Tag Archives: FDA

FDA

FDA Restaurant Study Finds Employees Not Properly Washing Hands or Keeping Foods to Temp

By Food Safety Tech Staff
No Comments
FDA

Yesterday FDA released the initial phase of its findings of a 10-year nationwide study that looks at the relationship between food safety management systems, certified food protection managers, and the occurrence of risk factors and food safety behaviors/practices, and how this contributes to foodborne illness outbreaks in retail establishments. This first phase collected data from 2013–2014; subsequent data collection will be from 2017 and 2021. The entire span of the study is 2013–2023.

The data collected and used in the 84-page “Report on the Occurrence of Foodborne Illness Risk Factors in Fast Food and Full Service Restaurants, 2013-2014” will be used as a baseline to evaluate trends in the occurrence of risk factors during the 2017 and 2021 data collection periods. Key findings in the report include the following:

  • Food safety management systems are important!
  • Restaurants had the most effective control over ensuring there is no bare hand contact with RTE foods as well as cooking raw animal foods (including meat, poultry and eggs) to the required temperature
  • Unsafe food behaviors in fast food and full-service restaurants. Improvement needed in:
    • Employee hand washing (knowing when and how to do it)
    • Proper temperature control of foods that require refrigeration to limit pathogen growth

Study results will be used to help advise retail food safety initiative and policies, industry partnerships and specific intervention strategies that target foodborne illness risk factors. It will also aid in providing technical assistance to state, local and other regulatory professionals. FDA put together a factsheet with highlights of the study.

Duncan Hines cake mix, recall

Duncan Hines Recalls Cake Mixes After Finding Salmonella

By Food Safety Tech Staff
No Comments
Duncan Hines cake mix, recall
Duncan Hines cake mix, recall
The following Duncan Hines cake mixes were recalled by Conagra Brands over concerns of Salmonella. (Click to enlarge)

–UPDATE–

“FDA and the CDC informed Conagra Brands that a sample of Duncan Hines Classic White Cake Mix that contained Salmonella Agbeni matched the Salmonella collected from ill persons reported to the CDC. This was determined through Whole Genome Sequencing, a type of DNA analysis. The sample was collected by Oregon health officials. Based on this information, Conagra Brands is working with FDA to proactively conduct a voluntary recall of Duncan Hines cake mixes from the market. The FDA is conducting an inspection at the Conagra Brands-owned manufacturing facility that produced the cake mixes. The FDA is also collecting environmental and product samples.” – FDA, November 7, 2018

 

–END UPDATE–

After a retail sample tested positive for Salmonella, Duncan Hines issued a recall of four varieties of its cake mixes. The sample that tested positive for the pathogen was the Classic White cake mix, but out of an “abundance of caution”, the company recalled its Classic Butter Golden, Signature Confetti and Classic Yellow cake mixes that were manufactured during the same period of time.

According to a Conagra Brands press release, the FDA and CDC are investigating five occurrences of Salmonella that may be linked to the Duncan Hines cake mix.

“Several of the individuals reported consuming a cake mix at some point prior to becoming ill, and some may have also consumed these products raw and not baked. Consumers are reminded not to consume any raw batter. Cake mixes and batter can be made with ingredients such as eggs or flour which can carry risks of bacteria that are rendered harmless by baking, frying or boiling.” – Conagra Brands

The recalled products have a “Best If Used By Date” ranging from March 7 to March 13, 2019 and were distributed to U.S. retailers as well as exported internationally (on a limited basis). Consumers are advised to return the recalled products to the store in which they were purchased.

FDA

FDA’s Final Guidance on Mandatory Food Recall Authority Part of Efforts to be Robust and Transparent

By Food Safety Tech Staff
No Comments
FDA

Yesterday FDA released the final guidance on its mandatory recall authority under FSMA. Although the agency has only taken a mandatory recall action once since 2011—in April, FDA issued a recall of Triangle Pharmanaturals Kratom Products—the FDA’s authority to recall products “plays an important role in ensuring that potentially dangerous food products are removed from the marketplace,” states the agency in a release. “The agency remains committed to working with firms to facilitate the orderly and prompt voluntary removal of potentially dangerous products from the food supply. FDA Recall Coordinators are available to assist firms during the recall process.”

