FDA Grant of Abandonment Petition (05/20/2022)

Specifically, the administrative record does not support a determination that the substances caused food to be adulterated, for example either because: 1) the substance causes food to be adulterated under section 402(a)(2)(C) of the FD&C Act; and/or 2) the substance causes food to be adulterated under section 402(a)(1) of the FD&C Act. [...] Under section 409(c)(3) of the FD&C Act, we will not establish a regulation for the use of a food additive if a fair evaluation of the data fails to establish that the proposed use of the food additive, under the conditions of use, to be specified in the regulation, will be safe. [...] Therefore, assessments conducted for the purpose of evaluating children’s toys and child care article uses do not necessarily apply to the safety of food contact uses due to the different conditions of use, and you have not provided an explanation in your petition for why the CHAP report’s assessments of phthalates in children’s toys and child care articles should apply directly to the safety of p. [...] The term “prior sanction” derives from section 201(s)(4) of the FD&C Act, which excepts from the definition of a food additive any substance “used in accordance with a sanction or approval granted prior to” September 6, 1958, the date of enactment of the Food Additives Amendment to the FD&C Act. [...] The only evidence you submitted in support of this request is your food additive petition, which proposes to treat a large, diverse number of ortho-phthalates as a class for purposes of a safety assessment, apply a proposed ADI value for one phthalate to all the phthalates in the purported class, and compare the exposure of all the phthalates against that single proposed ADI.