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FDA’s 2022 Food Program Accomplishments for Customer Protection & Food Supply.

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

In a recent post, FDA highlights the challenges the US Food & Drug Administration’s (FDA) Foods Program has encountered and their resolutions to achieve their mission of protecting the safety of human foods, as increasing access to safe and nutritious foods for all consumers in 2022.

The post highlights 4 main elements: Infant formula, food safety, nutrition and innovation.

The article reads as follows:

“Despite being a challenging year, the U.S. Food and Drug Administration’s Foods Program has taken important strides in 2022 to protect the safety of human foods and expand access to safe and nutritious foods for all consumers last year. 

We know the infant formula issue created hardships for far too many families across the country, so first we’d like to take a moment to highlight our work to address the Cronobacter sakazakii related illnesses in infants and the ensuing infant formula shortage, one of the toughest challenges the FDA has faced since the passage of the Food Safety and Modernization Act (FSMA). This situation reinforced our public health mission.

Infant Formula (Frank Yiannas)

As the infant formula incident unfolded, we worked around-the-clock with infant formula manufacturers to increase production and used data tools to monitor industry-provided production volumes for infant formula and assist with tracking and addressing infant formula supply shortages throughout the country. Additionally, we have expanded access to infant formula by exercising enforcement discretion for 12 firms to temporarily import their foreign-produced infant formula products into the U.S. market. The agency has provided a pathway for those manufacturers to bring their products into full compliance with U.S. requirements and be able to sell in the U.S. permanently. Importantly, we also worked with manufacturers to increase their production capacity by exercising flexibility on ingredient and packaging supply chain issues and by working with other government partners activated the Defense Production Act to ensure availability of critical ingredients.  Finally, the FDA has outlined a prevention strategy on Cronobacter sakazakii and powdered infant formula that will help us do our part to reduce illnesses associated with Cronobacter sakazakii contamination. We continue to be fully committed to protecting the safety of infant formula and safeguarding this essential source of nutrition for so many babies in this country. 

Food Safety ( Susan T. Mayne, Ph.D.)

In 2022, we made significant advances in implementing FSMA and, building upon it, through the advancement of the FDA’s New Era of Smarter Food Safety goals: In November, the FDA issued the Food Traceability Final Rule mandated by FSMA, with its list of foods for which additional recordkeeping will apply, allowing for faster identification and rapid removal of potentially contaminated food from the market.   We continued work to finalize the pre-harvest agricultural water requirements for covered produce other than sprouts. In March, we released an on-line Agricultural Water Assessment Builder to guide farmers in an interactive format.   We released the first in a series of Prevention Strategies to Enhance Food Safety that target specific commodity-hazard pairings. Our Office of Human and Animal Food Operations trained more than 1,000 FDA staff to recognize elements of Food Safety Culture in food operations.  We expanded Domestic Mutual Reliance partnerships with states, adding Iowa, Minnesota, and Virginia.  We entered into a Memorandum of Understanding between the FDA and the Centers for Disease Control and Prevention to strengthen food safety in retail and foodservice establishments. In September, we released the “Activities for the Safety of Imported Produce” to detail how the agency is working to enhance the safety of fresh fruits and vegetables. We enhanced oversight of imported shrimp from the three largest exporting countries through increased examination and sample collection. Additionally, we collaborated with foreign governments to provide training and outreach events focusing on seafood safety and import requirements. We enhanced regulatory oversight of foreign firms the agency cannot routinely inspect by leveraging tools such as the Foreign Supplier Verification Program, remote regulatory assessments, importer seafood inspections, and sampling to ensure supply chain security and compliance with good manufacturing practices.     Susan T. Mayne, Ph.D. Other advances in our food safety work included making available the testing results for per-and polyfluoroalkyl substances (PFAS) in seafood samples collected at retail. As a result of the findings, two companies issued voluntary product recalls. Additionally, we advanced the Closer to Zero initiative. In support of those goals, the agency is working with federal partners to study the role of seafood consumption, the primary dietary source of mercury, in child growth and development. The FDA also issued a draft guidance to industry on action levels for lead in single-strength juices and juice blends. 

