Consumers Union Petitions FDA to Require Safety Assessment on the Use of Nanoparticles

Posted on November 5, 2008 by Lynn L. Bergeson

On October 30, 2008, Consumers Union petitioned the Food and Drug Administration (FDA) to require a full safety assessment on the use of engineered nanoparticles, particularly in cosmetics, sunscreens, and sunblocks, and “to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.” Consumers Union cites new findings in the December 2008 issue of Consumer Reports, and states that the findings “confirm that use of certain nanoparticles is widespread in mineral-based sunscreens, and that company representatives are making erroneous assertions about these particles in their products.” Consumers Union purchased sunscreens that contain titanium dioxide and/or zinc oxide, focusing on products that, according to company representatives, do not contain nanoparticles. According to the Consumer Reports article, Consumers Union found that four of the five companies’ statements about their products, asserting that they did not contain nanoparticles, were incorrect.

The petition states:

Given the apparent widespread use of these nanoparticles of titanium dioxide and zinc oxide in sunscreens in the US, as determined by our tests, we urge the FDA to do the same [as the European Union]:  to require safety assessment data on nanoparticles used in sunscreens.  We also urge the FDA to require manufacturers to disclose the presence of nanoparticles on the label of any cosmetic or over-the-counter drug product that contain such particles, and to immediately investigate misstatements by manufacturers to Consumer Reports about absence of these nanoparticles in sunscreen products.  Furthermore, we specifically urge the FDA to investigate whether the failure to disclose the presence of nanoparticles renders these sunscreen products misbranded, within the meaning of Section 201(n) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 321(n), in violation of 21 U.S.C. § 332(b).

 
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FDA Nanotechnology Meeting

Posted on September 12, 2008 by Lynn L. Bergeson

The United States Food and Drug Administration (FDA) held its publicized Public Meeting on Nanotechnology on Monday, September 8, 2008, near its main offices in Rockville, Maryland. The meeting consisted of a plenary session led by Dr. Norris Alderson, Co-Chair of the FDA Nanotechnology Task Force, followed by separate breakout sessions for prescription and over-the-counter (OTC) drugs, cosmetics, medical devices, food and color additives (including food contact substances), and dietary supplements.  In general, the meeting yielded no new information pertinent to FDA’s nanotechnology plans or policies.

At the beginning of the meeting, Dr. Alderson and the other FDA plenary session speakers made it clear that FDA was not there to present its views on nanotechnology, or describe its activities. Rather, FDA hoped that the speakers and participants from industry, academia, and the public would provide input on the factors it should consider in providing guidance on the information and data that might be needed to demonstrate the safety and effectiveness of regulated products containing nanoscale materials. The FDA speakers also solicited information about the circumstances under which the regulatory status of a product might change if nanoscale materials were utilized in place of the macro-sized materials evaluated by FDA when the product was first cleared for marketing. In the Federal Register notice announcing the meeting, FDA posed questions, the answers to which would help to start providing the information it needed to provide guidance. For the most part, the speakers attempted to provide information on the requested subjects, although the information exchange was hampered by concerns regarding the protection of the confidentiality of commercial information. Dr. Rick Canady, FDA Senior Health Scientist, stated that FDA was hoping to have industry establish food master files, in which confidential information could be protected. FDA would become the consolidator of knowledge and the stronger knowledge base would produce better science.
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Federal Agencies Will Hold Workshop on Enabling Standards for Nanomaterial Characterization

Posted on August 21, 2008 by Lynn L. Bergeson

The National Institute of Standards and Technology (NIST) will hold an October 8-9, 2008, workshop regarding enabling standards for nanomaterial characterization.  According to the workshop overview, there is an “urgent need” to elevate new protocols and practices for characterizing the physicochemical properties of nanomaterials, and their in vitro and in vivo properties with respect to biological systems, to that of internationally accepted standards to accelerate research, development, risk identification, regulation, and widespread public adoption of nanotechnology. The workshop is intended to address this need on several fronts. Workshop sponsors and contributors include:  ASTM International; Food and Drug Administration (FDA); Nanotechnology Characterization Laboratory (NCL) at NCI-Frederick; National Cancer Institute (NCI); National Institute for Occupational Safety and Health (NIOSH); NIST; National Institute of Environmental Health Sciences (NIEHS); and Oregon Nanoscience and Microtechnologies Institute (ONAMI).  The workshop is limited to 100 attendees.

