April 20, 2015

TO: JPA Members

FROM: Patricia Faison

RE: JPA Regulatory Update
(1) Hogan Lovells Memo – Food Facility Registration
(2) FDA Food Safety Modernization Act (FSMA)

Hogan Lovells Memo - Food Facility Registration
Earlier this month, JPA notified members that the Food and Drug Administration (FDA) had issued a proposed rule in the Federal Register (80 FR 19160; April 9, 2015), available here, to amend the Registration of Food Facilities regulation (Title 21 Code of Federal Regulations Part 1, Subpart H). Attached is a memorandum prepared by JPA’s legal counsel, Hogan Lovells, summarizing the provisions of the proposed rule.

JPA will be considering whether comments should be submitted to the Agency in the near future.

FDA Food Safety Modernization Act (FSMA)

FDA’s Implementation of FSMA
JPA has been providing updates regarding the FDA’s public meeting to be held on April 23 – 24, 2015 pertaining to implementation of the FDA Food Safety Modernization Act (FSMA). A copy of the Federal Register notice with additional details regarding the meeting (“FDA Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards”) was previously shared with members. The agenda for the meeting and breakout session questions are available via the Agency’s public meeting website.

Today, the FDA posted new information on the Agency’s FSMA website, in which two FDA representatives (Roberta Wagner and Joan Givens of the FDA Office of Regulatory Affairs) provide insight on FDA’s implementation of FSMA. In the FDA’s “Questions and Answers” document, available here, the Agency notes the final rules are expected to be published for preventive controls for human and animal food in August 2015. The final rules for produce safety and two import-oriented final rules [foreign supplier verification program and third-party accreditation] are expected to be published in October 2015. In addition, the final rules on sanitary transportation and intentional adulteration are expected to be published in March 2016 and May 2016, respectively.

FDA’s Report to Congress on Recall Authority
The FDA recently published the “Annual Report to Congress on the Use of Mandatory Recall Authority – 2014,” which is mandated by enactment of FSMA. FSMA gives FDA the authority to recall FDA-regulated products that pose a danger to health, except infant formula. According to the report, available here, an update on public health advisories (communications related to the recall process) is also required to be included in the report. In fiscal year (FY) 2014, the Agency issued a Notification of Opportunity to Initiate a Voluntary Recall letter to USPlabs, LLC (Dallas, Texas) advising the firm to cease distribution of adulterated dietary supplements OxyElite Pro and VERSA-1. According to the Centers for Disease Control and Prevention (CDC), 97 people with acute non-viral hepatitis were affected by the outbreak with 72 individuals exposed to the OxyElite Pro product. At least 47 people were hospitalized, at least 3 received a liver transplant, and 1 death was reported.

JPA will continue to monitor FDA’s efforts to implement the provisions of FSMA.

Please do not hesitate to contact me with questions or comments.

Patricia Faison

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