Nutrition

The FDA’s Foods Program is committed to helping to ensure that consumers have access to healthy foods and have the information they need to make informed choices for themselves and their families.  In September, we participated in the White House Conference on Hunger, Nutrition, and Health during which one of the priorities was empowering consumers to make healthy choices. At the conference, the FDA announced the proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging.  In December, we issued the 2022 edition of the FDA Food Code, which provides guidance to state and local authorities and retailers to help mitigate foodborne illness risks at retail and provide a uniform set of national standards for retail food safety. The 2022 update specifically addressed food donations as part of an effort to reduce food waste that is part of the Biden-Harris Administration’s National Strategy on Hunger, Nutrition, and Health. 

Innovation ( Judy McMeekin, Pharm.D.)

We are constantly striving to find smarter and more modern ways to improve food safety and increase access to nutritious foods. In 2022, the agency: Continued to explore the use of Artificial Intelligence (AI) to strengthen import screening. We entered the third phase of the Artificial Intelligence Imported Seafood Pilot program, which uses AI and machine learning to help predict the likelihood that an import shipment is potentially harmful and not compliant with FDA regulations.  Completed our first pre-market consultation for a human food made from cultured animal cells. As the Human Foods program undergoes some important changes, at our core the talented and dedicated employees from the program look forward to continuing this important work with our public and private sector partners in the year ahead. Together we will bend the curve of foodborne illness, protect consumers from unsafe foods, and support them in making healthy food choices”.

If you have any additional questions, please don’t hesitate to contact us HERE.

References:
 https://www.fda.gov/news-events/fda-voices/what-fdas-foods-program-achieved-2022-protect-consumers-and-food-supply?utm_medium=email&utm_source=govdelivery

We are excited to share our client’s feature in The New York Times.

We are beyond ecstatic to share our client’s feature in The New York Times.  

Congratulations to MINA on yet another excellent creation. Mina’s Moroccan Harira is a flavorful soup full of chickpeas and lentils. The heartiness and earthiness of this Harira will make your taste buds sing.

Try it today ➡️ by clicking HERE.

Check out the article below to read the full story.
https://lnkd.in/eDwikaAA

To schedule a discovery call and see how ETC can help grow your business, contact us here ➡️ https://lnkd.in/e84Ti6hg

Food Industry Update: FDA opens a Voluntary Qualified Importer Program (VQIP) allowing importers to move their food products to the U.S with greater speed and predictability.

The anticipated VQIP application opens as of January 1st, 2023. According to fda.gov, buyers and wholesalers will benefit from this program.

The full announcement reads as follows:

“Participating importers will be able to import their products to the U.S. with greater speed and predictability, avoiding unexpected delays at the point of import entry. Consumers will also benefit from the importer’s robust management of the safety and security of their supply chains.

To participate, importers must meet eligibility criteria and pay a user fee that covers cost associated with the FDA’s administration of the program.

Importers interested in applying can start their application by submitting a notice of intent to participate by setting up an account via the FDA Industry Systems website. Once you have an account, selecting VQIP under the FSMA Program options will take you to the VQIP Application Page with an option for submitting a Notice of Intent to Participate. Importers applying for the next benefit period may wish to refer to the VQIP Portal User Guide as they prepare their applications.”

Here are the steps to apply for the VQIP:

  • Create an account on the FDA Industry Systems website
  • Submit a Notice of Intent to Participate in VQIP between January 1 and May 31, 11:59pm (EST).
  • Pay the user fee.

Begin the VQIP application process, which will take you through the above steps.

Check the status of your application on your VQIP Application home page at http://www.access.fda.gov.

 Most Frequent Asked Questions to assist you with the application:

” What are the benefits of participating in VQIP?

Quicker, easier entry

FDA will expedite import entry into the United States for all foods included in an approved VQIP application.

FDA will use its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening tool to recognize shipments of food that are part of an approved VQIP application. The screening tool will be programmed to recognize and, in most cases, immediately release the shipment, unless examination and sampling are necessary for the public health reasons listed below.

