Food manufacturers using the following seven (7) synthetic flavoring substances and adjuvants should take note that the safety of these ingredients is being challenged:
- Benzophenone (a/k/a diphenylketone),
- Ethyl acrylate,
- Eugenyl methyl ether (a/k/a 4-allylveratrole, methyl eugenol, or Methyleugenol),
- Myrcene (a/k/a 7-methyl-3-methylene-1,6-octadiene),
- Pulegone (a/k/a p-menth-4(8)-en-3-one),
- Pyridine, and
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:
- Breast Cancer Prevention Partners,
- Center for Environmental Health,
- Center for Food Safety,
- Center for Science in the Public Interest,
- Environmental Defense Fund,
- Environmental Working Group,
- Natural Resources Defense Council, Inc., and
- WE ACT for Environmental Justice.
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:
- Identify an alternative flavoring substances for any of the FAP substance being used; and
- Contact FDA about providing for a reasonably delayed effective/compliance date for any final rule that amends § 172.515 so as to rescind authorization for use of any synthetic flavoring substance subject to the FAP. See e.g., Final Determination Regarding Partially Hydrogenated Oils, 83 Fed. Reg. 23,358 (May 21, 2018) (setting compliance dates for both last date rescinded substance could be added to foods and last date food containing rescinded substance could be in marketplace).
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.