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FDA Announces Public Meeting on Nanoscale Materials

Posted on August 11, 2008 by Lynn L. Bergeson
In an August 7, 2008, Federal Register notice, the U.S. Food and Drug Administration (FDA) announced that it will convene a public meeting on September 8, 2008, on FDA-regulated products that may contain nanoscale materials. According to the Federal Register notice, FDA also is seeking public comments and available data “that will assist [FDA] in further implementing the recommendations of the Nanotechnology Task Force Report . . . relating to the development of agency guidances.” Written comments in response to the Federal Register notice must be received by FDA no later than October 24, 2008.

FDA states that the main objective of the public meeting “is to determine what factors [FDA] should consider in providing guidance on” the following:

  • The information and data that may be needed to demonstrate the safety and effectiveness of FDA-regulated products containing nanoscale materials; and
  • The circumstances under which a product’s regulatory status might change due to the presence or use of nanoscale materials (for example, making a device no longer exempt from [Section] 510(k) submission requirements).

Persons wishing to speak at the meeting must register and submit a presentation summary by September 2, 2008. Registration details are provided in the Federal Register notice.
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FDLI and PEN Will Cosponsor First Annual Conference on Nanotechnology Law, Regulation, and Policy

Posted on December 18, 2007 by Lynn L. Bergeson

The Food and Drug Law Institute (FDLI) and the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) will hold a conference on February 28-29, 2008, on “Nanotechnology Law, Regulation and Policy.” Questions addressed during the conference will include:

  • How is the Food and Drug Administration (FDA) going to implement its Nanotechnology Task Force Report?
  • How is the Occupational Safety and Health Administration (OSHA) going to deal with nanotech issues in the workplace?
  • Is Congress ready to act on nanotechnology if federal regulators don’t?
  • What first and second generation nanotechnology products are already on the market, and what’s to come?
  • Do Europe and Asia approach nanotechnology safety and oversight differently than the United States?
  • When it comes to nanotechnology, should size make a regulatory difference?
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Bush Administration Releases Principles for Nanotechnology Environmental, Health, and Safety Oversight

Posted on November 16, 2007 by Lynn L. Bergeson
On November 8, 2007, the Office of Science and Technology Policy (OSTP) and the Council on Environmental Quality (CEQ) issued a memorandum regarding “Principles for Nanotechnology Environmental, Health, and Safety Oversight.” According to the memorandum, OSTP and CEQ “led a multi-agency consensus-based process” to develop principles intended to guide the development and implementation of policies for nanotechnology environmental, health, and safety oversight at the agency level.  The memorandum says that federal agencies such as the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Occupational Safety and Health Administration (OSHA), and the National Institute for Occupational Safety and Health (NIOSH) “must implement sound policies to protect public health and the environment,” and “agencies that perform nanotechnology research and development or that use nanotechnology in accomplishing their mission must provide appropriate oversight.”

The memorandum states that these agencies should follow the following principles in developing policies for environmental, health, and safety oversight related to nanotechnology:

  • Purpose:  Federal oversight approaches should be cognizant of the potential benefits of nanotechnology, including health, economic, and environmental benefits, while recognizing uncertainties surrounding the evolving science and technology.  The purpose of considering environmental, health, and safety oversight approaches in the context of nanotechnology is to protect human health and the environment.
  • Current Understanding:  The federal government’s current understanding is that existing statutory authorities are adequate to address oversight of nanotechnology and its applications.  As with any developing area, as new information becomes available the federal government will adapt or develop additional oversight approaches, as necessary, to address the area of nanotechnology.
  • Information Development:  Adequate information should be developed with respect to the effects of nanomaterials on human health and the environment.  To the extent practicable and respecting confidential information (e.g., Confidential Business Information (CBI)), this information should be developed in an open and transparent manner by stakeholders, including the federal government and developers of nanomaterials.
  • Risk Assessment and Risk Management:  The federal government should use standard oversight approaches to assess risks and benefits, and manage risks, considering safety, health and environmental impacts, and exposure mitigation.  As experience is gained, these approaches can be refined.  The federal government should strive to reach an appropriate level of consistency in risk assessment and management approaches across the government.
  • International:  Recognizing the global efforts to develop nanotechnology, the federal government should proactively promote international cooperation.  The federal government should encourage coordinated and collaborative health and environmental research and test data development across the international community.  The federal government should also promote access to information across the international community.  These efforts will allow the federal government to contribute to, and take advantage of, risk assessment and risk management approaches, as appropriate, across the international community.
  • Regulatory Path Forward:  In light of the “Purpose” of oversight as described above, the federal government should consider the following, to the extent permitted by law and where applicable, in establishing environmental, health, and safety regulations for nanotechnology:
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First Annual Nanotechnology Safety for Success Dialogue Held in October

