FDA Warning Letter Issued to Texas Importer of Frozen Sliced Strawberries for Lack of FVSP

A Texas based importer was issued a Warning Letter by FDA for not being in compliance with the  FSVP requirements for Frozen Sliced Strawberries   The company had not identified or evaluated biological, chemical or physical hazards potentially present before your suppliers load the products.  There were no established  and written procedures to ensure that  import foods only come from foreign suppliers previously approved based on evaluation conducted to determine a foreign supplier’s performance and the risk posed by the food,  The company did not establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the imported foods.

FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/campimex-inc-610730-12112020
Campimex, Inc.
MARCS-CMS 610730 — December 11, 2020 

Imported Herring Product Recalled Due to Listeria

B&I Overseas Trading Inc from Van Nuys, CA is recalling frozen “Veladis herring in oil with Italian spices” because they have the potential to be contaminated with Listeria monocytogenes,  The product was imported from Ukraine.  There was no information on how the Listeria was determined to potentially be in the product.

Listeria would have contaminated the product during handling.  Although frozen which would prevent growth during frozen storage, the directions of  "Defrost before use and keep refrigerated for up to 30 days", would have provided opportunity for growth.  This product would then be consumed as a ready-to-eat product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bi-overseas-trading-recalls-product-due-potential-contamination-listeria-monocytogenes
B&I Overseas Trading Recalls Product Due to Potential Contamination with Listeria Monocytogenes
Summary
Company Announcement Date:  December 23, 2020
FDA Publish Date:  December 24, 2020
Product Type:  Food & Beverages  Fish
Reason for Announcement:  Listeria Monocytogenes
Company Name:  B&I Overseas Trading, Inc
Brand Name:  Veladis
Product Description:  Herring in oil 

CA Distributor Recalls Imported Wood Ear Mushrooms After Linked to Salmonella Outbreak

CDC and FDA are investing a Salmonella outbreak linked to imported wood ear mushrooms distributed by Wismettac Asian Foods, Inc.  As of September 24, 2020, a total of 41 people infected with the outbreak strain of Salmonella Stanley have been reported from 10 states after eating wood ear mushrooms or ramen noodles containing wood ear mushrooms (aka Black Fungus or Kikurage)

Wismettac Asian Foods, Inc., Santa Fe Springs, CA recalled Shirakiku brand imported Dried Fungus (also known as Black Fungus or Kikurage).  Product was distributed to a multitude of States across the country and Canada.

https://www.cdc.gov/salmonella/stanley-09-20/index.html
Outbreak of Salmonella Stanley Infections Linked to Wood Ear Mushrooms
Updated September 24, 2020 at 5:10 PM ET
At A Glance
Reported Cases: 41
States: 10
Hospitalizations: 4
Deaths: 0
Recall: Yes

FDA Warning Letter - Another Importer Without a FSVP Program for Their Imported Food Items

FDA issued a Warning Letter to Mission, LLC of, Renton, WAS for not have a FSVP (Foreign Supplier Verification Program) in place for the food items that the company was importing.  Specifically, they did not have a FSVP for imported black tea.  As part of this analysis, the company would conduct a hazard analysis on this item and determine if any of the hazards are significant, requiring control by their supplier.

WARNING LETTER
Mission LLC
MARCS-CMS 593118 — February 06, 2020

FDA Warning Letter - Bakery Supply Company with No FSVP in Place for Their Imported Food Items

FDA issued a Warning Letter to a bakery supply company for not having a Foreign Supplier Verification Program (FSVP) for items that they are importing and then selling.  These items include multi-color sprinkles, Strawberry filling, and Bavarian cream.

Companies who import products must have assurances that food made overseas meets US standards.  For those who are importing and reselling that food in the US, whether that food will be sold without further processing (sold as-is) or sold to a company who will use it as an ingredient in food they process (such as in the case here), that importer must have a FSVP in place for all items / each supplier in place.

It is important for companies who are using imported ingredients purchased from a US broker / importer, that they know that importer / broker does indeed comply with the FSVP rule.

