Regulatory DevelopmentsJune 26, 2014
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products." One final guidance addresses FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively. FDA states that the three final guidance documents reflect its current thinking on these issues after taking into account public comment received on the corresponding draft guidance documents previously issued (draft agency guidance in 2011; and draft cosmetics and foods guidances in 2012). Comments on the draft guidance are due September 10, 2014.
FDA states that it "does not make a categorical judgment that nanotechnology is inherently safe or harmful, and will continue to consider the specific characteristics of individual products." FDA notes that all four guidances "encourage manufacturers to consult with the agency before taking their products to market." According to FDA, consultations early in the product development process "help to facilitate a mutual understanding about specific scientific and regulatory issues relevant to the nanotechnology product, and help address questions related to safety, effectiveness, public health impact and/or regulatory status of the product."
Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
This final guidance provides an overarching framework for FDA's approach to the regulation of nanotechnology products. It identifies two points to consider when determining whether the FDA-regulated product involves the application of nanotechnology:
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 nanometer (nm) to 100 nm); and
- Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm).
The final guidance states that these considerations apply not only to new products, but also when changes to manufacturing processes alter the dimensions, properties, or effects of an FDA-regulated product or any of its constituent parts.
According to the final guidance, an affirmative finding to either of the points might suggest the need for particular attention by FDA and/or industry to the product to identify and address potential implications for safety, effectiveness, public health impact, or regulatory status of the product. According to FDA, these points "are intended to be a broad screening tool for FDA purposes, reflecting the fact that for purposes of ensuring that all applicable requirements are met, FDA's interest extends to the properties exhibited by products that involve the use of nanotechnology, and does not focus on size alone." FDA states that it may further refine these points to consider as the science evolves. FDA notes that the final guidance does not establish a regulatory definition of the term nanotechnology or any related vocabulary. The final guidance is available online.
Final Guidance for Industry: Safety of Nanomaterials in Cosmetic Products
This final guidance describes FDA's current thinking on the safety assessment of nanomaterials when used in cosmetic products. FDA states that:
Cosmetics and cosmetic ingredients (with the exception of color additives) are not subject to premarket approval; they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled, however.
Cosmetics manufactured using nanomaterials are subject to the same legal requirements as any other cosmetics. Companies and individuals who market cosmetics are legally responsible for the safety of their products.
- In general, the framework currently in use for assessing safety of cosmetics is appropriate for cosmetics containing nanomaterials. Data needs and testing methods should be evaluated in light of the properties, behaviors, and/or effects that may be exhibited by nanomaterials used in cosmetic products, however.
The final guidance is available online.
Final Guidance for Industry: 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 states that this final guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including those involving nanotechnology, on the safety and regulatory status of food substances. The final guidance describes the factors manufacturers should consider when determining whether a significant change in manufacturing process for a food substance already in the market:
Affects the identity of the food substance;
Affects the safety of the use of the food substance;
Affects the regulatory status of the use of the food substance; and
- Warrants a regulatory submission to FDA.
The final guidance is available online.
Draft Guidance for Industry: Use of Nanomaterials in Food for Animals
FDA states that the draft guidance describes its current thinking regarding the use of nanomaterials or the application of nanotechnology in food for animals. The draft guidance addresses the legal framework for adding substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient. FDA's draft recommendations for developing an FAP for a nanomaterial animal food ingredient highlight considerations for the following sections of an FAP:
Manufacturing Methods and Controls;
Intended Use, Use Level, and Labeling;
Safety Evaluation and Proposed Tolerances for the Food Additive;
Proposed Regulation; and
- Environmental Assessment.
Comments on the draft guidance, which is available online, are due September 10, 2014.
Each of the final and draft guidances encourages industry to consult with FDA, either early in the product development process, when considering a significant change to the manufacturing process for a food substance already in the market, or early in the development of their nanomaterial animal food ingredient and before submitting an FAP. This has been a consistent element in FDA's advice to industry in all matters pertinent to nanotechnology. According to FDA, early consultations "facilitate a mutual understanding of the specific scientific and regulatory issues for nanotechnology products." In the Nanotechnology Fact Sheet, available online, FDA states that it will continue to regulate nanotechnology products under its existing statutory and regulatory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction. FDA notes that its regulatory policy approach "is consistent with relevant overarching U.S. government policy principles, and supports innovation under appropriate oversight." FDA notes also that "ndustry remains responsible for ensuring that its products meet all applicable legal requirements, including standards for safety -- regardless of the emerging nature of a technology involved in the manufacturing of a product."