FDA Reorganizes to Create Human Foods Program; Introduces Updated Complaint Portal

The FDA announced the reorganization creating the Human Foods Program, "a new model for field operations and other modernization efforts is now in effect."  According to the release, this "is is the single largest reorganization in the agency’s modern history, as it impacts more than 8,000 employees and touches almost every facet of the FDA."

The goal is to better "zero in on those issues where intervention has the greatest opportunity for the prevention of disease and for the promotion of wellness."  FDA states that "An important part of this reorganization also includes restructuring and renaming our field operations unit to focus on inspections, investigations and imports as its core mission. Restructuring the Office of Inspections and Investigations, formerly known as the Office of Regulatory Affairs, extends beyond foods and has an impact on how the FDA oversees all FDA-regulated products. We have created an enterprise-wide structure that will enhance collaboration between our field investigators and other subject matter experts throughout the agency and modernize and strengthen the entire agency to work more cohesively and collaboratively in accomplishing our collective public health mission."

FDA also announced "a new, streamlined approach for processing complaints, including whistleblower complaints, that will improve the Agency’s ability to detect and respond to problems related to FDA-regulated products and better protect public health. A complaint may be about an illness, injury, allergic reaction, or other health-related issue or about defects in the quality or safety of an FDA-regulated food, dietary supplement, or cosmetic product. Now, the public will be able to direct complaints about foods and dietary supplements to HFP by using our online reporting forms."

https://www.fda.gov/news-events/press-announcements/fdas-unified-human-foods-program-new-model-field-operations-and-other-modernization-efforts-go
FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect
The following is attributed to Robert M. Califf, M.D., FDA Commissioner, and Jim Jones, Deputy Commissioner for Human Foods and Michael Rogers, Associate Commissioner for Inspections and Investigations

For Immediate Release:
October 01, 2024

Soup Temperature - What is the best serving temperature?

An article in Food Republic provides a short review of impact of serving temperature on soup.  While the article was not overly researched, it does provide something to ponder....what temperature do you like to have your soup?  And here, we are focusing on heated soups rather than cold soups.

There are a few hard numbers.

- For hot hold, the temperature has to be at 140F (135F professionals) for hot hold.

- For safety, reaching a temperature of at least 165F instantaneous for meat containing soups, although we are more likely to bring them to a boil.

-  The pain threshold of the tongue is around 152 to 153 degrees (according to this article).

There are other factors that come into play, including our perception of saltiness, sourness, and sweetness, among others.  Then there is our emotional response (article below).

Provide me your thoughts on this.


https://www.foodrepublic.com/1664166/best-temperature-for-soup/
What's The Best Temperature For Serving Soup?
BY LOUISE RHIND-TUTT•SEPT. 25, 2024 8:15 AM EST

Texas Meat Processor Recalls Fried Pork Skin For Undeclared Soy

Pork Dynasty Inc., a Houston, Texas establishment, is recalling approximately 469 pounds of ready-to-eat fried pork skin products due to misbranding and an undeclared allergen - the product contains soy, a known allergen, which is not declared on the product label.  The problem was discovered during routine FSIS in-plant verification activities when FSIS personnel observed that a seasoning containing soy, a known allergen, was being used as an ingredient and soy was not declared on the finished product label.

https://www.fsis.usda.gov/recalls-alerts/pork-dynasty-inc--recalls-ready-eat-fried-pork-skin-products-due-misbranding-and
Pork Dynasty Inc. Recalls Ready-to-Eat Fried Pork Skin Products Due to Misbranding and Undeclared Allergen

Pork Dynasty, Inc.
FSIS Announcement

WASHINGTON, Sept. 27, 2024 – Pork Dynasty Inc., a Houston, Texas establishment, is recalling approximately 469 pounds of ready-to-eat fried pork skin products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen, which is not declared on the product label.

On Passing Gas

"A person produces about 30 to 91 cubic inches (500 to 1,500 milliliters) of flatus every day regardless of their diet, and over 99% of those gases are odorless".    But what happens when we hold that gas in?  What causes some gas to be really smelly?  Two articles posted on Live Science address these important questions.

