• By way of background, the Produce Safety Rule under FDA’s Food Safety Modernization Act establishes two sets of criteria for microbial water quality based on the presence of generic coli, which can indicate the presence of fecal contamination. The first does not allow any detectable generic E. coli in agricultural water for certain uses, such as water used to wash hands and water used on food-contact surfaces. The second is for agricultural water that is applied directly to growing produce other than sprouts.
  • FDA has received feedback from stakeholder pointing out that some of these standards may be too complex to understand, translate and implement. As a result, the Agency announced on March 20, 2017, that it is considering how to simplify the water standards. FDA will work with stakeholders during this process. A copy of the announcement can be found here.
  • Previously, FDA clarified how it interprets the compliance dates for certain provisions related to agricultural water testing in the Produce Safety Rule in an August 24, 2016, Federal Register notice.
  • “Slack fill” cases are on the rise across the U.S.  Slack fill is the empty space between products and their packaging. Companies can be challenged for including “nonfunctional slack fill” in product packaging under both the Federal Food Drug and Cosmetic Act (“FDCA”) and state unfair business practice statutes (particularly in California).  At the federal level, 21 C.F.R. §100.100 of FDA’s regulations provides that a food is “misbranded” if “its container is so made, formed or filled as to be misleading.”  Section 100.100(a) further provides that “a container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill.”
  • On October 9, 2015, a class-action lawsuit was filed against GNC Holdings Inc. (GNC) for allegedly deceptively packaging its Whey Protein products, including AMP Amplified Gold Whey Protein, AMP Amplified Wheybolic Extreme, and 100% Whey Protein products. The complaint alleged that the containers for these products were opaque and contained approximately 40% empty space in violation of the FDCA and California state consumer laws. (Gioia et al v. GNC Holdings, Inc., Case No. 15-cv-2273, S. D. CA.). In defending itself, GNC argued that “the products’ containers specifically stated the amount of product on the label . . . the labels contain the products’ net weight, serving size and the number of servings contained within each container. Thus, consumers are receiving the exact amount of product disclosed.” The plaintiffs countered that GNC’s arguments justifying the slack fill were inappropriate as they revolved around factual issues that should be resolved on a motion for summary judgment.
  • On March 17, 2017, GNC and the putative class of consumers agreed to end the slack fill lawsuit (subscription to Law 360 required).
  • Slack fill lawsuits are an increasing source of litigation exposure for marketers of FDA-regulated food and dietary supplement products. Given the duration of this case and the fact that the court did not dismiss the complaint per GNC’s request in earlier proceedings, this lawsuit demonstrates that marketers of FDA-regulated food and dietary supplement products should not assume that simply disclosing on a label the amount of product contained in a package will result in the quick dismissal of a slack fill suit.  Instead, consumer perception may be viewed as a fact-intensive inquiry requiring further discovery and summary judgment proceedings.  While settlement of such claims are certainly an option (and the path chosen here), manufacturers should seriously consider vigorous defenses against these claims given a number of favorable decisions to date.
  • As our readership is well aware, USDA’s Food Safety and Inspection Service (FSIS) regulates the production of meat, poultry, and egg products.  To help achieve its enumerated food safety goals, FSIS works with industry to develop and promote best practices at slaughter that may be used to prevent, eliminate, or reduce levels of potential microbiological contamination of the food products subject to its jurisdiction.
  • On March 3, 2017, FSIS released an updated Compliance Guideline for Minimizing the Risk of Shiga Toxin-producing Escherichia Coli (STEC) and Salmonella in Beef (including Veal) Slaughter Operations.  The guideline seeks to assist regulated establishments that slaughter beef (including veal) to:
    • Implement effective sanitary dressing procedures designed to prevent carcass contamination;
    • Implement effective decontamination and antimicrobial interventions;
    • Properly assess microbial testing results, including results for indicators of process control, at any point during slaughter; and
    • Use the results from the implementation of these components of the food safety systems to assess the effectiveness of the overall HACCP system.
  • FSIS will be accepting comments on this guideline through May 2, 2017.

Court places “natural” challenge on hold pending FDA action (subscription to Law 360 required)

  • As the food industry is well aware, lawsuits challenging “natural” claims continue to proliferate nationwide. Many challenges have focused on the presence or use of synthetic ingredients or processing aids in products positioned as “all-natural” or “100% natural.”
  • For example, Kraft Foods Group (Kraft Foods) has recently been embroiled in a “natural” class action lawsuit over claims that it falsely marketed its Shredded Fat Free Cheddar cheese as “natural” when it allegedly contains artificial ingredients.  Kraft Foods asked the court (the U.S. District Court for the District of Puerto Rico) to stay the case pending FDA guidance on “natural” (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).
  • On March 6, 2017, a Puerto Rico federal judge placed a hold on the false labeling suit explaining that the case is being stayed until the FDAprovides guidance on the use of the term “natural” on food products. In granting the stay, the judge pointed to three recent rulings in support of Kraft Foods’ argument that the case should be stayed pending the completion of the FDA’s rulemaking process concerning the definition of “natural”.  The three rulings are the Ninth Circuit’s 2016 decisions in Kane v. Chobani and Astiana v. Hain Celestial Group, as well as the Southern District of New York’s 2016 ruling in In re Kind LLC “Healthy & All Natural” Litigation.  See our previous blog coverage of the Kane v. Chobani case here.
  • Because any FDA action on “natural” claims may take several years, it remains to be seen just how long trial courts actually may be willing to wait and see.

