Category: Cosmetics

EU logoAs various articles on this blog (Search: EU) have demonstrated over the past couple of years, the EU has been more proactive than the U.S. in targeting potential health and environmental risks posed to consumers by nanomaterials and seeking to generate and compile relevant and helpful information with an eye toward appropriate regulation.  The EU scientific panel is now calling for comments on opinions of the EU Scientific Committee on Consumer Safety (SCCS) on several nanosubstances used as sunscreens in cosmetics.

The opinions posted for comment indicate what is known about these substances and point to the gaps in the studies.  For example, with regard to dermal absorption of titanium dioxide nanoparticles, SCCS states, in part: 

            “[T]here is a body of open literature on this subject. The evidence from these studies supports the conclusion that TiO2 nanoparticles are unlikely to penetrate across the skin to reach viable cells of the epidermis. . . . Studies have also shown that TiO2 nanoparticles do not penetrate the (simulated) sunburnt skin.

            – Despite the extensive database showing a general lack of TiO2 nanoparticle absorption via the dermal route, there are a few gaps in the knowledge. For example, it is not clear whether TiO2 nanoparticles will be able to penetrate through cuts and bruises, or over repeated or long term applications of a sunscreen formulation.

            – A number of studies have indicated that TiO2 nanoparticle can enter the hair follicles and sweat glands, and that they may remain there for a number of days. This is a scenarioin which TiO2 nanoparticles are likely to get and remain in a close proximity to the living cells for a length of time. A photocatalytic nanoparticle in such a situation may cause . . . potential harmful effects when exposed to sunlight. . . . [M]ore data would be needed to justify the use of those TiO2 nanoparticles in skin applications that have a considerablelevel of photocatalytic activity.”  (Scientific Committee on Consumer Safety SCCS,Opinion on Titanium Dioxide (nano form), p. 97)

The document also indicates the need for study of the potential of these substances of the nano-related properties of the substances to be mutagenic or genotoxic.  (p. 97-98)

These few small examples of the more extensive information contained in the opinions gives a sense of where the SCCS’s attention is currently on nanosubstances in cosmetics, which is one of the most pervasive uses of nanosubstances in consumer use.  With study of such materials moving along in laboratories around the world, it is essential that the information be collected and evaluated to determine what risks, if any, may be presented to consumers by the nanoscale properties of the substances.  The EU is moving in the right direction.

All of the SCCS opinions are available at

Sometimes the Government  just might work as it was intended.

In an earlier post, I reported on a lawsuit brought by a coalition of environmental and consumer safety groups requesting declaratory and injunctive relief under the Administrative Procedure Act to force the FDA to respond to a 2006 petition seeking action by the agency to assure the safety of members of the public exposed to nanomaterials, particularly nanoparticles in sunscreens.  On May 14, 2012, the coalition voluntarily dismissed its action, International Center for Technology Assessment v. Hamburg, a case that had been brought in federal court for the Northern District of California (No. 11-6592).

In other posts on this blog, I have reported on the draft guidances recently issued by the FDA on the safety of nanomaterials in food, food packaging, and cosmetics, as well as the upcoming International Cooperation on Cosmetics Regulation (ICCR), to be hosted by the FDA.  The coalition has withdrawn its lawsuit because the FDA has in fact finally responded to the earlier petition by issuing the draft guidances.  Although attorneys for the coalition have emphasized that the FDA’s response does not propose all the relief the coalition sought in its lawsuit, at the present time the FDA is showing interest in the safety of engineered nanomaterials in products within the agency’s jurisdiction.  The lawsuit had sought, among other things, regulation of these nanomaterials.  But the FDA guidance documents made recommendations for voluntary measures by industry, not new regulation.  This, of course, leaves open the possibility of a future lawsuit challenging the steps taken – or not taken – by the FDA in furtherance of the safety initiatives.

