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  • On August 19, two consumer groups, Center for Food Safety (CFS) and Center for Environmental Health (CEH), filed suit against the FDA in California federal court for its failure to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA). At issue in the lawsuit is Section 422 of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by FSMA.  Section 422 (21 U.S.C. 350k) required that by January 4, 2013, FDA establish a program to detect and address foodborne illness outbreaks with more accredited laboratories and provide a database of accredited labs.  Among other requirements, FDA was to establish a program for the testing of food by accredited laboratories; establish a publicly available registry of accreditation; and develop model standards that a laboratory must meet in order to be accredited by a recognized accreditation body. 21 U.S.C. §350k(a).
  • In the complaint, CFS and CEH allege that missing the 2013 deadline and failing to propose final regulations by six years violated FSMA and the Administrative Procedures Act (APA), and “is putting millions of lives at continued risk from contracting foodborne illness, contrary to Congress’s commands.” According to CFS staff attorney, Ryan Talbott, “[a]ccurate laboratory testing is essential to reduce the foodborne illness threat. […] FDA was required to establish a comprehensive food testing program years ago, but has yet to do so. We will hold FDA accountable and protect the public health, as we always have.”
  • The lawsuit comes after 2018 saw several foodborne illness outbreaks, most notably the multistate outbreak of E. coli linked to romaine lettuce. In 2018, the Centers for Disease Control and Prevention (CDC) investigated 24 foodborne illness outbreaks as compared to 7 outbreaks in 2017.  This year, the CDC has already investigated 12 outbreaks.
  • CFS and CEH have sued FDA over missed FSMA deadlines twice before. Our readers may recall the 2012 suit against FDA after the agency missed seven statutory Congressional deadlines for promulgating FSMA’s food safety regulations. See Str. For Food Safety v. Hamburg, 954 F.Supp.2d 965 (N.D. Cal. 2013). The 2012 Court held that “FDA’s failure to promulgate the mandated regulations by their statutory deadlines constituted a failure to act under the Administrative Procedure Act (APA) and unlawful withholding of the regulations in violation of FSMA and the APA.” The Court granted injunctive relief and established a timeline for FDA to promulgate the final regulations. In October of 2018, CFS and CEH sued the agency for failure to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods by the statutory deadlines. On June 7, 2019, via Consent Decree, FDA agreed to a schedule of deadlines to establish reporting requirements for “high-risk” foods.
  • FDA has yet to respond to the current CFS and CEH complaint. Keller and Heckman will continue to monitor the developments of this case.
  • On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP).  As our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, including, but not limited to, HARPC requirements or produce safety standards. The first FSVP compliance date began May 30, 2017, however there are a range of compliance dates according to a number of considerations.
  • The warning letter, dated July 30, was issued to Brodt Zenatti Holdings LLC in Jupiter, Florida who imported tahini from the Israel-based manufacturer, Karawan Tahini and Halva. In May, the tahini was implicated in a Salmonella outbreak and was voluntarily recalled. In response to the Salmonella outbreak, FDA conducted an FSVP facility inspection, and found that the importer was in significant violation of the FSVP rule. As discussed in the warning letter, the importer did not develop an FSVP for the tahini as required by section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L. Within 15 working days, FDA has requested a response to the warning letter that demonstrates plans to correct or evidence that they have corrected the violations. Should the importer fail to correct the violations, they may be placed on the newly established Import Alert #99-41.
  • Since 2017, FDA has been conducting FSVP inspections in order to help importers understand the requirements and how to take corrective actions if deficiencies are observed. FDA will continue to take steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk. Additionally, as outlined in FDA’s Strategy for the Safety of Imported Food, FDA is committed to working with importers to come into compliance with all applicable FSMA regulations, including FSVP.  FDA’s Strategy is guided by four goals:
    • (1) Food offered for import meets US food safety requirements
    • (2) FDA border surveillance prevents entry of unsafe foods
    • (3) Rapid and effective response to unsafe imported food
    • (4) Effective and efficient food import program.

An overview of the Strategy can be found here.

Keller and Heckman attorneys are available to assist interested parties in preparing the necessary documentation for and navigating compliance under the FSVP rule. For assistance, please email: fooddrug@khlaw.com.