More Calls for a National Food Safety Strategy 

  • A month after four senators asked the Trump administration to implement the food safety recommendations in a General Accounting Office (GAO) report calling for a national food strategy (see our February 21, 2017 blog for more details), researchers at Vermont and Harvard law schools released the results of a collaborative project that also calls for a national food strategy. “Blueprint for a National Food Strategy” was produced by the Center for Agriculture and Food Systems (CAFS) at Vermont Law School and Harvard Law School Food Law and Policy Clinic (FLPC), with support form the W.K. Kellogg Foundation.
  • The report’s authors began by looking at national food strategies in other countries. These strategies include ones that simply aim to reduce the degree to which federal agencies, laws, and policies work at cross purposes, to ones that also seek to fulfill broader functions, such as: strengthening vital systems; addressing an overlooked policy area; and preventing or mitigating a national crisis.
  • “Blueprint for a National Food Strategy” is intended to provide a roadmap to develop a national food strategy and identifies four major principles to guide the process, namely: Coordination; Participation; Transparency and Accountability; and Durability. The report concludes by stating, “A national food strategy in the United States could provide a framework for more informed, effective, and coordinated law and policy-making at the federal level and throughout the country. While much of the conversation around a national food strategy will focus on the substance of such a strategy (the policy goals and priorities themselves), process is equally important.” It adds that the process “can ensure that a comprehensive national food strategy creates a structure to advance a more healthful, sustainable, equitable, and economically vital food system.”
  • By way of background, all meat and poultry food products are potentially subject to regulation by USDA’s Food Safety and Inspection Service (FSIS) upon import into the U.S.  Turning to raw beef, in particular, when FSIS has determined that a foreign country is “equivalent” to export raw beef, FSIS may assign an E. coli O157:H7 MT51 Type of Inspection (TOI) at an Increased Level of Reinspection (LOR) that is above the Normal LOR.  This targeted verification testing of shipments of raw beef products aims to verify that the foreign country’s raw beef products inspection system is adequately addressing these pathogens.
  • On March 13, 2017, USDA’s Food Safety and Inspection service issued a notice instructing its inspection program personnel (IPP) at official import inspection establishments to subject beef product from the following foreign countries to an “Increased Level of Reinspection” for purposes of an E. coli O157:H7 MT51 type of inspection (TOI): France, Ireland, and the Netherlands.
  • Additional information concerning the targeted, increased inspection of beef imports is available here.

Industry and consumer stakeholders recommend hybrid approach to defining “healthy” (subscription to Law360 required)

  • As previously covered on this blog, on September 28, 2016, FDA called for public comments on the use of the term “healthy.” Comments will be accepted through April 26, 2017. In addition to accepting written comments, FDA recently held a public meeting on this topic on March 9, 2017.
  • During the March 9, 2017 public meeting, industry and consumer stakeholders suggested a hybrid approach to defining “healthy.” For example, one leading food company presented a framework for defining healthy via a rubric that ranked foods by their nutritional makeup. Under that proposal, foods like avocados, nuts and seeds would qualify as healthy, while margarine and french fries would not. Another company proposed a definition of healthy that would not contain a threshold for “good” nutrients, but rather would contain a “meaningful amount” of foods that comprise a healthy diet.
  • To date, FDA has received nearly 900 comments on the definition of “healthy.” Parties interested in submitting written comments or receiving a detailed summary of the March 9th meeting are invited to contact us at fooddrug@khlaw.com.
  • As previously covered on this blog, FDA’s recently published final nutrition facts rule requires a mandatory declaration and a daily value (DV) for “added sugar”.
  • Since last summer, honey groups – spearheaded by the American Beekeeping Federation (ABF) – have been involved in efforts to push back against the “added sugar” labeling requirement.  Most recently, ABF urged its members to voice their opinion on the “added sugars” requirement by submitting comments to FDA’s draft guidance concerning the final nutrition facts rule; the comment period closed on March 6, 2017.  In general, ABF contends that “it would be much more logical and prudent if the FDA would consider listing the naturally occurring sugar content of 100% pure honey as ‘Total Sugars’ and not ‘Added Sugars’.”
  • With a new administration at the helm, it remains to be seen whether the honey industry will make any headway on the “added sugars” front.

Delays at USDA could jeopardize timely roll out of new federal GMO food disclosure rules (subscription to Food Chemical News required)

  • As previously discussed 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.  To support the development of the regulations and standards required by the new law, USDA is slated to conduct a study to identify potential technological challenges that might impact whether consumers would be able to rely on electronic or digital links on food packages.
  • A recent news report indicates that USDA has secured funds to conduct the required study and has made progress on drafting an Advanced Notice of Proposed Rulemaking to support the implementation of the new federal GMO food disclosure requirements, but has encountered some delays as the Agency awaits direction from Trump administration officials – particularly with the USDA Secretary pick not yet confirmed.
  • 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.
  • As our readership is well aware, in May 2016, FDA issued final rules to implement changes to the nutrition and dietary supplement labeling and serving size regulations.  Detailed summaries of both rules may be found here.  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).
  • In a letter dated February 24, 2017, a number of health advocacy groups urged FDA to stick with the July 28, 2018 mandatory compliance date for the updated nutrition facts rule noting that food companies have been afforded ample time to prepare for the change in labeling requirements.  Signatories of the letter include, but are not limited to: the Academy of Nutrition and Dietetics, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Diabetes Association, the American Heart Association, and the American Institute for Cancer Research.  The February 24th letter comes on the heels of the House Freedom Caucus’ push to have the nutrition facts rule added to a list of federal regulations for possible review and revocation by the Trump administration.
  • Given that many in the industry have started down the path of compliance with the updated nutrition facts rule, it is not immediately clear that the rule will be completely undone, but a compliance date delay is certainly a possibility.  We will continue to keep a close eye on any developments in this regard and report them to you here.