Our high school civics classes teach us that the tripartite structure of the federal Government is intended to allow the various parts of the Government to act as a check on the actions or inactions of the other parts.  In recent years, the judicial system has been much maligned.  In the matter of nanomaterials and the FDA, the threat of judicial intervention – being told by the courts what it should do – was likely one (and only one) motivation for the FDA to pursue a safety agenda for nanomaterials.  Instead of needlessly consuming resources at this stage, the coalition withdrew its lawsuit when the FDA moved forward on this subject.  So let’s give a hand all around for the Government working as it was intended.

The withdrawal of the coalition’s lawsuit was reported by

Pat Rizzuto, Coalition Withdraws Lawsuit Against FDA Following Agency’s Release of Guidance, 100 Daily Env’t Rep. (BNA) A-15 (May 24, 2012) (by subscription)

Earlier I reported that the FDA had recently shown some intense interest, per its recent draft guidance document, in the safety of food and food packaging products containing nanomaterials.  In contrast, the FDA seemed to merely urged caution to the cosmetics industry about nanoparticles in their products.  Now, however, the FDA appears to be on the move toward giving nanomaterials in cosmetics their fair amount of attention.

In July, the FDA will host the International Cooperation on Cosmetics Regulation (ICCR), which is expected to include cosmetics regulators fromCanada, the EU,Japan,Brazil,China,Australia, and other countries.  The conference is scheduled to include opportunities for participation by the industry and any other interested parties.  Nanomaterials represent only one item on the agenda (which includes alternatives to animal studies and regulation of trace elements of substances such as lead).

The conference’s interest in nanoparticles in cosmetics will be focused on methods to characterize nanoparticle ingredients with safety in mind.  The primary interest is in the use of nanoscale titanium dioxide and zinc oxide in sunscreen products.

T he upside to the attention FDA is giving to nanoparticles in cosmetics is that it begins a long process of deciding how to determine safety, whether to regulate, and whether new regulations for nanoparticles in sunscreens and other cosmetics will be necessary.  Recently, the FDA postponed the effective date of new labeling for sunscreens until after the current summer season.  Perhaps information learned about nanosubstances in sunscreens will make its way onto those new labels, or at least some version of the labels in the future.

Another upside is the use of an international forum including not just regulators, but industry attendees and others to identify the issues raised by nanoparticles in cosmetics.  A theme of this blog has been the need for a “same-page” approach in the international commercial arena.

The downside is the long slog of regulatory information gathering and activity – and sometimes inactivity.  And it is altogether possible that the various jurisdictions will go their own ways in approaching the subject.

After the ICCR meets in July, I will report on the proceedings.  For access to the official announcement of the conference, and for information from the FDA on previous ICCR conferences, reports, and other materials, see

prod liab imageIt had to happen sooner or later.  And it’s happening now.  A coalition of nonprofit consumer safety and environmental groups brought an action on December 21 in federal district court in California against the Food and Drug Administration (FDA).  The action seeks an order for declaratory and injunctive relief under the Administrative Procedure Act to require the FDA to respond to a petition filed with the FDA in 2006 which sought action by the agency to assure the safety of the public exposed to nanomaterials, particularly sunscreen products.  The requested relief is detailed on pages 3-4 of the petition.  The lawsuit is International Center for Technology Assessment v. Hamburg (N.D. Calif., CV 11-6592).

The coalition includes the International Center for Technology Assessment (ICTA) as lead plaintiff for Friends of the Earth, Greenpeace, Food and Water Watch, the Center for Environmental Health, the Action Group on Erosion, Technology and Concentration (ETC Group), the Institute for Agricultural and Trade Policy, and several other groups.

Among other things, the petition detailed the status of research on and knowledge of the risks of nanomaterials, both relating to consumer products and the environment.  This information included studies that have indicated some of the ways that engineered nanoparticles may harm living cells through new channels of exposure.  Moreover, in 2007, the FDA’s own Nanotechnology Task Force issued a report recommending that the FDA issue guidance to manufacturers using nanomaterials and take steps to improve scientific knowledge of nanotechnology.

