• The U.S. Department of Agriculture (USDA) announced on September 24 that it will hold a public meeting to provide interested parties an opportunity to address items on the agenda of the 41st Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). Meeting participants will be given the opportunity to comment on agenda items and the agency’s draft positions to be discussed at the CCNFSDU session.
  • The CCNFSDU session is an annual meeting convened under the authority of the Codex Alimentarius Commission (CAC), an international body that publishes a collection of reference standards, guidelines, and codes of practice (“Codex Alimentarius” or “Food Code”). The annual CCNFSDU session provides member countries and observers an opportunity to address new issues involving “special dietary uses” of foods, such as dietary supplements. In addition to the CCNFSDU, the CAC maintains a Committee on Food Additives (CCFA) and a Committee on Contaminants and Toxins in foods (CCCF).
  • The USDA’s public meeting will address multiple items on the CCNFSDU agenda, including ready-to-use therapeutic foods, proteins, trans fatty acids, and labeling of infant formula, among other topics.
  • The USDA’s public meeting is scheduled for November 1, 2019 at the U.S. Food and Drug Administration’s (FDA’s) Harvey H. Wiley Building in College Park, Maryland, and the CCNFSDU session will take place from November 24­-29, 2019, in Dusseldorf, Germany.  Registration for the November 1, 2019 meeting may be made via email until October 30.

For additional questions regarding Codex Alimentarius and the regulation of dietary supplements and food additives, Keller and Heckman clients may contact Katia Merten-Lentz, mertenlentz@khlaw.com in Keller and Heckman’s Brussels office, or Mel Drozen, drozen@khlaw.com, in the U.S. office.

  • USDA’s Agricultural Marketing Service (AMS), which promulgated the National Bioengineered (BE) Food Disclosure Standard, has announced additional responses to its Frequently Asked Questions (FAQs).   A total of five new FAQs have been published, one of which confirms that BE labeling information need not be provided online or in catalogs (i.e., disclosure on the label itself is sufficient).
  • AMS also released a Disclosure Determination Tool, which walks users through a series of questions and advises whether the food requires BE labeling.
  • The implementation date of the disclosure standard is January 1, 2020, except for small food manufacturers, which have until January 1, 2021.  The mandatory compliance date is January 1, 2022.
  • The FDA has partnered with the University of Arizona, the Wellton-Mohawk Irrigation and Drainage District (WMIDD), and members of the Yuma area leafy greens industry, with support from the Arizona Department of Agriculture, to better understand the ecology of human pathogens in the Yuma agricultural region.  The Yuma agricultural region encompasses Yuma County in Arizona and the Imperial Valley in California, and is a leader in the production of leafy greens in the United States. The initiative will be a multi-year study to focus on how these pathogens survive, move, and possibly contaminate produce prior to harvest.
  • The launch of the initiative comes on the heels of the largest E. coli O157:H7 outbreak in the United States since 2006.  As our readers may know, the outbreak began in the spring of 2018 and was linked to romaine lettuce grown in Yuma. The outbreak resulted in 210 reported illnesses from 36 states, 96 hospitalizations, 27 cases of hemolytic uremic syndrome (HUS), and 5 deaths. In response, FDA conducted an Environmental Assessment (EA) of the Yuma growing region in collaboration with the Centers for Disease Control and Prevention (CDC), the Arizona Department of Agriculture, WMIDD, and state partners from June through August 2018. A summary of the EA can be found here.
  • The findings of the EA made clear that further collaboration among leafy greens stakeholders and FDA is needed to better understand potential sources of microbial contamination, the prevalence and persistence of human pathogens in the ecosystem near growing areas, and the best management practices to prevent future outbreaks. Thus, in this new partnership, FDA will work with water quality, food safety, and agricultural experts from the University of Arizona Cooperative Extension, representatives from the WMIDD, and members of the Yuma area leafy greens industry. Throughout the initiative, research teams will collect and examine samples from the environment, such as surface waters, canal sediment, and dust. The team will also collect scat samples to assess the impact that animal intrusion and native wildlife may have on the growing environment. FDA intends for the results from the partnership to lead to improved practices that prevent or mitigate food safety risks, and enhance the safety of produce grown in the region.
  • A bipartisan group of members of Congress sent a letter to FDA on September 19 urging the Agency to quickly provide legal clarity and establish a regulatory pathway for food products containing hemp-derived cannabidiol (CBD). “We appreciate FDA’s proactive approach towards pursuing a legal pathway for the production of hemp-derived products containing CBD … However, FDA’s current regulatory posture on CBD has created significant regulatory and legal uncertainty for participants in this quickly evolving industry,” wrote the lawmakers.
  • Expressing concern about FDA’s estimate that a rulemaking process could span 3 to 5 years, the lawmakers stated, “We believe there are more expeditious measures that FDA could take that would establish regulatory clarity while pursuing enforcement actions against bad actors.” These include: first, announce a policy of enforcement discretion and, second, consider issuing an interim final rule to establish a clear regulatory framework for CBD as a dietary supplement and food additive.
  • This is not the first request from Congress to FDA to provide legal clarity on the use of CBD in foods and dietary supplements.
    • As previously reported on this blog, in a January 12, 2019 letter to FDA Commissioner Scott Gottlieb, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) urged the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements.
    • Congresswomen Chellie Pingree (D-Maine), who was the lead author on the September 19 letter, points out in a press release that she first wrote to FDA in February 2019 requesting guidance on legal pathways for food products containing CBD.
    • Last week, we reported on an amendment to the Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD).
  • We will continue to report on developments in the regulation of CBD by FDA.
  • As previously reported, both states’ departments of agriculture and FDA have begun visits to produce farms to conduct inspections for compliance with the Produce Safety Rule. The FSMA final Produce Safety Rule was published on November 27, 2015 (80 FR 74353) and establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce. Our detailed summary of the rule is available here.
  • On September 9, 2019, FDA announced the award of a cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to provide information and resources to help state and territorial regulatory agencies plan and help carry out implementation of the Produce Safety Rule.
  • In addition to the funding that will allow NASDA to assist state and territorial produce safety regulatory programs in developing produce safety programs, the five-year cooperative agreement also provides for an annual National Consortium meeting of state and territorial regulatory agencies involved with implementation of the Produce Safety Rule.