  • On June 25, FDA issued warning letters to two marketers and distributors of kratom products – Cali Botanicals and Kratom NC. FDA determined that the companies were illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. Additionally, FDA found that the companies also made claims about treating pain, as well as other medical conditions like depression, anxiety, and cancer.
  • In FDA’s press release, Acting FDA Commissioner Ned Sharpless noted that there are no FDA-approved uses for kratom and the agency has been active in warning consumers about the serious risks associated with kratom. For example, as our readers may know, FDA has warned about both the high levels of heavy metals found in kratom products and the contamination of certain kratom products with salmonella. Indeed, FDA issued its first ever mandatory recall order for the salmonella-containing kratom products.
  • The June 25 warning letters allege that the companies used their websites and social media to illegally market kratom products and made unproven claims about the ability of the products to cure, treat, or prevent disease. Examples of the claims include:
    • “Kratom acts as a μ-opioid receptor-like morphine.”
    • “In fact many people use kratom to overcome opiate addiction.”
    • “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”
    • “Usage: It is for the management of chronic pain, as well as recreationally.”
  • FDA reiterates that “[t]hese products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.” FDA has requested responses from both companies within 15 working days.
  • The Executive Office of the President recently released the Spring 2019 Unified Agenda. As we described in our post for the release of the Fall 2018 Unified Agenda, twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top regulatory priorities for the coming months.
  • The agenda includes significant regulatory undertakings by the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Of particular note for USDA is the hemp production program rule, which the Unified Agenda indicates will be released as an interim final rule in August 2019.  As readers of this blog may recall, the 2018 Farm Bill removed hemp from the Controlled Substances Act, and assigned regulation of the growth of hemp to the states with oversight by USDA.  The Secretary of USDA, Sonny Purdue announced in March his intent to have a final rule in place in late 2019 in time for the 2020 growing season.  Though many were skeptical due to the time generally required to promulgate a regulation, if USDA adheres to its estimated completion date of August 2019 (estimated completion dates for regulations published in the Unified Agenda are often inaccurate), Mr. Purdue’s promise may be fulfilled.   Other USDA regulatory priorities include USDA’s National Organic Program plan to strengthen oversight of organic imports to deter fraud, enhance enforcement and protect organic integrity and swine slaughter inspection.
  • Interim FDA commissioner Sharpless, in an FDA Voice blog, highlighted several of the agency’s proposed regulatory actions related to tobacco and standards of identity for food. The Unified Agenda includes several actions related to tobacco products, including implementing safety standards for Electronic Nicotine Delivery Systems, product standards for characterizing flavors in cigars and nicotine levels in products.  As was also the case in the Fall 2018 Unified Agenda, FDA still plans to update the definition of the claim “healthy” on food labels, to revoke outdated standards of identity for French salad dressing and frozen cherry pie, and to reopen the comment period (expected September 2019) on the proposed rule establishing general principles to update the framework for standards of identity.  FDA also continues to state that they will issue a proposed rule on the revocation of uses of partially hydrogenated oils in food, a final rule on gluten-free labeling of fermented, hydrolyzed, or distilled foods, and a final rule regarding the soy protein and coronary heart disease health claim.  A new item on the Spring 2019 Unified Agenda includes a final rule regarding calorie labeling for foods sold from certain vending machines and front of package type size.
  • As previously reported on this blog, Ned Sharpless succeeded Scott Gottlieb as Acting FDA Commissioner in April 2019.  Prior to Sharpless’ tenure, it was unclear whether the agency would continue Gottlieb’s efforts in the area of food and tobacco, including reevaluating certain standards of identity, modernizing the oversight of imported food and product recalls, and curbing youth e-cigarette use.
  • In remarks to the 2019 FDLI Annual Conference, Acting Commissioner Sharpless made clear that “there will be no pause at FDA,” so as to not disrupt the progress the agency made under former FDA Commissioner Gottlieb.  The agency will continue its work on the Nutrition Innovation Strategy and the rollout of the Food Safety Modernization Act (FSMA) regulations.  A strategy for food safety has already been announced, which we have reported on here.  Acting Commissioner Sharpless also referenced the agency’s continued work on labeling, as the agency rolls out the new Nutrition Facts label and looks to reevaluate certain standards of identity.
  • As a centerpiece of former Commissioner Gottlieb’s tenure, Acting Commissioner Sharpless also highlighted the Center for Tobacco Product’s (CTP) efforts to prevent youth use of e-cigarettes.  Specifically, CTP has been acquiring data on electronic cigarette products to enable the agency to reverse the use of those products by children.  Acting Commissioner Sharpless also highlighted the agency’s recent enforcement actions against companies selling e-liquids with labeling or advertising that resemble kid-friendly food products.