In the weeks to come, we will be anticipating the response from the FDA, which may very well insist that it has undertaken the efforts sought by the petitioners.  There are several other legal strategies that the FDA could employ, including claiming the lack of legal authority to put into place some or all of the relief sought in the petition or the need for interagency coordination.

The greatest significance of this lawsuit is that it puts nanotechnology into the courts.  This may be the first time, but it certainly won’t be the last time.

The 80-page petition is available at

The 2007 Nanotechnology Task Force report is available at

white-house-south-2007-djIn a June 9, 2011, memorandum to the heads of U.S. executive departments and agencies, entitled Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials, the White House confirmed its commitment to a “science-based” approach to health and safety matters related to nanotechnology.  The memorandum issued from the Office of Science and Technology Policy, the Office of Management and Budget, and the Office of the U.S. Trade Representative. The memorandum described its approach as

“generally applicable principles relevant to promoting a balanced, science-based approach to regulating nanomaterials and other applications of nanotechnology in a manner that protects human health, safety, and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation.”

The memorandum went on to explain that the approach it establishes is inherent in the risk-based approach commonly used by federal agencies such as the FDA, but is grounded in best available, and evolving, science.

 This is a tall order.  It is important that the White House explicitly addressed nanotechnology and nanomaterials, rather than using the vague term “emerging technologies,” as it has done in the past.  But perhaps the most significant part of the memorandum is in its elevation of the science-based approach over other possible approaches (technology-based, economics-based, etc.) to the study and regulation of nanomaterials.

 Intending to provide guidance to existing federal agencies, the memorandum stated:  “Federal agencies should avoid making scientifically unfounded generalizations that categorically judge all applications of nanotechnology as intrinsically benign or harmful.”  Consumer trust, the memorandum went on to say, is important in encouraging technological innovation.

 On the one hand, the memorandum eased industry concerns that nanotechnology will be viewed as “bad” and all nanomaterials as “hazardous” because of the flurry of attention focused on the technologies and the concerns voiced by various groups.  But on the other hand, the message is clear that science will govern the study of nanomaterials and any decisions about whether or how to regulate.  And that is also a message to industry to come forward with the science that the agencies need.

 The memorandum also announced the creation of an interagency working group to coordinate this basic framework across agency lines, promote coordination of regulatory activities, and share information.

 How is this policy likely to play out in the relevant departments and agencies?  Here are a couple of recent steps that illustrate the initial approach:

 ●  On June 10, 2011, the FDA issued a Draft Guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, to provide manufacturers, suppliers, importers, and other stakeholders with the FDA’s “current thinking” on the subject.  The Draft Guidance was issued in conjunction with the White House memorandum.  The document provided no definitions, nor did it provide any information on the regulatory status of any products.  Rather, the document stated that its purpose is “to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness, or public health impact that may arise with the application of nano-technology in FDA-regulated products.”

 The FDA Draft Guidance is available at

 ●  A similar document was issued by EPA setting forth its proposed policy for obtaining data on nanoscale materials in pesticides, pursuant to its authority under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).  Another important aspect of what EPA is considering is a case-by-case analysis of whether a nanoscale ingredient in a pesticide is considered “new” for the purpose of study and regulation.  This is a sharp departure from EPA’s earlier stance that it would consider all nanoscale ingredients as “new,” whether or not a non-nanoscale form of the ingredient was already registered under FIFRA.  The new approach is consistent with the urging of the White House memorandum that agencies avoid generalizations about nanomaterials and based all decision on the scientific evidence.