Keller and Heckman attorneys are available to assist interested parties in preparing for and navigating compliance inspections under the Produce Safety Rule. For assistance, please email: fooddrug@khlaw.com.

  • As we have previously covered on this blog, on February 1, 2018, FSIS put forward a proposed rule to establish a voluntary, opt-in inspection system for market hog slaughter establishments, called the New Swine Slaughter Inspection System (NSIS). The proposal had received pushback from consumer groups and several media outlets, with FSIS defending its proposal in a direct response to a Washington Post article earlier this year.
  • On September 17, 2019, FSIS released the final rule establishing the NSIS. Under the final rule, hog slaughter plants may voluntarily join a new inspection system whereby establishment personnel would be responsible for sorting and removing unfit animals and identifying defects before FSIS inspection. FSIS online inspectors would be reduced to a maximum of three per line per shift.  The rule also revokes maximum line speeds in processing plants.
  • In a press release, USDA Secretary Sonny Perdue stated: “The final rule is the culmination of a science-based and data-driven rule making process which builds on the food safety improvements made in 1997, when USDA introduced a system of preventive controls for industry. With this rule, FSIS will finally begin full implementation of that program in swine establishments.”
  • Senate Majority Leader Mitch McConnell (R-KY) has introduced language into a Senate appropriations bill that would require FDA to issue temporary guidance on enforcement related to products containing cannabidiol (CBD). 
  • The amendment, which was shared with the U.S. Hemp Roundtable, would require FDA to provide Congress with a report on how it will develop its enforcement discretion policy and how it will evaluate CBD for use in FDA-regulated products within 90 days of passage.  Within 120 days, FDA would be required to issue its enforcement discretion policy for CBD. 
  • The market for CBD products is rapidly increasing, and the regulation of CBD in foods and supplements has not kept pace.  McConnell has shown a great interest in limiting the regulatory uncertainty faced by hemp farmers in his state of Kentucky, where hemp production is replacing tobacco production. 

