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  • As of the time of this blog’s publication, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact departments and agencies across the federal government. Both the U.S. Department of Agriculture and the U.S. Food and Drug Administration are directly affected.
  • In an announcement regarding the lapse in funding, FDA will continue activities within the scope of its user fee funded programs, including those for prescription drugs, generic drugs, biosimilars, medical devices, animal drugs, and tobacco products. FDA will also continue activities to respond to outbreaks, manage high-risk recalls, review import entries, and other activities critical to public health. However, the announcement notes that FDA will not be able to support some routine regulatory and compliance activities, including some medical product, animal drug, and most food-related activities. In addition, FDA will pause routine establishment inspections, cosmetics and nutrition work, and many ongoing research activities.
  • Starting January 1, 2019, a number of USDA activities have not been continued, including payments for agricultural research, issuing loans for rural development, etc. USDA announced that it will continue other activities beyond January 1, 2019, including meat, poultry, and processed egg inspection services, grain and other commodity inspection, weighing, grading, and IT support services funded by user fees. The full press release regarding the shutdown can be found here.
  • As discussed in this blog two and three weeks ago, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce.  On November 20, CDC advised consumers, retailers, and restaurants not to eat, sell, or serve any romaine lettuce until the source of the outbreak was better understood.
  • On November 26, FDA announced that it had narrowed down the traceback to romaine lettuce grown in the central coast growing regions of northern and central California.  FDA also said that lettuce known to be grown outside of this region is safe to eat, sell, or serve.  On the same date, the United Fresh Produce Association issued a press release confirming that a number of grower shippers had negotiated an agreement with FDA.  Under the agreement, supported by multiple produce associations, including United Fresh Produce Association, grower shippers agreed to label their romaine products with the region where they were grown and the approximate harvest date.
  • On December 13, FDA provided an update on the outbreak.  The onset of the last of the 59 confirmed illnesses, with 23 hospitalized, was November 16.  FDA and CDC announced that they have narrowed down the source of the outbreak to “Monterey, San Benito, and Santa Barbara counties in California. Romaine lettuce from outside those counties need not be avoided. Consumers may notice that romaine lettuce is beginning to be available in stores with new labeling. Additionally, romaine from Ventura, San Luis Obispo, and Santa Cruz counties harvested after November 23, 2018 should be labeled with harvest area and harvest date, allowing it to be distinguished from romaine lettuce that should be avoided.”  FDA and CDC also confirmed that Hydroponically- and greenhouse-grown romaine are likely safe.
  • Of particular note, FDA and CDC confirmed via whole genome sequencing a sample from Adam Bros. Farming Inc. with the same strain of E. Coli as the outbreak.  Adam Bros. has not shipped romaine since November 20 and experts are working with the farm to identify the source of the contamination and safety measures to take before the next growing season.
    • Adam Bros. is likely not the only source of the contamination.  Per the FDA press release, “[t]he finding on this farm, however, does not explain all illnesses. The FDA’s traceback activities of romaine lettuce will continue as FDA works to determine what commonalities this farm may have with other farms and areas that are being assessed as part of the investigation.”
  • In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which 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.
  • Over the past year, FDA has issued numerous warnings about the serious risks associated with the use of kratom. The agency has also issued an import alert, seized product containing kratom, and issued warning letters to kratom marketers. Most notably, earlier this year, 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.
  • Continuing its actions to address the regulation and enforcement of kratom, the Commissioner’s November 27th statement notes that FDA scientists tested 26 separate kratom products obtained by field investigators. Lead and nickel were found at levels not considered safe for human consumption. In addition to those 26 products, the Commissioner noted FDA’s concern that there may be other kratom products on the market that also contain heavy metals. In light of the current opioid epidemic in the United States, FDA states they will continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider.
  • As we reported on this blog last week, FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, were investigating a multistate outbreak of E. coli O157:H7 illnesses that was likely linked to romaine lettuce. On November 20, the CDC advised consumers not to eat any romaine lettuce, and retailers and restaurants not to serve or sell any until more was known about the source of the outbreak. We also noted that the Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency also were coordinating with U.S. agencies as they investigated a similar outbreak in Canada.
  • On November 26, FDA announced that the E. coli O157:H7 illnesses were likely linked to romaine lettuce grown in California this fall. Preliminary traceback information indicates that ill people were exposed to romaine lettuce harvested in the central coast growing regions of northern and central California, the Agency reported. Consequently, FDA said that consumers and retailers no longer need to avoid using romaine lettuce that is certain to have been harvested from areas outside of the central coast growing regions of northern and central California.
  • FDA further announced that—based on discussions with producers and distributors—romaine lettuce entering the market will now be labeled with a harvest location and date or labeled as being grown hydroponically or in a greenhouse. “If it does not have this information, you should not eat or use it,” FDA cautioned. The United Fresh Produce Association issued a press release on November 26 confirming that a labeling agreement was negotiated between FDA and a number of romaine grow-shipper-processors, who pledged to label their romaine products with the region where they were grown and the approximate harvest date. Other produce associations, including the United Fresh Produce Association, also agreed to support the initiative, according to the release.
  • The FDA and the Centers for Disease Control and Prevention (CDC), along with state and local agencies, are investigating a multistate outbreak of E. coli O157:H7 illnesses that are likely linked to romaine lettuce. On November 20, the CDC advised consumers not to eat any romaine lettuce, and retailers and restaurants not to serve or sell any until more is known about the outbreak.
  • According to the CDC, there are currently 32 cases of E. coli across 11 states, which have been linked to the consumption of romaine. Thus far, no deaths have been reported, but 13 people have been hospitalized and one person has developed hemolytic uremic syndrome, a type of kidney failure.
  • Additionally, the Public Health Agency of Canada (PHAC) and Canadian Food Inspection Agency are also coordinating with US agencies to investigate a similar outbreak in Canada. PHAC has identified 18 people sick with the same strain across Ontario and Quebec.
  • The current outbreak E. coli strain is the same as the one identified in a 2017 outbreak, which was linked to leafy greens. However, the strain is not related to the E. coli outbreak from early 2018. Our readers may remember, we’ve previously discussed that outbreak, which was declared officially over on June 28 and may have been caused by concentrated animal feeding operations in the Yuma, Arizona area.
  • The FDA is conducting a traceback investigation to determine the source of the romaine outbreak. FDA and state authorities are also conducting laboratory analysis of romaine lettuce samples potentially linked to the current outbreak. Until a source is determined, authorities recommend people do not eat romaine lettuce.

