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Industry News and Press: Regulatory Updates

April-May 2018 Regulatory Update

Wednesday, May 30, 2018   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from April 1, 2018 through May 4, 2018.  Please contact Seth Mailhot, Leah Ziemba, or Paulette M. Mara for additional information on regulatory issues that may impact upon your business. Thank you to Associate Attorney Taylor Fritsch for his contributions to this update.

The April-May 2018 Regulatory Update includes several MUST READ updates, including USDA Proposes National Bioengineered Labeling Standard; FDA Issues Supplemental Guidance on Menu Labeling; FDA Finalizes Extension of Nutrition Facts and Serving Size Final Rule Compliance Date; Food Safety Modernization Act (FSMA) Updates; Other Developments of Interest


USDA Proposes National Bioengineered (BE) Labeling Standard

On May 3, 2018, U.S. Department of Agriculture (USDA) released a proposed rule establishing the national bioengineered (BE) food disclosure standard. This represents the first public look at how a uniform mandatory federal genetically modified labeling standard will be implemented in the United States. While the proposed rule provides significant insight into USDA’s current approach to implementing the labeling standard, the proposed rule includes more than a dozen explicit requests for additional public comment on key elements of the rule.

In general, the proposed rule requires disclosure when consumer-facing end product comprises or contains ingredients that appear on lists of commercially available BE foods (i.e., those crops for which a genetically modified cultivar is commercially available in the United States) unless documentation establishes that the food does not contain bioengineered ingredients or is otherwise exempt from the disclosure standard. The rule embraces multiple methods of making the disclosure, such as text disclosures, symbols, or through an electronic or digital link, as required by Congress when it enacted the labeling standard.  >>Proposed Rule

Learn more about the proposed rule in Michael Best’s Food and Beverage Alert

Comments should be submitted by July 3, 2018. 

FDA Issues Supplemental Guidance on Menu Labeling Requirements

In early May, FDA released supplemental guidance to industry on menu labeling requirements, including "expanded and new examples” of labeling options. The guidance covers several topics of potential interest to restaurants and similar retail food establishments covered by menu labeling requirements, including guidance on (1) signage for self-service food such as buffets, salad bars, and beverage stations; (2) criteria for distinguishing between menus or menu boards (required to carry declarations) and marketing material (generally not required to include such disclosures); (3) methods for disclosing calorie counts in specific scenarios (e.g., ordering through a tablet or "build-your-own” food options); (4) determining the nutrient content of menu items; and (5) compliance and enforcement. FDA also included numerous graphics depicting what calorie disclosure might look like in a given scenario and to help communicate the agency’s approach to implementing the rule. The compliance date for the menu labeling rule was May 7, 2018. >>Read more

FDA Finalizes Extension of Nutrition Facts, Serving Size Final Rule

On May 4, 2018, FDA finalized its move to extend the compliance date for compliance with recent rules updating the nutrition facts label and serving sizes. In October 2017, FDA proposed an approximately 18-month delay of two final rules: (1) "Food Labeling: Revision of the Nutrition and Supplement Facts Labels” 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.” 

The new compliance date for manufacturers with $10 million or more in annual food sales is January 1, 2020. The new compliance date for manufacturers with less than $10 million in annual food sales is January 1, 2021.


FDA Website Q&As Provide Insight on FSMA Implementation, Impact   

FSMA website includes access to several question-and-answer interviews with key figures in FSMA implementation. While the interviews focus on "big picture” impacts of FSMA and the FSMA foundational rules, they also provide insights into the nuts and bolts of FSMA implementation and enforcement. >>Read more

(to access interviews, click on "FSMA’s Impact on Public Health” to expand)


New Guidance: "Highly Concentrated Caffeine in Dietary Supplements”

On April 13, 2018, FDA released guidance announcing that it considers products "consisting of or containing only pure or highly concentrated caffeine” to be adulterated under the Food, Drug, and Cosmetic Act. In the guidance document, FDA observed that "dietary supplements containing pure or highly concentrated caffeine in powdered or liquid forms have been increasingly marketed to consumers, often through online retailers.” As FDA explained, these products are "often marketed in bulk packaging with up to thousands of servings per container, requiring the consumer to measure out a safe serving[.]” Given the ease with which a consumer could consume a harmful or toxic amount, FDA believes supplements containing pure or highly concentrated caffeine "can present a significant or unreasonable risk of illness or injury” if consumers are responsible for accurately separating a safe serving from a potentially lethal serving. >>Read more

New FDA Website to Focus on FDA Food Safety, Animal Health Research

On May 2, FDA introduced a new webpage that provides a "central source of information for scientists and other stakeholders” interested in learning more about research priorities and activities occurring in FDA’s Foods and Veterinary Medicine Program. According to FDA, the FVM program focuses on human and food animal safety, animal health, and nutritional sciences. The webpage includes "links to FDA’s analytical laboratory methods for regulatory food and feed testing.”  >>FDA Announcement   >>FVM Science & Research Webpage

Reminder - FDA Draft Guidance on "The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products”

As noted in our March Update, FDA released draft guidance on "The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products” on March 1, 2018. On April 25, 2018, FDA extended the comment deadline to June 15, 2018.  >>Read more

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