EpiPen Price Hike Impacts People with Food Allergies

EpiPens, those self-given injection needles to prevent allergic reactions, have gone up in price to over $600 for a set of pens..  Even with insurance, the price can be as much as $200 to $300 per set.   And considering these pens have a limited shelf-life of a year, this is a reoccurring cost.

EpiPens deliver epinephrine, a drug that slows the symptons of the immune response such as swelling.  In those people that are highly allergic to an allergenc such as peanuts or crustacean shellfish,  swelling of body tissue including the throat can be life threatening.  So these folks need to carry EpiPens.

NY Times
http://well.blogs.nytimes.com/2016/08/22/epipen-price-rise-sparks-concern-for-allergy-sufferers/?_r=0
EpiPen Price Rise Sparks Concern for Allergy Sufferers
By Tara Parker-Pope and Rachel Rabkin Peachman August 22, 2016 6:05 pm August 22, 2016 6:05

A steep increase in the price of the EpiPen, a lifesaving injection device for people with severe allergies, has sparked outrage among consumers and lawmakers who worry that parents won’t be able to afford the pens for children heading back to school.

Frozen Chicken Entrees Recalled Due to Foreign Material

Another recall due to consumer complaints on foreign objects in product.   In this case, a GA company is recalling chicken entrees with glass or hard plastic.

FSIS Recall Notice
http://www.fsis.usda.gov/wps/wcm/connect/FSIS-Content/internet/main/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-074-2016-release
Sentry Foods Recalls Frozen Chicken Entrées due To Possible Foreign Matter Contamination
Class II Recall 074-2016

Warning Letter Issued to Facility with Recurring Strain of Listeria

Jeni's Splended Ice Cream was issued a warning letter by FDA.  Basically FDA inspected the firm in January, and during that inspection, they found 2 of 75 swabs positive for Listeria.  Both positives were from the floor - non-food contact surfaces.  They also found two GMP issues - 1) "our investigator observed a dust-like material adhering to the guard over the fan on the west end of the underside of the ceiling-mounted cooling unit located in the dish room, where containers, equipment parts, and utensils used in production are washed, rinsed, sanitized, and stored." and 2) observed an employee in the prep room placing  “skinned” bags of sugar on a cart in the prep room, then moving these bags beside a prep table where they were picked up and manually poured from the bags into clear plastic containers such that the outside of the sugar bags came into direct contact with the inner food contact surface of the plastic containers.

Now, it is important to point out that an inspection had been done the previous year and that the 2 GMP violations were previously noted.  More impactful however, is that during that 2015 inspection, FDA had found 20 samples positive for Listeria.  It is also important to note that this audit had been done as a result of a state laboratory finding Listeria in a product sample.

Further, the Listeria was the same strain in all samples "Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from a FDA environmental sample collected on January 26, 2016, twenty (20) L. monocytogenes isolates obtained from a FDA environmental sample collected on April 21, 2015, and two (2) L. monocytogenes isolates obtained from a finished product sample of ice cream collected by Nebraska Department of Agriculture in April 2015".  (Associated Recall)

So while the firm conducted corrective actions  (conducted a voluntary recall of ice cream, frozen yogurt, sorbet, and ice cream sandwiches for all flavors and containers in 2015, made changes in the production flow including no longer manufacturing finished ice cream, frozen yogurt, or sorbet on-site (instead just manufacturing frozen flavor bases that are shipped to co-manufacturers, and conducted training for employees), the same organism is still in the facility.

"The reoccurring presence of an identical strain of L. monocytogenes in your environment indicates a resident strain or niche harborage site present in the facility. These findings also demonstrate that your sanitation procedures have historically been inadequate to control, reduce, or eliminate this pathogenic organism from your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism."

A few things to note:

1) This is a reason for facilities to consider using Whole Genome Sequencing (WGS) when they find Listeria in their facility.  Too often the assumption is that it is reentering the facility, but it may be worth determining if there is a resident strain.

2) Although this firm went to great lengths to escape the problem, including changing the products they make, they did not solve the fundamental issue of systematic contamination in the facility.  Although the facility findings were not huge or overly impactful, that issue still existed and resulted in further scrutiny .  WGS had an impact on how FDA evaluated this facility, and making marginal issues bigger than they should have been.  Including finding 2 samples of Listeria in the facility.

3) It is important to fix the issues in an FDA audit report and ensure that they are being followed. Clearly, by having old issues recited gives an auditor or inspector the impression that things have not changed..

4) This points out the long term impact of finding product in the field positive for Listeria.  It the company had more proactive programs first time around, they wouldn't be still trying to work out of the negative image created.

5) The press has been brutal, and although the company claims the product is safe, it is hard to overcome the amount of negative coverage.  Below is an article in the Wall Street Journal countered by an article in Columbus Business First.

