Feds Take Enforcement Action Against Unlawful Supplement Manufacturers

 The US Justice Department along with other Federal Departments announced that they are filing cases against a number of supplement manufacturers that "make health or disease treatment claims that are unsupported by adequate scientific evidence".  

It is about time.  There are too many of these modern day snake oil salesmen who are taking advantage of people's wanting to find that secret cure / silver bullet answer to their medical woes.  Not only are claims false, but in some cases, these drugs can be dangerous.

If you had to bet, there are more out there.  While these are probably the worst of the worst, others will continue to sell products that provide little or no benefit to consumers.

 

Department of Justice - News Release

http://www.justice.gov/opa/pr/justice-department-and-federal-partners-announce-enforcement-actions-dietary-supplement-cases

 

FOR IMMEDIATE RELEASE

Tuesday, November 17, 2015

Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases

  

Criminal Charges Brought against Bestselling Supplement Manufacturer

 

As part of a nationwide sweep, the Department of Justice and its federal partners have pursued civil and criminal cases against more than 100 makers and marketers of dietary supplements. The actions discussed today resulted from a year-long effort, beginning in November 2014, to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide. In each case, the department or one of its federal partners allege the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.

 

Frozen Bagged Chicken Wings Recalled Due to Off Odor

Tyson is recalling  approximately 52,000 lbs because of consumer complaints they received about an off odor.  This covers two day codes - Sell by October 24, 2016 and October 25, 2016.  There have been no illnesses reported.

USDA News Release
http://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-141-2015-release
Tyson Foods Inc. Recalls Chicken Product Due To Possible Adulteration
Class II Recall 141-2015
Health Risk: Low Nov 17, 2015
Congressional and Public Affairs  Gabrielle N. Johnston   (202) 720-9113 

WASHINGTON, Nov. 17, 2015 – Tyson Foods Inc., a Pine Bluff, Ark. establishment, is recalling approximately 52,486 pounds of chicken wing product that may be adulterated because of having an “off odor” scent, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Fast Food Worker in NY Positive for Hepatitis A

A McDonald's worker in Seneca, NY has been diagnosed with Hepatitis A and may have spread that virus to coworkers and patrons during the time before the diagnosis.

Seneca County NY News Release
http://www.co.seneca.ny.us/
Hepatitis A Confirmed in Seneca County Food Worker

 The Seneca County Health Department has confirmed a case of Hepatitis A in a food service worker employed at the McDonalds located at 2500 Mound Rd. Waterloo, NY. Public health officials are stressing there is a low risk of contracting illness, however, individuals who have not been previously vaccinated for Hepatitis A and who consumed food/drink from McDonalds on the following dates should consider treatment. 

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.

 

FSIS Updates Allergen Guidance with Focus on Incoming Ingredients

FSIS issued an updated version of their Allergen Control Guidance.  Allergen issues remain on the leading causes for recalls.  According to FSIS:

What is causing undeclared allergen recalls?

• New Ingredient
• New Supplier
• Misprinted Label
• Product in Wrong Package
• Product Reformulation
• Ingredient Reformulation

 A focus of this update involves ingredient related allergen issues. Inspectors are discovering issues as they evaluate incoming ingredients and a company's formulation. 

"FSIS has found that many of these recalls occurred because of a change in product formulation by the establishment or a change in a supplier’s ingredient formulation that was not reflected on the labeling of the finished meat or poultry product. "

A noted change was an explanation of a Letter of Guarantee (LOG) and a Certificate of Analysis (COA). Too many rely on a LOG to protect them against a supplier related allergen issue, but a LOG cannot be counted on to prevent allergen issues.

"An establishment should review and update the LOGs regularly to ensure that the decisions made in the hazard analysis are supported and to ensure that any formulation changes made by its suppliers are detected prior to incorporating the associated ingredient into the production process. Generally, an annual LOG will not be sufficient to support decisions made in the hazard analysis."

One of the nice additions is Appendix 6 - Allergenic Ingredients in Foods.  In this appendix, there is a list of common ingredients that contain specific allergens that may be missed.  This is a nice reference.  (For example, marzipan may contain eggs).

