What the new FDA guidance on nanomaterials means for cosmetic players

Although this continues to be a gray area for many due to a continued lack of scientific data on how nanomaterials behave in cosmetics formulations and how they are absorbed when topically applied, the move aims to establish a clear framework to evaluate such formulations.

In an effort to help those manufacturers wishing to have support in trying to fulfill the new requirements of the new framework, the FDA has also offered to consult with companies to discuss specific safety considerations regarding nanomaterials in cosmetics.

Angela Diesch, an attorney specializing in representation for the cosmetics industry, with law firm Greenberg Traurig, believes that the use of nanomaterials in formulations can throw up some specific challenges of which companies should be aware.

Law expert says testing and labeling will be very important​

Diesch points out that formulations containing such materials are regulated in the same way as other cosmetics, which means they do not need pre-market approval, but they also have to be proven to be safe under customary conditions and properly labelled.

“Additionally, although the FDA has explained that the current safety framework used for conventional cosmetics is still appropriate for cosmetics using nanotech, companies should keep in mind the unique properties of nanomaterials when testing safety,”​ she said.

“Ultimately, as this guidance reminds, companies are legally liable for ensuring the safety of their products."​

Three FDA final guidance documents​

The FDA issued three final guidance documents on the use of nanomaterials in both cosmetics and foods, although they are all said not to be ‘legally enforceable’.

The two main points to consider in the document are whether or not a material or end product is engineered to have any elements in the nanoscale and whether or not it is engineered to have properties attributable to those nano dimensions.

“The safety of a cosmetic product should be evaluated by analysing the physico-chemical properties and the relevant toxicological endpoints of each ingredient in relation to the expected exposure, resulting from the intended use of the finished product,”​ the document states.