Tag Archives: FDA

Peanut Butter

Candies, Protein Snacks and Ice Cream Among Latest Jif Peanut Butter-Related Recalls

By Food Safety Tech Staff
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Peanut Butter

The FDA has posted an updated list of additional recalls related to the multistate outbreak of Salmonella Senftenberg infections linked to certain Jif brand peanut butter products produced at the J.M. Smucker Company facility in Lexington, Kentucky.

The recalls are being conducted by companies that have used the peanut butter as an ingredient in the manufacturing of a new product or in repackaging the product. The recalls include:

Deskins Candies of Bluefield, West Virginia, is recalling the following 16 oz. products: Deskins Candies Peanut Butter Fudge, Deskins Candies Peanut Butter No-Bake, Deskins Candies Peanut Butter Pinwheel, and Deskins Candies Chocolate No-Bake

F&S Produce Co. of Vineland, New Jersey is recalling a limited quantity of Fresh Garden Highway Protein Power Snacks

Taharka Brothers Ice Cream of Baltimore, Maryland is recalling its Peanut Butter Cup ice cream

J.M. Smucker Company has voluntarily recalled Jif brand peanut butter products that have the lot code numbers between 1274425 – 2140425, only if the first seven digits end with 425 (manufactured in Lexington, KY).

Additional information including advice for consumers, restaurants and retailers is available on the FDA Outbreak Investigation of Salmonella: Peanut Butter page.

Baby Bottle

FDA Investigating Another Infant Death Potentially Related to Abbott Baby Formula

By Food Safety Tech Staff
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Baby Bottle

On Wednesday, June 22, the FDA announced that it was investigating the death of an infant that occurred in January 2022 and is potentially related to Abbott baby formula. In a statement, the FDA said that it was notified of the death through a consumer complaint received on June 10, 2022. “The agency has initiated an investigation, given that the complaint referenced that the infant had consumed an Abbott product. However, the investigation of this most recent consumer complaint is in its preliminary stages and the agency will provide an update as it learns more,” the statement read.

The FDA has previously reported its review of complaints related to nine infant deaths. Two were found to be associated with the Abbott Nutrition Sturgis plant investigation. However, the FDA notes that, despite extensive investigation, the evidence does not rule in or rule out a definitive link between these infant deaths and the product produced at Abbott Nutrition’s Sturgis, Michigan-based plant.

 

Man on Computer

FDA Announces Online Retail Program Standards Self Assessment and Verification Audit Courses

By Food Safety Tech Staff
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Man on Computer

Individuals conducting self-assessments and verification audits of the FDA Retail Food Program Standards can now take part in online self-guided FDA Retail Food Program Standards Self-Assessment/Verification Audit Courses.

The Retail Program Standards are designed to help food regulatory programs enhance the services they provide to the public by:

  • Identifying program areas where an agency can have the greatest impact on retail food safety
  • Promoting wider application of effective risk-factor intervention strategies
  • Assisting in identifying program areas most in need of additional attention
  • Providing information needed to justify maintenance or increase in program budgets
  • Leading to innovations in program implementation and administration
  • Improving industry and consumer confidence in food protection programs by enhancing uniformity within and between regulatory agencies

These following courses are now open for registration and additional courses are scheduled to be added soon.

  • An introduction to the Program Standards and the Administrative Procedures (Prerequisite to the other nine courses)
  • Standard 1:  Regulatory Foundation (coming soon)
  • Standard 2:  Trained Regulatory Staff (coming soon)
  • Standard 3:  Inspection Program Based on HACCP Principles
  • Standard 4:  Uniform Inspection Program
  • Standard 5:  Foodborne Illness and Food Defense Preparedness and Response (coming soon)
  • Standard 6:  Compliance and Enforcement (coming soon)
  • Standard 7:  Industry and Community Relations (coming soon)
  • Standard 8:  Program Support and Resources (coming soon)
  • Standard 9:  Program Assessment (coming soon)

Register at the FDA Voluntary National Retail Food Regulatory Program Standards page.

 

 

Plastic Bottles

FDA To Reconsider Safety of BPA in Food Packaging

By Food Safety Tech Staff
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Plastic Bottles

The U.S. Food and Drug Administration (FDA) has agreed to reconsider the safety of using bisphenol A (BPA) in polycarbonate plastics, metal can coatings and other materials that contact food. The FDA’s decision comes in response to a food additive petition filed by the Environmental Defense Fund and a coalition of physicians, scientists and public health and environmental organizations. The law requires that FDA make a final decision by October 31, 2022.

In a press release announcing the FDA’s acceptance of its petition, the EDF noted that since submitting the petition in January, a new study, published in Environment International has added to the existing evidence that BPA triggers children’s immune systems. The study of more than 3,000 mothers and their children linked BPA exposure in the womb to higher rates of asthma and wheezing in school-age girls.

The research supports last year’s unanimous findings by a panel of experts convened by the European Food Safety Authority (EFSA).

