Food manufacturers using the following seven (7) synthetic flavoring substances and adjuvants should take note that the safety of these ingredients is being challenged:
Each of these substances is authorized for food use by FDA. 21 C.F.R. § 172.515. However, such authorizations are being challenged in a food additive petition (FAP) submitted by several consumer groups to FDA and officially published in the Federal Register on February 10, 2016. See FAP 5A4810, and 81 Fed. Reg. 42. The FAP asserts that each substance is carcinogenic and, therefore violates the Delaney Clause of the FD&C Act. The Delaney Clause provides:
[N]o additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.
21 U.S.C. § 348(c)(3)(A).
Pursuant to FDA failing to take action on the FAP within a period well over 180 days from the date of filing, a Petition for Writ of Mandamus was drafted and submitted to the U.S. Court of Appeals for the Ninth Circuit on May 2, 2018 by the following groups:
The Petition essentially requests that the Court issue an Order compelling FDA to decide the FAP within 30 days.
The plaintiffs’ class action bar presumably is waiting eagerly for the Ninth Circuit’s decision and, if so ordered, FDA’s prompt resolution of the FAP. If FDA revokes its regulatory authorizations for the seven flavoring substances, demand letters from plaintiffs’ attorneys almost certainly will be sent to food manufacturers having used and/or using the substances.
Such food manufacturers ought to undertake the following preparatory/contingent actions:
A reasonably delayed effective date would permit food manufacturers time to transition to alternative flavoring substances and, perhaps, provide courts with basis (e.g., FDA’s primary jurisdiction) to forestall class action lawsuits until the effective/compliance dates pass.