FDA Issues Further Nanotechnology Guidance

Late last month, the U.S. Food and Drug Administration issued one draft and three final guidance documents related to the use of nanotechnology in regulated products.

One final guidance addresses the agency’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics and food for animals, respectively.

Readers may know from our earlier posts (and here and here) that nanotechnology is an emerging technology that allows scientists to create, explore and manipulate materials on a scale measured in nanometers—particles so small that they cannot be seen with a regular microscope. The technology has a broad range of potential applications, such as improving the packaging of food and altering the look and feel of cosmetics.

The three final guidance documents reflect the FDA’s current thinking on these issues after taking into account public comment received on the corresponding draft guidance documents previously issued (draft agency guidance in 2011; and draft cosmetics and foods guidances in 2012).

The FDA  continues to favor an approach to consider the specific characteristics of individual products. All four guidance documents encourage manufacturers to consult with the agency before taking their products to market. Consultations with the FDA early in the product development process may 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.

The guidance documents are:

Final Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

This guidance outlines overarching considerations for all FDA-regulated products, identifying points to consider when determining whether a product involves the use of nanotechnology. It is intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness or public health impact that may arise with the application of nanotechnology in FDA-regulated products.

Final Guidance for Industry: Safety of Nanomaterials in Cosmetics

This guidance describes the FDA’s current thinking on the safety assessment of nanomaterials when used in cosmetic products and encourages manufacturers to consult with the FDA on test methods and data needed to support the substantiation of a product’s safety.

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

This guidance alerts manufacturers to the potential impact of any significant manufacturing process change, including changes involving nanotechnology, on the safety and regulatory status of food substances. This guidance also describes considerations for determining whether a significant manufacturing process change for a food substance already in the market affects the identity, safety, or regulatory status of the food substance, potentially warranting a regulatory submission to the FDA.

Draft Guidance for Industry: Use of Nanomaterials in Food for Animals

This draft guidance addresses issues related to the use of nanotechnology in food ingredients intended for use in food for animals. Public comments on this draft guidance are requested by September 10, 2014.

The FDA said it will continue to pursue ongoing scientific research and regulatory efforts and will consider new studies and data, as they become available, to determine any future actions. 

Class Complaint Dismissed WITH Prejudice

The Second Circuit recently affirmed a trial court decision dismissing a proposed class action challenging the marketing of certain cosmetic products.  See DiMuro v. Clinique Labs, LLC, No. 13-4551 (2d Cir. 7/10/14) (unpublished).

Plaintiffs filed a putative class action complaint asserting claims under the Connecticut, New Jersey, and Illinois consumer fraud statutes, along with claims for breach of express warranty, breach of implied warranty, and unjust enrichment, arising from defendants’ marketing of seven different cosmetic products sold under the “Repairwear” product line. But while plaintiffs’ consolidated class action complaint asserted claims arising out of the marketing of seven different products, the named plaintiffs only alleged to have purchased and used three of the seven products.

Plaintiffs argued that they nevertheless had class standing to bring claims for Repairwear products that they did not buy-- a commonly attempted but seldom successful tactic.  Here, each of the seven different products have different ingredients, and defendant allegedly made different advertising claims for each product. Unique evidence would therefore be required to prove that the 35-some advertising statements for each of the seven different products were false and misleading. As a result, the court could not conclude that claims brought by a purchaser of one product would raise a set of concerns nearly identical to that of a purchaser of another Repairwear product. Accordingly, plaintiffs lacked standing to bring claims for the four products that they did not purchase.

The court also affirmed the dismissal of plaintiffs’ consumer fraud claims because plaintiffs failed to plead them with the requisite particularity under Fed. R. Civ. P. 9(b).  Rule 9(b) requires that a complaint specify the statements that the plaintiff contends were fraudulent, identify the speaker, state where and when the statements were made, and explain why the statements were fraudulent.  E.g., Mills v. Polar Molecular Corp., 12 F.3d 1170, 1175 (2d Cir. 1993). One of the cardinal purposes of Rule 9(b) is to “provid[e] a defendant fair notice of plaintiff’s claim, to enable preparation of [a] defense.” See DiVittorio v. Equidyne Extractive Indus., Inc., 822 F.2d 1242, 1247 (2d Cir. 1987). Plaintiffs’ consolidated complaint was wholly conclusory and lacked the particularity required to ensure that defendant received fair notice of the claims.

Specifically, plaintiffs’ "group-pleading" as to the products and the advertisements at issue was
inconsistent with Rule 9(b)’s particularity requirement in that the complaint failed to specify which
of the alleged statements were fraudulent and with regard to what product.  It simply alleged that the products, collectively, cannot work. Given that the seven different products have different ingredients, different intended uses, and that defendant made different advertising claims for each one, this was wholly insufficient to satisfy Rule 9(b). Plaintiffs failed to address the different product ingredients, different intended uses, and different claims.

The complaint also failed to allege that any of the named plaintiffs even used the product, let alone used the product as directed. Similarly, the named plaintiffs did not allege what results they received from their use of the product. They only alleged that they received “no value,” “did not receive what they bargained for,” or “did not get what they paid for.” Since they did not allege which particular advertising claims each of the named plaintiffs relied on when purchasing the product, the conclusion that they did not receive what they bargained for had no ascertainable meaning. 