It's also good to know if the items you use are imported.  One could guess that few question whether their multi-colored sprinkles are imported.  And it's not like someone is sourcing imported sprinkles like choosing imported fine wines...ah yes, I use only the Châteauneuf-du-Pape sprinkles please.  Or that the sprinkles can only be sourced from some exotic location...there is no Juan Valdez trekking up into the Andes to pick them from the scarce Jimmy trees.  So where do your sprinkles come from?

Is it a big deal?  From risk perspective, as an RTE item, we would want to have knowledge that the items must meet US standards for safety, including measures that prevent cross-contamination.  The FVSP Rule requires importers to evaluate the hazards of the items and ensure necessary controls are in place.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/el-molino-bakery-supplies-inc-593693-12162019
FDA WARNING LETTER 

El Molino Bakery Supplies Inc
MARCS-CMS 593693 — December 16, 2019

FDA Releases Report on Strategy for Imported Food

FDA released a report on their strategy for ensuring the safety of food imported into this country.  Full report can be found here.

First, a few facts

• There is a continued 15 year trend of increasing importation of food 
• Annually, the US imports:
• 32 percent of the fresh vegetables, 
• 55 percent of the fresh fruit, and 
• 94 percent of the seafood 
• US imports food from more than 200 countries or territories and approximately 125,000 exporting food facilities plus farms
• In 2019, between 14 and 15 million shipments of imported food are expected to enter the United States
• Mexico accounts for the largest percentage of shipments followed by Asia.

FDA applies the same U.S. food safety requirements to all food consumed in the United States, regardless of whether the facility or farm that produces the food is located within the United States or half way across the globe.  But the strategy for overseeing this is different than for domestic product.  Much of this is based upon a risk based approach with focus on highest risk items with a continued optimization of the process.  It also utilizes partnerships as well as pre-approvals.

GOAL 1: Food Offered for Import Meets U.S. Food Safety Requirements

Objectives

1. Optimize use of foreign inspections
2. Ensure importer use of verified foreign suppliers through effective implementation of the Foreign Supplier Verification Programs final rule
3. Take into account the public health assurances of reliable audits such as those issued under FDA’s Accredited Third-Party Certification Program or pursuant to other assurance programs aligned with FDA food safety requirements
4. Incentivize importers to use verified suppliers of safe food through the Voluntary Qualified Importer Program
5. Leverage the oversight efforts of regulatory counterparts with strong food safety systems
6. Increase awareness of and training on food safety requirements and strengthen the capacity of foreign suppliers to produce safe food

GOAL 2: FDA Border Surveillance Prevents Entry of Unsafe Foods

Objectives

1. Continue to enhance and refine FDA’s import screening and entry review processes
2. Optimize use of physical examination and sampling of imported food
3. Strategically utilize import alerts and import certifications
4. Improve testing methodologies and tools used to determine admissibility of food offered for import
5. Maximize the benefit to border surveillance from state and other partnerships

GOAL 3: Rapid and Effective Response to Unsafe Imported Food

1. Maximize effectiveness of FDA response to an event involving an imported food
2. Enhance the efficiency and effectiveness of imported food safety recalls
3. Use information-sharing opportunities to prepare for and respond to the entry of unsafe imported food

GOAL 4: Effective and Efficient Food Import Program

1. Optimize resource allocation by developing a comprehensive global inventory of food facilities and farms and assessing the cumulative oversight applied to the global inventory
2. Ensure effectiveness of import activities through performance assessment and continuous improvement

$18 Million in Smuggled Drugs Found in Shipment of Bananas

In Texas, a shipment of bananas was found to be carrying a hidden load of cocaine..540 packages.....18 million dollars worth.

The Produce News
http://theproducenews.com/the-produce-news-today-s-headlines/25022-this-18-million-drug-bust-is-bananas
This $18 million drug bust is bananas
September 24, 2018

Complying With Licensing Requirement and SFCR for Shipping Food To Canada

Food companies shipping food products into Canada are going to be required to obtain a license from the Canadian Food Inspection Agency, CFIA.  It can be obtained by using the online portal.   Who needs a license:

"Generally speaking if you are doing any of these activities, you would need a licence: importing, manufacturing, processing, treating, preserving, grading, packaging, or labelling a food that will be exported or moved between provinces and slaughtering a food animal."

