These Regulatory Updates are brought to you by Michael Best & Friedrich. 
This Regulatory Update includes information from August 1 through October 5, 2019. Please contact Leah Ziemba, Mark Yacura, Paul Benson, or Taylor Fritsch for additional information on regulatory issues that may impact your business.

The August-September 2019 Regulatory Update includes several MUST READ updates: 

FDA AND USDA UPDATES

  • FDA Releases Final Guidance on Converting Units of Measure in Updated Nutrition Facts Labels
  • FDA Releases Final Guidance on Date of Compliance for Labeling of Dried Cranberry Products with Added Flavoring
  • FDA Solicits Public Comment on Hazard Analysis and Critical Control Point (HACCP) for Juices
  • FDA Launches CFSAN Online Module to Streamline Food Ingredient and Food Packaging Material Submissions  (MUST READ)
  • FDA Moves Process for Dietary Ingredient Notification and Structure/Function Claim Notification Submissions to CFSAN Online Submission Module

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

  • FDA Hosts Public Meeting on Food Safety Modernization   
  • FDA Aims to Track FSMA Performance with New Food Safety Dashboard  (MUST READ)
  • FDA Updates Food Adulteration Mitigation Tool

OTHER DEVELOPMENTS OF INTEREST

  • Interagency Food Safety Analytics Collaboration Releases 2017 Annual Report on Sources of Foodborne Illness (MUST READ)
  • FDA Releases 2017 Annual Report on Pesticide Residue
  • FDA Provides Fact Sheet for Menu Labeling
  • Kellogg Submits Food Additive Petition for Vitamin D3
  • FDA Approves Color Additive Soy Leghemoglobin

FDA AND USDA UPDATES

FDA Releases Final Guidance on Converting Units of Measure in Updated Nutrition Facts Labels

In 2016, FDA amended the regulations for the nutrition labeling of conventional foods and dietary supplements to include updated Daily Values (DV) as Reference Daily Intakes (RDI) for certain nutrients.

This August, FDA published a guidance document on Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels. The guidanceprovides step-by-step instructions to U.S. food product manufacturers for establishing the required RDI units on updated Nutrition Facts labels. Additionally, the guidance provides conversion factors for each nutrient, and sample RDI calculations for both conventional foods and dietary supplements. Read the guidance here.

 

FDA Releases Final Guidance on Date of Compliance for Labeling of Dried Cranberry Products with Added Flavoring

In August, FDA published a guidance document on Policy Related to Cranberry Products with Added Flavoring. The guidance extends the date for compliance with updated Nutrition Facts labeling and Serving Size rules for dried cranberry products with added flavoring.

FDA had previously granted enforcement discretion relating to certain cranberry products in guidance finalized in June 2019. That guidance did not extend enforcement discretion for compliance with updated rules to dried cranberry products with added flavoring. In response to industry feedback, FDA is extending the date of compliance with these rules until July 1, 2020 for these products. Read the guidance here.

 

FDA Solicits Public Comment on Hazard Analysis and Critical Control Point (HACCP) for Juices

The public is invited to comment on the collection provisions of FDA’s regulations mandating the application of hazard analysis and critical control point (HACCP) principles to the processing of fruit and vegetable juices.

Comments are due by November 25, 2019. Submit comments here. Read the Federal Register notice here.

 

FDA Launches CFSAN Online Module to Streamline Food Ingredient and Food Packaging Material Submissions

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) launched a new online process in early September to assist industry users assembling agency petitions or notifications related to food ingredient and packaging materials. The CFSAN Online Submission Module (COSM) now enables users to log into the system and follow step-by-step instructions to input required information and submit forms electronically.

CFSAN’s Office of Food Additive Safety (OFAS) will continue to accept paper submissions of all petitions and notifications. As of September 2019, however, OFAS will accept any of the following submissions via COSM:

  • Biotechnology Notification File (BNF)
  • Color Additive Petition (CAP)
  • Food Additive Petition (FAP)
  • Food Contact Notification (FCN)
  • Generally Recognized as Safe Notice (GRN)
  • New Protein Consultation (NPC)
  • Pre-Notification Consultation (PNC) for a food contact substance
  • Food Master File (FMF) for food additives
  • Food Master File (FMF) for a food contact substance
  • Color Master File (CMF) for color additives

Access COSM here. Read more about COSM here.

 

FDA Moves Process for Dietary Ingredient Notification and Structure/Function Claim Notification Submissions to CFSAN Online Submission Module

As part of FDA’s ongoing efforts to streamline various submission processes, the agency is retiring its online FDA Unified Registration Listing System (FURLS) for new dietary ingredient notification (NDIN) and structure/function claim notification (SFCN) electronic submissions in favor of COSM. User information previously stored in the FURLS database will automatically transfer to COSM.

However, as of early September, all system users will now see a new interface when accessing the electronic portal for NDIN and SFCN submissions.

Users with draft submissions currently pending in FURLS may need to be resubmitted in COSM for agency review. For assistance with this issue, contact the agency at [email protected] or call 240-402-1200.

Read more about submitting an electronic NDIN or SFCN on the FDA website pages for New Dietary Ingredients Notification Process or Structure/Function Claim Notification for Dietary Supplements.


 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

FDA Hosts Public Meeting on Food Safety Modernization

FDA invites stakeholders to participate in an upcoming public meeting entitled “A New Era of Smarter Food Safety” on October 21, 2019, from 8:30 a.m. to 5 p.m. EST. This meeting aims to foster critical dialogue concerning the agency’s modern approach towards food-related public health challenges including predictive analytics and artificial intelligence applications. Based on comments collected for this meeting, FDA will generate a “Blueprint” to outline agency action in the near- to medium-term.

