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Industry News and Press: Regulatory Updates

April 2017 Regulatory Update

Monday, May 22, 2017   (0 Comments)
  
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The April 2017 Regulatory Update includes the following topics. 
 
1. Dr. Scott Gottlieb Confirmed by Senate as FDA Commissioner

2. Sonny Perdue Sworn in as New U.S. Secretary of Agriculture

3. Other developments of interest   >>Read more
a. Updates on the use of the term "healthy” in the labeling of Food Products
b. Compliance Date Extended for Disclosure of Certain Nutrition Information in Certain Restaurants and Retail Food Establishments
c. Appropriation Funds Not to be Used for Sodium Reduction Actions
d. Open Comment Periods:  Use of Genome Editing Techniques to Produce New Plant Varieties for Human or Animal Food; Sprout Operations; Listeria Control in RTE

 

This Regulatory Update includes information from April 1 through 30, 2017. Please contact Seth Mailhot, samailhot@michaelbest.com, Leah Ziemba, lhziemba@michaelbest.com, or Paulette Morgan, pjmorgan@michaelbest.com, for additional information on regulatory issues that may impact upon your business.
 
 
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DR. SCOTT GOTTLIEB CONFIRMED BY SENATE AS FDA COMMISSIONER
On April 27, 2017, the Senate Committee on Health, Education, Labor, and Pensions had voted in favor of the nomination of Dr. Scott Gottlieb for FDA Commissioner, moving the nomination to the full Senate for the last stage of the confirmation process. On May 9, 2017, the Senate confirmed Dr. Gottlieb as FDA Commissioner. 
 
 
 
 
SONNY PERDUE SWORN IN AS NEW U.S. SECRETARY OF AGRICULTURE
Sonny Perdue was sworn in as the new U.S. Secretary of Agriculture on April 25, 2017.  >>See USDA press release and biography of Secretary Perdue.
 


a. Use of the Term "Healthy” in the Labeling of Food Products  

b. Compliance Date Extended for Disclosure of Certain Nutrition Information in Certain Restaurants and Retail Food Establishments (Menu Labeling)  

In December 2014, FDA published a final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments, now codified at 21 CFR § 101.11. FDA is extending the compliance date for the final rule from May 5, 2017 to May 7, 2018. The compliance date was extended to enable FDA to consider further reducing the regulatory burden or increasing flexibility while achieving regulatory objectives, consistent with the Administration’s policies.  A sixty-day comment period commenced May 4, 2017.   
 

c. Appropriation Funds Not to be Used for Sodium Reduction Actions

The April 30th congressional spending deal included a rider that prohibits the U.S. Food and Drug Administration (FDA) from using appropriation funds to "develop, issue, promote, or advance any regulations applicable to food manufacturers for population-wide sodium reduction actions or to develop, issue, promote or advance final guidance applicable to food manufacturers for long term population-wide sodium reduction actions until the date on which the dietary reference intake report with respect to sodium is completed.” This move is consistent with a House Appropriations Report from April 2016 that "encouraged” FDA to wait until the Dietary Reference Intake for sodium report was finalized before issuing any voluntary or mandatory guidance on sodium reduction reports, so that any guidance was based on the latest sound science. See FDA’s June 2016 release of its sodium reduction targets. Congress’s most recent activity on this issue signals that sodium reduction efforts are not likely to be advanced soon.


d. Comment Period Extends Until June 19, 2017 for Use of Genome Editing Techniques to Produce New Plant Varieties for Human or Animal Food

We note again for our readers that the comment period extends until June 19, 2017 for "Genome Editing in New Plant Varieties Used for Foods” (Center for Food Safety and Applied Nutrition) regarding the use of genome editing techniques to produce new plant varieties that are used for human or animal food, "Genome Editing in New Plant Varieties Used for Foods; Request for Comments.” FDA intends to continue offering consultations for developers of new plant varieties to help developers ensure that applicable safety and legal questions are resolved prior to market. The comment period, including on specific questions included in the Notice, extends to June 19, 2017


e. Comment Period Remains Open

Compliance With and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations; Draft Guidance for Industry. Availability – Draft Guidance; Proposed Rule (Publication Date January 23, 2017 – Comments Close July 24, 2017)


f. Comment Period Remains Open

Draft Guidance for Industry Control of Listeria monocytogenes in Ready-To-Eat Food (Publication Date January 2017; Comments close July 17, 2017)


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

Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.
 

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