FDA Publishes Q&A Guidance on Mandatory Food Recalls

  • The Food Safety Modernization Act (FSMA) added Section 423 to the Federal Food, Drug and Cosmetic Act to give the U.S. Food and Drug Administration (FDA) the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded, and that use or exposure to the food will cause serious adverse health consequences or death to humans or animals (a Class I recall).
  • On November 5, 2018, FDA released a final guidance, in the form of questions and answers, on how the Agency will use its mandatory recall authority. (Also see: 83 Fed. Reg. 55551, November 6, 2018.) FDA issued a draft guidance on this topic in 2015 and requested comments at that time (see our May 7, 2015 blog for more information on the draft). The final guidance provides additional clarity, including some modifications based on comments received.
  • In addition to explaining the mandatory recall process, the final guidance identifies evidence that FDA “might” consider when making the decision to proceed with a mandatory recall, namely: 1) observations made during inspections, 2) results from sample analyses, 3) epidemiological data, 4) vulnerability of the populations that normally consumes the food, 5) nature of the product, 6)Reportable Food Registry data, 7) consumer and trade complaints, and 8) whether the responsible party has failed to initiate a voluntary recall. (See Q&A #8 in the final guidance.)
  • FDA has only issued a mandatory recall order of a food product once. (See our April 4, 2018, blog on FDA’s recall order for kratom products.). In two other instances, FDA began the process to initiate a mandatory recall authority under FSMA but the companies ultimately chose to voluntarily recall their product.

FDA Issues New Final and Draft Guidance Documents on Nutrition Facts Label and Serving Size Rules


  • In May 2016, FDA issued final rules changing the Nutrition Facts label for packaged foods and also updating regulations on serving sizes to – among other things – provide realistic Reference Amounts Customarily Consumed (RACCs).  Detailed summaries of both rules may be found here.
  • Today, FDA announced a final guidance, titled ‘‘Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals,” which replaces FDA’s January 2017 draft guidance.  The 2018 Final Guidance is intended for conventional food and dietary supplement manufacturers and offers new Q&As regarding added sugars (including examples for calculating added sugars in certain products).  Additionally, the document reflects the extended compliance dates for the Nutrition Facts label and Serving Size final rules.  For manufacturers with $10 million or more in annual food sales, the compliance date is January 1, 2020.  For manufacturers with less than $10 million in annual food sales, the compliance date is January 1, 2021.
  • FDA also announced a new draft guidance, titled ‘‘Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics.’’  The 2018 Draft Guidance includes Q&As on single-serving containers, RACCs, formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and miscellaneous topics, including compliance issues relevant to chewing gum, multi-unit retail food packages, and beverages.  Comments on the Draft Guidance document need to be submitted by January 4, 2019, to be considered by FDA before it begins work on the final guidance document.
  • Keller and Heckman attorneys are well-versed in the nutrition labeling requirements and would be glad to assist interested parties in preparing comments for submission to FDA.


FDA Announces Release of Environmental Assessment for E. Coli Outbreak Associated with Romaine Lettuce

  • As previously reported in the Daily Intake Blog and many other sources, there was a widespread outbreak of E. coli O157:H7 in the Spring of 2018.  The outbreak, which was linked to romaine lettuce grown in the Yuma, Arizona growing region, was responsible for over 200 confirmed infections and five deaths.  During FDA’s Leafy Greens Food Safety Task Force meetings on July 31 and August 1, The agency posited a theory that the contamination was due to use of water from a canal adjacent to a Concentrated Animal Feeding Operation (CAFO) and they promised an environmental assessment report once the investigation was complete.
  • Onn November 1, FDA Commissioner Dr. Scott Gottlieb announced the release of the environmental assessment report.  Of note:
    • FDA found E. coli O157:H7 in several samples of canal water but not in any other environmental samples tested;
    • FDA believes that the most likely source of contamination was from the canal water, but FDA could not rule out other causes; and
    • FDA believes the CAFO is the most likely source of the contamination, but did not find an obvious route of contamination.
  • FDA provided a number of recommendations regarding the growing and processing of leafy greens, including full implementation by growers and processors of the Food Safety Modernization Act (FSMA) provisions (see our blog posts relating to FSMA here).  This includes
    • Continued development of the Food Produce Rule and the agricultural water standards;
    • Implementing traceability systems; and
    • Conducting thorough root cause investigations and implementing corrective actions.
  • Dr. Gottlieb also announced that the FDA is taking steps to provide consumers with more timely information and to respond to food safety issues sooner.  This includes a newly announced plan for FDA to collect and analyze samples of romaine lettuce for contamination with human pathogens.

