Why FDA Currently Can’t Require “Nanotech” Labeling on Cosmetics

Recently, calls have been mounting for FDA to require manufacturers of cosmetics to highlight the presence in their products of what are variously referred to as “nanomaterials,” “nanoingredients,” and “nanoscale materials,” among other descriptors. The objective of this requirement would be to enable consumers to avoid any potential risks posed by “nanomaterials.” Whatever its merits from a policy standpoint, such a requirement would have little grounding in science or law.

As FDA noted in its 2007 Nanotechnology Task Force Report, there is no scientific basis on which to conclude that “nanoscale materials” as a class are inherently more hazardous than “non-nanoscale” materials. In fact, FDA declined to even attempt to define “nanoscale material” or any similar term for regulatory purposes, in recognition of the fact that currently there exists no scientific rationale for drawing any particular definitional lines. Without a supporting scientific rationale, a regulatory definition of “nanoscale material” for purposes of imposing label declaration requirements could not be grounded in the misbranding provisions of the act, and would be vulnerable to a First Amendment challenge.

Similarly, calls for FDA to more vigorously exercise its regulatory authority to require substantiation of ingredient safety fail to acknowledge the limits of FDA’s statutory authority. It is true that the FDCA prohibits the introduction into interstate commerce of a cosmetic that is adulterated because it bears or contains a poisonous or deleterious substance which may render it injurious to users, and thus places the burden on cosmetic manufacturers to ensure that the ingredients they use are safe. However, the FDCA does not authorize FDA to require proof from a cosmetics manufacturer that any particular ingredient (other than a color additive) is safe. To the contrary, in the context of a judicial proceeding, FDA would bear the burden of demonstrating that a particular ingredient is unsafe (i.e., is a poisonous or deleterious substance that may render the cosmetic injurious to users).

One is reminded of calls for FDA to require label declaration of the presence of bioengineered ingredients in foods. In the absence of demonstrable risk posed by those ingredients, FDA demurred, noting that the agency lacks authority to require labeling statements for the purpose of satisfying consumer interest. This view is likely to guide FDA’s position on “nanotech” labeling, at least until there is a change in the law or the underlying science.

By Ricardo Carvajal