• The U.S. Food and Drug Administration (FDA) has issued a final Compliance Policy Guide (CPG), Sec. 540.750, on the “Use of The Seafood List to Determine Acceptable Seafood Names.”  The Seafood List is FDA’s guide to acceptable market names for domestic and imported vertebrate and invertebrate seafood sold in interstate commerce.  The Seafood List provides information on the proper labeling of seafood and products containing seafood ingredients, such as in the statement of identity and ingredient list.  In addition, FDA’s Seafood List Guidance (“Guidance for Industry: The Seafood List – FDA’s Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce”) provides guiding principles to determine the acceptable market name for a new seafood species introduced into the marketplace and defines the various categories of names in the Seafood List (acceptable market name, common name, scientific name, and vernacular name).
  • The CPG (guidance directed towards FDA staff that also informs industry of FDA’s interpretations of policy on regulatory issues) is intended to be used together with the Seafood List and Seafood List Guidance, upon consultation of existing standards of identity, FDA statutes, regulations, and other CPGs (e.g., CPGs specifically addressing snapper and caviar), in an effort to reduce or eliminate mislabeled and misbranded products in the marketplace.
  • The CPG finalizes a draft version issued in November 2016, and includes updated language, such as guidance acknowledging that the United States Department of Agriculture’s Food Safety and Inspection Service (USDA FSIS), through its mandatory inspection program, regulates fish of the order Siluriformes, including catfish and products derived from catfish.  The CPG also discusses potential enforcement actions that may be taken and provides specimen charges relating to domestic seizure and import refusal.  Finally, it provides regulatory action guidance to FDA’s field staff in an effort to address misbranding violations and clarifies acceptable names for labeling seafood species.
  • On July 21, 2020, the U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consuming certain cranberry products and a reduced risk of recurrent urinary tract infection (UTI) in healthy women.  FDA’s letter was in response to a health claim petition submitted on behalf of Ocean Spray Cranberries, Inc.  The petitioner requested that FDA authorize a health claim regarding the relationship between the consumption of cranberry products and the reduced risk of recurrent UTI in healthy women.  By way of background, a health claim characterizes the relationship between a substance and a disease or health-related condition.
  • FDA concluded that there is limited and inconsistent credible scientific evidence to support a qualified health claim for the consumption of cranberry juice beverages, and limited credible scientific evidence to support a qualified health claim for the consumption of cranberry dietary supplements and a reduced risk of recurrent UTI in healthy women.
  • In its response to the petition, FDA noted that it will exercise its enforcement discretion regarding claims for the association between consumption of cranberry juice beverages containing at least 27 percent cranberry juice and cranberry dietary supplements containing at least 500 milligrams (mg) of cranberry fruit powder (100% fruit) and a reduced risk of recurrent UTI.   FDA noted that the claims do not include other conventional foods or food products made from or containing cranberries, such as dried cranberries or cranberry sauce.
  • The following qualified health claims for cranberry juice beverages are included in the FDA’s letter of enforcement discretion:
    • “Limited and inconsistent scientific evidence shows that by consuming one serving (8 oz) each day of a cranberry juice beverage, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
    • “Consuming one serving (8 oz) each day of a cranberry juice beverage may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
    • “Consuming one serving (8 oz) each day of [this identified cranberry juice beverage] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that the scientific evidence supporting this claim is limited and inconsistent.”
  • The following qualified health claims for cranberry dietary supplements are included in the FDA’s letter of enforcement discretion:
    • “Limited scientific evidence shows that by consuming 500 mg each day of cranberry dietary supplement, healthy women who have had a urinary tract infection (UTI) may reduce their risk of recurrent UTI.”
    • “Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”
    • “Consuming 500 mg [X capsules/tablets/soft gels] each day of [this identified cranberry dietary supplement] may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim.”
  • The U.S. Food and Drug Administration has published a draft guidance document that details the agency’s current thinking about how drug developers can perform compliant clinical research when developing new drugs containing cannabis or cannabis-derived compounds.
  • This guidance is meant to clarify the agency’s approach to reviewing human clinical trial applications involving drugs that contain cannabis, given the 2018 Farm Bill’s change to the control status of hemp. The FDA’s document provides drug developers with recommendations regarding new potential options to source cannabis and cannabis-derived compounds for drug development, highlights informational resources for stakeholders to review to ensure quality considerations are being met, and indicates how and when percent delta-9 tetrahydrocannabinol (THC) calculations should be performed.
  • The FDA’s publication makes it clear that, when performing clinical research, sponsors and investigators of clinical studies can utilize hemp that does not exceed a 0.3 percent delta-9 THC limit as a source of cannabis and cannabis-derived compounds. This constitutes a significant expansion of accessibility to those looking to develop drugs with cannabis and cannabis-derived compounds for appropriate medical applications. In releasing such guidance, the agency affirms its support of the development of these new drugs that satisfy the necessary review and approval processes. This draft guidance is open for comment submission until September 21, 2020.
  • On July 15, 2020, the FDA announced that routine inspections of small businesses (those with fewer than 500 employees) to verify compliance with the Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) Rule will begin in March 2021. The compliance date is July 27, 2020.