United Airlines Faces Multiple Food Safety Whistleblower Lawsuits

  • United Airlines is facing three whistleblower lawsuits filed by employees who reported food safety concerns at its Newark catering facility.  The suits have been filed by United’s former senior manager of food safety, Marcia Lee; the General Manager of the Newark catering facility, Eliot Mosby; and Newark Food Safety Manager, Gustavo Moya—who allege that, after reporting food safety concerns, they experienced retaliation, were relocated, and/or pushed to resign.
  • Central to the three cases are allegations that United ignored the employees’ concerns regarding Listeria monocytogenes (“L. mono”) at the Newark facility.  In a report by CNBC, the network states that it has been provided environmental test results taken from February to mid-August that included 175 positive results for Listeria species and 27 positive results for L. mono at the Newark catering facility.  No foodborne illnesses have been associated with foods handled at the Newark facility.
  • The employees—two of whom have filed in federal court and one of whom has filed in New Jersey state court—are seeking relief under New Jersey whistleblower and anti-discrimination laws. Section 402 of the Food Safety Modernization Act added whistleblower provisions to the Federal Food, Drug, and Cosmetic Act under Section 399d; however, the plaintiffs have not challenged United Airlines on this basis.

FDA Announces Plant and Animal Biotechnology Innovation Action Plan

  • In an October 30 press release, FDA announced their new Plant and Animal Biotechnology Innovation Action Plan in an effort to foster advances in the field as new technologies to edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity, and food security. For example, new forms of biotechnology allow for the modification of living organisms which may generate opportunities to improve public health, such as through the creation of novel pharmaceuticals, new food varieties, or disease-resistant crops.
  • The Action Plan provides an overview of FDA’s priorities to support innovation in plant and animal biotechnology and to advance the agency’s public health mission. Specifically, the Action Plan identifies priorities in three key areas:
  1. Advancing public health by promoting innovation
  2. Strengthening public outreach and communication
  3. Increasing engagement with domestic and international partners
  • In all, the priorities are intended to ensure the safety of plant and animal biotechnology products, foster continued public confidence in FDA’s regulation of these products, and avoid unnecessary barriers to future innovation consistent with FDA’s mission to protect and promote the public health. While many of the priorities outlined in the Action Plan are already underway, FDA intends to continue implementation of the commitments made under the Action Plan through 2020.
  • To begin implementation of the Action Plan, FDA will adopt a comprehensive policy framework for the development and regulatory oversight of animal biotechnology products in order to advance the Agency’s commitment to safety while stewarding innovation. FDA also intends to publish several guidance documents that will provide greater clarity on how FDA is applying its regulatory oversight to evaluate new biotechnology products. In addition to the Action Plan, FDA announced two upcoming programs:
    • A public webinar on December 3, 2018 on genome editing in animals which will focus on the current science, promising technology, and potential risks. Additionally, the webinar will provide information about the Center for Veterinary Medicine’s flexible, risk-based approach to the regulation of intentional genomic alterations in animals.
    • The Veterinary Innovation Program (VIP) is a new pilot program intended to facilitate advancements in the development of innovative animal products. The goal of VIP is to provide greater clarity and certainty in the regulatory process, encourage development and research, and support an efficient and predictable pathway towards approval for intentionally genetically altered animals (IGA animals) and animal cells, tissues, and cell- or tissue-based products (ACTPs).
  • FDA emphasized that the Action Plan is intended to help the agency ensure the safety of plant and animal biotechnology products while fostering innovation. FDA further stated their hopes for the Action Plan to produce a collaborative effort among all biotechnology stakeholders to promote efficient and clear regulatory pathways and to ensure safe products enter the marketplace.