 

  • FDA will hold a public meeting on October 21, 2019 to hear from a broad cross-section of stakeholders on their new food safety approach, called “A New Era of Smarter Food Safety.” The new approach is intended to combine the implementation of FSMA with the use of new and emerging technologies, like blockchain, sensor technology, the Internet of Things, and artificial intelligence.  FDA is working towards enhancing its ongoing efforts to implement FSMA by creating a more digital, traceable, and safer system to help protect consumers from contaminated food.
  • At the meeting, the public will have a chance to discuss and comment on FDA’s new approach to food safety and the input received both at the meeting and in comments submitted to the accompanying Federal Register docket will help shape the FDA Blueprint for a New Era of Smarter Food Safety. As our readers may remember, the Blueprint will outline how FDA plans to address several areas of food safety, including traceability, digital technologies, and evolving food business models. FDA intends for the strategic plan to outline how this new approach will address public health challenges, including being able to trace sources of contaminated foods and using new predictive analytics tools to assess risks and prioritize the agency’s work and resources.
  • Persons interested in attending the public meeting either in-person or by webcast must register online by October 11, 2019. The deadline to submit written/electronic comments is November 20, 2019. Keller and Heckman attorneys are well-versed in FSMA and food safety requirements and stand ready to assist interested parities in preparing comments for submission to FDA.
  • The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry, titled, “Reconditioning of Fish and Fishery Products by Segregation.” This draft guidance explains two potential approaches to separating non-violative portions of fish and fishery products from portions that are adulterated due to pathogens, unlawful animal drugs, scombrotoxin (histamine), or decomposition. The two approaches to reconditioning adulterated fish and fishery products, described in the draft guidance, are:
      1. Segregation based on a production-related rationale supported by production records identifying the cause of the adulteration and its restriction to only a portion of the article along with sampling and testing to confirm that the segregation was successful; or
      2. Segregation based on the results of statistically significant sampling and testing.
  • These approaches can be used if they satisfy the requirements of the applicable statutes and regulations but do not apply when reconditioning is proposed by means other than segregation, such as be cooking or conversion to animal feed, according to FDA (84 Federal Register 48935). Although, the Agency cautions that anyone introducing, delivering, or receiving fish and fishery products in interstate commerce is ultimately responsible for ensuring that the food is safe and complies with all applicable laws and regulations.
  • FDA has requested feedback on the draft guidance. The comment period will be open for 60 days until November 18, 2019. Electronic comments can be submitted on https://protect-us.mimecast.com/s/VHGXCmZEzmSj03MjIQWIRD to docket FDA-2019-D-3324.

Chipotle Wraps Up False Ad Suit With $6.5M Settlement (subscription to Law360 required)

  • As previously covered on this blog, a plaintiffs’ class action lawsuit was filed against Chipotle in the “Food Court” (Northern District of California) in connection with the chain’s nationwide advertising campaign premised on a pledge to serve only “non-GMO” foods.  On October 1, 2018, the court certified three classes of consumers, in California, Maryland, and New York, who claim to have purchased food at Chipotle advertised as “non-GMO,” but which contained meat and dairy ingredients from animals that had consumed genetically modified (GM) feed.  The issue is whether reasonable consumers would have been deceived by such advertising.
  • On September 11, 2019, just days before the scheduled trial date of September 16, 2019, the plaintiffs asked the court to approve a deal in which Chipotle has agreed to pay $6.5 million to settle the false advertising claims.  As part of the settlement, the three classes, in California, Maryland, and New York, would be consolidated into a single class consisting of all U.S. residents who purchased Chipotle food during the class period from April 27, 2015 to June 30, 2016.  Class members would receive refunds of $2 per meal for up to 5 meals without documentation and up to 10 meals with documentation, for a total limit of 15 meals per household.  The four class representatives would receive $5,000 each.  The attorneys would receive fees of $1.96 million and out-of-pocket expenses of up to $650,000.
  • While Chipotle has discontinued the advertising at issue, the debate over the meaning of “non-GMO” is certain to continue.  As discussed here, the Non-GMO Project sponsors labels certifying adherence to standards that define the meaning of “non-GMO,” which would clear up the potential for consumer misunderstanding of the scope of the “non-GMO” claim, as was at issue in the Chipotle lawsuit. However, according to a Citizen Petition to the Food and Drug Administration (FDA) dated September 24, 2018 by the Information Technology & Innovation Foundation (ITIF), even a “non-GMO” label that is clear on the scope of the claim may mislead and deceive consumers about non-existent differences in health and safety of the labeled food and should, therefore, be prohibited.  FDA has not yet taken substantive action on the Citizen Petition and is unlikely to do so in the near future.