May 29, 2015

TO: JPA Members

FROM: Patricia Faison

RE: JPA Regulatory Update

(1) FDA Warning Letter – Juice HACCP Violations
(2) Federal Regulatory Agendas Published - Hogan Lovells Summary
(3) Hogan Lovells Summary - FDA Draft Guidance on Mandatory Recalls
(4) FDA's Determination of the GRAS of Partially Hydrogenated Oils

Attachments: HL_Memo_-_OMB_Releases_Spring_2015_Unified_Agenda_of_Regulatory_Actions.pdf

FDA Warning Letter – Juice HACCP Violations
The Food and Drug Administration (FDA) recently published a Warning Letter to Vital Juice (Seattle, Washington) citing violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 Code of Federal Regulations Part 120) pertaining to a variety of juice products. A copy of the Warning Letter is available here.

Federal Regulatory Agendas Published
The White House recently published the "Current Regulatory Plan and the Unified Agenda of Regulatory and Deregulatory Actions" for Spring 2015. It details the Agency's proposed rulemaking activities and includes regulatory activities undertaken by the Department of Health and Human Services, United States Department of Agriculture (USDA) and the Environmental Protection Agency. JPA's legal counsel, Hogan Lovells, memorandum detailing key regulatory activities by the FDA and USDA is attached above.

Hogan Lovells Summary - FDA Draft Guidance on Mandatory Recalls
On May 8, 2015, JPA members were notified that the FDA had published the "Draft Guidance for Industry: Questions and Answers Regarding Mandatory Food Recalls." The draft guidance "provides answers to common questions that might arise about the mandatory recall provisions and FDA's plans for implementation." Hogan Lovells' memorandum related to the draft guidance is attached above.

FDA's Determination of the GRAS of Partially Hydrogenated Oils
In 2013, JPA members were notified that the FDA had published a notice in the Federal Register announcing that the Agency had tentatively determined that partially hydrogenated oils (PHOs), the primary source of artificial trans fat in the diet, should no longer be considered "generally recognized as safe" (GRAS) for use in food.

According to the May 28 issue of Food Chemical News, the FDA is expected to make a final determination on PHOs on or before June 15 based on a filing in the U.S. District Court, Central District of Illinois. The article notes the American Bakers Association (ABA) is working with members of the U.S. Senate to urge the FDA to delay making a final decision until the Agency has reviewed a pending food additive petition to be submitted by the Grocery Manufacturers Association (GMA). According to the article, ABA also wants Congress to direct the FDA to define PHO and permit a reasonable timeframe for product reformulation. Senator Mark Kirk (R-IL) submitted a letter to FDA Commissioner Stephen Ostroff warning that if the Agency finalizes the position prior without considering the food additive petition, "it would have the same effect as rule making without going through the appropriate rule making process."

Please contact me with questions or comments.

Pat Faison

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JPA Staff
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