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|Lynn L. Bergeson
Bergeson & Campbell, P.C.
On April 25, 2012, the U.S. Food and Drug Administration (FDA) announced the issuance of two new draft guidance documents on the use of nanotechnology in food and cosmetic products -- "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process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," and "Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.
April 26th, 2012
FDA Issues Two New Draft Guidance Documents on Nanotechnology in Food Substances and Cosmetics
On April 25, 2012, the U.S. Food and Drug Administration (FDA) announced the issuance of two new draft guidance documents on the use of nanotechnology in food and cosmetic products -- "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process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," which is available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm300661.htm and "Guidance for Industry: Safety of Nanomaterials in Cosmetic Products," which is available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm300886.htm 77 Fed. Reg. 24722. These documents follow FDA's issuance in June 2011 of an over-arching guidance on determining whether an FDA-regulated product involves the application of nanotechnology -- "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," which is available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm Comments on the two new guidance documents are due by July 24, 2012. As with all draft guidance documents, these documents are not binding and are potentially subject to change. They do, however, represent the direction and background of FDA's thinking on this evolving topic.
In general, the guidance documents reaffirm FDA's view that it regulates products not technologies, that the science of nanotechnology is expanding, and that its oversight of nanotechnology is iterative and adaptive. The guidance documents themselves will be useful to entities subject to FDA jurisdiction, and provide much needed clarity on certain topics, including what is a "significant change" in a manufacturing process such that manufacturers should be mindful of the potential regulatory implications of such changes.
Draft Guidance on Manufacturing Changes Involving Food Ingredients,
Food Contact Substances, and Food Ingredients That Are Color Additives
The primary point in FDA's new draft guidance on the use of nanotechnology in food is to determine when use of nanotechnology in manufacturing food ingredients and food contact substances (FCS), including packaging and pigments, may affect the safety of the end product. FDA takes great care to outline the regulatory pathways for various components of food and the steps necessary to demonstrate their safety. FDA points out that alteration in particle size distribution on the nanometer scale, which alter the physical and/or chemical properties of food ingredients and FCSs, can sometimes be significant manufacturing changes requiring new testing or regulatory filings. The guidance is clear, though, that FDA's primary concern is with the intentional alteration of particle size on the nanometer scale of food substances already used in food. FDA also reiterates its position that use of nanotechnology in FDA-regulated products is not in itself inherently harmful or benign. Rather, FDA considers the characteristics of the product and the safety of its intended use -- whether derived from conventional manufacturing or from nanotechnology.
Much of FDA's draft discusses the how changing a food ingredient or FCS to a nanoscale dimension can alter the identity, chemical composition, technical effect, self-limiting levels of use, and dietary exposure and safety studies. All of these elements impact the potential safety of the food and may result in conditions of use that are not authorized. For example, FDA notes that changing the physical and chemical properties of a food substance such as fiber used to replace flour in baked goods can change the amount of liquid absorbed and change the nutritional content of the resulting food product. Similarly, the color of a food additive may change simply by reducing the particle size of the substance. Changes to nanoscale size in self-limiting food ingredients, like flavorings, may result in food that is unpalatable, unappealing, or otherwise unfit for consumption. Significant alterations to physical or chemical properties and any associated changes to the self-limiting use levels are important considerations in the safety assessment and in establishing the conditions of safe use.
Of particular importance is the impact of nanoscale particles on the bioavailability of a substance through altered absorption, distribution, metabolism, and excretion of the substance in the body. These elements are, according to FDA, critical in determining the safety of the substance and in establishing a safe level of exposure. FDA notes that the migration of FCSs might be significantly affected by alteration of existing substances to a nanoscale dimension. Consequently, studies conducted with particles of a conventional scale, rather than at a nanoscale, may have little relevance to the safety of the substance manufactured in a significantly smaller size. In such circumstances, FDA advises continuing to utilize its guidance on toxicology when preparing a comprehensive toxicology profile and consulting with FDA on how best to develop, integrate, or adapt testing methodologies to accommodate the shift to nanoscale manufacturing.
The implications of this new draft guidance on manufacturers seeking to utilize nanotechnology could be significant. FDA is signaling that a new regulatory filing will be required in most circumstances when manufacturing changes result in nanoscale dimensions of food ingredients, FCSs, and color pigments -- especially if the substance is already in the market. Consultation with FDA is encouraged, particularly for GRAS substances as manufacturing changes involving nanotechnology are likely to involve a new regulatory filing.
Draft Guidance on the Safety of Nanomaterials in Cosmetic Products
With the exception of color additives, FDA does not subject cosmetic products or cosmetic ingredients to premarket approval. Manufacturers may use any ingredient, except for color additives, as long as such use does not cause the product to become adulterated or misbranded. Manufacturers or distributors should obtain all the data and information necessary to substantiate the safety of the product before marketing.
As with food substances and ingredients, cosmetic ingredients at the nanoscale might change the product's performance, quality, safety, and/or effectiveness. In addition, use of nanomaterials may alter the bioavailability of the cosmetic formulation. In some cases, the traditional tests relied upon to determine safety might not be fully applicable.
FDA is encouraging manufacturers to meet with it before incorporating new nanomaterials or an altered nanosized version of an existing ingredient into a product's formulation to discuss the test methods and data needed to substantiate the product's safety. This might include chronic toxicity and other long-term toxicity data.
For purposes of analyzing uptake and absorption, FDA divides nanomaterials into two groups: (1) soluble and/or biodegradable nanoparticles that disintegrate into their molecular components upon application to skin; and (2) insoluble and/or biopersistent nanoparticles. FDA notes that risk assessment based on mass metrics may be adequate for the soluble nanoparticles, but insoluble components may require other metrics.
FDA will expect to see studies on both intact and impaired skin to determine exposure via dermal absorption. FDA notes that there is a substantially increased probability for entry of nanomaterials through skin with an impaired barrier layer (e.g., sunburned, atopic, eczematous, psotiatic skin). Use of nanomaterials in aerosolized products may also result in exposure of nanomaterials via the respiratory tract. Additional or altered studies may also be needed for this category of products.