Tag Archives: FDA

STOP Foodborne Illness
Food Safety Think Tank

Food Safety Culture Webinar To Broadcast Live from IAFP

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STOP Foodborne Illness

The FDA and the Alliance to STOP Foodborne Illness have announced that the fourth installment of the “Collaborating on Culture in the New Era of Smarter Food Safety” webinar series will take place on August 3 from 12:15pm – 1:15pm ET.

The webinar, entitled “What More Do You Want to Know About Food Safety Culture?” will be broadcast live from the International Association for Food Protection 2022 Annual Meeting. Speakers and attendees will have the opportunity to engage in a question-and-answer session. Registration is available for both in-person and virtual attendance.

The webinar series was designed to bring together experts from the public and private sectors for a collaborative exchange of ideas and experiences related to the importance of food safety culture in ensuring safe food production.

 

Woman shopping

FDA Seeks Information on Fluorinated Polyethylene Food Contact Packaging

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Woman shopping

The FDA is seeking scientific data and input from industry on current food contact uses of fluorinated polyethylene, as well as consumer dietary exposure that may result from those uses. On July 19, the agency issued a request for information due to concerns that fluorination of polyethylene may result in the formation of per- and polyfluoroalkyl substances (PFAS).

The FDA authorized fluorinated polyethylene for general use in contact with food in 1983 (21 CFR 177.1615). However, the regulation requires specific manufacturing conditions that must be in place during the fluorination process. In 2021, testing by the Environmental Protection Agency (EPA) noted the migration of perfluorooctanoic acid (PFOA), a type of PFAS, from fluorinated polyethylene containers used to hold pesticides. In response, the FDA issued a letter to food manufacturers, reminding industry that only certain fluorinated polyethylene containers are authorized for food contact use.

The July 19 call for input and data is part of the FDA’s efforts to monitor new scientific information on food contact surfaces (FCS) as it becomes available. “This includes reviewing scientific literature and studies from other regulatory and health agencies in the U. S. and in other countries. Considering recent developments, the FDA is seeking additional information on current practices to ensure the safe use of fluorinated polyethylene in contact with food,” said the FDA in its letter to industry.

Those interested in providing information can submit comments electronically on Regulations.gov to docket number FDA-2022-N-1526.

Submit written/paper submissions with Docket No. FDA-2022-N-1526 for “Fluorinated Polyethylene Containers for Food Contact Use; Request for Information” to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

 

 

Accreditation

FDA Recognizes JANAAC as an Accreditation Body Under FSMA

By Food Safety Tech Staff
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Accreditation

The U.S. Food and Drug Administration (FDA) has recognized Jamaica National Agency for Accreditation (JANAAC), as an accreditation body under the Accredited Third-Party Certification Program for a period of five years.

Accreditation bodies recognized by FDA have the authority to accredit third-party certification bodies. These certification bodies, once accredited, can conduct food safety audits and issue certifications of foreign food facilities (including farms) and the foods—both human and animal—that they produce. Those certifications are required to be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program. In addition, those certifications may be used in certain circumstances where the FDA can require that imported products be certified before entering the United States.

JANAAC is being recognized as having the authority to accredit certification bodies with the ability to conduct food safety audits under the following scopes of accreditation:

  • Acidified Foods (AF)
  • Dietary Supplements
  • Juice Hazard Analysis and Critical Control Points (Juice HACCP)
  • Low-Acid Canned Foods (LACF)
  • Medicated Feed Current Good Manufacturing Practices (Medicated Feed CGMPs)
  • Preventive Controls for Animal Food (PCAF)
  • Preventive Controls for Human Food (PCHF)
  • Produce Safety
  • Seafood Hazard Analysis and Critical Control Points (Seafood HACCP)
  • Shell Eggs

For more information on the eligibility criteria for recognition, see Key Facts about the Accredited Third-Party Certification Program.

Gary Nowacki
FST Soapbox

It’s Time To Embrace Ingredient Agility

By Gary Nowacki
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Gary Nowacki

In a recent Politico report, critics blasted the U.S. Food and Drug Administration (FDA) for chronic failures, including instances of contaminated baby formula, outbreaks of contaminated produce and the agency’s institutional reticence to implement changes.[1] Compounding the situation is the most fragmented global supply chain in history, making it a particularly challenging time for food and beverage companies.

Ingredients are the building blocks of the supply chain, so when circumstances threaten their integrity and availability, the ripple effect can linger for weeks, months or even years. As the FDA’s limitations become more apparent and supply chain challenges persist, brands must take responsibility for foundational change that addresses and mitigates risks related to food-, beverage- and supplement-borne illness.

Food Safety and Supply Chain Issues Challenge CPGs

As the Politico coverage pointed out, high turnover at the top of FDA has contributed to the agency’s challenges: five different commissioners have led the FDA over the last three years. In addition to concerns with federal oversight, brands are still navigating a broken supply chain, which has taken a beating over the last few years. And while the damage has come from war, trade tariffs and shipping congestion, food safety also emerged as a culprit when the FDA announced a recall of some of the country’s most popular infant formula brands. In February, the agency announced it was investigating consumer complaints of bacterial infections in four infants who were hospitalized. This bacterial infection might have contributed to death in two cases.[2]

While the recall emerged as a catalyst for the U.S. formula shortage, it wasn’t the only factor. Import restraints and market concentration (four companies produce 90% of the formula sold [3]) contributed to this perfect storm that rocked an already strained supply chain. National out-of-stock rates peaked at 70% near the end of May, and regulators announced that they did not expect relief until July. [4]

In scenarios such as this, the best defense brands can employ is to build a diverse supplier base and agile ingredient supply chain. Relying on a limited number of ingredient suppliers is a risky strategy even under the best of market conditions. But when disaster strikes, it can cripple a manufacturer and grind production to a halt. For the sake of consumers, creating agility and resilience around ingredients and sourcing is critical.

