Changes in FDA Leadership Announced
The Food and Drug Administration (FDA) recently issued a Constituent Update announcing Michael Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, will be leaving the Agency on June 1, 2016. Dr. Stephen Ostroff, who formerly served as FDA’s Acting Commissioner, will replace Mr. Taylor. Refer to the Constituent Update for additional details.
National Organic Program – National List of Allowed and Prohibited Substances
The United States Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) recently issued a notice in the Federal Register (81 FR 12680; March 10, 2016) announcing the availability of the National List Petition Guidelines (NOP 3011). According to the Agency, the document provides guidelines on submitting a petition to amend the National List of Allowed and Prohibited Substances (National List) codified at 7 Code of Federal Regulations Parts 205.600 – 205.606. The National List identifies those substances that may or may not be used in the production of organic products.
FDA Publishes Animal Feed Safety Guidance
In April 2015, JPA staff notified members of the availability of a draft guidance issued by the FDA, “Ensuring Safety of Animal Feed Maintained and Fed On-Farm.” A copy of the memorandum prepared by JPA’s legal counsel, Hogan Lovells, providing insight regarding the potential impact of the guidance on human food manufacturers was previously shared with JPA members. The FDA recently issued a notice in the Federal Register (81 FR 12498; March 9, 2016) announcing the availability of the final guidance. Human food manufacturers that divert their by-products directly to farmers for use in animal feed should review the final guidance to determine the impact on their business.
FDA Extends Date for Menu Labeling Enforcement
JPA staff has previously provided updates regarding a final rule published by the FDA in 2014 to require calorie information and other nutrition information for standard menu items sold/served in restaurants and retail food establishments. The FDA had established December 1, 2015 as the compliance date for those covered by the rule and later extended the compliance date to December 1, 2016.
The FDA recently issued a statement, below, on behalf of Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, noting enforcement of the final rule would be delayed “to the date that is one year after it issues final, Level 1 guidance on menu labeling.”
“As a result of language in the omnibus appropriations bill enacted December 18, 2015 (Public Law 114-113 Consolidated Appropriations Act, 2016), FDA is delaying enforcement from December 1, 2016, to the date that is one year after it issues final, Level 1 guidance on menu labeling. The draft Level 1 guidance was issued on Sept. 11, 2015, and FDA is considering all comments received and will issue the final guidance as soon as possible.
FDA appreciates the extensive input received from stakeholders throughout the process of establishing requirements for menu labeling and in developing guidance. We will work flexibly and cooperatively with establishments covered by the menu labeling final rule to facilitate compliance and will provide educational and technical assistance for covered establishments and for our state, local, and tribal regulatory partners.”
FDA Annual Report to Congress on the Use of Mandatory Recall Authority
The FDA recently published the “Annual Report to Congress on the Use of Mandatory Recall Authority.” According to the report, the FDA Food Safety Modernization Act (FSMA) requires the Department of Health and Human Services (HHS) to submit a report to Congress regarding the FDA’s use of the recall authority and public health advisories issued by the Agency notifying the public that a food is adulterated and poses a danger to health and advising against consumption of such foods. According to the report, in fiscal year (FY) 2015, FDA had no mandatory recall activity to report and as such, the Agency did not issue any public health advisories as described in section 206(f) of FSMA.