The final guidance, “Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff”, is as its title states, in a Q&A format, offering answers to the most common questions about the mandatory recall provisions in section 423 of the FD&C Act.

FDA Commissioner Scott Gottlieb, M.D. also released a statement about the agency’s commitment to keeping unsafe products off the market. “When issues arise that would put consumers at risk, we won’t hesitate to mandate the removal of a product from the market using the full extent of our authorities. It’s our responsibility. And it’s critical to our mission to ensure the safety of Americans,” stated Gottlieb in a press release. He added that most companies are cooperative in closely working with FDA to initiate voluntary recalls.

FDA will be making additional moves to enhance its recall policies, according to Gottlieb.

Frank Yiannas, Walmart

Stephen Ostroff to Retire from FDA, Walmart’s Frank Yiannas to Take the Reins

By Food Safety Tech Staff
No Comments
Frank Yiannas, Walmart

Today it was announced that FDA Deputy Commissioner for Foods and Veterinary Medicine Stephen Ostroff, M.D. is retiring and Frank Yiannas, vice president of foods safety at Walmart, will join FDA as the Deputy Commissioner for Food Policy and Response.

FDA Commissioner Scott Gottlieb, M.D. made the announcement in an email to agency employees. Yiannas will have a different title than Ostroff’s, which is reflective of the reorganization at the agency—FDA will reportedly be creating a new office called the Office of Food Policy and Response. Yiannas will also reportedly take on the role of senior scientific advisor to Commissioner Gottlieb on issues related to food safety and supply chain.

Ostroff will retire in January 2019 and will assist in the transition of Yiannas into his new role at FDA.

The Future of Food Safety: A Q&A with Walmart’s Frank Yiannas

 

Allen Sayler, EAS
FST Soapbox

Fast Track to FDA FURLS—Expediting or Impeding Access to Overseas Markets

By Allen Sayler
No Comments
Allen Sayler, EAS

Is the FDA Unified and Listing Systems (FURLS) system with its newly updated electronic Export Listing Module (ELM) a pathway to overseas markets or just one more regulatory hurdle that has been put in place by the U.S. government to impede export of U.S.-processed foods? A review of the new updates is needed to provide the answer to this question.

Regardless of the answer to this question, whether your company is already participating in this program or is looking for new markets outside the United States in countries that do not require the FDA listing of U.S. food companies, you must understand how the FURLS system works, how to electronically register and better understand the regulatory challenges of the importing country.

The FDA recently released a notification that their FDA Unified and Listing Systems (FURLS) system has been updated to include an Export Listing Module (ELM). This update allows U.S. food manufacturers to electronically submit, and for FDA to receive and process requests for inclusion on the export lists for FDA-regulated food products and present these lists to countries that require them, whether your company is already participating in this program or is looking for new markets outside the United States.

As background, the FDA has established and maintains export lists for countries that require some assurance that U.S. food manufacturers exporting to these countries, at a minimum, meet all applicable food safety regulations enforced by FDA. These lists, in an unofficial way, serve as a “certification” by the FDA, representing the U.S. government, that either included facilities have provided information to the FDA to assert they are in compliance with the importing country’s regulations and requirements or, more likely, that the U.S. food manufacturer is meeting the currently applicable U.S. laws and regulations.

Other options for U.S. food manufacturers that are interested or already exporting to countries that do not require the FDA lists, include the FDA’s export certificates, which give the agency’s official attestation concerning a product’s regulatory or marketing status. The fact that FDA has issued an export certificate does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate. CFSAN issues “certificates of export” for seafood, food additives and food contact substances. CFSAN issues “certificates of free sale” for land food, dietary supplements, infant formula, medical foods and foods for special dietary use. U.S. firms wishing to apply for an export certificate for a food product may log in to FDA Industry Systems and submit an online application through the Certificate Application Process.