There are some exemptions - alcoholic beverages, food additives, among others (see 48)

Like the recently enacted FSMA regulations in the US, Canada has updated their food regulations - Safe Food for Canadians Regulations or SFCR.  CFIA has a webpage, Understanding the Proposed Safe Food for Canadians Regulations: A Handbook for Food Businesses, that provides more information on the regulation.

There are many similarities between FSMA and SFCR including the use of Preventive Controls in food manufacturing operations. This document states (19c):

Preventive control Measures: This Part would set key food safety controls that must be met by all food businesses. It would also outline the requirements for developing, implementing, and maintaining a written preventive control plan that documents how you meet food safety and marketplace fairness requirements (e.g. for labelling, packaging, standards of identity, grades, humane treatment and net quantity).

 While there are some differences the SFCR preventive controls from FSMA , especially in terms of market fairness requirements such as humane treatment, standards of identity, and net quantity (In the US, these are handled by regulations outside of FSMA), the two systems will be viewed as compatible.

Canadian Firm Recalls Fully Cooked Chicken Skewers for Listeria Contamination

A Canadian firm is recalling fully cooked chicken skewers for Listeria.  The Listeria was discovered during FSIS import inspection.  Product had been shipped to retail locations in Arizona, Connecticut, Florida, Illinois, Maryland, Michigan and Texas.


USDA FSIS Recall Notice
https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2017/recall-095-2017-release
Expresco Foods Inc. Recalls Chicken Skewer Products Due to Possible Listeria Contamination
Class I Recall 095-2017
Health Risk: High Aug 23, 2017
En Español
Congressional and Public Affairs Mitch Adams (202) 720-9113 

Press@fsis.usda.gov

US Stops Imported Beef from Brazil for Food Safety Concerns

The US has stopped all importation of fresh beef from Brazil for food safety concerns.  Brazil is the fifth largest exporter of beef to the US.  Since an investigation into the Brazilian meat industry in March, the US has been inspecting all meat products from that country, refusing 11% of those shipments due to "public health concerns, sanitary conditions, and animal health issues."

USA Today
https://www.usatoday.com/story/money/2017/06/23/us-bans-beef-imports-brazil-due-food-safety-concerns/422865001/
US bans Brazil beef imports over food safety concerns
Roger Yu , USA TODAY

Published 8:39 a.m. ET June 23, 2017 | Updated 0 minutes ago

Brazilian Meat Industry Rocked by Investigation into Unsanitary Practices

Brazilian meat is returning to a number of countries that banned import of the product after Brazilian authorities found that some of the Brazilian meat companies were bribing inspectors to look the other way as they packed less-than-desirable product.  The US did not ban imports as it appears that none of the plants shipping to the US were under investigation (maybe our supply control systems are better?).

Brazil is one of the largest exporter of meat products in the world.  This scandal has had a huge impact on exports.

Tri-State Livestock News
http://www.tsln.com/news/brazil-resumes-exporting-meat-to-major-markets/
Brazil resumes exporting meat to major markets

CDC Report - Outbreaks Associated with Imported Food

A report in Emerging Infectious Diseases investigated outbreaks associated imported foods.  "The proportion of US food that is imported is increasing; most seafood and half of fruits are imported. We identified a small but increasing number of foodborne disease outbreaks associated with imported foods, most commonly fish and produce. New outbreak investigation tools and federal regulatory authority are key to maintaining food safety."


Emerging Infectious Diseases
Volume 23, Number 3—March 2017
https://wwwnc.cdc.gov/eid/article/23/3/16-1462_article
Dispatch
Outbreaks of Disease Associated with Food Imported into the United States, 1996–2014
L. Hannah Gould , Jennifer Kline, Caitlin Monahan, and Katherine Vierk
Author affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (L.H. Gould, J. Kline); US Food and Drug Administration, College Park, Maryland, USA (C. Monahan, K. Vierk)
Highlight and copy the desired format. EID Gould L, Kline J, Monahan C, Vierk K.

