1. The Use of “NATURAL” in Food Labeling: FDA’s Request for Comments Developing Your Position

2. “Common sense is not so common” -Voltaire

3. 1.Review FDA request for comments regarding “natural.” 2.Review the FDA current position, regulatory filings, propose legislation and recent court rulings. 3.Determine how regulation of “natural” may affect your business; and 4.Suggest the steps to take in developing your position.

4. FDA poses numerous questions in an effort to cover the subject comprehensively. FDA used a number of questions addressing:  Food types  Food ingredients  Food processes  Food production practices, including genetic engineering  Consumer perceptions NOTE: FDA expressly advises that after receiving comments they may choose to take no further action.

5. Prior to 1993, the FDA chose not to establish any general rules concerning the use of “natural”. Since 1993, “natural” on food labeling means that: “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would normally be expected to be in the food.”

6. Current policy does not directly address:  Food production  Food processing  Genetic modification  Nutritional or health benefits

7. 1. Recent class actions litigation. 2. Proposed legislation. 3. Citizen Petitions filed with the FDA.

8.  Cases involve “natural” claims involve allegation of the use of GMO’s synthetic/artificial ingredient, undisclosed “processes” and implied health attributes.  Some observations from the litigation:  Many cases involving GMO’s have been deferred pending FDA action.  There has been some success by plaintiff where an “artificial” or “synthetic” ingredient is found even in very small quantities.  Defendants are losing most requests for “federal” pre-emption of state law claims due to FDA’s limited position on “natural”.  Defendants are beginning to achieve some success in questioning the “class action certification” and the ability of the plaintiff to quantify the damage. (Did the consumer reasonably rely on the use of “natural” to a make a purchase decision and if so to what degree.)

9.  Many users of “natural” are taking corrective action to clarify their labels, modify their ingredients or discontinue the use of the term.  Nonetheless there are hundreds of products that have substantial use (and investment) of the term on processed products. Our review of registered trademarks indicated over 600 trademark filings. There are likely thousands of food products still using the term in some way.  Use of GMO’s or artificial or “synthetic” ingredients are likely to continue to draw attention of class action lawyers where “natural” is used on the label.  Very few cases have indicated significant exposure simply with regard to degree of processing.

10. Safe and Affordable Food Labeling Action (H.R. 1599)  Would require FDA to promulgate rules regarding the distribution and labeling of GMO products.  Removes state’s authority to regulate the matter; also require FDA promulgate a definition of “natural” final regulation within 30 months of passage.  Passed the House in July 2015 – government track gives its 27% change of passage.  Senate version does not require “natural” regulations. Earlier legislative attempts would require labeling of GMOs and prohibit the use of the term “natural” on any product containing GMOs. (These earlier Bills have not been moved in over a year).

11.  GMA  Sara Lee  The Sugar Association  Consumer Reports

12.  FDA should revise current policy on “natural” to authorize use of “natural,” on the label of foods that contain GMO technology.  Genes added to foods are not ingredients, and are neither artificial nor synthetic.  Biotech does not affect the objective attributes of the food derived from that plant.  FDA action could prevent patchwork of state rules directly at odds with FDA’s science-based policies on biotech foods.

13. SARA LEE RECOMMENDATION  FDA and FSIS should devise a unified, flexible policy governing use of “natural “to describe a good or food ingredient that does not contain any artificial flavor or flavoring, coloring ingredient (regardless of source) or any artificial or synthetic ingredient not normally expected in the product.  The degree of processing needed to produce the food or food ingredient should be considered in determining consumer expectation.  Case-by-case consideration of “natural” claims should be permitted under this flexible policy.

14.  FDA should define “natural” based on FSIS’s two-factor definition found in the Food Standards and Labeling Policy Book.  Product does not contain any artificial flavor or flavoring, coloring ingredient, chemical preservative or any other artificial or synthetic ingredient, and  The product and its ingredients are only minimally processed. *Traditional processes used to make food edible, or to preserve it, or to make it safe for human consumption, or physical processes that don’t fundamentally alter the product, and/or which only separate a whole food into component parts.

15.  FDA should prohibit use of “natural” on all food labels. I call these folks “Settlers”. They want to define “natural” to mean foods as they existed in the 1800’s. CONSUMER REPORTS RECOMMENDATIONS

16. How does “natural” impact your Association? 1)Are you currently marketing a product utilizing “natural”? 2)Do you sell significant product to others that rely on your product being “natural”? 3)How are your competitors (direct or substitute) affected? 4)How important is using “natural” to you or your competitors? 5)Are GMO’s used in your industry or are they foreseeable in your industry?

17. ACTION STEPS Convene a working group of your key staff (marketing, legal, quality control and other departments):  Review your current labels and those of your competitors.  Assess impacts of “natural” on you and your competitors.  Identify expert resources to help.  Monitor FDA submissions, court rulings and legislation.  Develop a compelling response/position.

18. DEVELOPING YOUR POSITION 1)How might the positions proposed in each citizen petition affect you currently and in the foreseeable future? 2)Do any of the current points of view fit your needs or do you need to create your own? 3)Of the questions posed by the FDA, which are most critical to your strategic business objectives? 4)Who in your industry or others are likely to share your position? Should you ally? 5)Consider if you need “focus groups” or consumer input? 6)Develop an action plan to make your position known. CURRENT FDA COMMENT DEADLINE IS MAY 10, 2016

19. Presented by Peter G. Latham, General Counsel Citrus World, Inc. c/o Latham, Shuker, Eden & Beaudine, LLP 111 N. Magnolia Avenue, Suite 1400 Orlando, Florida 32801 407-481-5800 E-mail: platham@lseblaw.com