Search recall

  • FDA Commissioner Scott Gottlieb announced on September 26, 2018 a new FDA policy on disclosing retail information for products subject to food recalls—particularly in Class I recall situations, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.  Historically, the agency has not released information on retailers where recalled food may have been purchased because such information potentially can reveal confidential supply chain information.
  • In conjunction with the announcement, FDA issued draft guidance detailing the circumstances under which FDA intends to publicly disclose the retail locations that may have sold or distributed a recalled human or animal food.  The guidance discusses FDA’s policy to publicize retailer information (e.g., specific retail store name and address) when recalled food is not easily identified as being the subject of a recall from its retail packaging or lack thereof (e.g., deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually).
  • This is the second in FDA’s policy efforts to provide consumers with “actionable information” for protecting themselves from recalled FDA-regulated products.  The first was a draft guidance issued in January on the use, content, and circumstances for issuing public warnings for consumers in the event of a recall.  FDA is inviting comments on this new draft guidance for a period of 60 days.
  • In an unusual move, FDA Commissioner Scott Gottlieb, M.D., released a statement on July 24 regarding the voluntary recall of certain products that contain whey powder that may be contaminated with Salmonella. FDA stated that they are working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products, including varieties of Goldfish and Ritz crackers, several brands of swiss roll dessert products, and Hungry Man frozen microwaveable dinners. The Hungry Man products fall under the jurisdiction of USDA’s Food Safety and Inspection Service (FSIS) because they contain poultry, but the other voluntarily recalled products are within FDA’s jurisdiction.
  • It is currently not known how many food companies used the potentially contaminated whey powder, and there may be other recalls initiated in the coming days. However, federal officials have not received any reports of confirmed Salmonella illnesses related to the recalled foods. Commissioner Gottlieb made clear that these recalls are being initiated because of the potential risk and out of an abundance of caution, and that the FDA is actively engaged in the investigation.
  • When recalls involve food and food ingredients that are sold only on a business-to-business basis, the FDA has not historically revealed the companies involved, as such information is said to be protected as “confidential corporate information.” However, in the instant matter, both FDA and USDA named Associated Milk Producers Inc. (AMPI), a Minnesota-based milk company, as the ingredient supplier. Perhaps in an effort to mitigate the effects of the potential contamination, Commission Gottlieb stated that because the products are widely consumed, FDA is “taking steps to intervene early on this potential risk” and “will be communicating regularly with the public to provide information and updates on this issue.”
  • On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella. FDA issued the recall after the company failed to cooperate with FDA’s request to conduct a voluntary recall. This is FDA’s first ever mandatory recall.
  • Under the FDA Food Safety Modernization Act (FSMA), FDA has the authority to order the recall of certain food products when FDA determines that there is a reasonable probability that the article of food is adulterated or in violation of certain allergen labeling requirements and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.
  • Mitragyna speciosa, commonly known as kratom, is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, and has been marketed in the U.S. to treat muscle pain, diarrhea, and opiate withdrawal. Out of concern for the public health, FDA advises consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. The agency also has received concerning reports about the safety of kratom, including deaths associated with its use.
  • Numerous brands of kratom-containing products have been linked to a multi-state outbreak of salmonellosis from multiple strains of salmonella. The FDA continues to advise consumers to avoid kratom and kratom-containing products and discard any in their possession. All salmonella bacteria can cause the foodborne illness salmonellosis, although the strains found related to this recall are not currently linked to the outbreak.
  • On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity
  • The manufacturer of the products, Divinity Products Distribution, has also agreed to stop selling all products containing kratom
  • As discussed previously in this blog, FDA has used its administrative detention power followed by seizure against large volumes of kratom containing dietary supplements
  • In its current press release, FDA stressed the potential dangers of kratom as having opioid-like properties and indicated that there are no FDA-approved therapeutic uses of kratom
  • FDA urged all manufacturers of kratom containing supplements to cease marketing and to submit New Dietary Ingredient Notifications to FDA for kratom prior to marketing

Clients who are interested in pursuing appropriate regulatory status for their dietary ingredients or dietary supplements are invited to contact Mel Drozen at drozen@khlaw.com or 202-434-4222 for assistance.