 

  • A large number of pathogen-related recalls of ice cream (16 over the three-year period of 2013, 2014, and 2015) and a deadly outbreak of listeriosis in 2015 that was linked to ice cream from Blue Bell Creameries (reported here), spurred a special assignment by the Food and Drug Administration (FDA).  Specifically, FDA conducted inspections and environmental sampling of 89 of the nation’s largest ice cream production facilities in 32 states from September 12, 2016, to August 30, 2017.
  • On April 24, 2019, FDA announced the release of its report on the inspection and environmental sampling of about 16% of the domestic ice cream manufacturers in fiscal year 2017/2017 for Salmonella and Listeria monocytogenes.  FDA’s activity began about a month before larger food facilities were required to comply with the Preventive Controls for Human Food Rule that was established by the Food Safety Modernization Act (FSMA).  No objectionable conditions or practices were found at 44 of the 89 inspected plants.  Listeria monocytogenes was detected on non-food contact surfaces in 19 plants and from a food contact surface at 1 plant.  Salmonella was less prevalent, reportedly detected only from a non-food contact surface and only in one facility.
  • FDA suspended Food Facility Registration for one of the inspected plants, Working Cow Homemade, Inc., after it was linked to a clinical listeriosis case.  After ceasing operations, the firm later resumed business as a warehouse distributor of ice cream products with no production operations.  FDA worked with two other firms to conduct voluntary recalls, held seven regulatory meetings, and notified management at 39 facilities of the need to take voluntary corrective actions.  FDA is also conducting follow-up inspections at all six of the facilities where objectionable conditions or practices warranting official action were observed in the first inspection.
  • FDA’s findings underscore the need for ice cream production plants and other food production facilities to develop and implement a food safety plan.  Please email us at fooddrug@khlaw.com with any questions regarding the Preventive Controls for Human Food Rule or other FSMA requirements.

 

  • In November 2018, FDA announced that it had tested 26 kratom products with “disturbingly” high heavy metal levels.  Also known as Mitragyna speciose, kratom grows naturally in Southeast Asia and has opioid-like properties.  The Daily Intake blogged on the topic here.
  • Besides concerns regarding kratom’s opioid-like properties, FDA also has taken action and issued its only mandatory recall order due to Salmonella contamination.
  • On April 3, FDA released a summary of the heavy metal testing – now on 30 products.  In his comment accompanying the data release, Dr. Scott Gottlieb, the outgoing Commissioner of FDA, noted that FDA has “been attempting to work with the companies whose products were found to contain high levels of heavy metals”
  • FDA’s attention on kratom brings to the fore important reminders for all food and dietary supplement producers regarding raw materials testing, supplier verification and validation, and FDA recall authority.
  • On March 12, 2019, snack bar producer, KIND, submitted a Citizen Petition to the FDA asking the agency to update the framework for regulating nutrient content claims (NCCs). In sum, the petition requests that FDA consider the overall quality of the food, rather than just the quantity of a certain nutrient when regulating nutritional claims on labeling. KIND argued that the NCC regulatory framework is outdated, does not reflect key principles of today’s evidence-based dietary guidance, and is ineffective in helping consumers make appropriate dietary choices.  Instead, KIND insisted the framework allows the use of NCCs that “mislead consumers to believe that the products bearing such claims provide useful evidence-based dietary value, when they do not.”
  • Through the Citizen Petition, KIND requested FDA take the following actions:
    • “Revise its nutrient content claim regulations to only allow a food to bear a nutrient content claim highlighting the presence or absence of a nutrient if the food contains a meaningful amount of at least one health-promoting food, such as: vegetables, fruits (especially whole fruits), whole grains, legumes, nuts, and seeds, which are recommended in the most recent Dietary Guidelines of Americans.”
    • “Amend 21 C.F.R. 101.13(h) to include disclosure levels for added sugar and trans fat and to remove disclosure levels for total fat and cholesterol.”
    • “Revise its nutrient content claim regulations to disqualify foods, other than meal products or main dish products, that contribute more than 25 percent of the daily value for saturated fat, sodium, or added sugar or more than 1.0 gram of trans fat from bearing nutrient content claims.”
    • “Revise its nutrient content claim regulations to require that, where a nutrient content claim is based on a nutrient that has been added to a food, such fortification is in accordance with FDA’s policy on fortification of foods in 21 C.F.R. 104.20.”
  • As stated, KIND argued the current framework allows for the use of claims based solely on the quantity of nutrients, without any consideration for the quality of the food.  KIND provided the following example in support: “[F]or most nutrients, a food can bear a “good source” or “excellent source” claim, regardless of whether the highlighted nutrient is naturally-occurring or was added through fortification, and regardless of whether the food is otherwise nutrient-dense. This means that a pack of gummy bears, fortified with inulin (a dietary fiber), could be labeled as a “good source of fiber” so long as the gummy bears contain about 3 grams of fiber – i.e., 10 percent of the daily value for fiber – per reference amount customarily consumed (RACC).”
  • Longtime readers may recall that this is not the first time KIND has petitioned FDA. In December 2015, KIND submitted a Citizen Petition that requested FDA reevaluate its NCC regulations with specific focus on those related to the term “healthy.” KIND argued that FDA’s “healthy” definition — which has remained the same since 1994 — is outdated and fails to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods. KIND submitted the Citizen Petition in response to an FDA Warning Letter, which requested the company remove the word “healthy” from its packaging. However, by May 2016, FDA reversed their decision and KIND was allowed to continue using “healthy” on its products.
  • As previously reported on this blog, on March 5, FDA Commissioner Scott Gottlieb announced plans to resign from his post as FDA Commissioner beginning in April. Gottlieb was confirmed as FDA Commissioner in May 2017 and drove several significant initiatives from food safety modernization to youth nicotine use.
  • On March 12, 2019, Alex M. Azar III, Secretary of Health and Human Services announced that Dr. Ned Sharpless would serve as acting FDA Commissioner when Scott Gottlieb steps down in April. The appointment is temporary as the administration searches for a permanent replacement to Gottlieb. Since October 2017, Sharpless has served as director of the National Cancer Institute. He is also the chief of the aging biology and cancer section in the National Institute on Aging’s Laboratory of Genetics and Genomics. “Dr. Sharpless’s deep scientific background and expertise will make him a strong leader for F.D.A.,” said Mr. Azar, in a statement.
  • Mr. Azar noted, “[t]here will be no let up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.” However, with Gottlieb’s departure, it remains to be seen whether the agency will continue Gottlieb’s efforts in the area of food and tobacco, including reevaluating certain standards of identity, modernizing the oversight of imported food and product recalls, and curbing youth e-cigarette use.