Report on FDA Import Refusals

A report issued by USDA Economic Research Service on FDA import refusals shows that seafood, vegetables and fruits are the items that are most often rejected at port of entry.  FDA physically inspects about 1% of food, but uses a risk based approach to hopefully best utilize its limited resources to focus on real issues.

 

Regarding food safety issues, we look to those products that were rejected due to adulteration.  A few key points gleaned from the document:

• Violations for pathogen/toxin adulteration were highest for fishery and seafood products in both 1998-2004 and 2005-13. Spices, flavors, and salts had the second largest number of pathogen/toxin violations per year in 2005-13.
• The most frequent violation in 2005-13, by far, in the pathogen/toxin adulteration category was for the presence of Salmonella. The most Salmonella violations were in fishery and seafood products (42.0 percent of total), followed by spices, flavors, and salts (33.2 percent). 
• Listeria was the second-most common violation for pathogen/toxin adulteration in 2005-13.  Fishery and seafood products had 59.4 percent of Listeria violations.  Listeria violations in cheese and cheese products fell to 32.0 percent.
• Vegetables/vegetable products. Almost three-quarters of these chemical violations were for unsafe pesticide residues  Fruit/fruit products had the second-most violations per year for chemical adulteration in 2005-13.

Another interesting quote:

As the total volume of imported food has risen, the number of shipments refused has declined relative to the volume of food imports. This relative decline may reflect improvements in compliance with U.S. laws among foreign producers and importers, or it may reflect FDA’s limited resources and capacity to inspect, detain, and refuse imported food.

 

  

USDA ERS

http://www.ers.usda.gov/amber-waves/2016-march/patterns-in-fda-food-import-refusals-highlight-

most-frequently-detected-problems.aspx#.Vv6a3032Z9B

Patterns in FDA Food Import Refusals Highlight Most Frequently Detected Problems

by John Bovay

March 28, 2016

 

FDA Releases FSMA Rules on Produce, Foreign Suppliers, and Third Party Auditors

FDA released three new rules as past of the Food Safety Modernization Act. 

• The Produce Safety Final Rule focuses on requirements for farm activities associated with growing and harvesting produce.
• The Foreign Supplier Verification Program (FSVP) rules sets requirements for those importing food into the US to ensure that those suppliers are following the same requirements as US food manufacturers.
• Associated with FSVP, there is the Accredited Third Party Audit Certification Rule which sets up a program for certifying third party auditors who will evaluate foreign suppliers.

FDA Website

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm472505.htm

FDA Releases Groundbreaking Rules on Produce and Imported Foods to Modernize and Strengthen Food Safety System

Constituent Update

November 13, 2015

 

The U.S. Food and Drug Administration today took major steps to prevent foodborne illness by finalizing rules that establish enforceable safety standards for produce farms, and make importers accountable for verifying that imported food meets U.S. safety standards. The agency also issued a rule establishing a program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits of foreign food facilities.

 

China's 2015 Food Law - Understanding Import Challenges

There is a nice piece in National Law Review on China's recently enacted 2015 Food Law and some of the challenges they face.  While the law was made to look like US law, there are many differences in components that are not easily regulated - "....it lacked the right enforcement devices.  Part of the food safety regime in Western countries relies on active consumer groups, industry self-enforcement, and media scrutiny.  China does not have these mechanisms."

While the 2015 law tries to encourage better 'local regulatory enforcement, food industry associations, and media oversight' there is little detail on how this can be done.  Add to this the fact the food industry is very fragmented with many smaller processors, it can be difficult to provide oversight.

Still, China is currently the third largest importer of food into the US.  With the soon to be released FDA's Foreign Supplier Verification Rule, additional attention will be required by companies and brokers importing food.

