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Industry News and Press: Regulatory Updates

July-August 2018 Regulatory Update

Monday, September 17, 2018   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from July 2018 through August 2018.  Please contact Seth Mailhot, Leah Ziemba, or Emily Lyons for additional information on regulatory issues that may impact upon your business. Special thanks to associate Taylor Fritsch and summer associate Jecoliah Williams for their assistance in putting together this update. 



The July-August 2018 Regulatory Update includes:

  • FDA Issues Proposed Rule on Front-of-Pack Labeling
  • FDA Announces FY 2019 Facility Reinspection and Recall Fees (A MUST-READ)
  • Food Safety Modernization Act (FSMA) Updates, Other Developments of Interest

Click on the >>Read more link for the complete regulatory update.

 

FDA AND USDA UPDATES

FDA Issues Proposed Rule to revise front-of-pack type for labeling packaged

foods sold in glass-front vending machines.  The proposed rule would require the type size of the calorie declaration be at least 1.5 times of the size of the net quantity of contents (i.e., net weight) declaration. The FDA proposed a compliance date of January 1, 2020.   Comments due date Sept. 25, 2018.     

 >>Read more

FDA Announced FY 2019 Facility and Importer Reinspection and Recall Fees (A MUST-READ) 

For certain domestic and foreign facility re-inspections, failures to comply with a recall order, and importer re-inspections. These fees are effective on October 1, 2018 and will remain in effect through September 30, 2019. 

Fees for reinspection are assessed when FDA needs to return to a facility to determine whether corrective actions have been implemented and are effective, and compliance has been achieved. Recall fees are assessed when (1) a facility fails to initiate a recall as ordered by FDA, (2) a recall is not conducted in the manner specified by FDA in a recall order, or (3) a facility does not provide FDA with information requested by FDA regarding the recall.

 >>Read more

 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATE

FDA Releases Guidance on Food Facility Registration (A MUST-READ)

This will help food facilities comply with the biennial facility registration requirements including requirements where multiple entities use shared physical space, such as, self-storage warehouses or shared-use commercial kitchens.   

Registration renewal period begins October 1st and concludes December 31st. 

>>Read more

 


OTHER DEVELOPMENTS OF INTEREST

USDA appoints Scott Hutchins as chief scientist and undersecretary of agriculture for research, education, and economics

>>Read more

 
 
 

 
 

FDA AND USDA UPDATES

FDA Issues Proposed Rule on Front-of-Pack Labeling 

The Food and Drug Administration (FDA) has proposed to revise the front-of-pack type size requirements for labeling packaged foods sold in glass-front vending machines. The proposed rule would require the type size of the calorie declaration be at least 150 percent (1.5 times) of the size of the net quantity of contents (i.e., net weight) declaration. All other requirements in the 2014 final rule on calorie labeling for vending machines would remain the same.

Because FDA has not completed this rulemaking before the July 26, 2018 compliance date for the other vending labeling requirements, the FDA intends to exercise enforcement discretion with respect to products sold in glass-front vending machines that provide a front-of-pack calorie disclosure. The FDA has proposed a compliance date of January 1, 2020 for the final rule resulting from this rulemaking and will exercise enforcement discretion until then in order to provide sufficient time for the packaged food industry to revise their labels consistent with any new requirements. >>Learn more

Written comments on this proposal are due to FDA on September 25, 2018. 

 

FDA Announces FY 2019 Facility and Importer Reinspection, Recall Fees

The FDA announced the 2019 fee rates for certain domestic and foreign facility re-inspections, failures to comply with a recall order, and importer re-inspections. These fees are effective on October 1, 2018 and will remain in effect through September 30, 2019. 

Fees for reinspection are assessed when FDA needs to return to a facility to determine whether corrective actions have been implemented and are effective, and compliance has been achieved. Recall fees are assessed when (1) a facility fails to initiate a recall as ordered by FDA, (2) a recall is not conducted in the manner specified by FDA in a recall order, or (3) a facility does not provide FDA with information requested by FDA regarding the recall. 

The 2019 fee rates are as follows:

  • Hourly rate if domestic travel is required - $253
  • Hourly rate if foreign travel is required - $282

 >>Learn more

 
 


FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

FDA Releases Draft Guidance on Food Facility Registration 

On August 17, 2018 FDA released guidance that will help food facilities comply with the biennial facility registration requirements. One of the documents is to assist facilities understand the regulation requirements because FSMA added new requirements. The other document includes questions and answers to further clarify the registration requirements in situations where multiple entities use shared physical space. For example, these include situations where manufacturers lease their facility, store food at self-storage warehouses, or use commercial communal kitchens that are also used by other manufacturers to process food.

Both guidance documents can be found here.

As a reminder, the 2018 biennial food facility registration renewal period begins October 1st and concludes December 31st.

 
 
 

OTHER DEVELOPMENTS OF INTEREST

USDA Appointment 

In the past month, the Trump Administration announced the appointment of Scott Hutchins as chief scientist and undersecretary of agriculture for research, education and economics for the U.S. Department of Agriculture  >>Learn more

 

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