 

FSIS Website

FSIS Compliance Guidelines 

http://www.fsis.usda.gov/wps/wcm/connect/f9cbb0e9-6b4d-4132-ae27-53e0b52e840e/Allergens-Ingredients.pdf?MOD=AJPERES

Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control, and Declaration through Labeling 

November 2015

[from the document - page

Purpose 

 

This document provides guidance to assist establishments in addressing the hazard posed by allergens in their products. In doing so, establishments must comply with the Food Safety and Inspection Service (FSIS) hazard analysis and critical control point (HACCP) and labeling regulations. 

Cans of SpaghettiOs Recalled Due to Potential Choking Hazard

Campbell soup is recalling one code date of SpaghettiOs (14.2 ounce cans of SpaghettiOs Original) due to a potential choking hazard posed by pieces of red plastic found in a small number of cans. This plastic material is from parts of the can lining which may peel off.

 FDA News Release
http://www.fda.gov/Safety/Recalls/ucm472508.htm
SpaghettiOs Original 14.2oz Cans Recalled Due to Potential Choking Hazard
For Immediate Release
November 12, 2015

Unpasteurized Apple Juice Leads to Two Outbreaks

Fresh apple cider in autumn...nothing better.

But unfortunately, contamination on apples can make its way into the cider unless preventive controls are taken.  So far this season, there have been two examples of contamination in fresh cider.

A small California farm stand, High Hill Ranch, was linked to seven cases of E. coli illness among  residents who consumed the unpasteurized apple juice from High Hill Ranch in mid-October.
In an statement issued by the owners of the farm, it appears that they are missing the point (below).
E. coli is more likely to be picked up from ground apples (wind fallen apples, drops, or whatever you want to call them).

A second case in Illinois may be a case of cryptosporidium, a parasite often originating from a contaminated water source, such as contaminated wash water or irrigation water.  Again, apples off the ground can be an issue.

Many folks like to have that fresh juice, however having it processed can eliminate any potential risk.  This is the reason the Juice HACCP regulation of 2001 was implemented.  There are other means of having it process that do not impact the flavor as much as heat pasteurization.  One is UV treatment and the other is high pressure processing.  These two methods impact flavor less but can help retain that fresh

County of El Dorado
https://www.edcgov.us/pressreleasedetail.aspx?id=30064771392
High Hill Ranch Issues Voluntary Recall of Unpasteurized Apple Juice

Department: Public Health Contact: Creighton Avila  Phone#: (530) 621-5153
Date: October 23, 2015

High Hill Ranch, located in the community of Camino in El Dorado County, has initiated a voluntary recall of its unpasteurized apple juice following notification from local health officials of suspected contamination with bacteria, likely Escherichia coli (E. coli.). El Dorado County health officials are warning consumers to not drink and dispose of any unpasteurized apple juice purchased from High Hill Ranch on or after October 6, 2015.

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

CDC - Multistate Foodborne Outbreaks — United States, 2010–2014

In MMWR, the CDC published an analysis of data in the Foodborne Disease Outbreak Surveillance System from 2010 - 2014. The document can be found here.

What were the important results:

• During this 5-year period, 120 multistate foodborne disease outbreaks (with identified pathogen and food or common setting) were reported to CDC.
• These multistate outbreaks accounted for 3% (120 of 4,163) of all reported foodborne outbreaks, but were responsible for 11% (7,929 of 71,747) of illnesses, 34% (1,460 of 4,247) of hospitalizations, and 56% (66 of 118) of deaths associated with foodborne outbreaks. [Listeria accounted for the largest percentage of deaths - 86%]
• Salmonella (63 outbreaks), Shiga toxin-producing E. coli (34), and Listeria monocytogenes (12) were the leading pathogens.
• Fruits (17), vegetable row crops (15), beef (13), sprouts (10), and seeded vegetables (nine) were the most commonly implicated foods.
• Imported foods were linked to 18 multistate outbreaks.

It is interesting to read the headlines that follow this release.
Big and deadly: Major foodborne outbreaks spike sharply (Washington Post) goes on to say that major foodborne outbreaks in the United States have more than tripled in the last 20 years.
Well, our improvement in being able to see outbreaks has improved in the last twenty years.  With Pulsenet, CDC can work with states to find outbreaks.  This system came online 20 years ago and has continued to improve, especially with the development of whole genome sequencing.  So of course we see more outbreaks than we saw 20 years ago, but that does not mean they didn't exist.  And if you had to guess, you would say that there were more 20 years ago then there are today.

