The U.S. FDA recently reaffirmed its denial of an activist petition seeking a ban on eight ortho-phthalates. The Flexible Vinyl Alliance offers its thoughts:
The U.S. Food and Drug Administration (FDA) denied a petition on July 21, 2023 requesting that the agency reconsider its denial of a citizen petition issued on May 19, 2022.
The citizen petition requested a ban on the use of eight ortho-phthalates and revocation of the prior sanctioned uses for five other ortho-phthalates in food based on alleged safety concerns.
In denying the latest citizen petition, FDA concluded "that it does not provide a basis for modifying the FDA's response to the original petition (of May 19, 2022)."
An industry petition from the Flexible Vinyl Alliance (FVA), also granted on May 19, 2022 removed 25 phthalates from authorized use due to lack of use and kept authorizations for five. As stated by FDA at that time "… based on the information currently available to FDA, we do not have a basis to conclude that dietary exposure levels from approved orthophthalates exceed a safe level…"
"We are pleased that FDA has again relied on the most up-to-date data on these substances, including data provided by FVA members, in their evaluation of these materials, minimally used in food contact," said Kevin Ott, Executive Director of FVA. "We will continue to ensure the safe use of these materials in accordance with ongoing FDA food contact regulations."
"It's also apparent, in denying the citizen petition today, that the FDA came down, again, on the side of science and data, in making its decision," said Ott. "Beginning many years ago, industry permanently moved on to manufacturing next generation substances for food packaging that are supported by science and demonstrate safety." In its December 22, 2022 filing to the docket in regard to the subject citizen petition, which can be viewed here, FVA detailed the substantive data and science underscoring the safety of phthalates in food contact