Supermarket's Communication on Food Recalls Varies

A report published by CSPI shows that supermarket chain procedures for handling recall communications varies from chain to chain.  By regulation, stores are supposed to post information in a conspicuous spot for 14 days after the recall.  Not everyone is doing it the way they are supposed to be doing it according to this report.

Center for Science in the Public Interest
https://cspinet.org/news/supermarkets-do-uneven-job-notifying-consumers-recalls-20160824#.V72z-5n5eqs.twitter
Supermarkets Do Uneven Job Notifying Consumers of Recalls

Acorns.......the New Old Superfood?

More people are looking for that food or pill that will improve health.  Well, instead of a cache of pills or some over processed beverage drink, let's consider eating what squirrels and bears eat....acorns.

In an review article in Comprehensive Reviews in Food Science and Food Safety, researchers found that the lowly acorn is chock full of healthful stuff.  In addition to a whole host of phytochemicals, acorns are a good source of fiber, protein, and vitamins A and E, and unsaturated fatty acids.

FDA Releases Draft Guidance on GMPs for Animal Feed

 FDA issued Draft Guidance for Industry #235 - Current Good Manufacturing Practice Requirements for Food for Animals "to help facilities that manufacture, process, pack or hold animal food for consumption in the United States comply with CGMP requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distribution. The guidance also includes information on training and related recordkeeping. The CGMPs required under the Preventive Controls for Animal Food rule are flexible to address the diversity of facilities and animal foods, the wide range of animal food activities, and the potential safety risks posed by some animal foods."

This guidance contains information to help these facilities determine whether they need to comply with the current good manufacturing practice (CGMP) requirements for animal food and provides additional information and recommendations for compliance with the CGMP requirements for animal food, as well as compliance with related requirements such as training and recordkeeping.

FDA Issues Draft Guidance for Facilities Sending By-Products for Use in Animal Feed

FDA issued a draft guidance for food processing facilities that send their by-products for animal feed. For example, a company sending peels or rinds after processing produce, or a company sending over baked cookies to a hog farmer.  The following is the important sections from this draft guidance.

FSMA - FDA Extends Deadline for Certain Provisions of Four Major Rules

As you know, the compliance dates are approaching for FSMA.  For Preventive Control for Human Foods, the compliance date for large firms in September 18th, 2016.  (This has not changed.)

But with this much of a major change in regulations, there will be areas where more guidance is needed from FDA for companies to figure out how to comply.  This is the case where these 6 issues resulted in the compliance dates being moved back, essentially 2 years from the proposed compliance date.

• certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules. 
• for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. 
• for certain facilities that color RACs.  
• for facilities solely engaged in the ginning of cotton. 
• for importation of food contact substances. 
• for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.

The most impactful for those processing human and animal foods is the customer assurance requirement.  This provision requires the processor to make sure the downstream customer was going to take care of a hazard in the ingredient being sold.   Basically, if Company A is selling to Company B an ingredient containing a hazard, say for example Salmonella, where Company B said they were going to heat process that ingredient.  By Rule, Company A would need assurance that Company B was going to cook it sufficiently.   This, as written, may not be easy information to get.  (Specific sections of the posting below)

The other impactful section being delayed is for facilities holding or packing raw agricultural commodities that are not classified as a farm.  These facilities are more like a farm than a processor, but because of the way the rule was written, it classifies them more as a processor.  To help determine what these facilities need to do, FDA will write a specific guidance for these facilities. (Specific sections of the posting below)

Selected sections from:
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
Final Rule; Extension And Clarification Of Compliance Dates For Certain Provisions.
 https://www.federalregister.gov/articles/2016/08/24/2016-20176/the-food-and-drug-administration-food-safety-modernization-act-extension-and-clarification-of#t-1

Hepatitis A Outbreak Link to Frozen Strawberries from Egypt

The VA Department of Health issued a health warning about a cluster of hepatitis A cases and has identified a potential association with frozen strawberries used in smoothies from Tropical Smoothie Cafe restaurants in Virginia.  The frozen strawberries came from Egypt.

This is not the first time that frozen fruit sourced from the Middle East has been a problem for Hepatitis A.   In 2013, frozen pomegranate seeds were linked to a Hepatitis A outbreak  where over 150 were infected.  Smoothies are an issue because there is no elimination step such as heating.  Any contamination on the fruit gets blended into the drink.

Virginia Department of Health News Release
http://www.vdh.virginia.gov/news/public-relations-contacts/news-releases/2016-statewide-news-releases/health-officials-warn-of-increased-hepatitis-a-risk/
Health Officials Warn of Increased Hepatitis A Risk
August 19, 2016