End-of-2023 Sees Cantaloupe, Applesauce Recalls: Is FSVP Working?

Two late 2023 recalls involving imported products (cantaloupes and cinnamon-flavored applesauce in pouches) are reminiscent of recalls that occurred in 2011 (Colorado-based Jensen Farms’ cantaloupes) and 2007 (the discovery of melamine in American pet food). However, the 2023 recalls both involve direct imports from foreign suppliers and beg the questions: Is the FDA’s Foreign Supplier Verification Program (FSVP) that was finalized in January 2023 working? Are importers paying attention to their responsibilities—doing their due diligence?

The first recall, posted by the FDA on November 8, 2023, involved exceedingly high levels of lead found in the cinnamon flavoring of applesauce in pouches, primarily aimed at the market for children. The second, posted by the FDA on November 22, 2023, covers distribution of cantaloupes containing Salmonella Sundsvall and Oranienburg from a Mexican supplier. Many of the cantaloupes were turned into RTE fruits and fruit salads—and involved several U.S. distributors and grocers.

Lead: Accidental or Intentional Adulteration?

While lead and other heavy metals have been an issue in cacao products imported from around the world, lead can also be a problem with cinnamon, and in this case, the FDA suspected that intentional adulteration may have been the reason it showed up in cinnamon used in apple sauce pouches. The problem is that the applesauce was manufactured in Ecuador by Austrofoods, and the cinnamon was supplied by a third-party, Negasmart. While the FDA does have jurisdiction over Austrofoods through FSMA, it has no control over Negasmart and its suppliers.

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In an FDA onsite inspection at Austrofoods, samples of cinnamon applesauce were checked for lead contamination, and the tests found extremely high levels, e.g., 5110 parts/million (ppm) and 2270 ppm. For context, the international standard-setting body, Codex Alimentarius Commission (Codex), is considering adopting a maximum level of 2.5 ppm for lead in bark spices, including cinnamon, in 2024.

In a December 14, 2023 letter to FDA Commissioner Robert M. Califf, Florida U.S. Senator Rick Scott suggested: “It appears that the company that was selling these fruit pouches was sourcing cinnamon from an Ecuadorian supplier that may have been purchasing cinnamon from Asian countries, such as Communist China. High lead or heavy metal levels in spices, such as cinnamon, typically come from three potential sources: either high levels in the soil the product was grown in, potential contamination in the supply chain during processing, or economically motivated adulteration such as adding lead chromate to increase the product’s weight.”

Scott added, “This is not the first time that there have been warnings of the dangers of heavy metals in herbs and spices, such as cinnamon.” He pointed to a 2021 Consumer Reports finding that roughly one-third of the tested products, 40 in total, had high enough levels of arsenic, lead and cadmium combined, on average, to pose a health concern for children when regularly consumed in typical serving sizes—levels were even a concern for adults.

The late 2023 recalled cinnamon apple puree and applesauce products were marketed toward children and contained extremely high levels of lead. Image courtesy of the FDA

Remember the Melamine Scandal in 2007?

Has history taught the industry a lesson? If indeed the original supplier of cinnamon added lead chromate to up the cinnamon’s weight to increase income, as suggested in Scott’s letter, this would not be a first-time occurrence of intentional adulteration to increase income by added product weight or perceived value. The melamine scandal of 2007 hadn’t really affected human food in the U.S., nevertheless the unknowing addition of melamine contained in a protein ingredient to pet foods caused a number of American pets to become gravely ill or die. In China, where the melamine problem originated, the substance was added to baby formula, killing four and sickening more than 6,000 Chinese infants, according to China Daily.

Melamine was added to Chinese gluten, grain and dairy products so analytical instrumentation would determine the products had more protein (based on nitrogen measurement) than they really did, thus increasing the value of the product containing the melamine. The results of consuming these products depended on species. For ruminants with multiple stomachs, there was no problem. However, for pets and humans—with mono-gastric stomachs that are unable to process melamine—the results ranged from severe sickness to death.

According to a Regulatory Watch story in FE in November, 2008, the FDA issued a ruling on safe levels of melamine in American food and set the level at 2.5 ppm, which the FDA said is not a health concern. However, the FDA recommended a zero-tolerance level for baby formula. At that time the International Dairy Foods Association stated there are no Chinese dairy products that meet USDA’s rigorous Grade A standards, and if such Chinese products are found in the U.S., they were imported illegally.

