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

This Regulatory Update includes information from October 5 through December 31, 2019. Please contact Leah Ziemba, Paul Benson, or Taylor Fritsch for additional information on regulatory issues that may impact your business.

 

The October–December Regulatory Update includes several MUST READ updates:

FDA AND USDA UPDATES

  • FDA Finalizes New Guidance on Food Labeling
  • FDA Updates 2017 Food Code 
  • FDA Warns Companies That CBD-Infused Food and Drink Remains Illegal MUST READ
  • FDA Publishes Newest in Multi-chapter Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food MUST READ
  • FSIS Updated Guidelines on Documentation of Certain Labeling Claims MUST READ
  • FSIS Requests Comment: Performance Standards for Salmonella in Beef
  • FDA Continues Work on PFAS Testing, Releases Latest Results of Food Sampling
  • FDA to Revisit Use of Ultrafiltered Milk in Cheese and Related Products MUST READ

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

  • FDA Flexibility for States to Begin Routine Inspections on Small Farms MUST READ
  • FDA to Continue Policy of Enforcement Discretion for Certain Co-Manufacturers under FSMA MUST READ
  • FDA Provides Index of FSVP Records MUST READ

OTHER DEVELOPMENTS OF INTEREST

  • FDA Proposes to Establish National Laboratory Accreditation Program
  • FDA Lifts Stay on Effective Date for Final Rule Authorizing Soy Leghemoglobin as a Color Additive
  • FDA Revises Calorie Labeling Rules for Glass-Front Vending Machines
  • FDA Revises Voluntary National Retail Food Regulatory Program Standards
  • USDA Establishes Domestic Hemp Production Program

FDA AND USDA UPDATES

FDA Finalizes New Guidance on Food Labeling
On December 31, 2019, FDA announced the publication of new industry guidance, entitled “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics.” Written as a Q&A, the guidance discusses compliance issues for two agency rules: (1) “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments”; and (2) “Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Compliance Dates.”

Specific topics covered by the guidance include formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and additional compliance strategies for conventional food and dietary supplement manufacturers.

Read the guidance here. Read more about the food labeling rules here and here.

 

FDA Updates 2017 Food Code  
The FDA Food Code provides a model for practical, science-based controls aimed at reducing the risk of foodborne illness in retail and food service establishments. In general, FDA encourages all state and local regulatory partners to adopt the Food Code in its current version. 

Now, FDA has announced that a new Supplement is available that incorporates current policies of the Centers for Disease Control and Prevention and the USDA Food Safety and Inspection Service, as well as insights from the 2018 Biennial Meeting of the Conference for Food Protection. The Supplement modifies several key provisions of the 2017 Food Code, including public health control requirements for ready-to-eat produce and hermetically sealed food and information required to be included in Hazard Analysis and Critical Control Point Plans.

Read the Supplement here.

 

FDA Warns Companies That CBD-Infused Food and Drink Remains Illegal
Though many companies are moving full-speed-ahead on developing and marketing food and beverage products containing cannabidiol (CBD), FDA recently reiterated its policy position that such uses violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) since the agency has not determined that CBD is "generally recognized as safe" (GRAS) for use in human or animal food.

Accordingly, FDA issued 15 warning letters to food and drink companies alleged to be selling products containing CBD. Consistent with the agency’s public health responsibilities, the letters continue to target manufacturers making CBD-related health or disease claims in their marketing. Contemporaneously, FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. 

Read the press release here. Read the Consumer Update here. Read Michael Best’s Client Alert here.

 

FDA Publishes Newest in Multi-chapter Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food
In October, FDA announced the availability of another draft chapter of a multi-chapter guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” Once finalized, this installment will address development of recall plans in compliance with FDA’s rule on “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”

Comments are due by February 4, 2020 in Docket No. FDA-2016-D-2343. Read the draft guidance here. Submit comments here.

 

FSIS Announces Updated Guidelines on Documentation of Certain Labeling Claims
In December 2019, USDA’s FSIS released updated versions of two industry guidance documents:

  • “Labeling Guideline on Documentation Needed To Substantiate Animal Raising Claims for Label Submission”; and
  • “Labeling Guideline on Statements That Bioengineered or Genetically Modified Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products.”
  • Unlike FDA-regulated products, labels on FSIS-regulated meat, poultry, and egg products are subject to agency pre-approval, which includes review of any label claims. Read the updated guideline on animal raising claims here and the updated guideline on bioengineered-free/GMO-free claims here.

 

FSIS Requests Comment on Performance Standards for Salmonella in Beef
In October 2019, FSIS announced and requested comment on new pathogen reduction performance standards for Salmonella in raw ground beef and beef manufacturing trimmings. The agency also detailed how it plans to assess whether establishments producing raw ground beef and/or beef manufacturing trimmings are effectively addressing Salmonella, using a 52-week moving window of FSIS sampling results and other related verification activities. Finally, FSIS stated that it intends to increase Salmonella sampling to once per week in beef establishments that produce greater than 50,000 pounds. FSIS is no longer accepting comments and is expected to publish notice of finalized standards in the coming months.

Read more about the new standards here.

 

FDA Continues Work on PFAS Testing, Releases Latest Results of Food Sampling
On December 20, 2019, FDA announced results from the second round of testing for 16 types of per- and polyfluoroalkyl substances (PFAS) in foods collected for the Total Diet Study (TDS). These findings, along with the first round of testing results posted in October 2019, will inform the agency’s continued work to understand the occurrence of PFAS in the general food supply.

