United States: FDA Issues Guidance Documents On The Use Of Nanotechnology In FDA-Regulated Materials

Last Updated: July 24 2014
Article by Mark L. Itzkoff

On June 24, 2014, the Food and Drug Administration (FDA) released three final and one draft guidance document regarding the use of nanotechnology in the manufacture of FDA-regulated products. Specifically, the agency issued the following:

Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

While FDA has not established a regulatory definition for "nanotechnology," the agency notes that the term is generally used to describe "materials that have at least one dimension in the size range of approximately 1 nanometer (nm) to 100 nm," where the unique dimensions enable novel applications. In the Guidance Document, FDA sets forth two points to consider when determining whether an FDA-regulated product involves the application of nanotechnology:

  1. Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm).
  2. Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, which are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm).

FDA uses the term "engineered" to differentiate materials intentionally designed or manufactured to contain nanomaterials from those that naturally contain material in the nanoscale range. The term "material or end product" is used to include the range of products regulated by FDA, including finished products (e.g.,a drug tablet) and materials used to produce the end product (e.g., a food additive).

The agency concludes that if a material or end product is "affirmative" for either point, additional attention may be needed to determine the safety of the material.

Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives

FDA approaches nanomaterials from current food substances (i.e., for the purposes of the Guidance Document, FDA uses the term "food substance" to include food additives, color additives, GRAS ingredients and food contact substances) in the same manner as it approaches food substances produced using a process that entails significant changes in the manufacturing process. The guidance document suggests that materials produced with any new process be evaluated to determine if a new regulatory submission is warranted. In the food ingredient guidance document FDA lists the factors that should be considered when reviewing the regulatory status of the new material:

  • A change in one or more starting materials;
  • A change in the concentration of starting materials;
  • A change in catalyst;
  • A change in the source microorganism (including a change in strain) used for a food substance derived from fermentation of a microorganism; and
  • A change in food manufacturing or ingredient technology, such as the use of emerging technologies that affect the particle size distribution of a food substance.

Any of these changes may require a new "regulatory filing" if it results in a significant change in the safety or intended use of the food substance. For example, the use of nanotechnology to produce a food additive may increase the amount of the additive that is absorbed through the digestive system, which may require a new safety evaluation.

Of particular interest is the agency's discussion of the impact of nanotechnology on food substances deemed to be generally recognized as safe (GRAS) when produced using conventional production methods. FDA notes that in some situations, "manufacturing changes are so novel as to preclude general recognition of safety." Furthermore, FDA notes that when nanotechnology or other emerging technologies are used, the technology may be "so new as to preclude a consensus among experts that the use of a food substance manufactured using that technology is safe, thus precluding a determination that the use of the food substance is GRAS" (emphasis added).

Safety of Nanomaterials in Cosmetic Products

This Guidance Document notes that, except for color additives, substances used in cosmetic products are not subject to FDA premarket approval. It is the responsibility of the cosmetic manufacturer to ensure that the product is not misbranded or adulterated. FDA states that the general principles for evaluating the safety of nanomaterials are the same as the principles for evaluating conventional materials. However, nanomaterials "may exhibit new or altered physicochemical properties that may affect biological interactions, which may raise questions about the safety of the product containing nanomaterials." These new or altered properties must be addressed as part of the overall safety evaluation." The guidance document includes specific recommendations on the components of a safety evaluation for nanomaterials, including characterization of the material and toxicology considerations.

Use of Nanomaterials in Food for Animals

In addition to the three final guidance documents discussed above, FDA issued draft guidance on the use of nanomaterials in food for animals. The agency notes that at the current time there are questions related to the "the technical evidence of safety as well as the general recognition of that safety" that would preclude a GRAS determination. FDA states that these questions are sufficient to "warrant formal premarket review and approval by FDA." For this reason, FDA suggests that nanotechnology-based animal feed ingredients be submitted for review as a food additive petition (FAP). The draft guidance includes recommendations on the contents of a FAP for these materials.

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