Equally important to cultivating relationships with alternate suppliers is the ability to have quick access to critical data. A robust digital document management system that offers manufacturers a unified view of products, data and processes across the business and the supply chain can help brands ensure they have a resilient ingredients network able to withstand supply chain or ingredient-sourcing issues. CPGs can benefit from instant access to millions of supplier documents to help fast-track sourcing, formulation and recipe development as well as protect themselves from potential disaster.

Pandemic Uncertainty and New Legislation

As the pandemic ramped up in March 2020, the FDA announced it would pause most foreign food inspections.[5] Additionally, regulators moved to virtual audits to keep their inspectors safe from COVID. Recalls fell. The FDA reported 495 recalls in the fiscal year 2020 and 427 in 2021. By comparison, the agency reported 526 recalls in the fiscal year 2019.[6]

The drop in recalls could be attributed to the ongoing rollout of the Food Safety Modernization Act (FSMA), which strengthened food production safeguards. In addition, a proposed rule change to FSMA, Section 204, would enforce better recordkeeping and quicker recall responses. The introduction of the Formula Shortage Reporting Act of 2022, requiring immediate action from manufacturers when future disruptions to production occur, is another step toward stricter food standards.

If passed, Section 204 would require companies who process, pack or hold items on the food traceability list (FTL) to capture and store ingredient data for two years, and submit it within 24 hours of a recall.[7] Without a formal system of record in place to manage food production, tracing ingredients—where, when and from whom they came—is a difficult and complex challenge to solve. Human error, overseas suppliers, recalls and other constantly changing variables all must be tracked and monitored constantly. This diligence demands automation and collaboration at scale.

Collaboration via holistic networked platforms can facilitate that diligence by enabling global ingredients suppliers, CPG brands, co-manufacturers and packing companies to build safer, stronger and more modern supply chain networks. Today, the stakes of not having a modern supply chain and access to real-time ingredient data have grown exponentially beyond profit and competitive advantage to a whole new level of costing lives.

Nimble Access to Ingredient Data is Crucial

On May 27, U.S. Sen. Edward J. Markey, D-Massachusetts, introduced the “Ensuring Safe and Toxic Free Foods Act.” The bill, co-sponsored by Sens. Richard Blumenthal, D-Connecticut, and Elizabeth Warren, D-Massachusetts, would—among other things—strengthen the Substances Generally Recognized as Safe (GRAS) Rule, which allows companies to avoid pre-market approval for food chemicals.[8]

The bill would direct the FDA to revise the GRAS Rule to include provisions that:

  • Prohibit manufacturers from designating substances as safe without supplying proper notice and supporting information to the Secretary of Health and Human Services
  • Require safety information to be publicly available on the FDA website and subject to a 90-day public review period
  • Prohibit carcinogenic substances from receiving GRAS designation
  • Prohibit substances that show reproductive or developmental toxicity from receiving GRAS designation
  • Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data regarding GRAS designations

Brands must have easy access to ingredient data to ensure compliance with the GRAS revisions as well as be proactive about food safety. Software that monitors threats and regulatory risks throughout the supply chain in real-time is essential to prevent both food safety issues and supply chain disruptions. These systems transform massive amounts of data into user-friendly, actionable insights for fast and effective risk management.

Food safety remains one of the gravest public health threats to consumers worldwide. The U.S. Centers for Disease Control and Prevention (CDC) insists that foodborne diseases cause 76 million illnesses in the U.S. annually, leading to 325,000 hospitalizations and 5,000 fatalities.[9]

With the FDA still struggling to regain the agency’s pre-pandemic diligence, it’s incumbent on manufacturers to double down on food safety. Digitization—evolving from paper to relevant, real-time data—is a critical component of the path forward to improve safety and increase ingredient agility.

Technology and automation help manufacturers and suppliers work better together, collaborate on ingredient data, move more quickly and problem solve together. In today’s modern supply chain, more CPGs are investing in partnerships to increase agility and gain more resilience over the shocks we’ve seen the past few years. More flexible and collaborative tools for engaging with global ingredient supplier networks can increase safety while improving bottom line efficiency.

References:

[1] Bottemiller Evich, H. (2022, April 8). The FDA’s Food Failure. Politico.

[2] U.S. Food & Drug Administration. (2022, May 12). Powdered Infant Formula Recall: What to Know.

[3] Muller, M. & Nyler, L. (2022, May 20). How US Baby Formula Monopolies Have Failed Families. Bloomberg.

[4] KHN. (2022, May 27). FDA Chief Suggests Stockpile Of Baby Formula Once Crisis Ends In July. Kaiser Health News.

[5] U.S. Food & Drug Administration. (2021, May). Resiliency Roadmap for FDA Inspectional Oversight.

[6] U.S. PIRG Education Fund. (2022, January 31). Food Recalls Decline in 2021, but That Doesn’t Mean Food is Safer.

[7] Govinfo.gov. (2022, June 13). Formula Shortage Reporting Act of 2022.

[8] Ensuring Safe and Toxic-Free Foods Act of 2022. (2022, May 27). Ensuring Safe and Toxic Free Foods Act.

[9] Centers for Disease Control and Prevention. (2018). Estimates of Foodborne Illness in the United States.

 

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.