FDA to Extend Compliance Dates for Nutrition Facts Label Changes

  • As previously covered on this blog, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations. Mandatory compliance with the new nutrition labeling requirements for food products that are initially introduced into interstate commerce is currently slated for July 26, 2018 (or July 26, 2019 for manufacturers with less than $10 million in annual food sales).
  • FDA updated its webpage on Changes to the Nutrition Facts Label today, June 13, to announce that the compliance dates for the Nutrition Facts Label Final Rules will be extended, although the Agency has not specified the length of the extension. FDA explained thatadditional time would provide manufacturers covered by the rule with necessary guidance from FDA, and would help them be able to complete and print updated nutrition facts panels for their products before they are expected to be in compliance.”
  • FDA further explained that, “The framework for the extension will be guided by the desire to give industry more time and decrease costs, balanced with the importance of minimizing the transition period during which consumers will see both the old and the new versions of the label in the marketplace.”
  • One of the arguments for extending the compliance date given by industry was that labels will need to be changed again in 2021 when USDA’s GMO labeling disclosure requirements are expected to come into effect. Aligning the compliance dates for changes to the Nutrition Facts Label and GMO labeling disclosure requirements would eliminate the need to change labels twice, industry explained at a March 22, 2017 House Agriculture Committee hearing (a blog entry on that meeting can be found here.) FDA said it will announce the new compliance dates in a future Federal Register Notice.

Lean Finely Textured Beef Litigation – BPI’s Defamation Lawsuit Against ABC News Heats Up

  • In the Spring of 2012, ABC News aired a series of reports on “Lean Finely Textured Beef” (LFTB), referring to the product as “pink slime.” The media coverage of LFTB and resulting consumer concern led many fast-food chains to discontinue using beef that contains LFTB.  In addition, over 220,000 people signed an online petition calling on the USDA to stop using LFTB in the federal school lunch program.  Many beef producers and politicians in states with significant beef industries called ABC’s coverage of LFTB a smear campaign.
  • Beef Products Inc. (BPI), the Dakota Dunes, South Dakota-based company that manufactures LFTB, is now suing ABC News and reporter Jim Avila for $1.9 billion in a defamation suit related to its series of Spring 2012 reports that referred to LFTB as “pink slime”. Central to the case is an allegation of “product disparagement” –  which in South Dakota makes BPI eligible for treble damages.  More specifically, in its complaint, BPI alleges that ABC’s disparaging series of news reports calling LFTB “pink slime” and implying that LFTB is not actually beef, is not nutritious, and is not safe cost the company $1.9 billion.  Last week, BPI and ABC News sparred over the nutritional value of LFTB with BPI’s expert – Mindy M. Brashears, a Texas Tech University professor of food microbiology and food safety and a beef industry expert – contending that LFTB is beef, is not a filler, is not like gelatin, is safe to eat, and is not pink slime.  ABC News sought to undermine BPI’s expert testimony by raising questions about the protein quality in LFTB.  To support its position, ABC News presented lab reports to the jury indicating that, in some cases, protein levels in LFTB were half those in ground beef.
  • This week, the jury is slated to hear depositions from reporter Jim Avila, former World News host Diane Sawyer, other ABC employees and some of the sources of the disparaging news reports.  This case brings into sharp focus the fine line between news reporting and disinformation.  The outcome of this case could potentially serve as a bellwether concerning how news networks report on food and food additives (and a variety of other consumer products) going forward.  We will continue to monitor any developments in this case and report them to you here.

USDA Continues to Make Progress on GMO Labeling Rules

  • As previously reported on this blog, a new federal law requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018.  Under the new law, food companies would have three options to disclose GMO ingredients: the use of on-package text, a USDA-created symbol, or an internet link — i.e., a QR code printed on the package that directs customers to GMO information.
  • Earlier this week at the Prime Label Consultants Food Label Conference in Washington, D.C., a key USDA official indicated that – notwithstanding delays to date due to the change in administration – the Agency is continuing to endeavor to meet the July 2018 deadline.  As previously reported on this blog, the labeling law requires a study to identify potential challenges presented by disclosures through electronic or digital means.  USDA has contracted with Deloitte to perform this study, which is reportedly on track to be completed next month. If the study demonstrates that digital options do not serve as an adequate means for GMO disclosure, USDA would be required to provide food manufacturers with alternatives options to label GMO foods in its forthcoming proposed rule.
  • In addition to creating mandatory GMO disclosure disclosure requirements, the Agency also plans to launch two public education campaigns. One is slated to educate consumers on what the GMO symbols and labels mean, and the other will be focused on educating shoppers regarding the safety of GMO foods. The most recent federal spending bill included$3 million for USDA and the FDA to develop a GMO education program.
  • We will continue to keep you apprised of the latest developments regarding USDA’s implementation efforts in connection with this new federal GMO labeling law.

