Regulatory Affairs Consulting Cases
2015 “Making Your Case” Competition

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Four Consulting Cases in Regulatory Affairs of Food and Food Industries
Mentor: Dr. Darin Detwiler, LP.D., M.A.Ed.

 

1. United States v. Bayer Corporation:
Dietary Supplement Structure-Function Claim Substantiation Case Study

Country represented in the case: United States

2. Preparing for FDA’s Proposed Nutrition Facts Labeling Updates and Serving Size Changes
Country represented in the case: United States

3. Generally Recognized As Safe: Issues Surrounding the FDA GRAS Notification Process
Country represented in the case: United States

4. A Dilemma for Grocery Retail Cooperatives: Compliance with the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Rule
Country represented in the case: United States

 

Details on the Cases’ Authors and Dilemmas Under Consideration: 

 

Jennifer
Rasp-Bickerton

MS in Regulatory Affairs

United States v. Bayer Corporation: Dietary Supplement Structure-Function Claim Substantiation Case Study

Country represented in the case: United States

The case initiates the discussion around the question of “How would individuals know whether Phillips’ Colon Health probiotic might be beneficial to them before they buy it?” The dilemma here is the following: Many consumers choose products based on what the label says the product’s benefits may be. The label of dietary supplement made by Bayer Corporation named Phillips’ Colon Health states that it contains “3 strains of good bacteria to promote overall digestive health” and it “helps defend against occasional constipation, diarrhea, gas, and bloating.” However, the Department of Justice filed a motion accusing Bayer of making unsubstantiated claims for Phillips’ Colon Health. The Department is preparing to show why Bayer should be held in civil contempt and alleges that Bayer is violating a 2007 court order with making unsubstantiated claims regarding any dietary supplement, multivitamin or weight-control product. The case investigates this situation from a consulting point of view.

 

 

 

 

Jennifer M. Krajewski

MS in Regulatory Affairs

 

 

 

 

 

Preparing for FDA’s Proposed Nutrition Facts Labeling Updates and Serving Size Changes

Country represented in the case: United States

 On December 1, 2014, to the surprise of many, the Food and Drug Administration (FDA) published the “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments.”  Compliance is set for December 1, 2015, which gives industry barely one year to comply. Wakefern Food Corp., a member-owned food retail cooperative, was one of those shocked by the new ruling.  Its leadership team is now faced with the following questions: 1) Are we covered by the rule, and if so, how will we comply? 2) Are we exempt, and should we voluntarily comply to stay competitive in the marketplace? The case-study investigates from consulting point of view Wakefern Food Corporation’s primary areas of concern and discusses such issues as applicability of the rule to cooperatives, definition of “substantially the same menu items,” clarity on “restaurant-type foods,” and the requirements for conveying information on websites and in catering menus.

 

Lynn D. Sampson

MS in Regulatory Affairs

 

 

Generally Recognized As Safe: Issues Surrounding the FDA GRAS Notification Process

Country represented in the case: United States

 Throughout the history of the Food and Drug Administration (FDA), it has been repeatedly shown that the agency is unaware of all substances added to foods, yet these substances are legal for businesses to use them in foods. The dilemma for the FDA is how can the agency ensure that it is aware of, and systematically review, all substances that have been deemed safe either by the agency or manufacturer to “ensure continued safety”? Succinctly, how can the FDA ensure the public is aware of all substances that have been determined to be generally recognized as safe for use in foods?

 


Katherine Kennedy

MS in Regulatory Affairs

A Dilemma for Grocery Retail Cooperatives: Compliance with the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Rule

Country represented in the case: United States

 The case represents a dilemma of TreeHouse Foods as a prime example of a large food manufacturer grappling with the dilemma of how to handle transitioning to the Food and Drug Administration’s (FDA) proposed Nutrition Facts Panel in serving size updates.  TreeHouseFoods is faced with the need to update all of their food labels as a result of labeling changes mandated by the FDA.  Given the problem of the FDA proposing rules on Revision of the Nutrition and Supplement Facts Labels; 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 all with a compliance data of January 1, 2019, TreeHouseFoods must determine how they will handle the requirements in a timely and cost efficient manner.


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