Limited examination and sampling

FDA will limit examination and/or sampling of VQIP food entries to the following situations: (1) “for cause” situations (i.e., investigation of an outbreak or illness) ; (2) to obtain statistically necessary risk-based microbiological samples (when building a product risk profile based on non-biased surveillance sampling); and (3) to audit a small percentage of import shipments covered by VQIP to verify that products declared in a VQIP entry are consistent with products covered in the VQIP application.

FDA sampling at preferred location

When FDA needs to examine an entry covered by VQIP, FDA will attempt, to the extent possible, to examine an import entry and collect samples at the VQIP food destination or other location preferred by the VQIP importer. If import entry to the U.S. is denied, FDA will assist in fulfilling an importer’s request to U.S. Customs and Border Protection (CBP) to export the refused products from the port preferred by the importer.

Faster lab results

In the event FDA collects a sample of a VQIP food import entry, FDA’s laboratories will prioritize processing of VQIP samples.

What are the eligibility criteria to participate in VQIP?

  • You have a 3-year history of importing food into the United States. Your import history is based on importation of all foods, including food that may not be covered under VQIP.
  • You have a Data Universal Numbering System (DUNS) numberExternal Link Disclaimer. Don’t have a DUNS number, Contact Dun and Bradstreet (D&B) at 866-705-5711 or via e-mail at government@dnb.com. All entities doing business with the U.S. government can receive a DUNS number free of charge through D&B using the basic service or pay a nominal fee to expedite service.
  • You use paperless filers/brokers who received an acceptable rating during their last FDA Filer Evaluation. The filer/broker is the person responsible for submitting import entry and entry summary data on the food into the Automated Commercial Environment (ACE) and as necessary submitting import documents into the International Trade Auxiliary Communication System (ITACS) or through Customs and Border Protection’s Document Imaging System (DIS).
  • None of the foods you import, including ones you do not intend to include in your VQIP application, is subject to an import alert or Class 1 recall at the time you submit your application.
  • Neither you nor the non-applicant entities associated with a VQIP food are subject to an ongoing FDA administrative or judicial action (e.g., Import Alert, injunction, and debarment), or have a history of significant non-compliances relating to food safety (e.g., an “Official Action Indicated” (OAI) FDA inspection classification; one or more voluntary Class 1 recalls relating to food safety) with no documentation of appropriate corrective actions. NOTE: “Non-applicant entities” are those entities associated with a VQIP food that conduct activities throughout the supply chain necessary for ensuring that the eligibility requirements of VQIP are met. Non-applicant entities associated with a VQIP food include, but are not limited to, the FSVP or HACCP importer of the food (if other than you), the foreign supplier of the food, and the import entry filer/broker.
  • If you are the FSVP or HACCP importer (U.S. owner or consignee at the time of entry into the United States or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the U.S.) for a VQIP food, you are in compliance with the supplier verification and other importer responsibilities under the applicable FSVP, juice HACCP, or seafood HACCP regulations.
    • If you are not the FSVP or HACCP importer for a VQIP food, you must identify the FSVP or HACCP importer for the food and ensure that the FSVP or HACCP importer is in compliance with the applicable FSVP or HACCP regulations.
  • You have a current facility certification for each foreign supplier of the food you intend to import under the VQIP.
  • You develop and implement a VQIP Quality Assurance Program (QAP). Documentation of your QAP must be submitted with your VQIP application.
  • Within the past 3 years, you have not been the subject of any U.S. Customs and Border Protection penalties, forfeitures, or sanctions that are related to the safety and security of any FDA-regulated product that you imported or offered for import.
  • You must pay the user fee before October 1, the start of VQIP fiscal year, each year that you are approved to participate in the VQIP.

Why is there a user fee to participate in VQIP?

Annual user fees to participate in VQIP cover FDA’s costs for administering the program. These include the costs of reviewing applications; the costs of conducting inspections of importers (both foreign and domestic) accepted into the program; and the annual Information Technology (IT) maintenance costs. The user fee rates are calculated each Fiscal Year and will be posted in a Federal Register notice on or before August 1 each year. “

To read the full article, click HERE.