Consumer Groups Sue FDA for Delaying Menu Labeling Rule

  • As previously covered on this blog, on May 4, 2017, FDA published an interim final rule that delays the compliance date for menu labeling requirements from May 5, 2017, until May 8, 2018 and invites comments for 60 days on the implementation of the menu labeling requirements.
  • Yesterday, the Center for Science in the Public Interest and the National Consumer League filed a complaint in U.S. district court in Washington, D.C. claiming that the delay of the menu labeling requirement is illegal and must be vacated.  The complaint specifically alleges that the Agency’s decision violated the Administrative Procedure Act (APA) by “departing from its prior interpretation of the Affordable Care Act and its prior conclusions about the importance of nutrition labeling without providing a rational explanation”, and without providing an opportunity for public comment.  The complaint further claims that FDA violated the APA by issuing a “Delay Rule” — a final agency action with legally binding effect — “without complying with mandatory rulemaking procedures, including advance notice and an opportunity for public comment before the Delay Rule took effect.” The plaintiffs are requesting that the court hold the Delay Rule to be “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law, and to have been published without observance of legally required procedure, in violation of the APA.” The Plaintiffs are also seeking an order vacating the Delay Rule, and declaring that compliance with the menu labeling rule is required within 15 days of the court’s order.
  • We will monitor developments in this case as they unfold and report them to you here.

FDA Slated to Extend Compliance Dates for Agricultural Water Standards

  • Agricultural water can be a major conduit of pathogens that can contaminate produce. FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes agricultural water standards.  In particular, the Produce Safety Rule sets microbial quality standards for agricultural water, including irrigation water that comes into contact with produce.  In March 2017, the U.S. Food and Drug Administration (FDA) announced that it was exploring ways to simplify the agricultural water standards established by FSMA’s Produce Safety Rule in light of feedback from stakeholders that some of the requirements were too complex to understand and implement.
  • Today, FDA announced its intention to extend the compliance dates for agricultural water requirements in the Produce Safety Rule (other than for sprouts).  According to the announcement, FDA intends to use this additional time to work with industry to develop an approach that addresses stakeholder concerns while achieving the Agency’s enumerated public health goals.
  • FDA intends to extend the compliance dates using appropriate administrative procedures at a later time.  We will be sure to report these developments to you here when they unfold.

Healthy Offerings Among Current Snack Food Trends

  • “Healthy Snacking” was identified as a leading trend by Convenience Store News at the 2017 Sweets & Snacks Show, held May 23-25 in Chicago with Asparagus Chips and Brussel Sprouts Puffs noted as prime examples of new healthy offerings. The National Confectioner Association’s (NCA) pick for the top salty snack at the show was Gouda & Romano Cheese Quinoa Chips, which capitalizes on the healthy image of quinoa.
  • The healthy trend was also identified in a Nielsen Co. study published last month which found that consumers scored cauliflower, avocado with black bean, and coconut chips as top 10 “non-traditional ingredients.”  In releasing the results of this latest study, Nielsen explained that these high scoring non-traditional ingredients put a more health-conscious twist on the traditional potato chip.  This latest study combined with the trends identified at the recent Convenience Store News Show demonstrate consumers’ continued appetite for “healthy” foods and sets the stage for continued innovation in the production and marketing of “healthy” foods.
  • That being said, the current trend towards healthy snacks could potentially be impacted by possible changes to FDA’s “healthy” definition.  (See previous blog coverage here, noting that FDA is currently considering industry comments on how best to redefine the term “healthy”).

