FDA Issues Draft Guidance on Use of Nanotechnology in Cosmetic Products

Apr 24, 2012   

On April 20, 2012, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a Draft Guidance for Industry entitled “Guidance for Industry: Safety of Nanomaterials in Cosmetic Products” (the “Guidance”) which outlines the FDAs current thinking on the safety assessment of nanomaterials in cosmetic products. According to FDA, the Guidance is “intended to assist industry and other stakeholders in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them.”

Nanomaterials, developed using nanotechnology, can have chemical, physical, and biological properties that differ from those of their conventionally-scaled counterparts. Nanomaterials are measured in nanometers”equal to about one-billionth of a meter”and are so small that they cannot be seen with a regular microscope. While FDA has not adopted a formal definition of “nanotechnology,” “nanoscale,” or related terms, “nanotechnology” is defined by the National Nanotechnology Initiative Program as “the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications.” Other definitions of “nanotechnology” consider other factors such as function, shape, charge, the ratio of surface area to volume, and other physical or chemical properties.

The Food, Drug, and Cosmetic Act (“FDCA”) does not subject cosmetics or cosmetic ingredients, with the exception of color additives, to premarket review or approval in order to be legally marketed in the United States. Therefore, except for color additives and some ingredients that are prohibited or restricted by regulation, a cosmetics manufacturer may use any ingredient in the formulation of a cosmetic without obtaining FDA approval, provided that the use of the use of the ingredient does not otherwise cause the cosmetic to be adulterated under section 601 of the FDCA (21 U.S.C. § 361) or misbranded under section 602 of the FDCA (21 U.S.C. § 362). Manufacturers of a cosmetic product are responsible for making sure a cosmetic product is not adulterated or misbranded. Cosmetic manufacturers and distributors are legally responsible for the safety of the products they market and should have proper testing and substantiation to support each products safety.

The current general framework for a cosmetic products safety assessment includes hazard identification, dose-response assessment, exposure assessment, and risk characterization. FDA believes that this current system for assessing safety is appropriately robust and flexible to be applied to nanomaterials. However, cosmetics manufacturers should make sure that data and testing methods properly address the unique properties and function of nanomaterials used in the cosmetic product.

In the Guidance, FDA recommends that safety assessment for cosmetic products using nanomaterials should address the following factors:

  • The physio-chemical characteristics,
  • Agglomeration and size distribution of nanomaterials at the toxicity testing conditions which should correspond to those of a final product,
  • Impurities,
  • Potential product exposure levels, and the potential for agglomeration of nanoparticles in the final product,
  • Dosimetry for in vitro and in vivo toxicology studies,
  • In vitro and in vivo toxicological data on ingredients and their impurities, dermal penetration, irritation of the skin and eyes, sensitization studies, mutagenicity/genotoxicity studies, and
  • Clinical studies to test the ingredient, or finished product, in human volunteers under controlled conditions.

The safety of a cosmetic product with nanomaterial ingredients should be evaluated by analyzing the physio-chemical properties and toxicological endpoints of each ingredient in relation to the expected exposure levels resulting from the intended use of the finished product. FDA encourages cosmetic manufacturers to consult with the Agency to address any questions related to safety and the test methods used to substantiate a products safety.

To ensure that FDA considers comments on the Guidance when developing the final guidance, electronic or written comments should be submitted within 90 days of the publication of the notice of availability in the Federal Register. Electronic comments should be submitted to http://www.regulations.gov. Written comments should be submitted to the Division of Dockets Management, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For more information on the FDAs regulation of cosmetics products or nanotechnology, please contact us at contact@fidjlaw.com or (305) 350-5690.