National Law Review
http://www.natlawreview.com/article/food-supply-chain-issues-china-or-china-s-new-food-safety-act-or-running-gauntlet
Food Supply Chain Issues in China (Or, China’s New Food Safety Act) (Or, Running the Gauntlet in China)
posted on: Monday, November 2, 2015

Food trade between the U.S. and China is on the rise. According to the most recent statistics, China is the third largest exporter of food and agricultural products to the U.S., behind only Canada and Mexico. And, the U.S. is China’s biggest source of foreign food and agricultural products. Under the current state of trade, the U.S. sends approximately five times the food products to China that China sends to the U.S. But in any event, with the coming into force of China’s newest Food Safety Law on October 1, 2015, food supply chain relationships between the U.S. and China are taking on additional significance.

 See more at: http://www.natlawreview.com/article/food-supply-chain-issues-china-or-china-s-new-food-safety-act-or-running-gauntlet#sthash.JcXfS3vT.dpuf

Egg Shortage - US Opens Door To Imported Eggs

The bird flu outbreak has caused an egg shortage in the US.  According to reports, some 47 million birds, 35 million hens have been affected.   To keep egg prices down and eggs available for commercial use, the US has permitted the Netherlands, Germany, Portugal, Spain and France (in Europe), and Chile and Argentina (in Latin America) to ship egg products to the US.


 Wall Street OTC
http://www.wallstreetotc.com/u-s-food-producers-trying-to-defuse-egg-crisis-with-dutch-imports/219030/
US Food Producers Trying to Defuse Egg Crisis with Dutch Imports

Jun 12, 2015 By David Warren

The U.S. Department of Agriculture had given the approval to five egg producers from the Netherlands to sell egg products to the U.S. amid efforts to alleviate egg shortage caused by the recent bird flu outbreak.

It is the first time in nearly two decades the U.S. decides to imports egg products from Netherlands. The only non-domestic egg supplier for food processors and bakeries considered safe by the USDA was Canada. Yet, egg shortage resulted in a jump in prices, so the federal government is looking for alternate solutions.

Imported egg products would be used in processed foods and bakeries, and states hope that imports would prevent prices from further rising. In Texas, a supermarket even put a limit to shell egg purchases.

Catfish and USDA Regulations - The Issue of Unintended Consequences and The One Food Agency Solution

In a New York Times article, a case study of how unintended consequences of a regulatory change has challenged the catfish industry.  The catfish industry wanted protection against imports, and so asked to be regulated as part of the USDA inspection.  It is however, not working out as intended.

Looking at the proposals being made to transition food safety oversight to one agency, it is not the things considered that will be a challenge, but all of the unintended consequences that follow.

NY Times
http://www.nytimes.com/2015/03/21/us/catfish-farmers-seeking-regulation-to-fight-foreign-competition-face-higher-bills.html?_r=1
Catfish Farmers, Seeking Regulation to Fight Foreign Competition, Face Higher Bills

By RON NIXONMARCH 20, 2015

WASHINGTON — In 2008, faced with increased competition from Vietnam and China, catfish producers in the United States did the unthinkable: They asked for more regulation of their industry.

Congress concurred and agreed to move the inspection of foreign and domestically produced catfish from the Food and Drug Administration to a more rigorous program at the Agriculture Department. The process, however, has dragged on for nearly seven years.

Now, as the Obama administration prepares to finalize the inspection regulations, domestic catfish farmers may have received more than they bargained for, experts say.

More rigorous inspections could cost an already beleaguered industry millions of dollars to comply with the new regulations, potentially driving more catfish farmers out of the business and costing hundreds of jobs in the rural South, said John Sackton, a seafood industry analyst.

Safety of Imported Foods - Spices and FSMA

A NY Times article released today (below with link) details the high contamination Salmonella rate of spices and the challenges that exist in importing products. Primarily, these spices are produced in tropical zones in ‘rustic’ conditions. Because of this, these items have a high risk of becoming contaminated with Salmonella (from birds, animal manure, reptiles, etc) and then, that organism can survive in these dried spices for months or longer.

Spices have been processed this way it has been since the time of the spice trade, thousands of years ago. But as consumers, do we generally worry about the safety of spices? Generally not. Companies that have been involved in buying and selling spices have secured their supply chains and where needed, have added interventions such as irradiation to eliminate these bacterial hazards. So there is no risk to the consumer, when you look at the vast quantities of spice consumed each day in this country.