  • The IA Rule is intended to prevent the adulteration of the food supply by intentional acts designed to cause wide-spread harm to the food supply and the public health (i.e. acts of terrorism). The rule generally applies to domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic Act (the rule does not cover farms) and, in an approach similar to the Hazard Analysis Critical Control Point (HACCP) system, requires that covered facilities develop a food defense plan. In particular, the rule requires:
    • Vulnerability identification: At every step in their food production process, covered facilities must evaluate 1) the severity and scale of the potential impact on public health, 2) the degree of physical access to the product, and 3) the ability to successfully contaminate the product;
    • Identification and implementation of mitigation strategies: At each step, vulnerabilities must be addressed with mitigation strategies tailored to the facility and its procedures. The implementation of these strategies must be monitored, with corrective actions taken where appropriate. Further monitoring and corrective actions should be subject to review by verification activities.
    • Training and record keeping: Personnel in vulnerable areas must receive proper training and facilities must maintain records of food defense monitoring, corrective actions, and verification activities.
  • While inspection for large businesses under the IA rule was scheduled to begin in March 2020, COVID-19 has thus far delayed the start of routine inspections under the IA Rule (for recent news regarding resumption of certain domestic food facility inspections, see Keller and Heckman’s coverage here). When inspections under the IA rule begin, they will occur during regularly scheduled food safety inspections and will consist of “quick checks” that will ensure that the basic requirements of the rule have been met and will also give FDA an opportunity to educate covered facilities regarding implementation of a food defense plan.  Keller and Heckman will continue to monitor updates on the IA Rule and the resumption of food facility inspections.
  • Numerous class action lawsuits have been filed, mostly by a single firm, involving products that are claimed to contain deceptive and misleading information on their labels regarding vanilla.  We have reported, for example, on a lawsuit filed June 26, 2020 against Hain Celestial Group involving soymilk, which specifically alleges that the challenged product contains vanillin (an artificial vanilla flavor), and is distinguished from a case dismissed in June against Kellogg for granola bars, where the claims were deemed too speculative because the Plaintiffs relied solely on the declaration of “natural flavors” in the ingredient list, as opposed to a listing for “vanilla” or “vanilla extract,” to conclude that a non-vanilla flavor was present.
  • Most recently, on July 16, 2020, in a case against Unilever (subscription to Law360 required), a California federal judge rejected procedural arguments in a motion to dismiss claims that Breyers Natural Vanilla Ice Cream is falsely marketed and labeled as containing vanilla flavor derived exclusively from the vanilla plant and is misleading consumers by failing to state that it also contains artificially flavored vanilla, as revealed in laboratory testing of the ice cream.  In a similar case involving Wegman’s vanilla ice cream, which was dismissed last week, the Plaintiffs did not allege the product was labeled as being exclusively flavored with vanilla bean or vanilla extract.  The New York federal judge in the Wegman’s case determined that data relied on by the plaintiff may not have been sufficiently sensitive to determine that vanilla was not present in the ice cream.  Additionally, perhaps misconstruing FDA’s labeling regulations, the judge questioned whether the labels were deceptive because they did not state that vanilla bean or vanilla extract were used, although Plaintiffs had argued that to be truthful the product should have been labeled as “flavored” vanilla ice cream.
  • Keller & Heckman will continue to monitor and provide updates regarding vanilla products and other class-action litigation in the food industry.
  • On July 14, 2020, a New York federal judge dismissed a lawsuit against Wegmans Food Market (“Wegmans”) concerning allegedly deceptive labeling of its vanilla ice cream.  The plaintiffs had alleged that the ice cream was deceptively labeled because it is flavored using flavors from sources other than vanilla bean or vanilla extract but was not described on the principal display panel as being “flavored” vanilla ice cream.
  • U.S. District Judge Louis Stanton dismissed the claims after determining that the analysis provided by the plaintiffs may not have been sensitive enough to detect all markers of vanilla and, therefore, could not prove that vanilla was not in the product.
  • In his opinion (subscription to Law360 required), Judge Stanton also questioned whether the labels for the ice cream were deceptive, as neither the label nor ingredients state that the ice cream uses vanilla bean or extract.  We note that, if asked, FDA may not have agreed that the labeling of this product was in compliance with flavor labeling and ice cream labeling regulations.
  • As we have previously reported, there have been many similar lawsuits alleging deceptive and misleading labels regarding vanilla products.

 

  • On July 9, 2020, USDA’s Agricultural Marketing Service unveiled an unpublished draft of Strengthening Organic Enforcement, which is a new rule for the National Organic Program aimed at bolstering enforcement and oversight of the US organic industry.  This proposal addresses challenges by making changes in four major areas.
  • First, the proposed rules limit the types of businesses that are exempt from organic certification, which closes gaps in oversight that increase the risk of fraud and mishandling that can compromise organic products.   This proposed rule applies to those businesses that “buy, sell or trade organics, or businesses that negotiate the purchase, sale or trade of organic products between buyers and sellers.”