If you have any additional questions, please don’t hesitate to contact us here.

References:

https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-importer-program-vqip?utm_medium=email&utm_source=govdelivery

ETC COOKS UP A DEAL-IGHTFUL FACTORING FACILITY FOR A WHOLESALER OF FROZEN VEGAN MEALS.

VP Ashley Orlando discovered the client through her extensive network and contacts in the plant-based food and beverage industry. Two years ago, the client created a Vegan frozen lasagna that quickly gained popularity and flew off the shelves. Like an Italian grandma serving a guest in love with her food, the client is back in the kitchen and using ETC’s patented financial sauce to cook up more Italian staples like vegan ravioli, mozzarella sticks, meatballs, and arancini. 
 
After rolling out to a good start in 2022, the client forecasts robust sales growth for 2023 as they continue to open more doors and gain precious shelf space. But they needed the working capital to get there. Through a referral, the client approached Ashley and ETC with the perennial problem of cash flow crunches caused by a disparity in payment terms between customers and suppliers. 
 
Since the client’s retail customers were paying on net 30-day terms, the client consistently ran into cash crunches with their copacker who provided only net 10-day payment terms. Although the client had several promising talks to open more doors with larger accounts, the logistics proved difficult as each new account required an industry standard of net 30-day terms or greater which only increased the client’s financial burden with each additional order. 
 
Looking to thaw the client’s frozen growth, ETC opened a factoring facility to accelerate the payment of advance receivables. With a bit of good history, the client has the option to add a PO funding facility, allowing them further flexibility to juggle the working capital required to scale rapidly. ETC is thrilled to welcome this new client into our expanding food and beverage portfolio and proud to help entrepreneurs creating sustainable, earth and health friendly products. No animals were harmed in the making of this facility.

Don’t hesitate to contact us here ➡️ https://lnkd.in/e84Ti6hg for questions about how Express Trade Capital can help your business. 

ETC LETS THE DOGS OUT WITH $4.5 MM FACTORING AND 500K PO FUNDING LINES FOR A CANINE BAKED GOODS CO.

For over 20 years, the client dug a niche producing bakery-style specialty dog treats exclusively out of their facilities in Arkansas.  The treats are human grade, decorated with dog friendly frosting, and intended as special treats for pets to enjoy on birthdays and holidays.  Their customer base ranged from smaller and mid-sized pet shops to big box pet retailers. 

Early in 2022, the client realized they needed help to manage cash flow gaps necessitated by increased demand from larger retail customers. After sniffing around the market, they found Express Trade Capital to help them unleash the beast of big growth. A current Express client was happy to make the referral.

With prior annual sales of $8MM growing to $12MM, the client was unwilling to sit or stay in place.  To facilitate growth, ETC laid out two bowls of funding: a factoring line capped at $4.5MM and a PO funding line of $500,000.  The two lines will expand, contract, and otherwise adapt based on the client’s sales revenue and history.  The client is now free to fetch as many POs as they can chew.  The deal was led and brought to heel by Ashley Orlando who chased the tail of required documents and smoothed the path for onboarding.  According to Ashley, the client was a pleasure to work with throughout the onboarding process and we are excited to build a long-standing financing relationship with such a great team while deepening our experience in this industry.

This deal emblematic of Express’ commitment to ensure every business owner we serve has their day in the sun.  The client also earned a treat for demonstrating that old companies can still learn new tricks. Though Express wouldn’t let sleeping dogs lie when it came to funding rabid growth, everyone got to sleep like a dog after closing this one.

Since 1993, ETC has helped companies grow, fulfill purchase orders, mitigate risk, and navigate supply chain issues, all while maintaining and enhancing their equity. Our consultative approach leverages our combined 100+ years of experience to ensure clients get maximum support to handle any obstacle. ETC specializes in financing companies through factoring, purchase order funding, letters of credit and inventory-based lines of credit. In addition, ETC offers back-end support from logistics to warehousing to credit protection. 