 

 

  • The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is concerned with an increase in recent years in the number of recalls of meat and poultry products contaminated with foreign materials.  Notably, in many cases, the recalling establishments had received multiple customer complaints before these recalls.  Customer complaints for meat and poultry products can often signal adulteration or misbranding issues that trigger regulatory requirements under 9 C.F.R. Part 416 – Sanitation, Part 417 – Hazard Analysis and Critical Control Point (HACCP) Systems, and Part 418 – Recalls.  FSIS recommends, but does not require, that an establishment develop a program to receive and process customer complaints.
  • On March 8, 2019, FSIS issued draft Guidelines for Industry Response to Customer Complaints to provide reference material on best practices and recommendations on how to receive, investigate and process customer complaints.  The new guidelines encompass all types of customer complaints, including quality issues that do not trigger regulatory requirements.  The new guidelines recommend also consulting a more narrowly focused related document developed by industry in 2018, Industry Best Practices for Customer Complaints of Foreign Material in Meat and Poultry Products.  When the evaluation, investigation, and corrective actions for FSIS regulated products are fully documented and available to FSIS for review upon request under a customer complaint program, the records of the program can be used to fulfill mandatory regulatory requirements.
  • The new FSIS guidelines address the following components of a consumer complaint program:  Customer Complaint Reporting, Substantiation of the Customer Complaint, Establishment Response to a Customer Complaint (including Establishment Response Plan and Investigation, FSIS Notification, and Corrective Actions), and Documentation of the Customer Complaint.  The new guidelines also provide an extensive discussion of 9 C.F.R. § 418.2 (“Notification”), which requires all establishments to report to the agency within 24 hours when they have shipped or received an adulterated USDA-regulated product and that product is in commerce.  FSIS stresses that product containing foreign material is adulterated even when a physical food safety hazard is not present.  Additionally, the new guidelines clarify when product is “in commerce” and when the 24‑hour time period starts.
  • FSIS will respond to public comments received by May 15, 2019 and will update the guideline as necessary.