This is not to say there have not been issues, but primarily those issues were linked to food companies using less than reliable sources for their spices. In the small number of cases where there have been issues, importers of spice did not have adequate control measures in place.

So what is the point of the NY Times article? It is directed at the Foreign Supplier Verification Program (FSVP) component of FSMA. In this proposed regulation, emphasis is put on the companies who import food to ensure the safety of those foods. It defines the importer as the person in the US who has purchased the item, and in many cases, this can be the retailer or the distributor. 

The NY Times piece provides ammunition for those who feel that the federal government should have a heavier hand in determining the safety of those imported food items. This would necessitate a heavy testing program conducted by the government agencies at the border for incoming foods and having FDA inspectors inspect foreign companies.

With about 15% of the food consumed in this country being imported, it is not financially feasible to have FDA take on that responsibility. The concept proposed in FSVP is better…making companies responsible for the foods they import. We just have to look at companies like McCormick who have practiced the safe importation and processing of spices for more than a century.  

For those identified as importers, FSVP provides the elements of a supplier verification program that these companies will need to establish for each suppler, including verifying that he supplier has a HACCP type system in place and conducting verification, corrective action, and record keeping activities.

In the long run, FSVP will create a stronger food supply system. Companies who sell imported foods will either be forced out of selling if they are not willing or capable of implementing such an adequate supplier contol system, or will need to align with an importer who does have the necessary capabilities.


NY Times
Spices’ Link to Food Ills Prompts Changes in Farming
By GARDINER HARRIS
Published: August 27, 2013
http://www.nytimes.com/2013/08/28/world/asia/farmers-change-over-spices-link-to-food-ills.html?pagewanted=1&_r=0

IDUKKI, India — Spices grown in the mist-shrouded Western Ghats here have fueled wars, fortunes and even the discovery of continents, and for thousands of years farmers harvested them in the same traditional ways. Until now.

Science has revealed what ancient kings and sultans never knew: instead of improving health, spices sometimes make people very sick, so Indian government officials are quietly pushing some of the most far-reaching changes ever in the way farmers here pick, dry and thresh their rich bounty.

The United States Food and Drug Administration will soon release a comprehensive analysis that pinpoints imported spices, found in just about every kitchen in the Western world, as a surprisingly potent source of salmonella poisoning.

CDC research shows outbreaks linked to imported foods increasing

The US currently imports about 16% of food consumed. For seafood, that figure is about 85%. Currently about 1% of imported food is checked by the FDA at the port of entry. Over a 5 year period (2005 to 2010), there have been 39 outbreaks and close to 2400 illnesses linked to imported foods.

While we get a glimpse of the risk associated with imported foods through outbreak reports, it is hard to really know the true extent. FDA has limited capabilities, especially with import analysis, although the Food Safety Modernization Act includes measures which will help support FDA.

Much of it comes down to making sure those who import those food products. Are they doing what they need to do to ensure their foreign suppliers have capable food safety systems in place? Are they conducting verification testing?

As consumers, we try to by local where we can, but there is still demand to have an assortment of fruits, vegetables and seafood year round. And do we do ourselves a disservice by forgoing these items just because it is from another county in that we are giving up important components of a healthy diet?

CDC research shows outbreaks linked to imported foods increasing
Fish and spices the most common sources
March 14, 2012

 http://www.cdc.gov/media/releases/2012/p0314_foodborne.html

 Foodborne disease outbreaks caused by imported food appeared to rise in 2009 and 2010, and nearly half of the outbreaks implicated foods imported from areas which previously had not been associated with outbreaks, according to research from the Centers for Disease Control and Prevention, presented today at the International Conference on Emerging Infectious Diseases in Atlanta.

FDA enacts new strategy to ensure safety of imported foods

The FDA’s news release regarding their new import strategy comes at the same time as a NY Times report that is critical of the FDA’s performance on handling of questionable food at port.  Clearly, the ever increasing level of imports into the US is challenging FDA’s ability to monitor and react to questionable food.  FDA will begin to focus on becoming a more global organization – extending its reach through developing partnerships with foreign regulators and developing systems to share real time information.  It will use information to focus on higher risk situations.