 The prepublication version of this notice is available at


The White House memo is available at

prod liab imageListening to the speakers at the American Bar Association section webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation,” discussed in a recent blog post, I was struck by the proliferation of “alphabet soup” agencies and programs involved in deciding whether and how to regulate nanomaterials in the workplace, consumer products, and the environment.  The short list includes such well-known acronyms as FDA, EPA, OSHA, NIOSH, CPSC, NNI, TSCA, FIFRA, FHSA, REACH, and ISO (International Organization for Standardization), as well as many lesser known acronyms, such as SNUR (Significant New Use Rule), PPPA (Poison Prevention Packaging Act of 1970), CPSIA (Consumer Product Safety Improvement Act), OCSPP (EPA’s Office of Chemical Safety and Pollution Prevention), NMSP (Nanoscale Materials Stewardship Program), NICNAS (Australian National Industrial Chemicals Notification and Assessment Scheme), WPMN (international Working Party on Manufactured Nanomaterials), and many similar legislation and agencies on the state level.

The good news is that nanotechnology is receiving much attention across the board from regulatory agencies.  The less good news is that the work of determining the health and safety effects of nanomaterials on humans and the environment, including ecological systems, is fragmented and slow.

The U.S. federal government, by necessity, is comprised of a web of agencies and programs, each with many jobs.  With so much work to be done, smaller and smaller groups are focusing on specific research and problem solving initiatives.  As the federal government is accustomed to doing in many areas of concern, efforts to coordinate agencies and programs devoting a fraction of their time to nanotechnology health and safety issues are being utilized.  One clearinghouse for the efforts across the government is the National Nanotechnology Initiative (NNI).  Is that enough to prevent duplication of effort and resources and to encourage communication and progress?

The dilemma is not new.  It is at the foundation of all complex systems.  To get something done, the groundwork must be laid by a highly focused group.  As recommendations move along the regulatory channels, eventually (maybe) the work results in action by way of regulations or new/amended statutes.  Greater oversight and decision making at the top of the regulatory pyramid may sound more efficient, but the careful groundwork could be lost and the democratic principles on which our regulatory system is based (including publication and public comment) could be diminished.

On May 19, 2011, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation and Right-to-Know Committee) and Section of Science and Technology Law (Nanotechnology Committee) presented a webinar on the subject of “Nano Governance:  The Current State of Federal, State, and International Regulation.”  Speakers came from all sectors, including private law firms and industry.

Listening to these excellent and expert speakers for a full afternoon, certain clear points and patterns emerged that I will share briefly here.

1.  Size.  It really is all about size.  Every speaker acknowledged the role of the size of nanoparticles in developing testing protocols and approaches to regulation.  Nanomaterials may behave differently from macroscale materials of the same substance, and may differ from one another in significant ways.

2.  Progress.  Regulatory agencies are turning their attention to the health and safety aspects of nanotechnology.  There is a pervasive concern about the prevalence of these technologies and the paucity of studies.

3.  Fragmentation.  Attention to the potential issues raised by nanotechnology continues to be highly fragmented.  There has been intensely focused attention to some issues, but others remain to be addressed.

For example, EPA, through its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), has focused attention on regulating nanosilver and other nanomaterials in FIFRA-registered products.  Under FIFRA, all pesticides need to be registered (i.e. licensed) before they may be sold, and as part of that process, a pesticide applicant must show that its product will not “cause unreasonable adverse effects on the environment.”  Currently, some pesticides that contain nanomaterials are already on the market, having been licensed prior to EPA’s scrutiny of nanomaterials.  Other applications are pending for registration of pesticides containing nanomaterials.  EPA’s draft policy proposal would treat a pesticide as “new” if it contains a nanoscale material, regardless of whether a non-nanoscale form of that same ingredient is already in a registered product.  Thus, for example, nanosilver would be treated as “new” even though silver is a registered pesticide.  But risks assessment lags behind.  According to webinar speaker William Jordan, Senior Policy Advisor, Office of Pesticide Programs for EPA, “more data are needed in all disciplines to have adequate information to assess the risks of nanosilver.”

