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Industry News and Press: Regulatory Updates

February 2017 Regulatory Update

Tuesday, March 14, 2017   (0 Comments)
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These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from February 1 through 28, 2017. Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.

The February 2017 Regulatory Update includes the following topics. Click on the link for the complete regulatory update. 

1. In January 2017, FDA issued a Draft Guidance on Nutrition and Supplement Facts Labels entitled "Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals:  Guidance for Industry” >>Read more

2. Other developments of interest  >>Read more
a. Use of the term "healthy” in the labeling
b. Draft Guidance on "Fruit Juice and Vegetables as Color Additives in Food”
c. FSIS public meeting to discuss the prevention of undeclared allergens, recalls due to undeclared allergens and best practices
d. Executive Order 13777 implementation of regulatory reform initiatives

The Draft Guidance provides questions and answers on topics related to compliance with two final rules FDA published on May 27, 2016:  
  • "Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742)("Nutrition Facts Label Final Rule”); and 

  • "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” (81 FR 34000)("Serving Size Final Rule”). 
The effective date of the Nutrition Facts Label Final Rule was July 26, 2016 and the compliance date is 2 years after the effective date (July 26, 2018), except for manufacturers with less than $10 million in annual food sales, which have a compliance date of 3 years after the final rule’s effective date (July 26, 2019). 

Some of the key changes to the nutrition facts label requirements made by the Final Rules include: 
  • Removing the declaration of "Calories from fat”;

  • Generally requiring the declaration of the gram (g) amount of "added sugars” in a serving of a product, establishing a Daily Reference Value (DRV) for added sugars, and requiring the percent Daily Value (DV) declaration for added sugars;

  • Changing "Sugars” to "Total Sugars” and requiring that the phrase "Includes X g Added Sugars” be indented directly below Total Sugars;

  • Updating the list of vitamins and minerals of public health significance;

  • Revising the prominence of "Calories”; 

  • Amending the definition of a single-serving container;

  • Requiring some dual-column labeling;

  • Amending certain reference amounts used to determine label serving size; and

  • Requiring the maintenance of supporting records.
With respect to support for nutrient declarations, food manufacturers must make and keep records to support the nutrient declarations on their product labels.  For those third parties involved in labeling, they must know that each nutrient declared is accurately stated, and should have access to records sufficient to verify the declarations.  Like manufacturers, such labelers must make the records available during an inspection.

A question and answer of interest in the Draft Guidance is FDA’s statement that it will consider refraining from taking regulatory or compliance actions against bottled water products and coffee beans (whole or ground), tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors.  

The Draft Guidance provides significant detail surrounding the labeling of Added Sugars and the declaration of quantitative amounts of vitamins and minerals.  Questions and answers address declarations of added sugar for concentrated fruit and vegetable purees, fruit and vegetable pastes and fruit and vegetable powders.  The Draft Guidance notes that if the ingredient contains the components of a whole fruit or vegetable, but has been processed so that the plant material is broken down into smaller pieces or water is removed, the sugars would not be considered to be added sugars.  But, if a fruit or vegetable is processed such that it no longer has the components of the portion of the fruit or vegetable typically eaten (i.e., pulp removed) and the sugars have been concentrated, such sugars in excess of what would be expected from an ingredient made from 100 percent fruits or vegetables would be added sugars.  

Other topics include fruit juice blends, fruit juice concentrates, fruit spreads, among others.  Vitamins and minerals topics include requirements for the declaration of quantitative amounts of vitamins and minerals and "levels of significance.”

a. The comment period on the use of the term "healthy” in the labeling of food products extends to April 26, 2017.

b. FDA reopened the comment period on its Draft Guidance on "Fruit Juice and Vegetables as Color Additives in Food” to May 1, 2017.

c. The Food Safety and Inspection Service (FSIS), with participation from FDA, CDC,  international partners, and academic institutions, is hosting a public meeting on March 16, 2017 to discuss the prevention of undeclared allergens, specifically,  the continued occurrence of product recalls due to undeclared allergens and best practices for preventing the presence of undeclared allergens in FSIS-regulated products.

d. Executive Order 13777 dated February 24, 2017 requires the head of every agency, except those receiving waivers, to, within 60 days, designate an agency official as its Regulatory Reform Officer to oversee the implementation of regulatory reform initiatives.

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