Plaintiffs’ claims for breach of express warranty and breach of implied warranty also relied on
allegations that the products did not perform as advertised. These allegations were wholly conclusory, and did not provide a sufficient factual basis to establish a plausible breach of any specifically identified express or implied warranty.

Pretty standard stuff, really, but let's turn to the most useful aspect of the analysis.  The complaint was dismissed with prejudice.  Leave to amend is given when justice so requires.  But what too often happens is that plaintiffs file a conclusory, fishing expedition of a complaint; the defendant expends considerable cost to point out the many deficiencies of the pleading; the court dismisses appropriately dismisses the complaint, and plaintiffs use the opinion as their model to draft an amended pleading-- often repeating the process several times, until they finally get a minimally acceptable pleading that bears little resemblance to their original complaint.  Here, the court recognized that plaintiffs are “not entitled to an advisory opinion from the Court informing them of the deficiencies in the complaint and then an opportunity to cure those deficiencies.” Bellikoff v. Eaton Vance Corp., 481 F.3d 110, 118 (2d Cir. 2007). Moreover, a plaintiff need not be given leave to amend if the plaintiff fails to specify either to the district court or to the court of appeals how amendment would cure the pleading deficiencies in its complaint. The district court’s decision to deny plaintiffs leave to amend their complaint was not an abuse of discretion. First, the plaintiffs failed to provide any detail as to what facts they would or could) plead to cure their pleading deficiencies. Second -- and this is very commonly the case --  much if not all of the information necessary for a properly pled complaint was and had always been in the possession of the plaintiffs. For example, which particular representations they relied upon, if and how they had used the products, what the results were.   Useful discussion of why leave should NOT be granted in these consumer fraud cases.

FDA Releases Draft Guidance on Nanotechnology

The U.S. Food and Drug Administration last week released draft guidance designed to move the process forward of providing its regulated industries with greater certainty about the use of nanotechnology (which generally involves materials made up of particles that are one billionth of a meter in size). The guidance outlines the agency’s current view on certain issues about regulated products that contain nanomaterials or involve the application of nanotechnology.

FDA has not to date established regulatory definitions of “nanotechnology,” “nanoscale” or related terms. The term is perhaps most commonly used to refer to the engineering (i.e., deliberate manipulation, manufacture or selection) of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers. For example, theNational Nanotechnology Initiative Program defines nanotechnology as the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications. Other factors such as function, shape, charge, the ratio of surface area to volume, or other physical or chemical properties have also been mentioned in various published definitions.

Our readers know that nanotechnology, the science involving manipulation of materials on an atomic or molecular scale, is an emerging technology with a broad range of potential applications, such as increasing bio-availability of a drug, improving food packaging, and in cosmetics.

The draft guidance document, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” represents a first step toward providing some regulatory clarity on the FDA’s approach to nanotechnology. Specifically, the agency named certain characteristics – such as the size of nanomaterials used and the exhibited properties of those materials – that may be considered when attempting to identify applications of nanotechnology in regulated products.

For products subject to premarket review, the FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials. For products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process so questions related to the regulatory status, safety, effectiveness, or public health impact of these products can be adequately addressed.

In 2006, the FDA formed the Nanotechnology Task Force, charged with identifying and addressing ways to better enable the agency to evaluate possible adverse health effects from FDA-regulated nanotechnology products.  The agency issued a report by the task force in 2007 that recommended that the FDA issue additional guidance and take steps to address the potential risks and benefits of drugs, medical devices and other FDA-regulated products using nanotechnology.

 

EU Council Adopts Regulations for Cosmetics with Nano-ingredients

We have posted about nanotechnology issues before. Readers following nano-issues will want to note that the Council of the European Union last week approved an updated set of regulations on cosmetic products, and they include a requirement that cosmetics containing nanoscale ingredients have that information on their labels. [In the European Union, regulations automatically apply to all  member states, while directives are implemented through national legislation. The regulation thus represents a common European code on cosmetic products, designed to reduce the uncertainties arising from a differentiated implementation of the previous directives in the 27 member states.]

Specifically, the regulation states that, “All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.”  see p. 61.  Some observers have questioned whether the mention of the term "nano" in labels will offer consumers much meaningful guidance. The FDA's 2007 Nanotechnology Task Force Report did not recommend labeling because current science did not support a finding that products with nanoscale materials necessarily present greater safety concerns than those without nanoscale materials.

The document indicates that the use of nanomaterials in cosmetic products may increase with the further development of technology. In addition, the EU Council suggest that in order to ensure a high level of consumer protection, free movement of goods, and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at the international level.  In the interim, "nanomaterial" for regulatory purposes means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.

The Council states that, at present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety, the Council calls for cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.

The new rule also will require manufacturers of new cosmetic products containing nanomaterials to notify the European Commission and to provide certain toxicological information before the products are placed on the market. Published reports suggest that manufacturers may have up to 3 years to comply with the new label regulations.