Nanomaterials elsewhere in products and the environment are subject to potential regulation under other federal statutes, and some state programs (California being represented at the webinar).  But progress in one area does not necessarily mean progress elsewhere.  The EU and Australia are progressing, but the need remains for some vehicle to standardize definitions and approaches.  And standardization remains a debatable issue in itself.

4.  Industry Uncertainty.  Webinar speaker Rosalind Volpe, Executive Director of an industry association, Silver Technology Working Group (a program of Silver Research Consortium LLC, Durham, NC), expressed the concerns of the industry that EPA’s steps to regulate nanosilver give the impression that nanomaterials are harmful.  The industry is concerned that there is a “cloud of uncertainty” over it, which discourages investors and deters innovation, even where the nanomaterials used may not pose any health or safety problems.

5.  Bottom Line.  The bottom line, as usual, seems to be the need for an appropriate balance between technological progress and safety of humans and the environment.

Other speakers at the webinar included representatives of:

Nanotechnologies Industries Association, Brussels, Belgium

Chemical Control Division, Office of Pollution Prevention and Toxics, EPA

U.S. Consumer Product Safety Commission

California Nanotechnology Initiative

California Department of Toxic Substances Control

Environmental Defense Fund, Inc.

. . . and several attorneys in private practice

nano 6In my previous post, I indicated that I would be moving on to discuss the relevancy arm of the Daubert admissibility test.  It turns out I have a few more thoughts about the reliability arm.

 What does it mean for admissibility purposes when the expert testimony sought to be introduced in litigation is based on an established methodology used in a new context?  This is likely to be an issue when parties seek to introduce studies of the health and safety effects of nanomaterials.    Does such a new subject of a study transform an established methodology into a new and untested methodology?  If so, the evidence would face a much more rigorous level of scrutiny.

 Researchers acknowledge that the state of research on the health and safety aspects of nanomaterials is in its infancy.  Some have noted that due to the costs of obtaining necessary quantities of nanomaterials for animal testing, that type of toxicological testing has given way to the use of more efficient in vitro laboratory tests.  While both animal testing and in vitro tests have been used to test toxicity for a very long time, their reliability in testing chemicals at the nanoscale has yet to be fully assessed.  This could lead to exclusion of the evidence under either the Frye or Daubert analysis, at least until such the use of the studies gains greater reliability.  In other words, courts could view this as a new and untested methodology.

 A related issue is the value of in vitro tests generally in litigation to show a connection between exposures and injuries.  Studies conducted in laboratory containers do not receive high marks from courts generally when introduced to demonstrate causation between an exposure and a person’s injuries.  Courts prefer both epidemiological studies – which determine statistical risks in human populations – and animal bioassays over in vitro studies.

 All of this adds up to some thorny questions that will have to be resolved.

supctThis post continues the discussions in earlier posts about evidentiary standards for admissibility of health and safety studies on nanomaterials under both the Frye standard and the Daubert standard.  I will resume the reliability discussion here, this time focusing on the reliability standards applied in the federal courts and other Daubert jurisdictions.

Under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), reliability of expert scientific evidence is determined in relation to four factors.  These four “general observations” set forth in the Daubert decision were intended to provide guidance to the trial court making a decision about admissibility of expert scientific evidence.  All four need not be favorable to the party seeking admission of the evidence for the evidence to be ruled admissible.  The Supreme Court has said that when it comes to scientific studies, evidentiary reliability is the equivalent of scientific validity.  What makes a scientific study (and the expert testimony relying on it) valid?  The Supreme Court set forth these “general observations”:

 (1)  Whether the scientific theory or technique on which the evidence is based has been tested (presumably by the scientific method);

(2)  Whether the study has been published or has undergone another form of peer review;

(3)  The known or potential rate of scientific error associated with the methodology;

(4)  Whether the methodology has achieved general acceptance in its field.

Although these factors reduce the weight of general acceptance (the sole Frye criterion) in the admissibility analysis, the reality is that the Daubert test has raised the bar in litigation for plaintiffs seeking to have their scientific proof admitted.  These factors are often applied strictly.

