Tag Archives: FDA

Alert

Family Dollar Recall Highlights Need for Sound Pest Management Plan

By Food Safety Tech Staff
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Alert

After finding evidence of rodent infestation during an inspection of a Family Dollar distribution facility in Arkansas, the FDA warned the public of usage and consumption of products purchased at certain stores from January 1 through present time. The affected products, which include food, were distributed to Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.

“Families rely on stores like Family Dollar for products such as food and medicine. They deserve products that are safe,” said Associate Commissioner for Regulatory Affairs, FDA, Judith McMeekin, Pharm.D. in an agency press release. “No one should be subjected to products stored in the kind of unacceptable conditions that we found in this Family Dollar distribution facility. These conditions appear to be violations of federal law that could put families’ health at risk. We will continue to work to protect consumers.”

The FDA inspection followed a consumer complaint and found both live and dead rodents, rodent feces and urine, and evidence of rodent presence, along with dead birds and bird droppings, throughout the facility in West Memphis, Arkansas. After fumigating the facility, 1100 dead rodents were recovered. FDA’s review of company records also revealed a history of infestation, with more than 2300 rodents collected between March 29 and September 17, 2021.

Among the range of hazards associated with rodents include Salmonella.

Family Dollar, Inc. initiated a voluntary recall of the FDA-regulated products that were stored and shipped from the infested facility. The company states that it is unaware of any reports of illnesses related to the recall.

COVID-19 has not slowed down pests, and the last thing a company needs is a failed audit due to preventable pest issues.

 

Alert

FDA Tells Consumers to Throw out Certain Powdered Infant Formulas due to Contamination

By Food Safety Tech Staff
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Alert

–UPDATE–March 14, 2022 — In an agency update, the FDA stated that it has removed the Salmonella Newport illness that was previously noted in the investigation. “In the early stages of this investigation, FDA included all consumer complaints of illness with exposure to products from the Sturgis, MI, facility. After further investigation, the FDA has determined that there is not enough information to definitively link this illness to powdered infant formula. CDC confirmed that this single Salmonella illness is not linked to an outbreak. The FDA and CDC are continuing to monitor for Salmonella cases and consumer complaints that may be related to this incident,” the FDA stated.

–END UPDATE–

Earlier this week Abbott issued a recall of infant powdered formulas (including Similac, Alimentum and EleCare) that were manufactured at the company’s Sturgis, Michigan plant. The company received consumer complaints in infants who had consumed powdered infant formula manufactured in this facility—specifically, three reports of Cronobacter sakazakii and one report of Salmonella Newport. All cases resulted in hospitalization, and one death was reported.

FDA began onsite inspection at the facility and thus far has found several positive Cronobacter results from environmental samples and reported adverse inspectional observations. “A review of the firm’s internal records also indicate environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter,” FDA stated in a CFSAN update.

The recalled Similac, Alimentum and EleCare products can be identified by their 7-to-9 digit code and expiration date:

  • First two digits of the code are 22 through 37 and
  • Code on the container contains K8, SH, or Z2, and
  • Expiration date of 4-1-2022 (APR 2022) or later.

In a company announcement published on FDA’s website, Abbott stated, during testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.” It added that “no distributed product has tested positive for the presence of either of these bacteria” but that the company will continue to conduct testing.

Parents and caregivers can find out whether the product they have is included in the recall by visiting the Similac recall website.

FDA

FDA Ready to Start Domestic Surveillance Inspections

By Food Safety Tech Staff
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FDA

Last week the FDA announced that it would resume conducting domestic surveillance inspections on February 7—affecting all commodities. The agency will continue with mission-critical domestic and foreign inspections, and leverage remote assessments when necessary. FDA will also conduct previously planned foreign surveillance inspections that have received country clearance and fall within the CDC’s Level 1 or Level 2 COVID travel recommendation.

“Throughout all these activities, the agency remains committed to the health and safety of its investigators and will provide the protection needed to safely inspect facilities and conduct investigations at the ports and in agency laboratories.” – FDA

FDA’s plans to start foreign prioritized inspections in April. It will also continue remote FSVP activities for human and animal foods. However, state inspections under the FDA contract have the authority to determine whether to make inspection decisions as per local information.

FDA

FDA Offers Help to Companies with Supply Chain Disruptions

By Food Safety Tech Staff
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FDA

FDA has given an update on its resources to provide the industry with continued assistance as it struggles through the challenges presented by the ongoing pandemic.