FDA has been working to decrease lead levels in food for toddlers, decreasing exposure from 43 mcg in 1980 to 1 mcg in 2016. Image courtesy of the FDA.

Cantaloupes in the News Again

The November 2023 cantaloupe recall was updated by the FDA on December 15, 2023, and added more retail stores to the list. According to the latest CDC update, 302 cases of salmonella had been reported from 42 states, with a latest onset date of November 28, 2023. Since the last update, Stop & Shop initiated a recall of TruFresh cantaloupe that was purchased between the dates of October 23 - November 11, 2023. In the 302 cases reported by the CDC, hospitalizations totaled 129 with four deaths. For the most recent update, visit FDA’s “Outbreak Investigation of Salmonella: Cantaloupes (November 2023).”

Unfortunately, there have been a number of cantaloupe recalls over the last two decades with infections caused by Salmonella Typhimurium, Salmonella Newport, Salmonella Panama, Salmonella Litchfield and Listeria Monocytogenes. One large salmonella recall occurred in the late summer of 2012 and involved cantaloupes from Chamberlin Farms in Owensville, Ind. In this incident, FDA investigators found Salmonella Typhimurium on the cantaloupes, which hospitalized 62 and killed two people.

While salmonnella has been the most frequently occurring bacteria to contaminate cantaloupes, listeria also poses as serious a threat and was the cause of the Jensen Farms (Colorado) listeria outbreak and recall in 2011. Although the FDA didn’t rule out that listeria may have originated in the fields, the FDA found no listeria on cantaloupes upon arrival at the packing plant. The FDA, however, did find listeria in several areas of the plant, including cold storage and pooling water on the floor, and the owners had acknowledged that the prior year’s washing/rinsing equipment had been changed out along with using non-chlorinated water. In 2010, the processor used a chlorinated wash treatment, and there were no reported contamination issues prior to the 2011 listeria contamination.

While cantaloupes can be contaminated with salmonella in the field from animals, soil or grey irrigation water, cross contamination during harvesting and processing, hands or contact surfaces can also transfer salmonella to cantaloupes. With lessons learned from these earlier, large-scale outbreaks and with FSMA and good agricultural practices in hand, it would seem that U.S.-based farms have cantaloupe processing well under control today. Can the same be said for foreign suppliers where continuous scrutiny of farm practices is not always practical?

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The late 2023 cantaloupe recall involved whole fresh cantaloupes with a label on the cantaloupe that says “Malichita” or “Rudy,” “4050,” and “Product of Mexico/produit du Mexique.” Images courtesy of the FDA

Foreign Supplier Verification Program and Importer Responsibilities

On January 10, 2023, the FDA issued the final guidance for the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. FSVP is a regulation under the foundational FDA Food Safety Modernization Act, which makes importers accountable for verifying foreign suppliers are producing food in a manner that meets U.S. safety standards.

This guidance provides information to importers of human and animal food about how they can comply with the FSVP regulation. It includes recommendations on the requirements to analyze the hazards in food; evaluate a potential foreign supplier’s performance and the risk posed by the food; and determine and conduct appropriate foreign supplier verification activities.

Stated in the FSVP regulation, importers must determine food risk and supplier performance. An importer must evaluate:

The hazard analysis
The entity that will be significantly minimizing or preventing the hazards, such as the foreign supplier or the supplier’s raw material or ingredient supplier
A foreign supplier’s procedures, processes and practices related to the safety of food
Applicable FDA food safety regulations and information regarding the foreign supplier’s compliance
The foreign supplier’s food safety history, including the responsiveness of the foreign supplier in correcting past problems
Other factors as necessary, including storage and transportation practices

It’s important to note that the evaluation of risk posed by the imported food and the supplier’s performance must be reevaluated at least every three years—or when new information comes to light about a potential hazard of the foreign supplier’s performance.

In light of the two 2023 recalls in this article, it would seem that importers may need to have a food safety consultant on hand at foreign suppliers continuously to verify that food safety preventive measures are being carried out as GMPs dictate.