In the first round of testing, FDA scientists identified two samples with detectable levels of a PFAS chemical out of ninety-one tested (ground turkey and tilapia); in the second round, FDA scientists identified one PFAS-contaminated sample out of eighty-eight tested (tilapia). FDA has stated that based on the best available current science, there is no indication that PFAS levels found in the limited sampling from these TDS datasets present a human health concern. Still, the results will inform FDA’s continued efforts to fine-tune its testing methodology, and to evaluate whether targeted sampling is necessary for certain foods.

Read more about PFAS in foods here. Read more about FDA’s approach to PFAS here.

 

FDA to Revisit Use of Ultrafiltered Milk in Cheese and Related Products
In 2005, FDA published in the Federal Register a proposed rule that would provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and cheese products. Entitled “Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk,” the proposal responded principally to citizen petitions filed by the American Dairy Products Institute, by the National Cheese Institute and the Grocery Manufacturers of America, Inc. (filed jointly).

While the original comment period expired in early 2006, FDA announced on December 30, 2019, that it will again review public comments related to the proposal. FDA has stated that it is reopening the comment period to receive new information and further comment on current industry practices regarding the use of fluid UF milk and fluid UF nonfat milk in the manufacture of standardized cheeses and related cheese products, and the declaration of fluid UF milk and fluid UF nonfat milk when used as ingredients in standardized cheeses and related cheese products.

Comments should be submitted to Docket No. FDA-2008-P-0086, on or before March 30, 2020. Read the proposed rule here. Submit comments here.


 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

FDA Offers Flexibility for States to Begin Routine Inspections on Small Farms
Routine inspections of small farms subject to the FDA’s Produce Safety Rule will generally begin in Spring 2020; however, the FDA has clarified that states receiving competition A/B funding as part of the State Produce Implementation Cooperative Agreement Program (CAP) may begin routine inspections as early as January 1, 2020. 

The first major compliance date for large farms, other than sprout operations, was set to begin on January 26, 2018. However, the FDA previously announced that routine inspections associated with the Produce Safety Rule would not begin until the spring of 2020 to allow time for more guidance, training, technical assistance, and planning.

Read the update here. Read more from FDA on regulatory inspections here.

 

FDA to Continue Policy of Enforcement Discretion for Certain Co-Manufacturers under FSMA
FDA has announced that it will be continuing its enforcement discretion policy for compliance with certain Food Safety Modernization Act (FSMA) supply-chain program requirements applicable to receiving facilities that are co-manufacturers. FDA intends to announce the extension in a forthcoming Federal Register notice.

In the meantime, co-manufacturers should continue to comply with other applicable requirements for which they are responsible under the Federal Food, Drug, and Cosmetic Act. 

Read the update here.

 

FDA Provides Index of FSVP Records

The Foreign Supplier Verification Programs (FSVP) Final Rule, established under FSMA, requires importers to verify that the food they are importing into the U.S. has been produced in a manner that meets applicable U.S. food safety standards.

To help importers determine the FSVP records they should develop and maintain, the FDA has made available a list of records required by the FSVP regulation. The list is organized according to applicable sections of the FSVP rule, so importers should carefully review the regulation to determine which records are actually required.

 

Read the update here.

 

OTHER DEVELOPMENTS OF INTEREST

FDA Proposes to Establish National Laboratory Accreditation Program
On November 1, 2019, FDA issued notice of its intent to amend its regulations to establish a program for the testing of food in certain circumstances by accredited laboratories, as required under the FD&C Act.

As drafted, the program will require testing of human and animal food in certain circumstances by accredited labs. Accredited laboratories will be required to follow model standards and will be subject to oversight by FDA-recognized accreditation bodies to help ensure consistently reliable testing results.

Comments should be submitted to Docket No. FDA-2019-N-3325, on or before March 3, 2020. Read the proposed rule here. Submit comments here.

 

FDA Lifts Stay on Effective Date for Final Rule Authorizing Soy Leghemoglobin as a Color Additive
In July 2019, the FDA amended its color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products (e.g., “veggie” burgers). Subsequently, FDA issued a stay of the final rule’s effective date while it reviewed objections submitted by the Center for Food Safety (CFS).

Ultimately, FDA provided notice on December 17, 2019 that it had concluded CFS’s objections do not raise genuine and substantial issues of fact, and do not provide any substantive evidence that would justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. Accordingly, FDA lifted the stay and the rule is now effective.

Read the update here. Read FDA’s response to objections here.

 

FDA Revises Calorie Labeling Rules for Glass-Front Vending Machines
On October 28, 2019, FDA issued a final rule to revise the type size labeling requirements when front-of-pack (FOP) labeling is used to meet the calorie declaration requirements for articles of food sold from glass-front vending machines. This rule was intended to reduce the regulatory burden on industry, increase flexibility for the labeling of certain articles of food sold from glass-front vending machines, and ensure that consumers continue to have visible FOP calorie information for articles of food at the point of purchase.

Read the final rule here.

 

FDA Revises Voluntary National Retail Food Regulatory Program Standards
On November 14, 2019, FDA issued a 2019 update to the Voluntary National Retail Food Regulatory Program Standards. The Retail Program Standards provide recommendations for designing and managing retail food regulatory programs and help regulatory jurisdictions (or other responsible organizations) facilitate more effective inspections, implement foodborne illness prevention strategies, and identify program areas in need of improvement.

Read more about the 2019 Standards here.

 

USDA Establishes Domestic Hemp Production Program
On October 29, 2019, Agriculture Secretary Sonny Perdue announced the establishment of the U.S. Domestic Hemp Production Program. This program, as required by the 2018 Farm Bill, creates a consistent regulatory framework around hemp production throughout the U.S. Under the rule, states will be permitted to administer their own hemp production programs approved by USDA if they so choose.

Read more about USDA’s approach to hemp here.

 

 

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