July 20, 2015

TO: JPA Members

FROM: Patricia Faison

JPA Regulatory Update

House to Vote on the “Safe and Accurate Food Labeling Act of 2015”

JPA has been providing updates regarding the “Safe and Accurate Food Labeling Act of 2015,” (H.R. 1599), which would create a federal standard for voluntary labeling of foods derived from genetically engineered materials and pre-empting states from enacting their own mandatory labeling laws. The House Committee on Agriculture recently passed the bill by voice vote. A copy of the current bill is available here. The bill also includes language directing the Secretary of Health and Human Services to develop regulations defining use of the term “natural.” According to the July 20 issue of POLITICO's Morning Agriculture, the full House of Representatives is scheduled to vote on the legislation this Thursday, July 23, 2015. At this time, similar legislation has not been introduced in the Senate.

Media coverage of the bill include: and JPA will continue to monitor and provide updates, as information becomes available.

Senate Committee on Appropriations Advances Appropriations Bill

The House of Representatives and the Senate are both considering the Fiscal Year (2016) appropriations bill, which allocates money to federal government departments, agencies, and programs. According to the July 17 issue of POLITICO's Morning Agriculture, the Senate Committee on Appropriations recently advanced the appropriations bill [known as the “Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2016”]. According to the article, “the draft report encourages the Food and Drug Administration (FDA) to release the results of its Nutrition Facts panel research on added sugars for comment and review before finalizing changes to the Nutrition Facts panel, expressing concern that the agency has not already done so.” As you may recall, last year the FDA published a proposed rule to require, in part, the declaration of “added sugars” on food and beverage labels.

POLITICO also notes “the draft report urges the FDA to wait until the science is a bit more settled before moving forward with its work on sodium reduction.” JPA has previously notified members that the Agency, as part of its nutrition labeling modernization efforts, had proposed lowering the current daily reference value (DRV) for sodium from 2,400 milligrams (mg) to 2,300 mg. Members were also advised that the FDA is planning to publish voluntary sodium reduction guidelines, but the timing for release of the guidelines is not yet known.

The Senate Committee’s report can be accessed here, and the Committee’s press release is available here. The Senate Committee’s report specifically states the following:

“Nutrition Facts Label —The Committee is concerned that the FDA has not published in the Federal Register the results of FDA’s ‘‘Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats and Declaration of Amount of Added Sugars’’ (78 FR 32394, May 30, 2013). The purpose of the study, as described by the Agency, is ‘to examine how consumers would comprehend and use this new information’. Given that sound science, peer review and transparency are essential to effective protection of public health, the Committee encourages the FDA to release this study for public review and comment prior to finalizing changes to the Nutrition Facts label.”

“Sodium —The Committee is concerned about FDA’s continued focus on voluntary sodium reductions and the Institute of Medicine’s [IOM] 2010 recommendation to modify the Generally Recognized as Safe [GRAS] status of sodium, particularly given the ongoing scientific discussion regarding appropriate sodium intake to maintain positive health. The IOM published a more recent study in 2013, which concluded additional research may provide further information with respect to the health effects of sodium intake on general and sub populations. The Committee recommends that a panel be convened, at the IOM or another leading Federal institution, which includes a representative array of research perspectives, including those who have raised concerns on the safety of low-sodium diets. The Committee does not believe any sodium reduction activities should be finalized until the disagreement between the impact of lower sodium on blood pressure (and an extrapolation to health) and direct research suggesting a negative impact of
very low-sodium intakes is resolved.”

“Dietary Guidelines for Americans —The Committee is concerned that the 2015 Dietary Guidelines Advisory Committee’s recommendations included issues outside of the nutritional scope of the Dietary Guidelines for Americans. The Committee directs the Secretary to ensure that the Guidelines are solely nutritional and dietary in nature and based on a preponderance of scientific evidence. Furthermore, the Committee includes new bill language directing the Secretary to only include nutrition and dietary information, not extraneous factors, in the final 2015 Dietary Guidelines for Americans.”

Funding for FSMA – “The Committee includes increases of $45,000,000 for the implementation of FSMA [FDA Food Safety Modernization Act]. These increases consist of: $20,500,000 for Inspection Modernization and Training; $8,000,000 for the National Integrated Food Safety System; $10,000,000 for Education and Technical Assistance for Industry; $3,000,000 for Technical Staffing and Guidance Development; and $3,500,000 for Import Safety. The increases provided in this bill and the increases provided since fiscal year 2011 should assist FDA in preparation for the implementation of FSMA prior to the effective dates of the seven foundational proposed rules.”

Also of particular interest, the Committee recommendations for funding did not include proposed user fees for food facility registration and inspection, food import, food contact substance notification, cosmetics, and international courier imports. According to the Committee’s report, Congress has not authorized such user fees. Earlier this year, JPA cosigned comments by a food industry coalition requesting that the Senate and House Committees provide congressional funding for FDA food safety activities rather than imposing new food taxes or regulatory fees on the food industry.

The appropriations bill has yet to be passed by the full House and Senate.

FDA Nutrition Labeling Modernization

JPA staff has learned that the White House Office of Management and Budget (OMB) recently approved a supplemental proposed rule submitted by the FDA on revision of the Agency’s Nutrition Facts label. At this time, the scope of the supplemental proposed rule is not yet known. JPA will monitor for publication of the supplemental proposed rule and provide updates, as information becomes available.

FDA Announces New Food Emergency Exercise

The FDA recently published a Constituent Update, available here, announcing the Agency is making available a new food emergency exercise titled “Mass Mayhem” to help public health and other officials prepare for a food-related emergency. According to the Agency, the exercise involves an outbreak of foodborne illness at a large public venue. The FDA also plans to release two additional food-related emergency exercises: “Wat’er You Thinking” and “Foul Fodder,” which address contamination of a municipal water supply and contamination of food and/or animal feed, respectively.

Legal Counsel Summary - Litigation Regarding Trans Fats and Partially Hydrogenated Oils

JPA members were previously notified that the FDA had issued a declaratory order announcing the Agency’s final determination that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) for use in any human food. The FDA established June 18, 2018 as the compliance date to allow, in part, products to be reformulated to remove PHOs or to allow companies to submit a food additive petition. Concerns have been raised that the FDA did not address the potential for lawsuits to be filed against companies that currently use industrially-produced PHOs in their products.

JPA's legal counsel, Hogan Lovells, has prepared a memorandum, available here, providing insight regarding recent litigation related to trans fats and PHOs in foods.

Please do not hesitate to contact me with questions or comments.

Patricia Faison

JPA Updates & News Scans are provided as a service exclusively to JPA members. Please do not share these communications outside the membership.

JPA Staff
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