TraceGains, verifying suppliers Need to learn more about supplier verification? TraceGains is here to help! Download our Foreign Supplier Verification Program Guidebook to learn the ins and outs of this complicated FSMA addition. TraceGains enlisted the help of Marc Sanchez, regulatory attorney specializing in FDA and USDA law, and Shawn Stevens, a global food safety lawyer, to provide insight and break down some of the confusion.

Back to the FDA list option. It is important to note that companies may request to be included on these lists at any time; however, updates to the lists are only published quarterly by the FDA. Additionally, final listing decisions are made by the competent authority of the importing country. This is to say, there can be a short or lengthy process between the time when FDA updates the list for a particular country and when that country formally accepts the updated list. Since there is no downside for a company to appear on one FDA list or many (lists maintained for each country), this potential delay in official acceptance of the list should drive U.S. food companies to apply to be on all of the country lists, before there is a specific need to do so. Remember the old adage, “When you are in a hurry, inevitably you end up standing in the slowest line.”

Market access for U.S.-manufactured dairy products to the EU, China and Chile, for example, are subject to these listing requirements in order to gain market access. Do ensure you have verified that your dairy product meets the standards and labeling requirements for the country to which you wish to export, as it is likely that a foreign country’s dairy product requirements will not necessarily be the same as what is found in the United States. Another example is that in order to export U.S.-manufactured collagen and gelatin products to the EU, companies must provide a laboratory report from an accredited, private laboratory demonstrating that the products comply with the established criteria. For exporters of U.S.-manufactured/processed seafood products to the EU or China, inclusion on the FDA-maintained list is required, as well as an export certificate which is provided by the National Oceanic and Atmospheric Administration (NOAA) Seafood Inspection Program after FDA listing has been completed.

Finally, U.S.-manufactured infant formula exports to China are also subject to listing requirements. It should be noted that the China Certification and Accreditation Administration (CNCA) defines infant formula as food intended for children up to 36 months of age, known as “infant and young children formula”. This differs from the U.S. definition. Please be advised that CNCA requires new applicants to submit evidence of third-party certification of compliance with Chinese laws and regulations as part of the application process. CNCA also requires that infant formula manufacturers/processors submit an Establishment Registration Application with additional information to CNCA.

One of the most important keys to gaining access to overseas markets is to get your company enrolled on as many of these FDA lists as possible, obtain FDA certificates of free sale ahead of time, and make sure you update your information and keep it current within the various FDA electronic database systems.

Whether your company faces a foreign market access challenge via being a part of the FDA List or needing to get an FDA “Certificate of Free Sale” or just have questions related to moving product out of a U.S. port and into a foreign port, contact a reputable consulting firm for assistance.

Stephen Ostroff, FDA

Too Many Recent Outbreaks, FDA Says Significant Food Safety Problems Continue

By Maria Fontanazza
No Comments
Stephen Ostroff, FDA

The serious outbreaks over the past few months indicate that industry continues to experience “significant food safety problems”, said Stephen Ostroff, FDA deputy commissioner for foods and veterinary medicine at the IAFP annual meeting last week. He referred to the most recent sizable produce-associated outbreaks involving romaine lettuce, pre-cut melon and veggie trays, as well as the Kellogg Company recall of Honey Smacks cereal and the Rose Acres eggs recall, both of which were due to Salmonella. “We have a lot of work to do,” said Ostroff, adding that the numerous recalls involving kratom products is concerning.

These issues highlight how the increasingly complex supply chain further complicates problems once they arise. Ostroff emphasized the necessity of end-to-end tracing, from product origination to where the consumer can access the product, and that it needs to be efficient, standardized and rapid, especially for commodities. Regarding the E. coli O157:H7 outbreak involving romaine lettuce, FDA is still trying to determine the source and mode of the contamination. And while the recent finding of the outbreak strain in the irrigation canal water is important, it still does not answer the question of how the contamination got into the canal, said Ostroff.

