April 30, By Electronic Mail

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1 April 30, 2018 By Electronic Mail Dr. Scott Gottlieb, Commissioner Office of the Commissioner Food and Drug Administration New Hampshire Avenue Silver Spring, MD Re: Request for Clarification and Extension of Compliance Date for Final Determination Regarding Partially Hydrogenated Oils (Agency/Docket Number: FDA-2013-N-1317) Dr. Gottlieb: The undersigned trade associations write to request that the Food and Drug Administration (FDA or the agency) (1) clarify that the June 18, 2018 compliance date for the determination that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) applies to the date the product is introduced into interstate commerce, and (2) extend the compliance date to provide time for FDA to respond to the food additive petition on certain uses of PHOs. We note at the outset the food industry has been working diligently since FDA finalized its determination to remove uses of PHOs from their product formulations. As these efforts continue, some PHO-containing products, particularly those with a long shelf life, will remain on store shelves and in consumers pantries after June 18 despite having been introduced into interstate commerce prior to the compliance date. We are asking FDA to recognize that products that were already in commerce before the compliance date may continue to remain in commerce. Absent a clear statement from FDA, companies and retailers could be forced to recall or remove from store shelves those products that remain in commerce that contain PHOs. It would seem needlessly burdensome to force the removal of these products from commerce. Additionally, an extension of the compliance date is needed because the agency has not yet issued the food additive regulation that will authorize certain uses of PHOs. By extending the compliance date, the agency will allow for a seamless transition for the continued use of those PHOs that will be covered by the food additive regulation. 1. FDA Should Clarify that the Compliance Date Applies to the Date Products are Shipped Into Interstate Commerce and that PHO-Containing Products Already in Commerce on June 18, 2018 Need Not Be Removed from Store Shelves. First, we request that the agency address the status of those products in commerce that contain PHOs after the compliance date. In particular, we ask FDA to recognize that the compliance date applies to the date products are shipped into interstate commerce and that products already in commerce on June 18 need not be removed from store shelves. The agency could accomplish this by issuing a letter, publishing a statement on its website, or issuing an immediate final guidance document (similar to the agency s September final guidance document on healthy claims, which was initially published as final guidance ) clarifying how the agency interprets the compliance date and recognizing the agency will not deem adulterated those PHO-containing products on the market on June 18, 2018, provided the product was initially introduced into interstate commerce prior to the compliance date.

2 - 2 - April 30, 2018 By way of brief background, many products that historically contained PHOs as ingredients have shelf lives of 3 24 months, or possibly longer. The stability of PHOs is one of the reasons manufacturers of long shelf-life foods historically formulated products with PHOs. Manufacturers have made formulation changes during the three-year transition period, but numerous products containing PHOs may still be present on retail shelves or in warehouses on June 18. Similarly, such products will remain in consumers pantries well after the compliance date. There is considerable confusion with respect to whether the compliance date applies to the date the food is shipped into interstate commerce, the date the food is manufactured, or the date the food is on the market. In light of this confusion, some retailers are questioning whether they should accept PHO-containing products prior to the June 2018 compliance date. The industry would benefit tremendously from clear communication from FDA on the interpretation of the compliance date in the final determination. Statements from FDA have alternatively suggested that the compliance date applies to the date the food is formulated or manufactured such as the statement below: FDA has issued a final determination that PHOs, the primary source of industrially-produced trans fat in processed foods, are not Generally Recognized as Safe or GRAS. This means that PHOs may no longer be added to food after June 18, 2018, unless they are otherwise approved by FDA. 1 or that it applies to the date the food is on the market, such as the following statement: By June 18, 2018, human food must no longer contain partially hydrogenated oils for uses that have not been otherwise authorized by FDA. 2 Additionally, FDA offered the response below, to a comment seeking clarification that the compliance date applies to the manufacturer that first introduces into commerce a PHO-containing product and not to distributors. Although we are mindful of the need to focus our enforcement efforts, those needs do not change the underlying law or FDA's legal authority. Food that is adulterated may be subject to seizure and distributors, manufacturers, and other parties responsible for such food may be subject to injunction. We recognize that manufacturers who have previously added PHO to food, rather than other parties such as distributors who merely receive and sell finished foods, are the members of the food industry who will be most directly affected by 1 Susan Mayne, Protecting Consumers from Trans Fat, June 15, 2015, (emphasis added). 2 Final Determination Regarding Partially Hydrogenated Oils (Removing Trans Fat), last updated Feb. 27, 2018, (emphasis added).