Nebraska Establishment Recalls 167,000 lbs of Ground Beef After E. coli Positive Test Result

A Nebraska meat establishment is recalling approximately 167,000 lbs of ground meat after USDA found a positive sample in their 'in-commerce' testing.  There have been no reported illnesses.

USDA News Release
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2015/recall-135-2015-release
All American Meats, Inc. Recalls Ground Beef Products Due to Possible E. Coli O157:H7 Contamination
Class I Recall 135-2015
Health Risk: High Nov 1, 2015

Congressional and Public Affairs   Kristen Felicione  (202) 720-9113 

WASHINGTON, Nov. 01, 2015 – All American Meats, Inc., an Omaha, Neb. establishment, is recalling approximately 167,427 pounds of ground beef products that may be adulterated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Chipotle Shuts West Coast Locations After Linked to E. coli Outbreak

UPATE - 12-21-15 - CDC reports that a total of 53 people have become infected in 9 different states.  From the CDC report - "The number of ill people reported from each state is as follows: California (3), Illinois (1), Maryland (1), Minnesota (2), New York (1), Ohio (3), Oregon (13), Pennsylvania (2), and Washington (27)."

Update - 11/4/15 - Reports have the total number of cases at 35 (as of Tuesday, 11/3) for those infected by E. coli O26.   


11/2/15
Chipolte restaurants closed 43 west coast restaurants because of a potential link to E. coli outbreak.  As of the Oct 31st, there were 22 reported illnesses.  The ingredient source of E. coli has not yet been identified.

This is the third major outbreak associated with the chain. In September, a California location was involved in a Norovirus outbreak where 80 individuals become ill.  In the same month, 22 locations were linked to 64 cases of Salmonella infection.  In this case, tomatoes were pinned as the source.

This has had a impact on the business as the stock price has dropped to a 4 month low.


Reuters Business News
http://www.reuters.com/article/2015/11/02/us-chipotle-ecoli-idUSKCN0SQ2CE20151102
Chipotle shuts Seattle, Portland stores after E. coli outbreak
Sun Nov 1, 2015 10:59pm EST
Related: Health, Mexico
NEW YORK/LOS ANGELES | By Ransdell Pierson and Lisa Baertlein
Chipotle Mexican Grill Inc said on Sunday it had closed all its restaurants in two West Coast markets due to a reported outbreak of E. coli bacteria that is being investigated by the company and health authorities.

Juice Processor Ordered to Cease Operations for Lack of Compliance

An Idaho juice processor was ordered to cease production after not complying  with FDA regulations.  The juice processor was not heat pasteurizing, and according to juice regulations, there must be validated reduction steps in place.  Normally, juice processors use heat pasteurization to accomplish this.  It is unclear what, if anything, this processor was doing.

FDA News Release
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm470328.htm
FDA orders juice manufacturer to cease operations
For Immediate Release
October 30, 2015
Release

Apples Recalled Due to Positive Screen for One of Three Pathogens

A MN firm is recalling apples because a test indicates the presence of Listeria or Salmonella or E.coli.  So basically, they don't know which because who ever did the test ran a screen which looks for indicator genes for each of the three.

The recall was probably based upon a positive reaction of the test without the isolation of the actually pathogenic organism.  This is the problem with a screen - not sure which organism or it is just a false positive result.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm470317.htm
Northstar Produce Inc. Recalls Granny Smith Size 175 Apples Because of Possible Health Risk

For Immediate Release  October 26, 2015

Contact Consumers Mike Abernathy 763-286-0110
Firm Press Release

Northstar Produce Inc.of St. Louis Park, MN the presence of Listeria monocytogenes, Salmonella, and / or Enterohemorrhagic E. coli. is recalling 33 cases of Granny Smith Size 175ct apples, because a test performed on a sample of the apples indicated the presence of Listeria monocytogenes, Salmonella, and / or Enterohemorrhagic E. coli.

Bagged Edamame Recalled Due to Allergen Labeling Deficiency...Contains Soy

Giant Foods is recalling frozen edamame because the allergen statement is not there...Contains Soy.   Of course edamame is soy, just the immature version still in the pods.  But some may not recognize this, and by regulation, the common name must be stated.

From the FDA Guidance Q&A document
Packaged foods that are made using soybeans as an ingredient or as a component of a multi-component ingredient (e.g., soy sauce or tofu) should continue to use the word "soybeans" as the appropriate common or usual name for this ingredient to identify properly the ingredient (e.g., "soy sauce (water, wheat, soybeans, salt)").

