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Industry News and Press: Regulatory Updates

November & December 2017 Regulatory Update

Sunday, December 31, 2017   (0 Comments)

These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from November 1 through December 12, 2017. Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.

This November-December 2017 Regulatory Update includes GRAS (Generally Accepted As Safe) Panel Best Practices; Allergen Labeling and Exemptions; Food Safety Modernization Act (FSMA) Updates; Other Developments of Interest


On November 15, 2017, FDA published a draft guidance, "Best Practices for Convening a GRAS Panel,” intended to assist those persons convening a panel of experts ("GRAS panel”) to evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food in relation to the generally recognized as safe (GRAS) provision of the federal Food, Drug and Cosmetic Act. The draft guidance provides best practices to identify the appropriate members of such a panel, address conflict of interest issues, and consider other suggested steps and strategies with respect to such panels. Public comments should be submitted by May 15, 2018.  >>Read more


On December 12, 2017, FDA published in the Federal Register a Notice of proposed collection activities with respect to Food Allergen Labeling and Reporting.  In the Notice, FDA estimates the annual information collection burden for manufacturers for new or reformulated products to comply with §403(w)(1) of the federal Food, Drug & Cosmetic Act (FD&C Act), 21 U.S.C. §343(w)(1), requiring food allergen labeling and seeks comments during a 60-day period. As background, under The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), foods regulated under the FD&C Act are misbranded if they do not declare on the label the presence of each major food allergen, as defined by FALCPA. A manufacturer may seek an exemption from FDA from the labeling requirements of §403(w)(1) in a petition founded on scientific evidence that demonstrates that the ingredient "does not cause an allergic response that poses a risk to human health” or in a notification, also founded on scientific evidence, that the ingredient "does not contain allergenic protein” or that there has been a previous determination that the ingredient "does not cause an allergic response that poses a risk to human health.”  21 U.S.C. §§ 343(w)(6) and (7); FDA June 2015 Guidance for Industry "Food Allergen Labeling Exemption Petitions and Notifications,” see link below.  The December Federal Register Notice estimates that FDA will receive an average of 5 such petitions and 5 such notifications annually over the next three years.  >>Read more (1 of 2)  >>Read more (2 of 2)


Food Defense and Emergency Coordination Staff Discuss Domestic and Foreign Food Facilities Requirements to Address Potential for Intentional Harm to Public Health

As part of FSMA, FDA issued a final rule in 2016 that requires domestic and foreign food facilities, unless excepted, to address the potential for intentional acts designed to create wide-scale harm to public health. On November 7, 2017, FDA posted a conversation between two members of the Food Defense and Emergency Coordination Staff, during which they discuss this rule, including what a food defense plan is, training, compliance dates, when inspections will begin, and how they are addressing concerns about cost.  >>Read more

FDA Issues Small Entity Compliance Guide on "Sanitary Transportation of Human and Animal Food”

In November 2017, FDA issued a Small Entity Compliance Guide entitled "Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation—Small Entity Compliance Guide.”  >>Read more

 FDA Collaboration with State Agricultural Departments for Integrated Food Safety Plan

On November 30, 2017, FDA Commissioner Scott Gottlieb, M.D., issued a letter to state agricultural commissioners, secretaries and directors recognizing the role of the states and the National Association of State Departments of Agriculture (NASDA) in developing a "truly integrated food safety plan” and the important collaboration in progress. Earlier in November, senior leaders at FDA and members of NASDA’s Food Regulation Committee and staff met  and addressed a number of issues, including: 1)   FDA’s intention to exercise enforcement discretion with respect to preventive controls or produce rules for certain types of packing, packaging, and/or holding facilities, with clarification as to packing houses and terminal markets to be made public by January 2018; 2) an inspection documentation and review process for produce inspections to enhance fairness and consistency in FDA and state inspections; 3) federal and state alert requirements for On-Farm Readiness Review (OFRR) visits; 4) participation by NASDA in the upcoming water summit to discuss agricultural water quality and testing, and development efforts of the Center for Food Safety and Applied Nutrition for a more comprehensive plan and timeline with respect to agricultural water standards to be shared with NASDA; and 5) a multi-day training workshop for state regulators to be hosted by FDA before the end of the year.  >>Read more

FDA Issues Draft Guidance Regarding Foreign Food Establishment Inspections 

FDA issued its draft Guidance for Industry, "Refusal of Inspection by a Foreign Food Establishment or Foreign Government” with a publication date of December 12, 2017. This draft guidance illuminates FDA’s position on when it may consider that a foreign food establishment of foreign government has refused to permit an inspection.  There is a 75-day notice period for comments. >>Read more


USDA’s FSIS Releases Fiscal Year 2018 Annual Plan

The U.S. Department of Agriculture Food Safety and Inspection Service (FSIS) released its Fiscal Year 2018 Annual Plan on December 1, 2017.  Identified as continuing priorities were further implementation of the New Poultry Inspection System (NPIS) and Siluriformes fish inspection, pathogen reduction performance standards for Salmonella and Campylobacter in poultry, and modernizing swine and egg products inspection systems. The Agency will also, among other activities, continue to work with public health partners to prevent Listeria monocytogenes in retail delicatessens.  >>Read more

Reminder - FDA Issues Draft Guidance, "Menu Labeling:  Supplemental Guidance for Industry”

As noted in our last update, on November 9, 2017, FDA issued a Draft Guidance, "Menu Labeling: Supplemental Guidance for Industry.” The draft guidance in intended to addresses concerns raised by stakeholders regarding the implementation of nutrition labeling for foods sold in covered establishments.* FDA announced that it "includes expanded and new interpretations of policy, and identifies places where FDA intends to be more flexible in its approach.” 82 FR 50236.  The draft guidance "addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer.”  The date for compliance with the menu labeling final rule is May 7, 2018.  

*A "covered establishment” is a "restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, e.g., individual franchises) and offering for sale substantially the same menu items, as well as a restaurant or similar retail food establishment that voluntarily registers with FDA to be covered by the federal menu labeling requirements.” 21 CFR 101.11(a).  >>Read more

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