3 - 3 - April 30, 2018 this order, and we intend to focus our outreach and enforcement resources accordingly. However, we remind distributors and other members of the food industry that they have an obligation to ensure that the food they manufacture, distribute, sell, or otherwise market complies with the FD&C Act. 3 We understand this language has resulted in distributors and retailers questioning whether they must refuse PHO-containing products not covered by a food additive regulation prior to June 18, 2018, or even remove such products from shelves on the compliance date, even if they were initially introduced into interstate commerce prior to the compliance date. The food industry has invested considerable time and effort to remove PHOs from product formulations. While the transition is largely complete for those uses that were not expected to be covered by the food additive regulation, some companies may have inventories of PHO-containing products in warehouses. In addition, there certainly may be PHO-containing products on store shelves given the shelf life of the products that historically used PHOs and the time it takes to exhaust existing inventory of such products. We urge FDA to recognize it is unnecessary for retailers to remove from their store shelves, or warehouses to destroy from their inventory, PHOcontaining products after the June 18, 2018 compliance date. We note FDA precedent supports the use of first introduction into commerce as a workable and practical compliance date. When FDA initially began enforcing the allergen labeling requirement under the Food Allergen and Consumer Protection Labeling Act (FALCPA), the agency recognized that products already in commerce as of the January 1, 2016 compliance date and that did not bear allergen labeling did not need to be removed from store shelves or relabeled, as long as they were labeled before the compliance date. Question: After January 1, 2006, will I still find products on the supermarket or grocery shelf without the improved labeling? FDA Response: Yes. FALCPA does not require food manufacturers or retailers to remove or relabel products from supermarket shelves that do not reflect the additional allergen labeling so long as the products were labeled before January 1, Therefore, FDA advises consumers with allergies to always read a product's ingredient statement in conjunction with any "contains" statement. 4 Additionally, for FDA labeling requirements, the uniform compliance date is based on the date when the product is initially introduced into interstate commerce. 5 Moreover, Congress has directed, via 3 80 Fed. Reg , (Comment 10) (June 17, 2015). 4 Food Allergen Labeling and Consumer Protection Act of 2004, Questions and Answers, question 12, 5 See, e.g., Uniform Compliance Date for Food Labeling Regulations, 81 Fed. Reg , (Nov. 25, 2016). Similarly, FDA has clarified that the compliance date for the new nutrition labeling regulations applies to the date the product is labeled, rather than requiring all products on

4 - 4 - April 30, 2018 a rider in the appropriations bill for each year since the final determination was issued, that only those products introduced or delivered for introduction into interstate commerce after the compliance date and that contain PHOs shall be considered adulterated: No partially hydrogenated oils as defined in the order published by the Food and Drug Administration in the Federal Register on June 17, 2015 (80 Fed. Reg et seq.) shall be deemed unsafe within the meaning of section 409(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(a)) and no food that is introduced or delivered for introduction into interstate commerce that bears or contains a partially hydrogenated oil shall be deemed adulterated under sections 402(a)(1) or 402(a)(2)(C)(i) of this Act by virtue of bearing or containing a partially hydrogenated oil until the compliance date as specified in such order (June 18, 2018). Given the precedent that has been established, the direction from Congress, and the significant market disruption that would occur if products in commerce are deemed adulterated after the compliance date, we urge FDA to recognize the compliance date applies to the initial introduction into commerce. The agency could issue a letter, a statement on its website, or a final guidance document to the effect that it will not deem adulterated those PHO-containing products initially introduced into commerce prior to June 18, FDA Should Extend the Compliance Date for the Final Determination on the GRAS Status of PHOs to Provide Additional Time for the Agency to Respond to the Food Additive Petition. As background, the agency received a food additive petition (FAP) covering the use of PHOs in a wide number of food products across the industry and at varying levels. 6 We understand the petitioned uses were subsequently narrowed in an amendment to the FAP. We remain optimistic FDA will agree the data support certain uses of PHOs and that the agency will issue a food additive regulation clarifying the uses that are covered. The industry will not know with certainty the uses that are authorized until the food additive regulation is issued. When establishing the compliance date, FDA expected the three year compliance period would provide FDA with sufficient time to issue a food additive regulation for authorized uses of PHOs. FDA stated: Based on our experience and on the changes we have already seen in the market, we believe that 3 years is sufficient time for the market as of the compliance date to comply with the revised labeling requirements. FDA Draft Guidance for Industry: 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 (Jan. 2017), question 1, on/ucm pdf. 6 FAP 5A4811, Uses of partially hydrogenated vegetable oils (PHOs) in select foods (Docket No. FDA-2015-F-3663). Submitted by the Grocery Manufacturer s Association, Oct. 1, 2015.