 Centre Daily Times
http://www.centredaily.com/2015/10/30/4992035/giant-announces-edamame-recall.html
Giant announces edamame recall
By From CDT staff reports
October 30, 2015

Caution: soybeans contain soy.

A warning like this was left off some edamame, causing a Pennsylvania food chain to pull the product from shelves.

Giant Food Stores, LLC and Martin’s Food Markets announced Friday that it was removing Nature’s Promise Organic Edamame products because they contain soy, but it is not listed on the labels as containing the ingredient, which can cause problems for people with a specific allergy.

Man Sentenced to 51 Months for Sales Scam - Industrial Bleach as a Miracle Drink

A Washington man was sentenced to 51 months in prison for selling an industrial chemical as  Medical Miracle Solution, MMS.  The solution, as detailed by the authorities, was sodium chlorite.  According to reports, the directions had the consumer add citric acid to this which creates chlorine dioxide, a very strong oxidizing solution.  This type of mixture is used in a number of industrial applications including use as a sanitizing solution for food contact surfaces.  But not for direct consumption.  A number of people had reported becoming ill.

Peanut Butter Recalled Due to Potential Metal Pieces

Hormel is recalling 153 cases of 16.3 oz jars of Skippy Peanut Butter due to a potential for metal.  Metal pieces were found on an in-line magnet, which probably raised concern that some could have made its way to the jars. 

The interesting thing to note is that product was already shipped given that sufficient metal was found to raise concern.  Also 153 cases, about 3 pallets of product, would probably represent less than an hour of production.  These types of issues can arise for a number of reasons...just in time shipping where product is being shipped as it is made.   Another reason can be inadvertent shipping of product placed on hold because of fact there was an equipment malfunction where that product was placed 'on hold' because the malfunction resulted in metal pieces being generated as indicated by the in-line magnet. An indicator that this may have been the case is the production code / Best if Used By date...if this product had just been made, the code would probably be further out than next December.


FDA Recall Notice
Recall: Firm Press Release
http://www.fda.gov/Safety/Recalls/ucm470175.htm
Hormel Foods Sales LLC Voluntarily Recalls a Limited Number of Jars of Skippy Reduced Fat Creamy Peanut Butter Spread Due to Possible Metal Pieces
For Immediate Release
October 29, 2015

Grocery Chain Recalls Deli Salad Items Due to Listeria Positive Samples

Whole Foods recalled various deli salads including chicken and pasta salad made at their central kitchen in Massachusetts.  Product was made on the 16th with a sell-by-date of the 23rd.
At the time of the recall, the product had already reached its expiration date.

A few things to note - the notice states that a sampling of the products tested positive which indicates more than one product.  Whether or not that is the case, they do have Listeria within the facility and there should be a question of whether it is under control.  Commissary operations may or may not do extensive testing for Listeria, mainly because the shelf-life is so short.  Since this product is one day beyond the Food Code limitation of 7 days (day one is the day product is made), there should be controls in place.  Also, since this is a dual jurisdiction plant (both FDA and USDA have oversight), from a USDA perspective of a facility with RTE product and post-lethality exposure, some testing should be taking place.

When Listeria is found on product, there is a high probability that it will still be in the environment unless there is a good explanation why contamination was limited to that day.  Hopefully before this facility restarts, they conduct ample cleaning and verification testing prior to starting production.

No illnesses have been reported...yet.  With Whole Genome Sequencing, further analysis of the LM found in the facility can now be matched against cases of Listeria infection that have occurred throughout the region.


USDA Recall Notice
Link
Whole Foods Market Recalls Curry Chicken Salad Product Due To Possible Listeria Adulteration
Class I Recall 131-2015
Health Risk: High Oct 24, 2015

En Español
Congressional and Public Affairs  Julie Schwartz   (202) 720-9113

WASHINGTON, Oct. 24, 2015 – A Whole Foods Market establishment located in Everett, Mass. is recalling approximately 234 pounds of curry chicken salad products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The chicken curry salad was packaged on Oct. 16, 2015, and was sold prepackaged, in salad bars, in store's chef's cases, and in sandwiches and wraps prepared in the stores. The following products are subject to recall: [Labels (PDF Only)]