Will scientific studies on the health and safety effects of nanomaterials be treated differently under the Daubert reliability analysis than under the Frye general acceptance test?  The primary difficulty under Daubert, as under Frye, is the newness of the studies.

Although the Supreme Court in Daubert said that the focus of the reliability analysis should be on the scientific methodology or technique – and not on the conclusions reached – the Court subsequently modified that statement.  In General Electric Co. v. Joiner, 522 U.S. 136 (1997), the Supreme Court said that “conclusions and methodology are not entirely separate from one another,” thus inviting the trial court to consider the conclusion and whether it constitutes the kind of novel theory that may not be admissible.

It may be true generally that newer methodologies may not have been sufficiently tested, peer reviewed, or accepted in the relevant scientific community, and that they could have a potentially high (or unknown) rate of error.  But one issue that will need to be sorted out in the era of nanostudies will be whether the methodologies for these studies consist of tried-and-true testing methods or, in contrast, will be viewed as novel because of their focus on materials at the nanoscale.  This distinction could make a critical difference in whether such studies will be admitted in litigation in a Daubert jurisdiction.  Tried-and-true carries more admissibility weight.

Perhaps one way to look at this issue – and one that is relevant to the emerging studies of nanomaterials – is the way that a federal district court analyzed the problem in Smith v. General Electric Co., 2004 WL 870832 (D. Mass. 2004).  When confronted with novel and admittedly “controversial” studies, the court concluded that the experts were “serious scientists with controversial views that are in many respects on the periphery of the mainstream, but views that are not so divorced from a scientific method of investigation that they can be dismissed as quackery or armchair conjecture.”  While the district court was likely correct in observing that Daubert did not require or perhaps even empower a court to “determine which of several competing scientific theories has the best provenance,” many would reject the flexible view of Daubert applied in Smith.

Reliability is only part of the admissibility analysis for scientific studies articulated by the Supreme Court in Daubert.  Relevance of the evidence is equally important, and my next post on the subject will look at the relevance of scientific evidence as it has been explained by the Supreme Court in Daubert and Joiner (mentioned above).

Lab beakerA couple of weeks ago, the International Organization for Standardization (ISO) announced the adoption of standards for some testing of nanoparticles.  Specifically the organization, based in Geneva, set standards for studying the inhalation toxicity of these substances.  The United States is a member of the ISO, through the American National Standards Institute (ANSI).  Of course, the new standard has no binding effect on governments and their regulatory agencies, unless it is adopted.

According to the ISO web site, Dr. Peter Hatto, who chairs the ISO technical committee that developed the new standard, explained the need for it:

 “With the rapid expansion of nanotechnology applications comes a growing risk of exposure to potentially toxic substances, especially for workers in nanotechnology-based industries.  Moreover, if airborne nanoparticles were liberated from products, the general public could also be affected.”

Call it an advisory standard.  What is its value then?

●  It’s a start.  And coming from the international community, it will reach across national boundaries, with the possibility that it will generate not just regulations, but a measure of consistency and uniformity from country to country.

●  The statement of Dr. Hatto expressly recognizes the potential hazards for both workers in the nanotechnology industries and for consumers.

●  The standard recognizes that nanoparticles may behave differently from non-nanoscale particles.  Thus, Dr. Hatto said:  “Traditional methods used in other areas are considered insufficient for testing nanoparticles since parameters specific to them like particle surface area or number, might be crucial determinants of toxicity.”  Accordingly, the ISO developed specific methodologies to address these differences and the unique characteristics of nanoparticles.

●  The ISO effort highlights the fact that knowledge of the health and safety risks of nanoparticles is still in its infancy.  As ISO states, “scientists still have a lot to learn about nanoparticles.”

Will the standard be adopted or just be one more effort that is interesting and useful but doesn’t propel the safety efforts forward?

For information on the ISO and the inhalation toxicity standard, ISO 10808:2010, see