5 - 5 - April 30, 2018 submission and review and, if applicable requirements are met, approval of food additive petitions for uses of PHOs for which industry or other interested individuals believe that safe conditions of use may be prescribed. For this reason, we are establishing a compliance date for this order of June 18, We recognize that the use of PHOs in the food supply is already declining and expect this to continue even prior to the compliance date. We recognize the challenges faced by small businesses, however, considering our determination that PHOs are not GRAS for any use in human food, we conclude that providing 3 years for submission and review of food additive petitions and/or food contact notifications is reasonable, and will have the additional benefit of allowing small businesses time to address these challenges. 7 As of today, the agency has yet to issue its conclusions on the PHO FAP. Industry has no clear expectation of when the agency will make its final decision and whether it will ultimately approve any uses of PHOs that will be covered by a food additive regulation. If FDA were to act on the FAP and authorize certain uses of PHOs sometime after June 18, 2018, that would place undue burdens on food companies whereby certain uses of PHOs would be considered banned on June 18, 2018 and would later be authorized under a food additive regulation. It also is impossible for the industry to know which if any of the petitioned uses of PHOs will be covered and which uses will not. Because we do not know how much additional time the agency will need to complete its review of the FAP and issue its conclusions (e.g., a food additive regulation), we are not in a position to identify how much of an extension is needed following June 18, If FDA issues a food additive regulation, we request that the agency provide industry a sufficient amount of time after issuing the food additive regulation to make any additional formulation changes that may be necessary for uses of PHOs that are not covered by the regulation. For example, it would seem reasonable to provide companies a one year compliance period after issuance of the final food additive regulation. * * * In conclusion, we urge the agency to make it clear it interprets the compliance date as applying to the date the PHO-containing product is initially introduced into commerce and that the agency would not consider adulterated those PHO-containing products that remain in commerce or on retail shelves after the compliance date that were initially shipped prior to that time. If FDA issues a food additive regulation, we also urge FDA to extend the compliance date to allow for a seamless transition for those uses of PHOs that will be covered by the food additive regulation by providing sufficient time for the agency to respond to the FAP. We thank you in advance for your consideration of this request Fed. Reg. at (emphasis added).

6 - 6 - April 30, 2018 Sincerely, American Bakers Association American Frozen Food Institute Food Marketing Institute Grocery Manufacturers Association Independent Bakers Association Institute of Shortening and Edible Oils International Dairy Foods Association International Foodservice Distributors Association National Automated Merchandising Association National Confectioners Association National Grocers Association National Restaurant Association North American Millers Association Peanut and Tree Nut Processors Association SNAC International cc: Dr. Stephen M. Ostroff, Deputy Commissioner, Office of Food and Veterinary Medicine Dr. Susan T. Mayne, Director, Center for Food Safety and Applied Nutrition Dr. Dennis D. Keefe, Director, Office of Food Additive Safety Rebecca K. Wood, J.D., Chief Counsel Anna Abram, Deputy Commissioner for Policy, Planning Legislation and Analysis Caitlin Boon, Senior Advisor to the Commissioner