  • Second, the proposed rule mandates electronic National Organic Program import certificates for all organic products.  This represents a change from the current system, which only requires import certificates from certain countries, like those in the EU, South Korea, and Japan.  The director of AMS’ Standards Division noted that requiring electronic National Organic Program Import Certificates for each shipment of organic products into the US will help ensure compliance of imported organics by “providing traceability to the port of entry and creating an auditable record trail.”
  • Third, the proposed rule includes standardized record-keeping requirements, which are meant to help prevent and quickly contain fraud at the operation level before it continues onto the supply chain.
  • Lastly, the new proposal requires that certifiers take additional steps to protect the integrity of the organic supply chain and addresses on-site audits.  For example, the proposed rule requires that all certifiers conduct unannounced inspections of at least 5% of the operations they certify annually.  We will continue to monitor any developments.
  • On July 13, the FDA announced its New Era of Smarter Food Safety Blueprint, which outlines the Agency’s plan to create a safer food system over the next decade. The Blueprint represents achievable goals to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of stronger food safety cultures. The Blueprint builds on the work that FDA has already implemented through FSMA and also outlines a partnership between government, industry, and public health advocates to create a modern approach to food safety.
  • The Blueprint is centered around four core elements:
    • Tech-enabled Traceability – FDA wants to utilize new technologies and integrate data streams to identify outbreaks and trace the origin of contaminated food to its source in minutes.
    • Smarter Tools and Approaches for Prevention and Outbreak Response – The Blueprint includes plans to strengthen the FDA’s procedures and protocols for conducting root cause analyses that can identify how a food became contaminated and figure out how to help prevent contamination from happening again. The need for greater traceability and predictive analytics is seen in the Agency’s most recent efforts to improve the safety of romaine and other leafy greens.
    • New Business Models and Retail Modernization – FDA is also examining new business models for the production and delivery of food, while ensuring that those foods continue to be safe for consumers. New business models include novel ways of producing foods and ingredients, such as cell-cultured food products. FDA is also committed to exploring new approaches of food safety that go beyond traditional training and inspection for retail establishments and restaurants.
    • Food Safety Culture – The Blueprint also focuses on fostering the growth of and strengthening the food safety culture on farms and in food facilities all over the world. For instance, in order to make dramatic reductions in foodborne disease, the Agency believes they must do more to influence and change human behavior, as well as to address how employees think about food safety and educating consumers.
  • FDA originally intended to publish the Blueprint in March, but was forced to postpone and turn attention to addressing the public health emergency posed by the COVID-19 pandemic. However, as explained by the FDA, the pandemic has made it even more clear that the actions outlined in the Blueprint are essential to protect and promote food safety.
  • On July 8, 2020, the District Court for the Eastern District of Wisconsin granted Defendant Champion Petfoods’ motion for summary judgment and dismissed a proposed class action which alleged that Champion Petfoods had deceptively marketed its pet food products, in part because they contained trace amounts of Bisphenol-A (BPA).
  • The Court, applying its precedent related to trace amounts of heavy metals in animal food products,  held that the failure to disclose trace, non-harmful amounts of BPA did not constitute misleading advertising because BPA is pervasive in the environment and present in many pet foods, and a decision holding Champion Petfoods liable would require virtually all pet food companies to pull their product from the Wisconsin market.
  • While false advertising claims based on the mere presence of BPA (in any amount) are likely to be dismissed, as the Court noted, claims which allege that an “excessive” amount of BPA is present or that BPA is present in a greater amount that other products, may present viable litigation theories. Keller and Heckman will continue to monitor and report on development in the food litigation space.
  • Risk-based inspection priorities mandated by the FDA Food Safety Modernization Act (FSMA) of 2011 require FDA to conduct routine inspections of high-risk domestic facilities at least once every three years.  In March 2020, FDA announced that it was temporarily postponing all routine on-site inspections of domestic food facilities and would instead resort to alternative means of oversight, such as evaluating records from facilities for as long as conditions warrant with respect to the corona virus pandemic.
  • FDA’s July 10, 2020 Coronavirus (COVID-19) Update: Daily Roundup announced the release of a statement on plans for resuming on-site domestic inspections beginning July 20, 2020 at certain food facilities.  Prioritized domestic inspections under this plan will be pre-announced to FDA-regulated businesses.  Facilities where on-site inspections can resume will be determined under a newly developed COVID-19 Advisory Rating system (COVID-19 Advisory Level).  The Advisory Level is based on the Phase of the State (as defined by the White House guidelines on Opening Up America Again) and statistics measured at the county level to gauge the current trend and intensity of infection.  The resumption of inspections is contingent on FDA observing downward trends in new cases of COVID-19 and hospitalizations in the geographic region where a facility is located.  FDA will identify regulatory activities that can occur at the county level as follows:
    • mission critical inspections only,
    • all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population, and
    • resumption of all regulatory activities.
  • Keller and Heckman attorneys and scientists are available to assist interested parties in preparing for and navigating FDA food facility inspections.  For assistance, please email: fooddrug@khlaw.com.