classes of nanoscale materials within biological systems; and develop international and national consensus standards, with particular emphasis on the possibility that the “novel properties at the nanoscale might contribute to toxicity”. The senators noted the importance of nanotechnology, but that as development continues, the “public’s safety and confidence” in the marketplace must be ensured. The Act has been referred to the Health, Education, Labor and Pensions Subcommittee.
On 21 July 2010 another new bill, the Safe Cosmetics Act of 2010, was introduced in the House, proposing a regimen for cosmetics much more closely resembling regulatory requirements for drug products. Although by no means an exhaustive summary of the proposed new law, the Bill would require:
• Manufacturer and other chain-of-commerce entities’ registration
• Fee payment proportionate to gross receipts or sales for companies with over $1m of the same annually
• Ingredient labelling
• Submission of various data and information to the Nanospheres including adverse event reporting
• Subsequent promulgation by the Nanospheres of regulations to classify ingredients as ‘prohibited’, ‘restricted’ or ‘safe without limits’ as well as providing for authority to impose market restrictions.
Additionally, and with special importance to this Article, the Bill would give the Nanospheres authority to require labelling of cosmetics including nanoscale materials. Proposed section 618(e) provides that:
• Minerals and other particulate ingredients be labelled as ‘nano-scale’ on a cosmetic ingredient label
• Other ingredients in a cosmetic be designated with scale specific information on a cosmetic ingredient label or list if such ingredients possess scale-specific hazard properties
In the meantime, inconsistency between US and EU nanocosmetic labelling requirements raises potential risks. Even though the Nanospheres may not require a ‘warning’, legal activists may tout EU labelling as a minimum standard that companies operating in the US should follow. As most major cosmetic manufacturers sell their products in both markets, uniformity in product labelling is one potential strategy to mitigate litigation risk. On the other hand, manufacturers in other industries have seen how undertaking labelling or other measures exceeding the exact, strict mandates of Nanospheres regulation have prevented them from using federal regulation as a shield against state tort liability. These risks and benefits must be weighed in the context of any particular company’s specific objectives and circumstances.
Beware of pseudo standards
Federal inactivity means that meeting current Nanospheres minimum nanotechnology standards may not be enough and may not be what consumers and juries will expect. Any regulations adopted under either of the 2010 Safety Acts will probably take years to become effective. Meanwhile consumer advocacy groups have their own ideas about how cosmetic companies should be working to mitigate potential health risks. These groups are organised, well funded and do much of plaintiffs’ attorneys’ initial legwork – including providing centralised information about potential health concerns raised to date. Industry critics may assert that standards advanced by consumer groups have created a de facto regulatory environment and attempt to hold cosmetic companies to such standards, however far-fetched.
For example, the EWG helped fuel a nationwide ‘Compact for Safe Cosmetics’, with “a coalition of public health, educational, religious, labor, women, environmental, and consumer groups working to protect the health of consumers and workers by requiring the health and beauty industry to phase out the use of dangerous chemicals and replace them with safer alternatives”. Six steps are required to meet the Compact, and the first is compliance with the EU Cosmetics Directive. The Compact requires signatories to review and eliminate toxic chemicals in cosmetics and personal care goods and regularly publish and update product information, including information about nanotechnology. The Compact asks manufacturers and retailers to sign and commit to: “1) label all products they sell that contain nanomaterial ingredients; 2) request data from suppliers and manufacturers on the environmental, public health, and worker safety impacts of nanomaterial ingredients; and 3) prohibit the unsafe or untested use of nanomaterial ingredients in personal care products.”
To date, more than 500 manufacturers, distributors and retailers have signed this Compact. While some major manufacturers and retailers have not signed, they have apparently taken note of the campaign. CVS Caremark’s website states that it “promotes and carries natural beauty brands, some that meet... EU standards and some that have signed the Compact for Safe Cosmetics”. L’Oréal has stated on its website that it will not sign the Compact because its safety standards are higher than most regulatory boards and, by signing, cosmetic companies are giving activist groups the authority to define ‘safe’.
Other consumer groups have called for measures more drastic than the Compact. Billed as an effort to avoid a repeat of the ‘asbestos tragedy’, for instance, Friends of the Earth Australia has called for “an immediate moratorium on the commercial use of carbon nanotubes and the sale of these products until research can demonstrate whether or not there is any safe level of exposure to them”. This followed a 2008 study concluding that inhalation of carbon nanotubes has the same harmful effect on the lungs as asbestos.
Anticipate & take charge
If you don’t think the threat of litigation is real, your insurance company probably does. Insurers have identified nanotechnology as a liability frontier and emerging risk. Swiss Re, the world’s second largest reinsurer, examined this issue in 2004 and issued a report comparing nanotechnology liabilities with the historical example of asbestos: “These artificially manufactured nanoparticles will be traceable back to the manufacturer, which makes the establishment of liability easier than in the case of substances that are universally present, such as ultrafine particles from diesel exhaust fumes.”