“Based on studies not previously considered by FDA, the EFSA Expert Panel found that harmful effects from BPA exposure can occur at levels tens of thousands times lower than previously thought,” said Maricel Maffini, coauthor of the petition who holds a doctorate in biological sciences. “These studies show that extremely low exposures to BPA can lead to an overactive immune system likely producing out-of-control inflammation. This inflammation can then trigger wheezing and asthma-like effects.”

“Most Americans get 5,000 times more BPA in their daily diet than the EFSA expert panel says is safe,” said Tom Neltner, Environmental Defense Fund’s Senior Director, Safer Chemicals. “It is imperative that FDA take action to limit BPA contamination of food. And given the significant risks, industry should not wait for FDA to act. They need to find safer alternatives to BPA or drastically reduce the migration of the chemical into food to protect children from harm.”

The January petition and an April supplement were submitted by the Environmental Defense Fund (EDF), Breast Cancer Prevention Partners (BCPP), Clean Water Action/Clean Water Fund, Consumer Reports, Endocrine Society, Environmental Working Group (EWG), Healthy Babies Bright Futures (HBBF), EDF consultant Dr. Maricel Maffini, and Dr. Linda Birnbaum, former director of the National Institute of Environmental Health Sciences and National Toxicology Program. FDA will be requesting public comment on the petition soon.

 

Baby Bottle

OIG To Audit FDA Over Infant Formula Response

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Baby Bottle

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG) has announced an audit of the FDA over its actions regarding the Abbott infant formula recall. The audit, announced on June 2, will “determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements.”

The OIG is specifically examining the FDA’s actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures related to conducting inspections of the manufacturing facility and overseeing Abbott’s initiation of the infant formula recall.

The FDA released a timeline of its infant formula-related activities, showing that inspectors first became aware of issues including standing water and inadequate handwashing during a routine inspection at Abbott Nutrition’s Sturgis, Michigan, facility in September 2021—the same month that the FDA received the first consumer complaint report of Cronobacter illness in an infant from the Minnesota Department of Health.

One key area of frustration during Congressional hearings in May was the delay of action on a whistleblower report filed with the FDA Detroit District Office in October 2021. The complaint was not reviewed by FDA leadership until February 2002, “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the FDA.

Additional inspections of the facility between January and March 2022 found “significant, fundamental sanitation, building and equipment issues.” Swabs taken during the inspections revealed six confirmed samples of Cronobacter. These findings led Abbott, on the recommendation of the FDA, to voluntarily cease production at the facility and recall potentially contaminated products. The contaminated formula has been linked to four hospitalizations and two deaths.

The OIG audit is scheduled to be completed in 2023.

 

 

Strawberries in bowl
Retail Food Safety Forum

FDA Update on Hepatitis A Outbreak Linked to Organic Strawberries

By Food Safety Tech Staff
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Strawberries in bowl

The FDA has released an update on its investigation into a multistate outbreak of hepatitis A infections in the U.S. linked to fresh organic strawberries. The potentially contaminated strawberries were imported from Baja California, Mexico, and branded as FreshKampo and HEB by a common supplier; they were purchased between March 5, 2022, and April 25, 2022.

Consumers, restaurants and retailers should not sell, serve or eat any fresh organic strawberries branded as FreshKampo or HEB if purchased between March 5, 2022, and April 25, 2022. People who purchased the fresh strawberries and then froze those strawberries for later consumption should not eat them. They should be thrown away. Currently, the potentially contaminated product is past its shelf life. If you are unsure of what brand you purchased, when you purchased your strawberries or where you purchased them from prior to freezing them, the strawberries should be thrown away.

If consumers purchased fresh organic strawberries branded as FreshKampo or HEB between March 5, 2022, and April 25, 2022, ate those berries in the last two weeks, and have not been vaccinated against hepatitis A, they should immediately consult with their healthcare professional to determine whether post exposure prophylaxis (PEP) is needed. PEP is recommended for unvaccinated people who have been exposed to hepatitis A virus in the last two weeks because vaccination can prevent a hepatitis A infection if given within 14 days of exposure. Those with evidence of previous hepatitis A vaccination or previous hepatitis A infection do not require PEP.

The Public Health Agency of Canada and Canadian Inspection Agency are also investigating an outbreak of hepatitis A. The investigation in Canada involves two provinces: Alberta and Saskatchewan. Imported fresh organic strawberries have been identified as the likely source of that outbreak.

Currently, these fresh organic strawberries branded as FreshKampo and HEB products are past shelf life and are not available for purchase in stores. These products may have been sold at the following retailers, including, but not limited to:

  • HEB
  • Kroger
  • Safeway
  • Sprouts Farmers Market
  • Trader Joe’s
  • Walmart
  • Weis Markets
  • WinCo Foods

If you are unsure of what brand you purchased, when you purchased your strawberries, or where you purchased them from prior to freezing them, the strawberries should be thrown away.

Contact your healthcare provider if you think you may have symptoms of a hepatitis A infection after eating these fresh organic strawberries, or if you believe that you have eaten these strawberries in the last two weeks.