Don’t hesitate to contact us HERE for questions about how Express Trade Capital can help your business.

The latest in TRADE: U.S. Customs and Border Protection – National Commodity Specialist Division May Webinars Schedule along with FDA’s Improvement Plan in the New Era of Smarter Food Safety.

National Commodity Specialist Division (NCSD) May 2022 Webinars have been announced by U.S. Customs and Boarder Protection in CSMS #51637091. You may register by accessing each individual link listed below (as the webinar date nears, you will receive additional correspondence from CBP).

The Cargo System Messaging Service looks as follows:

The Office of Trade’s National Commodity Specialist Division (NCSD) and the Office of Trade Relations is excited to present a series of approximately 40 commodity-specific, educational webinars to support Customs and Border Protection’s internal and external customers. The webinars began in February and will run through September 2022. Each webinar will be approximately an hour. The date and time will vary, so please be sure to check the time for each webinar.

To provide a more seamless experience, the webinar platform has been changed to Microsoft Teams, and each webinar will have its own link to join. The schedule for the May webinars is below. Please click on the webinar title to register. The link to join will be sent via email on the day of the webinar. We look forward to your participation!

The May schedule is as follow:

Other Electronics of Heading 8517
Tuesday, May 3, 2022 at 1:30 p.m. ET

Breaking Down Bags of Heading 4202
Wednesday, May 4, 2022 at 11:00 a.m. ET

Classification of Gender Neutral Garments
Thursday, May 5, 2022 at 1:30 p.m. ET

Cryptocurrency Miners
Tuesday, May 10, 2022 at 1:30 p.m. ET

2022 Changes to HTSUS for Wood, Ch. 44
Thursday, May 12, 2022 at 2:00 p.m. ET

A Treasure of Headquarters Rulings on Jewelry
Tuesday, May 24, 2022 at 2:00 p.m. ET

Earthmovers: Where on Earth Do They Go?
Thursday, May 26, 2022 at 11:00 a.m. ET

The New Era of Smarter Food Safety highlighted by The U.S. Federal Food & Drug Administration in their latest webinar, held on April 13th, 2022.

The webinar’s focus was on the Outbreak Response Improvement Plan , which was originally released in December 2021 that attracted over 1,600 registrants worldwide.

The webinar summary reads as follows:

Deputy FDA Commissioner Frank Yiannas and FDA experts across agency’s human foods program were available to explain and answer questions about the plan with the goal of raising awareness, enhancing understanding, and building support. Stakeholders were welcome to provide their insights as well as ask questions.

This response improvement plan focuses on tech-enabled product traceback, root cause investigations, analysis and dissemination of outbreak data, and operational improvements. It is intended to work in concert with FDA’s New Era of Smarter Food Safety Blueprint, which outlines specific approaches the FDA will take over the next decade to address food safety in the rapidly changing food system.

The plan was also informed by an independent review of the FDA’s structural and functional capacity to support, participate in, or lead multistate foodborne illness outbreak investigation activities. You will hear more about that review in this webinar.

The speakers:

  • Frank Yiannas, Deputy Commissioner for Food Policy and Response
  • RADM David Goldman, Chief Medical Officer, Office of Food Policy and Response
  • Stic Harris, Director, FDA’s Coordinated Response and Evaluation Network (CORE)
  • CDR Kari Irvin, Deputy Director, CORE
  • Scott MacIntire, Program Director, Office of Human and Animal Food Operations – West
  • Craig Hedberg, University of Minnesota, author of “An Independent Review of FDA’s Foodborne Outbreak Response Processes”

To view the webinar recording, you may click here.

Furthermore, FDA has been releasing a series of the “New Era of Smarter Food Safety TechTalk Podcast” episodes. You may find them here.

References:

https://content.govdelivery.com/accounts/USDHSCBP/bulletins/313eb63

https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/webinar-foodborne-outbreak-response-improvement-plan-04132022

https://www.fda.gov/food/new-era-smarter-food-safety/new-era-smarter-food-safety-techtalk-podcast