 

The Daily Intake will return Monday, November 26. We extend our best wishes to those of you celebrating the Thanksgiving holiday.

  • An outbreak of Salmonella Reading linked to raw turkey that began in November 2017 continues to sicken Americans in 35 states.  Raw turkey pieces, ground turkey, whole turkey, and turkey pet food have been linked to illnesses in humans.
  • A total of 164 people have been infected, 47% of whom have been hospitalized.  There has been one fatality in California.  The CDC reports that 68 isolates from ill people and 84 isolates from food contained genes for resistance to all or some of 10 listed types of antibiotics but notes that “most of the infections in this outbreak are susceptible to the antibiotics that are commonly used for treatment, so this resistance will not affect the choice of antibiotic resistance used to treat most people.”
  • The Center for Science in the Public Interest has criticized the U.S. Department of Agriculture for not identifying the 22 slaughter and 7 processing establishments where Salmonella Reading has been detected and determined to be “closely related genetically to the strains isolated from ill people.”  While FDA recently took steps to increase transparency and provide consumers will more “actionable information” in food recall situations, USDA has not yet expressed an interest in increasing transparency during food recalls.
  • 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.
  • On 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.
  • 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.
  • As reported by multiple outlets, Stephen Ostroff, FDA’s Deputy Commissioner for Food and Veterinary Medicine, will retire January 5. Ostroff assumed the role of Deputy Commissioner in 2016, previously serving as the acting FDA Commissioner on two occasions. Walmart’s Vice President for Food Safety and Health, Frank Yiannas, is set to replace Ostroff.
  • Yiannas will have a different title, Deputy Commissioner for Food Policy and Response, reflecting FDA’s ongoing efforts to reorganize the agency. The agency is planning to create a new office focused on food safety, the Office of Food Policy and Response, which will advance the Food Safety Modernization Act work and coordinate foodborne illness outbreak response.
  • However, Yiannas’ role will not be limited to food safety. In an email announcement to staff, FDA Commissioner Scott Gottlieb reportedly said of Yiannas, “we’re delighted to be welcoming Frank to FDA and believe his extensive expertise in supply chain security can help inform our work across our different product areas, including food but also when it comes to the safety and security of medical products.” These changes come amid increased attention on FDA over food recalls and Gottlieb’s pledges to reform the agency’s approach.
  • In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there is evidence that certain substances found in kratom are opioids and out of concern for the public health, FDA has advised consumers to avoid kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine, in any form and from any manufacturer. FDA notes that they are not alone in their concern about the opioids found in kratom, as it is already illegal or controlled in several other countries including Australia, Denmark, Germany, Malaysia and Thailand. The substance is also banned in a number of states and municipalities in the U.S.
  • Kratom has been sold as dietary supplements (e.g., teas, powders, capsules) that are marketed to relieve opium withdrawals and to treat ailments including diarrhea, depression, diabetes, obesity, high blood pressure, stomach parasites, diverticulitis, anxiety, and alcoholism, among others. However, according to FDA, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in human. Nor have there been studies on how kratom, when combined with other substances, may impact the body, its dangers, potential side effects, or interactions with other drugs. Thus, marketers are selling kratom with unsubstantiated claims. Selling unapproved kratom products with claims that they can treat opioid withdrawal and addiction and other serious medical conditions is a violation of federal law.
  • On September 4, 2018, FDA issued warning letters to two companies, Chillin Mix Kratom and Mitra Distributing, for marketing kratom products with scientifically unsubstantiated claims. In the letters, FDA states that the claims made establish that the kratom products are drugs as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Even more, FDA stated that the kratom products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA.
  • These warning letters are the latest action in FDA’s regulation and enforcement of kratom manufacturers and marketers. In May of 2018, FDA announced it had issued warning letters to three companies marketing kratom products with medical claims, similar to the claims presently at issue. Additionally, on April 2, 2018, FDA issued its first ever mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella.
  • In light of the current opioid epidemic in the United States, FDA states they will continue to urge consumers not to consume kratom and to seek appropriate medical care from their health care provider, as well as take action against those who put the safety of American consumers at risk.