FDA

Highlights of FDA’s 2021 Achievements in Food

By Food Safety Tech Staff
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FDA

At the end of his reflection on FDA’s 2021 accomplishments in the food realm, Deputy Commissioner for Food Policy and Response Frank Yiannas stated that he believes collaboration will enable industry to “bend the curve of foodborne illnesses in this decade”. It would be a significant milestone, and in his latest FDA Voices blog, Yiannas reviewed a host of FDA achievements that bring his statement much closer to a reality:

FDA Acting Commissioner Janet Woodcock gives of full report on the agency’s work in the “FDA 2021 Year in Review: Working For You”.

Compare this year’s review with that of 2020, where Yiannas reflected on the agency’s Food Program achievements during the first year of the pandemic and the 10-year anniversary of FSMA.

CDC, FDA, USDA logos

IFSAC to Continue Focus on Finding Sources of Foodborne Illnesses

By Food Safety Tech Staff
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CDC, FDA, USDA logos

The Interagency Food Safety Analytics Collaboration (IFSAC) has published its 2022–2023 Interim Strategic Plan, placing continued emphasis on foodborne illness source attribution for Salmonella, E. coli O157:H7, Listeria monocytogenes and Campylobacter. Over the next year, IFSAC will address several short-term goals surrounding improvement of methods to evaluate and identify foodborne illness source attribution through the use of outbreak and non-outbreak-associated disease data, and continued collaboration with external partners in an effort to boost data access and capabilities. The group will be targeting several efforts in the coming year, including:

  • Analysis of trends related to foodborne disease outbreak-associated illnesses over the past two decades, with a subsequent peer-reviewed journal article that reveals results.
  • Development and improvement of machine-learning methods used to predict food sources of illnesses that have an unknown source. WGS will be used to compare Salmonella isolates of known and unknown sources.
  • Collaboration with FoodNet when assessing key food sources for sporadic Salmonella Enteritidis and Campylobacter illnesses. The group will develop case-control studies using specific FoodNet data.

Formed in 2011, IFSAC is a partnership between FDA, FSIS and the CDC that seeks to strengthen federal interagency efforts and maximize use of food safety data collection, analysis and use. During 2022–2023, IFSAC will publish its yearly reports on foodborne illness source attribution for the previously mentioned priority pathogens.

Recall

FDA Continues Investigation of Listeria Outbreak in Packaged Salad

By Food Safety Tech Staff
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Recall

— UPDATE — January 12, 2022

Dole Fresh Vegetables, Inc. has now issued a voluntary recall of Dole-branded and private label packaged salads processed at its Springfield, OH (product ID lot code “W” and “Best if Used By” date December 22, 2021–January 9, 2022) and Soledad, CA production facilities containing iceberg lettuce.

–END UPDATE —

The FDA and CDC are investigating a multistate outbreak of Listeria monocytogenes illnesses linked to Fresh Express Packaged Salad and Dole Packaged Salad.

Last month Dole Fresh Vegetables issued a voluntary recall for salads processed at its facilities in Bessemer City, NC and Yuma, AZ due to the health risk. The company also temporarily suspended operations at both facilities. The brand names in which the salads were sold under include Dole, Kroger, Lidl, Little Salad Bar, Marketside, Naturally Better, Nature’s Promise and Simply Nature. The products have “Best if Used By” dates between November 30, 2021 and January 8, 2022.

The agencies’ investigation of Fresh Express Packaged Salad resulted in the company stopping production at its Streamwood, IL facility. It also initiated a recall of certain varieties of its branded and private-label salads that were produced at this facility.

The FDA’s investigation into the Listeria monocytogenes outbreak linked to both Dole and Fresh Express is ongoing. Thus far, no deaths linked to the outbreak have been reported.

Jonathan Sharp, Environmental Litigation Group
In the Food Lab

How Baby Food Companies Can Minimize the Concentration of Heavy Metals in Products

By Jonathan Sharp
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Jonathan Sharp, Environmental Litigation Group

On February 4, 2021, the U.S. House of Representatives made public a report concerning the existence of heavy metals in baby food. The heavy metals of concern were cadmium, arsenic, lead and mercury, which pose a tremendous hazard to developing children’s health. After reviewing internal documents and test results from seven of the largest baby food manufacturers in the country, the Subcommittee on Economic and Consumer Policy found each company’s products to contain dangerously high concentrations of heavy metals.