Red Apple

FDA To Host Industry Webinar on Draft Guidance on Action Levels for Lead in Juice

By Food Safety Tech Staff
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Red Apple

The U.S. Food & Drug Administration will be hosting a webinar on Tuesday, June 14, 2022, at 1:00 pm (ET) to discuss the recent draft guidance on lead action levels for juice. The draft guidance, titled “Action Levels for Lead in Juice; Draft Guidance for Industry,” issued in April provides action levels for lead in single-strength (ready to drink) apple juice and in other single-strength juices and juice blends.

These draft action levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods, and advance the FDA’s goals in the Closer to Zero action plan.

During the webinar the FDA will provide an overview of the draft guidance and additional information, as well as answer stakeholder questions.

Featured speakers include Dr. Susan Mayne, director of the Center for Food Safety & Applied Nutrition (CFSAN), Dr. Conrad Choiniere, director of the Office of Analytics and Outreach, CFSAN, and Dr. Paul South, director of Division of Plant Products and Beverages, Office of Food Safety, CFSAN.

To register for the webinar, visit the registration page. The webinar will be recorded and posted to the FDA website.

 

 

FDA

FDA to Limit Lead in Juice

By Food Safety Tech Staff
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FDA

FDA is continuing its efforts to reduce negative health effects as a result of dietary exposure to lead. The agency recently issued draft action levels for lead in single-strength, ready-to-drink apple juice, and other juices and juice blends.

“Exposure of our most vulnerable populations, especially children, to elevated levels of toxic elements from foods is unacceptable,” said FDA Commissioner Robert M. Califf, M.D. in an agency release. “This action to limit lead in juice represents an important step forward in advancing FDA’s Closer to Zero action plan, which we are confident will have a lasting public health impact on current and future generations.”

The draft guidance outlines recommended limits of lead in juice that can be achieved by industry and progressively lowered as appropriate. The draft action levels are part of the agency’s Closer to Zero action plan announced last year. [https://foodsafetytech.com/news_article/fdas-closer-to-zero-action-plan-to-reduce-exposure-to-toxic-elements-in-baby-food/]

“As we outlined in the Closer to Zero action plan, the agency is increasing targeted compliance activities as part of our efforts to monitor levels of these elements in foods through the FDA’s Total Diet Study, Toxic Elements in Food and Foodware program and sampling assignments,” said CFSAN Director Susan Mayne, Ph.D., in an agency release. “In addition, our work in this important area of food safety will progress with advancements in science. For example, action levels may be progressively lowered over time, as appropriate, to make continual improvements in reducing the levels of lead, arsenic, cadmium and mercury in foods eaten by babies and young children.”

CDC, FDA, USDA logos

NARMS Publishes 2019 Report on Antimicrobial Resistance Trends in Pathogens

By Food Safety Tech Staff
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CDC, FDA, USDA logos

The National Antimicrobial Resistance Monitoring System (NARMS) has published its 2019 Integrated Report Summary, which reviews antimicrobial resistance trends in Salmonella, Campylobacter, generic E. coli, and Enterococcus. The report also discusses genomic information for Salmonella, Campylobacter and E. coli in retail meat and food producing animals.

NARMS is a partnership between FDA, CDC, USDA’s FSIS, the Animal and Plant Health Inspection Service, the Agricultural Research Service, and other state and local public health departments and federal agencies. The national surveillance in the report helps all public health partners identify new types and patterns of resistance and changes over time.

“FSIS and the CDC use NARMS information on a case-by-case basis to investigate foodborne illnesses and outbreaks. FDA routinely uses NARMS data in its regulatory review and approval of new animal antimicrobial drugs, and to develop and update policies on the judicious use of antimicrobial in animals. NARMS findings help public health partners continually assess the nature and magnitude of bacterial antibiotic resistance at different points along the farm-to-fork continuum.” – USDA

The report includes a new way to calculate multidrug resistance (MDR), which means a resistance to three or more antimicrobial drug classes. The method is supposed to provide more consistency to the NARMS year-to-year MDR trend analysis and comparisons.

The Integrated Report Summary is available on FDA’s website.

Alpine Fresh Green Beans

Listeria Alert: Recall of Green Beans Spans 12 States

By Food Safety Tech Staff
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Alpine Fresh Green Beans
Alpine Fresh Green Beans
Alpine Fresh’s “Hippie Organics” French Beans

Florida-based Alpine Fresh, Inc. has issued a voluntary recall of its “Hippie Organics” French Beans due to potential contamination with Listeria monocytogenes. The recall affects 1-pound packages from lot# 313-626, and the products were sold across 12 states in Whole Foods, Aldi and LIDL retail stores.

The issue was uncovered during routing company testing and is isolated to the specific recalled lot, according to a company announcement on FDA’s website. Alpine Fresh states that corrective actions have been taken to prevent recurrence.

Thus far no illnesses related to the recall have been reported.