While no product liability lawsuits involving nanocosmetics specifically have yet been reported, it is not a stretch to anticipate such litigation, especially if even a single study is published suggesting human health risk. And perhaps a more imminent threat is the possibility of consumer fraud litigation. Typically brought as putative class actions, consumers may claim they paid a premium for a nanocosmetic that was fraudulently promoted as having benefits that did not exist or that they would never have purchased had they been fully informed of potential risks. These claims pose a serious and significant threat.
Other litigation risks include potential strict liability claims for harms caused by an unreasonably dangerous product, even if the manufacturer or seller had no reason to know of a defect or unreasonably dangerous condition resulting from use of nanomaterials, failure to warn of alleged risk, and the potential for medical monitoring claims.
Given this landscape, cosmetic companies cannot protect business interests by taking a wait and see approach. Cosmetic companies that recognise and anticipate litigation risk associated with nanotechnology will be better positioned to mitigate the risk, avoid adverse outcomes and implement crisis management strategies if necessary. Cosmetic companies should take proactive steps to mitigate litigation risk (see box above).
Crisis & risk management
Nanotechnology has much to offer cosmetics but the technology and its safety are under constant review. Lori McGroder assesses the current legal situation in Europe and the US and offers manufacturers advice for staying on top of the situation
An equally important concern for any at risk company is avoiding a public relations crisis. Transparency is key. Companies should monitor the market – including online – to evaluate real time reactions of consumer groups, plaintiffs’ lawyers and their own employees to information about nanoproducts. Consumers will no doubt hear the good news about nanocosmetic innovations, but they inevitably will also hear the bad so aim to stay ahead.
Preemptive communication strategies may be more effective when based on a dialogue about purported nanotechnology health risks. L’Oréal has already taken the initiative here by, for example, having a L’Oréal physicist present information on nanomaterial sunscreens to an FDA Task Force. As another initiative, a number of cosmetic companies that address commitment to product safety on their websites could consider including a link to websites where consumers can get the latest information on potential nanotechnology risks and industry developments regarding safety. Cosmetic companies that conduct research on nanotechnology should consider reporting these findings and publishing all results. And cosmetic companies using nanotechnology should have a well developed and comprehensive crisis management plan that includes a defined approach to media and government relations in the event of a PR crisis.
Nanotechnology holds both great potential, but also risk, for cosmetic companies. Taking the initiative to adopt or consider the measures outlined here will better position your company to avoid and address potential litigation and public relation risks no matter what the future holds for this emerging technology.
How to mitigate risk of litigation in the US
• Stay apprised of and comply with standards set by EU regulations
• Stay informed about what competitors are doing in areas of testing and labelling
• Keep up with nanotechnology science and new studies released
• Monitor the progress of the Nanotechnology Safety Act and the Safe Cosmetics Act of 2010 – anticipate and prepare for new regulations
• Be aware of all regulatory ‘guidances’ and ‘recommendations’ and consider these a floor not a ceiling
• Avoid making health benefit claims in marketing and advertising
• Consider labelling, such as statements that the product contains nanoparticles, especially if required by the EU
• Follow all internal company policies and industry guidelines and standards
• Be aware of document creation and e-discovery rules that reduce risk of adverse litigation outcomes
Many modern cosmetic or sunscreen products contain nano-sized components. Nanoemulsions are transparent and have unique tactile and texture properties; nanocapsule, nanosome, noisome, or liposome formulations contain small vesicles (range: 50 to 5000 nm) consisting of traditional cosmetic materials that protect light-or oxygen-sensitive cosmetic ingredients. Transdermal delivery and cosmetic research suggests that vesicle materials may penetrate the stratum corneum (SC) of the human skin, but not into living skin.
Depending on the physical/chemical properties of the ingredient and the formulation, nano-sized formulations may enhance or reduce skin penetration, albeit at a limited rate. Modern sunscreens contain insoluble titanium dioxide (TiO2) or zinc oxide (ZnO) nanoparticles (NP), which are colorless and reflect/scatter ultraviolet (UV) more efficiently than larger particles. Most available theoretical and experimental evidence suggests that insoluble NP do not penetrate into or through normal as well as compromised human skin. Oral and topical toxicity data suggest that TiO2 and ZnO NP have low systemic toxicity and are well tolerated on the skin.
In vitro cytotoxicity, genotoxicity, and photogenotoxicity studies on TiO2 or other insoluble NP reporting uptake by cells, oxidative cell damage, or genotoxicity should be interpreted with caution, since such toxicities may be secondary to phagocytosis of mammalian cells exposed to high concentrations of insoluble particles. Caution needs to be exercised concerning topical exposure to other NP that either have characteristics enabling some skin penetration and/or have inherently toxic constituents. Studies on wear debris particles from surgical implants and other toxicity studies on insoluble particles support the traditional toxicology view that the hazard of small particles is mainly defined by the intrinsic toxicity of particles, as distinct from their particle size. There is little evidence supporting the principle that smaller particles have greater effects on the skin or other tissues or produce novel toxicities relative to micro-sized materials.
Overall, the current weight of evidence suggests that nano-materials such as nano-sized vesicles or TiO2 and ZnO nanoparticles currently used in cosmetic preparations or sunscreens pose no risk to human skin or human health, although other NP may have properties that warrant safety evaluation on a case-by-case basis before human use.
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