Posted on November 13, 2007 by Lynn L. Bergeson

On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included:

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FDA Releases Proposed Rule Regarding Sunscreens

Posted on August 24, 2007 by Lynn L. Bergeson
Yesterday the Food and Drug Administration (FDA) released a proposed rule that would amend the final monograph for over-the-counter (OTC) sunscreen drug products as part of FDA’s ongoing review of OTC drug products. The proposed rule addresses formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, would introduce four-star rating system for the level of UVA protection, and would require a warning statement. FDA previously delayed regulations concerning UVA protection until reliable testing methodologies could be developed. The proposed rule specifically solicits comment on “the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.”  Comments on the proposed avobenzone combinations will be due 60 days after publication of the Federal Register notice. Comments on all other parts of the proposed rule and on FDA’s economic impact determination will be due 90 days after publication in the Federal Register. In the proposed rule, FDA states that it “recognizes that more sunscreens containing small particle size titanium dioxide and zinc oxide ingredients enter the market each year.” According to the proposed rule, FDA is interested in receiving comments and data about these sunscreen ingredients and products containing these ingredients, their safety and effectiveness, and how they should be regulated.  FDA notes that it received a citizen petition “shortly before publication of this document that, among other things, raises these issues.”  FDA is currently evaluating the citizen petition, which is filed as CP17 in Docket No. 1978N-0038.  FDA encourages other parties to submit additional data or information on the safety and effectiveness of sunscreen ingredients formulated in particle sizes as small as a few nanometers.
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July Issue of Consumer Reports Includes Article on Nanotechnology

Posted on June 5, 2007 by Lynn L. Bergeson
The July 2007 issue of Consumer Reports includes an article entitled “NANOtechnology: Untold Promise, Untold Risk.” According to Consumer Reports, while nanotechnology “promises to be the most important innovation since electricity and the internal combustion engine,” “some applications might pose substantial risks to human health and the environment.” The article states that nanomaterials are already being used in consumer products such as car wax, computer chips, and sunscreen, and that approximately $2.6 trillion worth of goods worldwide are expected to use nanotechnology by 2014, up from $50 billion in 2006. Consumers Union (CU), the nonprofit publisher of Consumer Reports, concludes that the responsibility for protecting consumers rests mainly with government and industry.  In particular, CU believes that the government should provide more funds for risk research and regulation, and that the Food and Drug Administration (FDA) should assess safety information on nanoingredients in cosmetics, food additives, and other products before they are sold, and should require manufacturers to report health problems linked with those ingredients. The full article is available in the July 2007 issue of Consumer Reports.
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Senate Requests GAO Review of NNI

Posted on March 22, 2007 by Lynn L. Bergeson
In a March 15, 2007, letter, the Senate Committee on Commerce, Science, and Transportation and the Congressional Nanotechnology Caucus requested that the Government Accountability Office (GAO) review the National Nanotechnology Initiative (NNI), which was created to accelerate the discovery, development, and deployment of nanoscale science and technology. For fiscal year 2006, NNI received $1.2 billion in research and development funding, and 22 federal agencies, including the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA), participate in NNI. According to the letter, one key expectation for NNI was “to ensure that adequate attention and research funding was made available to gain a better understanding of the potential environmental, health, and safety (EHS) risks associated with nanomaterials.” The letter states that the Committee and Caucus “are extremely concerned that this has not happened and that there is a lack of transparency with regard to how much federal attention and funding this important aspect of the initiative is receiving.”

To determine the extent to which federal agencies have undertaken EHS research and how they are prioritizing and managing this research, the Committee and Caucus ask GAO to:

  •  Review the extent to which NNI-related resources have been devoted to study the EHS risks of nanomaterials;
  • Identify the key areas of research for which this EHS funding has been used;
  • Determine what processes the Nanotechnology Environmental and Health Implications Working Group uses to prioritize and coordinate these various EHS research efforts; and
  • Review and identify any EHS-related research and regulatory activities, independent of the NNI, that EPA, FDA, CPCS, and OSHA have undertaken, the amount of funding made available for these efforts, and the extent to which information about these efforts has been communicated to the Working Group to ensure that they are considered in the overall research planning processes for the NNI.
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