FDA Considering Labeling for Sesame Allergies

  • In a statement from U.S. Food and Drug Administration (FDA) Commissioner Gottlieb, the agency announced that it is considering mandatory food labeling for sesame to help protect those that have sesame allergies. As required by the Food Allergen Labeling Consumer Protection Act, federal law provides that foods containing one of the eight “major food allergens”-milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans-declare the food source of the allergen using its common or usual name on food labels. When the law was first passed in 2004, those eight food groups, out of more than 160 identified food allergens, accounted for 90 percent of serious food allergic reactions occurring in the US.
  • Both the FDA and the United State Department of Agriculture’s Food Safety and Inspection Service (FSIS) have been under pressure for food recalls, with the leading reason being undeclared food allergens. Gottlieb has pledged to reform the agency’s approach to food recalls amid increased attention on the agency over food recalls, and possible regulatory action to add an additional major food allergen for mandatory disclosure is a sign of FDA’s expanding its efforts to protect and promote public health.
  • In light of new evidence that sesame allergies may be a growing concern in the US, FDA has issued a request for information “to learn more about the prevalence and severity of sesame allergies in the U.S., as well as the prevalence of sesame-containing foods sold in this country.” In addition, the request for information asks for comment on the possible costs of any future regulatory action regarding labeling for sesame allergies. Comments are due December 31, 2018.

FDA Will Hold Public Meetings Throughout the U.S. in November and December for Discussion of the New Draft Guidance on Standards for Compliance with the Produce Safety Rule


November 27, 2018
8:30 AM‐5:00 PM
Hilton Portland Downtown
921 SW Sixth Ave., Portland, OR 97204

November 29, 2018
8:30 AM-5:00 PM
Doubletree Suites by Hilton/Anaheim Resort Convention Center
2085 S. Harbor Blvd., Anaheim, CA 92802

December 11, 2018
8:30 AM-5:00 PM
Hilton Albany
40 Lodge St., Albany, NY 12207

December 13, 2018
8:30 AM-5:00 PM
Embassy Suites Atlanta at Centennial Olympic Park
267 Marietta St., Atlanta, GA 30313

  • Additional meeting specifics, including information on how to register for the meetings, will be made available on October 31, 2018 through a Federal Register Notice, and on the FDA public meetings website.


Final Comments Received Regarding FDA’s Nutrition Innovation Strategy

  • The Daily Intake has blogged on several occasions, and Keller and Heckman has published a client alert, about the Nutrition Innovation Strategy (NIS).  Briefly, the NIS is intended to improve public health via education regarding, and encouraging innovation in, the use of nutrition to promote health.  Areas of emphasis are modernizing the approach to label claims, modernizing standards of identity, modernizing ingredient labels, and the use of healthy symbols.  The deadline for comments was extended until October 11, 2018 and the last round of comments submitted appear to finally have been posted.
  • There were 1,357 public comments submitted.  Some notable companies or organizations to submit comments include, but are not limited to: Campbell Soup Company, Conagra Brands, Danone North America, Nestle, the Northwest Dairy Association, Food and Beverage Issue Alliance, American Olive Oil, American Dairy Coalition, Juice Products Association, Edge Dairy Farmer Cooperative, National Coffee Association, Kraft Heinz, Coca Cola, Grocery Manufacturers Association, and Chobani
  • On initial review of some of the food producer comments, companies appear to have provided comments on –
    • The definition of “healthy”;
    • A “healthy” symbol;
    • Consumer education, including updates to the nutrition facts label and qualified health claims; and
    • Standards of IdentityThough companies focused their comments on specific areas of interest or concern to them, i.e. Coca Cola partially geared its comments to beverage related issues, Chobani focused on yogurt and dairy, and Campbell Soup’s comments included a focus on foods that might impact the consumption of soup, certain patterns emerge. Companies are interested in adding clarity for consumers and increasing their ability to innovate.  For example, Chobani is seeking additional ability to market Greek Yogurt under a Standard of Identity as a high protein food and Campbell Soup believes that “a significant liberalization of qualified health claim language would help drive innovation and be beneficial to consumers” but that “an approved claim that is so laden as to render the claim entirely unappealing to consumers” is not commercially viable and will stifle research and innovation.   At the same time, companies stress their interest in protecting the public health, sometimes through maintaining the status quo or enforcing the standards of identity.  For example, Coca Cola is seeking to amend the rules prohibiting fortification of carbonated beverages – but Coca Cola stresses in its comments that it is not seeking to fortify traditional sodas; Chobani seeks revision to the standards of identity to include Greek Yogurt, and they noted their position that the consumption of “plant-milks is at a level that is likely to cause a public health concern”, suggesting that FDA should “consider consumer perceptions of foods defined by [standards of identity]” in setting policies.
  • We will continue to monitor FDA’s progress on this initiative.


