House Appropriations Committee approves bill amendment aimed at protecting food industry from PHO-related litigation until 2018.

  • As recently covered on this blog, FDA issued a final determination stating that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) under any conditions of use in food.  FDA specified a compliance date of June 18, 2018, suggesting that the Agency does not plan to take enforcement action against the continued presence of PHOs in the food supply for the next three years.  However, because FDA’s determination that PHOs are not GRAS took immediate effect, the food industry understandably is concerned about potential consumer litigation regarding PHOs present in foods even during the three-year “phase out” period.
  • During the House Appropriations Committee’s markup of the FY 2016 Agriculture Appropriations Bill, Rep. Andy Harris (R-MD) introduced an amendment intended to protect the food industry from litigation until June 18, 2018.  Specifically, the amendment would require FDA to publish a notice in the Federal Register clarifying that “until the compliance date specified [in FDA’s PHO determination], partially hydrogenated oils shall be considered generally recognized as safe within the meaning of section 201(s) of the [FD&C Act].”  The Committee approved this amendment.
  • If the amendment is enacted — and if FDA actually publishes the notice — FDA’s action would preserve the lawful use of PHOs in the food supply until June 18, 2018, thus potentially discouraging plaintiffs’ lawsuits premised on the allegation that food products contain an unapproved food additive.  This approach represents an interesting attempt by Congress to insulate the food industry from the litigation consequences of FDA’s recent determination.  The eventual effectiveness of this approach remains to be seen, however, particularly if FDA fails to publish the Federal Register notice in a timely manner, if someone challenges Congress’ authority to act this way, or if plaintiffs’ lawyers challenge the scientific and factual inconsistencies between the two notices.