The meeting will be held at the Hilton Washington DC/Rockville Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Read more about the Center here.

Comments are due by November 20, 2019. Submit comments here. Read the Federal Register notice here.

 

FDA Aims to Track FSMA Performance with New Food Safety Dashboard

On September 30, 2019, FDA launched its Food Safety Dashboard as part of the as part of the FDA-TRACK program overseeing implementation of FSMA’s foundational rules. In keeping with the agency’s current focus on “smarter” food safety, FDA’s Dashboard now provides initial metrics to track outcomes for FSMA rules on inspections and recalls. In particular, the metrics currently available include outcomes related to:

  • Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls rules for both human food and food for animals; and
  • Foreign Supplier Verification Program rules for imported food.

The data is expected to yield insight into current rates of domestic and foreign industry compliance with these rules and track the effectiveness of FDA oversight moving forward. Over the coming months, FDA expects to populate the Dashboard with additional data pertaining to other FSMA rules. Read more about the Food Safety Dashboard here.

 

FDA Updates Food Adulteration Mitigation Tool 

The intentional adulteration rules under FSMA require food facilities to implement defensive strategies to protect food products against unauthorized tampering likely to harm public health. To assist food facilities covered by the rule, FDA has maintained the Food Defense Plan Builder since 2013 as a framework to create food defense plans and facilitate compliance.

On September 19, 2019, FDA released an updated Food Defense Plan Builder, version 2.0, as an improved desktop tool allowing food facility owners to enter key information and generate vulnerability assessments, monitoring procedures, corrective action procedures, and more. However, owners should be aware that use of the updated builder is not required to satisfy, nor does it guarantee compliance with, FSMA’s intentional adulteration policy.

FDA will host a webinar demonstration of the new version on October 10, 2019 at 1 p.m. eastern time. Interested parties should register here in advance. Download the Food Defense Plan Builder here. Read more about the Food Defense Plan Builder here.

 

OTHER DEVELOPMENTS OF INTEREST

Interagency Food Safety Analytics Collaboration Releases 2017 Annual Report on Sources of Foodborne Illness

On October 4, 2019, the Interagency Food Safety Analytics Collaboration (IFSAC) released its newest annual report on foods responsible for foodborne illnesses caused by pathogens. The report utilized multi-year outbreak surveillance data to estimate the degree to which four pathogens— SalmonellaEscherichia coli O157, Listeria monocytogenes, and Campylobacter—triggered foodborne illness among U.S. consumers in 2017. Data indicated that Salmonella illnesses were broadly attributed to multiple foods; E. coli 0157 illnesses were most often linked to vegetable row crops and beef; Listeria monocytogenes illnesses were most often linked to dairy products and fruit; and Campylobacter illnesses were most often linked to chicken.

IFSAC coordinates food safety data among participating federal agencies, including the CDC, FDA, and USDA’s Food Safety and Inspection Service. Consensus estimates contained in the annual reports help inform agency priorities for food safety initiatives, interventions, and policies to reduce foodborne illness. Read the report here.

 

FDA Releases 2017 Annual Report on Pesticide Residue

On September 12, 2019, FDA released its newest annual report on the Pesticide Residue Monitoring Program for fiscal year 2017. Over this time, FDA analyzed over 6,000 human food samples, both domestic and imported, for residues of over 700 different pesticides and industrial compounds. FDA also carried out focused sampling surveys for two field assignments: (1) domestically produced animal-derived foods; and (2) selected domestic and imported foods for herbicides analysis.

Overall, the report confirms that that levels of pesticide residues in the U.S. food supply were well below established safety standards. FDA found that 96.2% of domestic and 89.6% of imported human foods were compliant with federal residue limits. In the first assignment, FDA found no residues in any milk or game meat samples, or in 87.5% of egg and 77.3% of honey samples. In the second assignment, no glyphosate or glufosinate residues were detected in any milk and egg samples, or in 82.1% of corn and 60.0% of soybean samples.

Violation rates were higher among import samples, and future sampling designs may target commodities more likely to contain chemical pesticide residues and the countries more likely to export them. Read the report here.

 

FDA Provides Fact Sheet for Menu Labeling

FDA has now issued a fact sheet regarding the ongoing implementation of menu labeling requirements for chain restaurants and similar retail food establishments.

Chain restaurants and similar retail food establishments were required to comply with the menu labeling requirements by May 7, 2018. As of August 2019, the fact sheet describes agency priorities for the second year of implementation to assess the extent of industry compliance and offer technical assistance and flexibility where necessary. The fact sheet also describes agency efforts to facilitate development of similar labeling requirements at the state and local levels. Read the fact sheet here.

Kellogg Submits Food Additive Petition for Vitamin D3

On August 12, 2019, FDA announced that it would consider a petition submitted by Kellogg Company to amend the food additive regulations to authorize the safe use of vitamin D3 as a nutrient supplement in breakfast cereals and in grain-based nutrition bars. Read the Federal Register notice here.

 

FDA Approves Color Additive Soy Leghemoglobin

On July 31, 2019, FDA approved a petition submitted by Impossible Foods, Inc. to authorize the use of soy leghemoglobin as a color additive. The rule now provides for the safe use of the substance as a color additive in plant-based beef analogue products, such as veggie burgers. Read the Federal Register notice here.

 

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