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Industry News and Press: Regulatory Updates

June-July 2018 Regulatory Update

Thursday, August 2, 2018   (0 Comments)
Posted by: Emily Allen
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from June 9, 2018 through July 6, 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 June-July 2018 Regulatory Update includes several MUST READ updates, including FDA Issues Guidance Identifying Eight Ingredients as Dietary Fiber, FSIS Seeks Comment on "Product of USA” Labeling, FDA to Host Public Meeting on Nutrition Innovation Strategy, FDA to host meeting on Animal Cell Culture Technology, Food Safety Modernization Act (FSMA) Updates, Other Developments of Interest

 
 

FDA AND USDA UPDATES

>>Read more

FDA Issues Guidance Identifying Eight Ingredients as Dietary Fiber including eight isolated or synthetic non-digestible carbohydrates (NDCs) as meeting the definition of "dietary fiber” pending completion of a comment process to revise the dietary fiber regulation. 

FSIS Seeks Comment on "Product of USA” Labeling requiring the USDA to clarify the requirements for labeling food a "Product of the USA.”  >>Read more

FDA to Host Public Meeting to Discuss Nutrition Innovation Strategy to gather feedback to establish more consumer-friendly ingredient information. The public meeting will be held in Rockville, MD on July 26, 2018 from 8:30 am to 5:30 PM, is also available via live webcast.  >>Read more

FDA Hosts Meeting on Animal Cell Culture Technology for Feedback on using existing regulations and policies to regulate this new technology for manufacturing methods and potential hazards.  >>Read more

 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATE

>>Read more 

FDA Releases Draft Guidance to Protect Against Intentional Adulteration

On June 20, 2018 FDA released draft guidance to help food facilities comply with the requirements of the FSMA Mitigation Strategies to Protect Food Against Intentional Adulteration rule. Under this rule, food facilities must develop and implement a food defense plan that identifies significant vulnerabilities and mitigation strategies to address those vulnerabilities. (A MUST-READ)  


OTHER DEVELOPMENTS OF INTEREST

>>Read more

President Trump Proposes to Consolidate Food Safety to USDA (A MUST-READ)

President Trump proposed to eliminate FDA’s authority over food safety and move responsibilities to one agency under the USDA to allow for better allocation of resources, enhanced communication during illness outbreaks, and improved policy and program planning.    

FDA Launches Website on Substances Added to Food

On June 2018, FDA launched a new online database called Substances Added to Food, includes information on food/color additives, Generally Recognized As Safe (GRAS) and prior-sanctioned substances

FDA Announces Reconsideration of Added Sugar Declaration for Maple Syrup and Honey 

Based on feedback, FDA announced it is considering revising its approach to declarations of added sugar on pure maple syrup and pure honey; providing truthful and non-misleading contextual information about the meaning of "added sugars.”

2017 Revisions to the Pasteurized Milk Ordinance (PMO) Available Online

Includes regulations for all dairy plants producing Grade "A” products, including fluid milk, cream products, yogurt, cottage cheese, eggnog, buttermilk and many dried dairy products. This revision aligns with the FSMA PMO-regulated facilities on Sept 2018.  (A MUST-READ)

 
 

 
 

FDA AND USDA UPDATES

FDA Issues Guidance Recognizing Eight Ingredients as Dietary Fiber

The Food and Drug Administration (FDA) issued guidance that identified eight isolated or synthetic nondigestible carbohydrates (NDCs) as meeting the definition of "dietary fiber.” Specifically, FDA recognized the following ingredients as dietary fibers: (1) mixed plant cell wall fibers; (2) arabinoxylan; (3) alginate; (4) inulin and inulin-type fructans; (5) high amylose starch (resistant starch 2); (6) galactooligosaccharide; (7) polydextrose; and (8) resistant maltodextrin/dextrin. 

FDA also announced that it is extending enforcement discretion regarding the declaration of these eight ingredients as dietary fiber on the Nutrition Facts and Supplement Fact label pending completion of a comment process to revise the dietary fiber regulation. In addition to the guidance, FDA also published a scientific review of the physiological effects of these NDCs as well as responses to several citizen petitions requesting these NDCs be added to the definition of dietary fiber.  >>Learn more

FSIS Seeks Comment on "Product of USA” Labeling

In June 2018, the U.S. Department of Agriculture’s (USDA) Food Safety Inspection Service (FSIS) was petitioned to change the requirements to label a food as a "Product of USA.” Specifically, the petition requests that USDA clarify the requirements that a product be processed in the United States as well as require the significant ingredients, such as meats, be of domestic origin. USDA is accepting comment on this petition via regulations.gov until August 17, 2017.  >>Review the petition 

 

FDA to Host Public Meeting to Discuss Nutrition Innovation Strategy

In late July, FDA will host a public meeting to gather public feedback on the agency’s Nutrition Innovation Strategy. Specifically, FDA is interested in feedback related to establishing an icon or symbol for healthy, building a more efficient review process for qualified healthy claims, promoting healthy eating patterns through product claims, modernizing standards of identity, changing ingredient information to make it more consumer friendly, and developing a consumer education campaign about the updated Nutrition Facts Label. The public meeting will be held in Rockville, MD on July 26, 2018 from 8:30 am to 5:30 PM, but is also available via live webcast.  >>Learn more

If you’re unable to attend the meeting in person and would like to provide feedback, FDA is also accepting written comments through August 27, 2018. 

