June 4, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update
1. National Organic Program
2. Draft Guidance for Industry - Voluntary Qualified Importer Program
3. FDA Issues Allergen Guidance
4. Labeling of Genetically Engineered Ingredients/Foods
5. IFIC Study on Added Sugars Labeling
6. FDA Publishes Declaratory Order That Partially Hydrogenated Oils Are Not GRAS
National Organic Program
JPA members were previously notified that the National Organic Standards Board (NOSB) would meet April 27-30, 2015 to consider in part, the review of substances on the National List of Allowed and Prohibited Substances (the National List) that are scheduled to sunset in 2016 and 2017. Prior to the NOSB meeting, JPA submitted comments requesting that a number of substances be maintained on the National List for use in organic juice and juice products.
The USDA recently published the Organic Integrity Quarterly newsletter, available here, providing news regarding a number of organic topics. A brief overview of the outcomes of the NOSB meeting are included. Of particular note, JPA recommended that cyclohexylamine, diethylaminoethanol and octadecylamine be mainted on the National List as boiler water additives for packaging sterilization. The NOSB approved a recommendation to remove these three boiler water additives from the National List.
JPA will continue to monitor activities related to the National Organic Program and provide updates, as information becomes available.
Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program
Earlier this month, JPA members were notified that the Food and Drug Administration (FDA) had announced publication of the "Draft Guidance for Industry: FDA's Voluntary Qualified Importer Program," a voluntary, fee-based program for the expedited review and importation of foods into the U.S., which can be accessed here. It was reported that the program was being implemented as mandated by the FDA Food Safety Modernization Act (FSMA). JPA's legal counsel, Hogan Lovells, has published a memorandum, available here, summarizing the key provisions of the draft guidance.
FDA Issues Allergen Guidance
Today, the Food and Drug Administration (FDA) issued a Constituent Update, available here, announcing publication of a final guidance, "Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications," which describes the information that must be submitted to the Agency when seeking an exemption from the allergen labeling requirements for an ingredient derived from a major food allergen.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) stipulates that ingredients may become exempt from the allergen labeling requirements via two processes. According to the FDA, an ingredient may obtain an exemption through submission and approval of a petition containing scientific evidence that demonstrates that the ingredient does not cause an allergic response that poses a risk to human health. An ingredient may also become exempt through submission of a notification containing scientific evidence showing that the ingredient does not contain allergenic protein or that there has been a previous determination through a premarket approval process that the ingredient does not cause an allergic response that poses a risk to human health. The guidance is available here and the pre-publication version of the Federal Register notice is available here.
Labeling of Genetically Engineered Foods/Ingredients
In March 2015, JPA members were notified that Representative Pompeo (R-KS) had introduced legislation, "The Safe and Accurate Food Labeling Act of 2015" to, in part, prohibit initiatives for labeling GE foods at the state level. According to an article published by the International Business Times, available here, the Health Subcommittee of the House Energy and Commerce Committee will hold a hearing today to consider the role of biotechnology in the U.S. food supply, the safety of foods derived from GE crops and the need for national review and labeling standards for such products.
In a related matter, beginning July 1, 2015, Taiwan will require that all raw GE materials (e.g., soybeans, corn, oilseeds) must be labeled in grocery stores and markets, according to an article published on Oregonlive.com, available here. The article notes that processed foods and beverages containing processed GE products are exempt from such labeling. The labeling requirement will also apply to restaurants.
IFIC Study on Added Sugars Labeling
The International Food Information Council (IFIC) Foundation recently announced consumer research sponsored by the group, which evaluated consumers' understanding of added sugars labeling on the Nutrition Facts Panel (NFP) has been published in the Journal of the Academy of Nutrition and Dietetics. As you may recall, the FDA issued two proposed rules in 2014 to modernize food labeling in the U.S. In part, the Agency proposed to require the declaration of "Added Sugars" on food labels.
IFIC's announcement related to the study is available here, and the study, "Including 'Added Sugars' on the Nutrition Facts Panel: How Consumers Perceive the Proposed Change" can be accessed here. According to IFIC, consumers were shown three NFPs of a nutritionally identical product but the declaration of sugars was different. The study found the NFPs with "Added Sugars" declaration were misleading and the resulting misperception influenced purchase intent. Consumers were better able to accurately identify the total amount of sugars in a product when and "Added Sugars" line is not included on the NFP. In addition, most consumers perceive that products with an "Added Sugars" declaration have a higher content of sugar than is actually present. Consumers were also confused regarding what constitutes an added sugar. According to IFIC, the "research demonstrated the need for increased consumer eductaion on food label comprehension and application, regardless of whether or not an 'Added Sugars' line appears on the revised NFP."
FDA Publishes Declaratory Order That Partially Hydrogenated Oils Are Not GRAS
In 2013, JPA members were notified that the FDA had published a notice in the Federal Register announcing that the Agency had tentatively determined that partially hydrogenated oils (PHOs), the primary source of artificial trans fat in the diet, should no longer be considered "generally recognized as safe" (GRAS) for use in food.
Yesterday, the FDA issued a Declaratory Order in the Federal Register (80 FR 34650: June 17, 2015), available here, announcing the Agency's final determination that PHOs are not GRAS for any use in human food. The FDA has established June 18, 2018 as the deadline for compliance (removal of PHOs from foods). JPA's legal counsel, Hogan Lovells, has published a memorandum, available here, summarizing the key provisions of the Declaratory Order.
As always, please contact me with questions or comments
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