The latest FDA update on the outbreak investigation stated that additional samples are being analyzed on an ongoing basis and any new matches would be publicly disclosed. As of June 28, the CDC announced that the outbreak was over.

FSMA

FDA Issues Draft Guidance on Supply Chain Program for PC Animal Food

By Food Safety Tech Staff
No Comments
FSMA

Under the FSMA Preventive Controls Animal Food rule, certain animal food manufacturers that receive raw materials and ingredients must develop and implement a risk-based supply chain program. This is required if the facility determines that a supply-chain-applied control is the appropriate preventive control for a hazard of an incoming ingredient. In order to better help animal food facilities meet these requirements, the FDA released a draft guidance, “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Foods for Animals: Supply-Chain Program”.

According to an agency news release, the draft guidance will help facilities in the following areas:

  • “Determine whether they need a supply-chain program;
  • Identify and implement the appropriate supply-chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
  • Establish frequency of supplier verification activities;
  • Meet documentation and recordkeeping requirements; and
  • Recognize situations that necessitate or allow for flexibility or different supplier verification activities.”

In addition, the document offers clarification for receiving facilities that are animal food importers and subject to the supply-chain program requirements of the FSVP rule.

The FDA is accepting public comments on the draft for the next 180 days.

FDA

FDA’s Data Dashboard Helps Companies Meet FSMA Supply Chain Requirements

By Food Safety Tech Staff
No Comments
FDA

FDA has launched a new section of its Data Dashboard to help food importers, manufacturers and processors meet supply chain requirements put forth by FSMA (specifically FSVP, and the PC rules). The dashboard provides ease in finding compliance and enforcement information related to companies.

Do you trust your suppliers? What about your supplier’s suppliers? | Food Safety Supply Chain Conference | June 12–13, 2018 | Learn more“The Foreign Supplier Verification Programs rule requires importers to perform risk-based activities to verify that their suppliers are meeting applicable U.S. food safety standards. One such activity is an evaluation of a supplier’s performance and the risk associated with the food, a process that includes evaluating a supplier’s compliance with FDA regulations such as whether the supplier is subject to an FDA warning letter, import alert, or other FDA compliance action related to food safety. The Preventive Controls rules require manufacturers/processors to perform supplier approval if the ingredient supplied contains a hazard requiring a supply-chain applied control. Supplier approval includes consideration of the supplier’s compliance with food safety laws and regulations.” – FDA

The agency also made improvements to its supplier evaluation resources page and added it to the dashboard so that companies can simultaneously search several databases. Users can search for information about warning letters, import refusal and import alerts.

 

FDA

FDA Launches New Web Page to Support Food Safety Science and Research

By Food Safety Tech Staff
No Comments
FDA

Last week FDA announced a new web page that will house information for scientists and other parties that are interested in the agency’s Foods and Veterinary Medicine’s (FVM) research priorities, activities, reporting and tracking. The page has information about the Science and Research Steering Committee (SRSC), a science and research roadmap, and the FVM’s strategic goals—which includes food safety, nutrition, animal health and organizational excellence. Under food safety, the key initiative is to “Protect America’s Consumers and Animals From Foreseeable Hazards Across the Global Farm-to-Table Continuum”.

Recall

Packaging Process Breakdown Causes Eataly Recall

By Food Safety Tech Staff
No Comments
Recall

Eataly USA has recalled its Eataly Artichoke Spread due to undeclared walnuts. A customer who is allergic to walnuts suffered a “light” allergic reaction after consuming the spread.

“The customer declined to fill out the Eataly incident form and just wanted to bring the seriousness of what happened to our attention.” – FDA

After investigating further, it was discovered that the issue was caused by a temporary breakdown in the packaging process, FDA stated in a safety recall.

The product was distributed at the company’s popular New York City Eataly Flatiron location.