FDA Files Petition to Revoke Clearances for Certain Phthalates

On April 12, 2016, the U.S. Food and Drug Administration (FDA) accepted for consideration a food additive petition that calls on the Agency to revoke the regulatory clearances for 30 ortho-phthalates when used as components of food-contact articles. The petition, submitted by the Natural Resources Defense Council (NRDC) and several other nongovernment organizations, also requested that FDA removed five ortho-phthalates from the list of prior-sanctioned substances in Title 21 Code of Federal Regulations (C.F.R.) Part 181.27 and prohibit the use of eight specific ortho-phthalates by issuing a new regulation in 21 C.F.R. Part 189. FDA did not accept for consideration the second two requests since they do not fall within the scope of a food additive petition. Specifically, the Agency explained in their April 12th letter to the NRDC that since the five ortho-pthalates (diethyl phthalate, ethyl phthalyl ethyl glycolate, butyl phthalyl butyl glycolate, diisooctyl phthalate, and di(2-ethylhexy1) phthalate) are prior sanctioned, they are exempt from the definition of a food additive. Similarly, the Agency informed the Petitioners that a food additive petition cannot be the basis of a request to ban the use of a food additive pursuant to the statutory provisions in Section 409(b) of the Federal Food, Drug, and Cosmetic Act.  The eight ortho-phthalates are diisobutyl phthalate, di-n-butyl phthalate, butyl benzyl phthalate, dicyclohexyl phthalate, di-n-hexyl phthalate, di(2-ethylhexyl) phthalate, and diisononyl phthalate. However, FDA suggested that both of these requests could be submitted through a citizen petition. FDA is statutorily obligated to publish a notice in the Federal Register that formally announces the petition has been accepted and is under review within 30 days after April 12th. The Agency has up to 180 days from the date of filing to consider the petition and make a formal decision on its merits.