Another State Bans Routine Antibiotic Use in Food-Producing Animals

  • As previously covered on this blog here and here, for years, FDA, USDA, and various industry stakeholders have sought to tackle public health concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In the U.S., FDA is working with industry to gradually phase out the use of medically important antimicrobials in food animals for production purposes.  Recently, states have also jumped into the fray, with California, for example, adopting strict limits in 2015 on the use of antibiotics in healthy livestock, effectively barring their routine use to prevent illness or promote growth.
  • On May 31, 2017, Maryland (MD) became the second state (after California) to ban the routine use of antibiotics on farms.  The bill, entitled “The Keep Antibiotics Effective Act” prohibits the administration of antimicrobial drugs to cattle, swine and poultry that are not sick, a practice many public health experts contend can fuel the spread of drug-resistant bacteria.  The new law, which is slated to take effect on January 1, 2018, also requires the MD Department of Agriculture to collect publicly available data on use of certain antimicrobial drugs in the state.
  • It remains to be seen whether and to what extent other states will seek to implement similar laws eliminating routine antibiotic use in food-producing animals.

House Passes ‘Securing our Agriculture and Food Act’, Under Consideration by Senate

  • On May 22, the United States House of Representatives passed H.R. 1238 in a bipartisan roll call vote, 406-6.
  • The Act would amend the Homeland Security Act of 2002 to make the Assistant Secretary of Homeland Security for Health Affairs responsible for coordinating the efforts of the Department of Homeland Security related to food, agriculture, and veterinary defense against terrorism, and for other purposes.
  • Of note, the Act would not alter or supersede the authority of the Secretary of Agriculture relating to food and agriculture.
  • The United States Senate is currently considering the bill, amended to carve out the authority of the Secretary of Health and Human Services in addition to the existing carve-out for the Secretary of Agriculture.
  • The ultimate impact of this legislation remains to be seen, but this bill is seen as an important step in combatting potential terrorist acts.

Kraft Motion to Dismiss ‘All Natural’ Lawsuit

Kraft seeks to end ‘all-natural’ sour cream labeling suit (subscription to Law360 required)

  • Kraft Heinz Foods Co. (Kraft) asked the court (the U.S. District Court for the Eastern District of New York) to dismiss a putative class action over claims the “All Natural” label on its Breakstone’s sour cream is misleading because the sour cream is made with dairy ingredients from cows fed genetically modified organisms (GMOs), arguing the claims are preempted by the National Bioengineered Food Disclosure Standard of January 2016, which requires the U.S. Department of Agriculture to promulgate a regulation that shall “prohibit a food derived from an animal to be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance.”
  • Kraft additionally referenced the dismissal of federal cases against Chipotle Mexican Grill’s use of “non-GMO” labeling for products derived from animals that ate GMO feed in arguing that a reasonable consumer is unlikely to believe the sour cream is not natural because the milk in the sour cream might have come from a cow that ate GMO feed, a contention that the plaintiff countered is a factual dispute that cannot be resolved in a motion to dismiss.
  • Kraft also argued that the case should be dismissed because FDA is reviewing the use of the term “natural” on food products.  This argument proved successful in gaining a stay in March 2017 for Kraft’s ‘natural’ labeling case (As previously covered on this blog, FDA has requested comments on the definition of “natural” to determine whether or how the FDA should define the term going forward).
  • Because there is no guarantee that FDA will ever define “natural” claims, it remains to be seen just how long trial courts may be willing to wait.

More Than 99.5% of ‘Gluten-Free’ Products Tested by FDA in Compliance

  • As previously reported on this blog, in August 2013, the U.S. Food and Drug Administration (FDA) issued a final rule on “gluten-free” food labeling. After the final compliance date of August 5, 2014, FDA measured the gluten level of more than 250 different products labeled “gluten-free.”
  • More than 99.5% of the food products labeled “gluten-free” that FDA tested were in compliance with the requirement that such foods have less than 20 ppm (parts per million) of gluten. In total, FDA collected and analyzed 702 samples from more than 250 products labeled “gluten free.” The products were collected between July 2015 to August 2016.
  • Only five samples from one of the products labeled “gluten-free” did not comply with the less than 20 ppm requirement. That product was recalled and subsequent sampling by FDA did not find levels of gluten that violated the regulation.
  • Products tested were from three commodity groups: cereals, grain bars and flours. Results of the surveillance sampling can be accessed from FDA’s website.