Four of the companies, Nurture, Beech-Nut, Hain and Gerber, responded to the request. They provided internal testing policies, test results for ingredients and finished products, and documentation about how they handled finished products and ingredients that exceeded their internal testing limits.

On the other hand, Walmart, Campbell and Sprout Organic Foods refused to partake in the investigation. The Subcommittee on Economic and Consumer Policy members are very concerned that the lack of cooperation of these manufacturers could obstruct the presence of even higher levels of heavy metals in their products than their competitors.

Practical Measures Baby Food Companies Can Take to Ensure Products Are Safe for Children

Baby food manufacturers may not intentionally add heavy metals to their products, but their lack of testing and a lack of regulation in this sense is a cause for great concern. The main ingredients in baby foods such as rice, sweet potatoes, wheat, and carrots absorb heavy metals from the soil and water and metal-containing pesticides and industrial pollution.

Therefore, the companies that manufacture baby food should tackle the issue of heavy metals at the root of the problem and abide by strict safety measures and protocols to ensure low concentrations of heavy metals, particularly arsenic. Some of the steps that they could take to minimize this issue are the following:

  • Sourcing cereals, fruits, and vegetables from fields with lower arsenic concentrations in the earth
  • Growing crops with natural soil additives that reduce heavy metal uptake
  • Using strains of food that are less prone to absorb heavy metals
  • Altering irrigation practices
  • Preparing the food with excess water that is afterward poured off
  • Blending it with lower arsenic grains in multi-grain products

Subsequently, when the end product is finished, manufacturers should collect a sample from the finite product and test it for cadmium, arsenic, lead and mercury. Fortunately, nowadays, testing baby food for heavy metals is easier than ever and cost-efficient. Every food facility that must comply with FSMA must implement HACCP and establish preventive controls. HACCP, which is recognized internationally, ensures the health and safety of consumers by avoiding hazardous toxins in food. When it comes to baby food companies, they should focus on chemistry testing, as it addresses chemical and physical hazards, including heavy metals.

Alternatively, baby food companies can test their products by using the guidelines of the Environmental Defense Fund. The non-profit advocacy group advises manufacturers to prohibit arsenic, cadmium explicitly, and lead in any packaging or food handling equipment and strictly avoid brass and bronze unless they are confident that no heavy metal was added. Manufacturers of baby food should test the products per se, the ingredients, and the packaging for arsenic, cadmium, and lead. More specifically, companies should:

  • Consistently test baby food and their main ingredients that may be contaminated with arsenic, cadmium, or lead by using the method approved by the FDA and examine potential sources of heavy metals where measurable concentrations are found
  • Periodically test the packaging that comes in contact with food anywhere along the supply chain for arsenic, cadmium, or lead through a CPSC-accepted, third-party certified lab that evaluates baby food for heavy metals

In December of 2019, the cost of heavy metal testing was between $50 and $100 per sample. Nevertheless, companies that produce baby food should invest in heavy metal testing, no matter how small or large. This is the only way of making sure they put exclusively clean and safe products of high quality on the market.

To make sure baby food companies keep following the guidelines concerning heavy metals and do not fail to test their products for these neurotoxins regularly, the authority of the FDA should be expanded. Accordingly, the agency should be able to request a recall of adulterated or misbranded baby food whose concentration of heavy metals exceeds the safe limit. Moreover, the FDA should establish health-protective standards for each heavy metal and implement a testing program for neurotoxins in foods eaten by infants and toddlers that could be similar to the agenda of the Consumer Product Safety Commission for children’s toys.

The Ethical Measures Baby Food Companies Should Take to Avoid Selling Tainted Products

Baby food companies should exercise their social and moral capacity at all times. Nonetheless, while few people achieve the extent of influence necessary to change society itself, the food industry can drastically change societies. Moreover, it can also act in morally beneficial or detrimental ways, which inevitably affects people, the environment, and, ultimately, the planet itself.