Proposed Amendments to Proposition 65 regulations on Calculating Level of Exposure to Chemicals Causing Reproductive Toxicity; California Extends Comment Period

  • California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed to amend Section 25821(a) and (c) of the Proposition 65 regulations, which dictate how to calculate exposure to reproductive toxicants for average consumers.  Currently, Section 25821 requires simply that exposure be determined by multiplying the “level in question” (i.e., the concentration of a chemical in a given medium) by the reasonably anticipated rate of exposure to the chemical by the average users of the consumer product.
  • The proposed amendments would make two changes.  First, the proposal would amend Section 25821(a) to clarify that where a business presents evidence of the “level in question” of a listed chemical in food based on the average of multiple samples of that food, the level in question cannot be calculated by averaging the chemical’s concentration in foods from various lots (i.e., “by averaging the concentration of the chemical in food products from different manufacturers or producers, or that were manufactured in different manufacturing facilities from the product at issue”).  Second, the proposal would amend Section 25821(c)(2) to require that exposures to reproductive toxicants from consumer products be calculated as the arithmetic mean of the rate of intake or exposure for product users (as opposed to the geometric mean).
  • The proposed amendments are a direct response to the 2015 appellate decision Environmental Law Foundation v Beechnut Nutrition Corp. et al. case, in which Section 25821 was interpreted to allow the averaging of concentrations of lead in multiple lots and to allow use of the geometric mean when calculating individual exposures.
  • Because of a request for public hearing filed by the California Chamber of Commerce, OEHHA has extended the public comment period from November 19 to November 26.  Comments can be submitted online.

FDA Emphasizes Continued Commitment to Develop a Strong Tobacco Product Application Review Process

  • In an October 22, 2018 press release, FDA Commissioner Scott Gottlieb, M.D., emphasized the agency’s ongoing commitment to significantly reduce tobacco-related disease and death, with particular emphasis on protecting kids from the dangers of nicotine. In order to do so, FDA asserted the critical need to have an efficient regulatory process that puts novel products, such as e-cigarettes, through an appropriate series of regulatory measures in order to fully evaluate their risks and possible benefits. FDA acknowledged that such a review process is important because it gives them the ability to evaluate important factors, like ingredients, product design, and health risks.
  • As part of this ongoing work, FDA held a two-day public meeting from October 22-23 to discuss the policies and processes for tobacco product application review. The meeting was held with the intention to improve public understanding and to seek feedback on FDA’s policies and processes for the submission and review of tobacco product marketing applications. In sum, the meeting addressed the following topics:
    • Overview of the tobacco product marketing applications types
    • Information that should be included in a tobacco product marketing application
    • Administrative processes involved in the submission and review of a tobacco product marketing application
    • Other relevant topics, including Grandfathered Review, Environmental Assessments, and Tobacco Product Master Files
  • The meeting builds on commitments FDA made in July 2017 when they announced their comprehensive regulatory plan for tobacco and nicotine products. For example, FDA continues to explore the development of product standards to protect the public health and make the review process more effective. FDA confirmed their intention to issue regulations and guidance outlining what information must be included in premarket tobacco product applications (PMTA), modified risk tobacco product (MRTP) applications, and substantial equivalence (SE) reports. FDA is hopeful that the information shared during the meeting can be used to ensure a clear and viable pathway for FDA tobacco product authorization, which could result in the marketing of potentially less harmful products for adult smokers. They also emphasized the importance of a strong application review process to ensure new tobacco products meet FDA’s standards and to reduce tobacco-related disease and death.
  • To learn more about this and other tobacco-related topics, be sure to subscribe to our sister blog, The Continuum of Risk.

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