  • As previously covered on this blog, a recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s current recall process can be too slow and puts consumers at risk.  Yesterday, FDA Commissioner Dr. Scott Gottlieb announced plans to strengthen the recall process for food, drugs, medical devices and cosmetics.
  • Today, FDA published a draft guidance (83 FR 2758) aimed at clarifying its approach to notices and warnings about recalled products to ensure consumers learn about such issues in a more timely way.  The Federal Register Notice announcing the draft guidance states that the intent of the draft guidance is to “increase and expedite the appropriate and accurate use of public warnings and public notification, to increase public health protection by better informing the public about violative products being recalled.” FDA also states that the draft guidance “clarifies and supplements existing policy for industry and FDA staff regarding the use of public warnings and public notification.”
  • The draft guidance outlines circumstances when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient. The draft guidance also sets out the Agency’s policy for posting recalls to FDA’s Enforcement Report before a final health risk determination is made.
  • In a press release, Dr. Gottlieb stated that new policies regarding the type of information the FDA shares with the public to identify “hazardous recalled food,” as well as a new approach to publicizing food recalls are being developed.
  • FDA will be accepting comments on the draft guidance until March 20, 2018. Keller and Heckman attorneys regularly advise clients on product recall and related crisis management matters and stand ready to assist interested parties with preparing stakeholder comments on the draft guidance.  We may be reached at fooddrug@khlaw.com
  • As our readership is well aware, the Food Safety Modernization Act (FSMA) equips the FDA with mandatory recall authority to remove a potentially dangerous food product from the marketplace when a company does not voluntarily cease distribution and initiate a recall. But the Agency has very rarely used this authority. In practice, the FDA most often works with companies to bring about voluntary recalls, with the goal of getting the product out of the marketplace as quickly and efficiently as possible.
  • A recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concludes that FDA’s current recall process can be too slow and puts consumers at risk.  This report follows on an “early alert” released by the OIG on June 8, 2016 finding that FDA did not have a process in place to ensure that regulated companies initiated food recalls promptly.
  • In preparing the December 2017 report, the OIG reviewed documentation from a sample of 30 voluntary food recalls initiated from October 1, 2012 to May 4, 2015 to analyze FDA’s oversight of companies’ initiation of recalls, as well as the Agency’s monitoring of firm-initiated recalls, and the Agency’s maintenance of data in an electronic recall data system.
  • In response to the OIG report, FDA Commissioner Scott Gottlieb issued a statement contending that FDA’s recall protocol is generally quite effective, noting, for example, that on average voluntary recalls are initiated within four calendar days of when a problem is discovered. At the same time, Commissioner Gottlieb acknowledged that there is room for improvement and stated that the Agency intends “to say more in early 2018 on additional policy steps [the Agency will] take as part of a broader action plan to improve [its] oversight of food safety and how [it] implements the recall process.” According to Commissioner Gottlieb, FDA is currently looking at ways to improve the timeliness and scope of information the Agency provides to the public about recalls of FDA regulated foods.
  • It remains to be seen whether this latest OIG report will prompt FDA to consider utilizing its mandatory recall authority on a greater scale.
  • For years, undeclared food allergens have been the leading cause of food recalls in the U.S. According to the Centers for Disease Control (CDC), more than 50 million Americans suffer from allergies each year.  Earlier this year, the Food Marketing Institute (FMI) reported that the prevalence of reported food allergies has significantly increased, with an estimated four to six percent of children and four percent of adults affected by food allergies.
  • On September 25, 2017, the Food Marketing Institute Foundation awarded the Food Allergy Research and Resource Program at the University of Nebraska – Lincoln’s Food Science and Technology Department – a $20,000 grant to identify root-cause labeling errors and to recommend best-practice procedures for manufacturers, suppliers and retailers in order to reduce undeclared allergen recalls.  The research will evaluate and classify the latest two years of U.S. Food and Drug Administration and USDA allergen recalls, in accordance with explanations supplied by the manufacturer and reported by these regulatory agencies.
  • FMI indicates that at the conclusion of this project, preliminary outcomes are slated to be presented at the annual Safe Quality Food International Conference in Dallas in November. A whitepaper publication will be prepared and submitted to the Food Marketing Institute Foundation, and the researchers intend to submit a paper for peer-reviewed publication.
  • In April 2016, the Food and Drug Administration established a team of Agency leaders to oversee challenging recalls and to help overcome obstacles and streamline the recall process. Shortly after the team—called SCORE (Strategic Coordinated Oversight of Recall Execution)—was created, we reported on this blog that the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued an “early alert” to indicate that its ongoing audit of FDA’s food recall program found that “FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply.”
  • Six-months after the creation of the rapid-response team, FDA posted on its blog, FDA Voice, an article about the SCORE team’s activities since its inception, and an interview with the co-chairs of SCORE: William Correll, Director of the Office of Compliance in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Douglas Stearn, Director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs (ORA). In the interview, the co-chairs discussed several of the cases that SCORE has been involved with, namely:
    • Suspension of a facility registration because the food there may have been contaminated with Listeria monocytogenes
    • Advising companies that made finished food items with flour containing a peanut protein that the agency would publicize the potential contamination if the company supplying the flour did not implement a voluntary recall within 24 hours
    • Advising a company that made sandwiches distributed in the U.S. Department of Agriculture’s Food Nutrition Service’s school lunch program and where Listeria monocytogenes were found on surfaces where the food was made that the agency would notify the press if a voluntary recall was not initiated within 24 hours
    • Threatened enforcement actions if a company that manufactured infant formula without testing for Cronobacter did not initiate a voluntary recall within 24 hours
  • Under the Food Safety Modernization Act (FSMA), FDA was given mandatory recall authority over conventional foods. Keller and Heckman attorneys can advise companies on FDA’s expanded recall and detention authority under FSMA, counsel companies on how to effectively remove products from the market if a recall is necessary, and help develop strategies to address publicity surrounding a potential recall.