 

FDA hosts meeting on Animal Cell Culture Technology

In June, FDA announced it has jurisdiction to regulate foods produced using animal cell culture technology. These foods resemble conventional meat, poultry, and seafood products, but are produced using cell cultures instead of animals.   FDA is hosting a public meeting on July 12, 2018 to allow the public an opportunity to provide feedback on this new technology. 

At the meeting, FDA intends to share its initial thinking on how the agency will use its existing regulatory tools and policies to regulate this novel area of technology. Specifically, FDA is seeking comment on the kinds of variations in manufacturing methods that would be relevant to the safety of such products when consumed as foods, the kinds of substances used in the manufacture of foods produced using animal cell culture technology, potential hazards associated with the production of such foods, and the need for unique control measures to address potential hazards.  >>Learn more

Comments can be submitted to FDA until September 25, 2018 if individuals are unable to attend the public meeting. 

 



FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

FDA releases draft guidance on Mitigation Strategies to Protect Against Intentional Adulteration 

June 20, 2018 FDA released draft guidance that will help food facilities comply with the requirements of the FSMA Mitigation Strategies to Protect Food Against Intentional Adulteration rule (IA Rule).  Under this rule, food facilities must develop and implement a food defense plan that identifies significant vulnerabilities and mitigation strategies to address those vulnerabilities. This first installment includes the first four chapters of the Draft Guidance, which provide FDA’s recommendations on how to develop a food defense plan, including how to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps, develop mitigation strategies for actionable process steps, and monitor mitigation strategies. The guidance also contains templates for various parts of a food defense plan. FDA will make the additional chapters available for public comment in the coming months.  >>Learn more

Comments on the draft guidance should be submitted to FDA by December 17, 2018.

 
 

 

OTHER DEVELOPMENTS OF INTEREST

President Trump Proposes to Consolidate All Food Safety Oversight in USDA

In June, President Trump proposed to eliminate FDA’s authority over food safety and move those responsibilities to one agency under the USDA to allow for better allocation of resources, enhanced communication during illness outbreaks, and improved policy and program planning. Currently, FDA and USDA have very different regulatory regimes, based upon different statutory authorities, including the Federal Food, Drug and Cosmetics Act for FDA, and the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Egg Products Inspection Act and the Humane Methods of Livestock Slaughter Act for FSIS. To align federal food safety oversight into one agency, Congress would need to reconcile these acts and the different regulatory schemes—a significant undertaking that Congress seems unlikely to prioritize.  >>Learn more

FDA Launches Website on Substances Added to Food

On June 26, 2018, FDA launched a new online database called Substances Added to Food. The new searchable inventory contains approximately 4,000 substances, and includes information on food additives, color additives, Generally Recognized As Safe (GRAS) and prior-sanctioned substances.  >>Learn more

 

FDA Announces Possible Reconsideration of Added Sugar Declaration for Maple Syrup and Honey

Based on feedback received on draft guidance, FDA has announced that it is considering revising its approach to declarations of added sugar on pure maple syrup and pure honey. In the final rule updating the Nutrition Facts label, FDA’s definition of added sugar includes sugars that are either added during the processing of foods or are packaged as such (e.g., a jar of honey, container of maple syrup, or a bag of table sugar). In the draft guidance, FDA stated it would allow food manufacturers to use an obelisk symbol, "†,” on the Nutrition Facts label immediately after the added sugars percent Daily Value information on containers of pure maple syrup or pure honey to direct consumers to language outside the Nutrition Facts label. The additional language would permit manufacturers to provide truthful and non-misleading contextual information about the meaning of "added sugars,” for these products to supplement the required added sugar disclosure. For example, a pure honey or maple syrup label could specify that the product does not contain corn syrup or other added sweeteners. FDA’s announcement suggests that the agency will likely revise its approach based on public comments received by the agency.  >>Learn more

 

2017 Revisions to the Pasteurized Milk Ordinance Available Online

FDA recently released the electronic version of the 2017 Grade "A” Pasteurized Milk Ordinance (PMO), which contains changes adopted during the National Conference on Interstate Milk Shipments conference in May 2017. The PMO is a set of standards and requirements that regulates all dairy plants producing Grade "A” products, including fluid milk, cream products, yogurt, cottage cheese, eggnog, buttermilk and many dried dairy products. This revision of the PMO aligns with the FSMA Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food rule, which goes into effect for PMO-regulated facilities on September 17, 2018.  >>Learn more


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