To prevent your baby food company from developing unethical conducts, such as allowing dangerous concentrations of heavy metals in the products that end up on the market, there are a series of measures you and the other people who are in charge of the business can take, the paramount being the following:

  • Hiring accredited, trustworthy and competent people is perhaps the most important, as well as the first, step you can take to ensure no foul play will occur, as they will be unlikely to cover up essential information from you and the other higher-ups
  • Sourcing your ingredients from ethical suppliers, that are, preferably, local farmers, as they usually employ transparent business practices
  • Make sure that your facilities are maintained clean 24/7 by hiring the right people to take care of this not-so-easy job as if you neglect the condition of your facilities. Other contaminants may end up in the food you sell
  • Systematically testing your baby food for cadmium, arsenic, lead and mercury to ensure the products you allow to go on the market do not contain dangerous levels of heavy metals
  • Partnering with experienced laboratories to have your baby food regularly tested for heavy metals, which may help you save money if it is going to be a win-win situation
  • Having clear labels, even if you add ingredients that are not so healthy in your products, which will result in the consumers you target trusting you as a company
  • Voluntarily recalling a line of baby food products as soon as you receive the positive test results for one or multiple heavy metals, which will spare you some liability if you willingly take your food off the market

The Changes the Baby Food Safety Act May Bring About if the Bill Becomes Effective

On March 26, 2021, Representative Raja Krishnamoorthi introduced the Baby Food Safety Act, a bill to set maximum limits for each heavy metal in infant and toddler food, which is defined as food manufactured for children younger than 36 months. The initiative was taken because the concentration of neurotoxins in baby food is poorly regulated in our country. There is only a maximum limit for arsenic set by the FDA, which is considered dangerous by multiple other health agencies. It applies solely to infant rice cereals. The other three harmful heavy metals are not regulated at all.

If the Baby Food Act of 2021 becomes effective, companies that manufacture, process, pack or hold baby food need to ensure that their food complies with the limits on heavy metals set by the bill. Furthermore, baby food companies would also have to provide public information, such as test results for neurotoxins in their infant and toddler.

FDA

FDA’s Foodborne Outbreak Response Improvement Plan Seeks to Expedite Investigations

By Food Safety Tech Staff
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FDA

Today FDA released a plan to help the agency and its partners improve the “speed, effectiveness, coordination and communication” of investigations surrounding foodborne illness outbreaks.

“We know that the 21st century has brought new challenges in identifying, investigating and controlling outbreaks of foodborne disease, but it has also brought new tools to meet those challenges,” stated Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, and Stic Harris, D.V.M. director of the FDA’s Coordinated Outbreak Response and Evaluation Network in an agency news release. “We also recognize that today’s U.S. food system is large and decentralized, with a broad array of widely distributed products, which we must adapt to in order to help ensure the safety of these products. That is why we are taking steps through this improvement plan to evolve our outbreak investigations to meet modern-day needs using the most modern-day tools available. Our investigations must be faster, more streamlined and more effective to identify, pinpoint and remove contaminated food from the market and identify root-cause factors in the food system to prevent similar outbreaks in the future.”

The Foodborne Outbreak Response Improvement Plan targets four areas that, if improved, will have the greatest effect on foodborne illness outbreaks:

  • Tech-enabled product traceback: Being smarter about using digital technology, regularly, to streamline traceback investigations
  • Root-cause investigations: Adapting and strengthening procedures for conducting root-cause investigations
  • Working with the CDC, USDA’s FSIS and other partners to improve the analysis and distribution of outbreak data (including identifying recurring, emerging and persistent strains of pathogens)
  • Enhancing performance measures across the agency’s food programs to enable better evaluation of the timeless and effectiveness of outbreak and regulatory investigation activities

In addition to this improvement plan, the agency also released “An Independent Review of FDA’s Foodborne Outbreak Response Processes”, which was contracted with the University of Minnesota’s School of Public Health. The independent report played an important role in the development of FDA’s improvement plan.

FDA

FDA Wants to Change Agricultural Water Requirements in Produce Safety Rule

By Food Safety Tech Staff
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FDA

After years of foodborne illness outbreaks that have been suspected to originate in pre-harvest agricultural water, FDA is proposing changes to the FSMA Produce Safety Rule. The proposed rule would revise subpart E, changing certain pre-harvest agricultural water requirements for covered produce other than sprouts.

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response in an agency update. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

Under the proposed rule, farms would be required to conduct yearly systems-based agricultural water assessments to assess and guide measures that would reduce risks related to pre-harvest agricultural water. According to the FDA, the assessment would consist of evaluating the water system, agricultural water use practices, crop characteristics, environmental conditions, potential impacts on source water by activities conducted on adjacent and nearby land.

With the current agricultural water compliance dates for covered produce other than sprouts set to begin in January 2022, the FDA plans to exercise enforcement discretion for those requirements while also proposing another rule that extends the compliance dates for all agricultural water requirements under the Produce Safety Rule.

The full details of the FSMA Proposed Rule on Agricultural Water are available on FDA’s website.