Complimentary Webinar TODAY:  Refresher on Food Recalls and Recall Protection

Don’t miss out!  Join Keller and Heckman partners, Art Garrett and Leslie Krasny, for a complimentary refresher webinar on recalls and what you can do now to protect your company.  The webinar is today, July 21, at 12 – 1 pm Pacific (3 – 4 pm Eastern).

For details and to register now, click here.

HHS OIG issues early alert criticizing FDA’s food recall procedures.

  • Under the FDA Food Safety Modernization Act (FSMA), FDA now has mandatory recall authority over conventional foods.  However, FDA has only threatened the use of this authority twice.  In reality, firms continue to work voluntarily with FDA to recall risky foods under the Agency’s recall procedures and guidance.
  • On June 9, 2016, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued an “early alert” to indicate that its ongoing audit of FDA’s food recall program found that “FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation’s food supply.”  Stating that FDA failed to ensure the prompt recall of risky foods, the OIG asserted that “consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.”  The OIG cited specific cases in which firms delayed the recall of foods potentially tainted with Salmonella and Listeria monocytogenes until 165 days and 81 days after FDA became aware of the contamination risk.  The OIG did not provide any specific recommendations regarding how FDA should improve its policies, only that the Agency “update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.”  A copy of the audit report is available here.
  • FDA issued a press release responding to the OIG’s findings, acknowledging that among the thousands of food recalls it had overseen in a 3-year period, a small number had fallen well outside the average time frame of less than a week for recall initiation.  Characterizing these days as “unacceptable,” FDA stated that it is already taking concrete steps to address the OIG’s concerns, including establishment of a rapid-response team made up of Agency leaders, and the introduction of new technologies to expedite the process.