This is all fine and dandy, but still, someone in the US – a broker, a food company, or food retailer – has to bring that product into the US. These folks also need to be held responsible and pay the price of ensuring compliance of these imported foods to US standards…and I would argue that they are in a better position to do so than the FDA .  If that adds cost to the imported product (through the broker inspecting their foreign supplier), then so it should.  Why should foreign product have a price advantage over domestic product when it comes to questionable standards?   

FDA unveils new global strategy to help ensure safety and quality of imported products

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259848.htm

Strategy calls for coalitions of international regulators, increased data sharing
The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the "Pathway to Global Product Safety and Quality."
“Global production of FDA-regulated goods has exploded over the past ten years.  In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.  "There has been a perfect storm - more products, more manufacturers, more countries and more access.  A dramatic change in strategy must be implemented." 
The FDA report calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change:
1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
3.  The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
"FDA regulated imports have quadrupled since 2000,” Hamburg said. "The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face.  The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission."
The change in strategy will address trends expected to be seen worldwide in upcoming years:

• Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes.
• Money, goods, data and people will increasingly and more quickly cross borders. Today, a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world.
• Growing demand, constrained supply, and increased regulatory and social scrutiny will determine what resources are used, how they are used, and the cost. Manufacturers will adopt new manufacturing processes and emerging technologies in response.
• Governments worldwide will increasingly be called upon to mitigate the sometimes negative impacts of globalization on their citizens, making the operating environment for companies more complex.

The new strategy also builds on changes already set in motion by the FDA. The FDA increased the number of foreign drug manufacturing inspections by 27 percent between 2007 and 2009 and has opened a series of international offices in key locations.  FDA has also collaborated with its counterparts in the European Union and Australia on drug inspections, worked to harmonize certain aspects of drug regulation via the International Conference on Harmonization, and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an organization of the drug manufacturing inspectorates from 39 countries.  The FDA and other global leaders are also creating an expanded global regulators forum for medical devices. 
The FDA is also broadening its food safety efforts under the FDA Food Safety Modernization Act (FSMA). This new law creates a new foods safety system, in which FDA has a legislative mandate to require comprehensive preventive controls across the food supply chain and has new tools to hold players in the supply chain responsible.  There are also new inspection mandates, including a mandate leading to the inspection of more than 19,000 foreign food facilities in the year 2016.
The FSMA recognizes the importance of partnerships in the success of this new food safety system, particularly in the area of imports.  For example, importers now have an affirmative obligation to verify the safety of the food they bring into the United States.  In addition, the FDA will establish a program for qualified third parties to certify that foreign food facilities are in compliance with U.S. requirements and can require certification as a condition of entry into the United States.  And, FSMA explicitly encourages arrangements with foreign governments to leverage resources.
“In order to cope with the fundamental global shifts on the horizon, the FDA will have to substantially and fundamentally revise our approach to global product safety.  We can no longer rely on historical tools, activities and approaches,” said Acting Principal Deputy Commissioner of Food and Drugs John M. Taylor, J.D.  “Implementing this strategy is vital to the public health.”
For more information, visit:

• Pathway to Global Product Safety and Quality¹
• FDA Food Safety Modernization Act²

FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Recalls of Imported Foods Are Flawed, a Government Audit Reports

By GARDINER HARRIS  NY Times

Published: June 21, 2011

http://www.nytimes.com/2011/06/21/business/21recall.html?_r=1&partner=rss&emc=rss

Government food officials are often sloppy and inattentive in their efforts to ensure that contaminated foods from abroad are withdrawn promptly and completely from the nation’s food supply, according to government investigators.

In an audit of 17 recalls, investigators found that the Food and Drug Administration often failed to follow its own rules in removing dangerous imported foods from the market, according to Daniel R. Levinson, inspector general of the Department of Health and Human Services. The products included cantaloupes from Honduras contaminated with salmonella, frozen mussel meat from New Zealand infected with listeria and frozen fish from Korea that contained the bacterium that causes botulism.

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