First, when hold gas in, it will eventually come back out.  "The external anal sphincter is the only part of the digestive process we have conscious control over. So, if we decide the time is not right to pass gas, we constrict the sphincter and the fart is trapped. Without a backdoor to escape from, the gases recede back into the colon.  But primarily, the body is trying to push gas out. So farts that are ignored during the day are mostly released during bathroom breaks or as the body relaxes in sleep at night."

What causes that anally-expelled gas to smell?  There are many variables that affect this including that person's intestinal microbiota.  One major culprit is "Sulfur-rich foods include legumes (such as lentils, beans and peas) and brassicas (such as broccoli and cabbage). These fibrous veggies also contain insoluble carbs that bacteria in the colon may convert into stinky gas."


https://www.livescience.com/health/what-happens-when-you-hold-in-a-fart
What happens when you hold in a fart?
News
By Sierra Bouchér published 9/28/24

We all hold in farts from time to time, but where does the gas go?.

FDA Reminds Food Companies That It Is Time to Renew Registration

FDA issued a reminder that FDA regulated food facilities must renew their registration.  "Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2024."

"All facilities must include a unique facility identifier (UFI) recognized as acceptable to the FDA with the food facility registration (FFR) submission. The UFI is used to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration."

If you are not responsible for registration, you may want to pass this reminder to whoever is responsible.

https://www.fda.gov/food/cfsan-constituent-updates/fda-reminds-animal-and-human-food-facilities-register-or-renew-their-food-facility-registration-ffr?utm_medium=email&utm_source=govdelivery
FDA Reminds Animal and Human Food Facilities to Register or Renew their Food Facility Registration (FFR) between October 1 and December 31, 2024
Constituent Update

September 27, 2024

Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2024.

FDA Issues Warning Letter to Missouri Sprout Producer

FDA issued a Warning Letter to St. Louis Calco, a sprout operation located in Fenton, MO.

The company was cited for:

1. Did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes (L. monocytogenes).
2. Did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens
3. Did not clean and sanitize food contact surfaces you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts

Issues included:   

• The sprouts pool was observed with buildup of residue on the walls, bottom of pool and drain covers.
• The belts of the sprouts pool had pieces of sprouts still present on the belts.
• The wall around the sprouts collection table at the end of the sprouts pool had apparent mold growth where sprouts are in contact with the wall.
• The mung bean sprout’s growing bins and soybean sprout’s growing buckets were observed to have buildup of brown residues when being actively used for growing your sprouts.
• The metal on the outside of your growing bins and wall holding pins were observed to have buildup of brown residues. This metal was observed to be in direct contact with growing mung bean sprouts.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/st-louis-calco-llc-669917-03212024
WARNING LETTER
St. Louis Calco, LLC
MARCS-CMS 669917 — March 21, 2024

FDA Issues Warning Letter to Company Failing to Properly Acidify Tea Beverage

FDA issued a Warning Letter to Brewing Market Coffee, an acidified manufacturing facility located in  Boulder, Colorado.  The company failed to file a process for Black Tea Chai and employees were not properly trained.  Along with this, they failed to properly monitor pH.

The company "failed to exercise sufficient control, including frequent testing, and recording of results, so that finished equilibrium pH values for acidified foods are not higher than 4.6, as required by 21 CFR 114.80(a)(2). Specifically, the pH buffers used to calibrate your pH meter are maintained at ambient room temperature. On December 15, 2023, you tested the final pH of your Black Tea Chai drink, Lot (b)(4), immediately after heating the drink. The temperature of the drink at the time of the pH measurement was observed to be (b)(4)oF. You did not allow the Black Tea Chai drink to reach ambient room temperature before taking your final pH reading. Additionally, you did not allow the Black Tea Chai drink to reach equilibrium before taking the final pH measurement. You are not measuring the pH of your chai drinks, which are shelf-stable, after they have reached equilibrium."

This is interesting in that there are no low acid particulates to classify this as an acidified food where the equilibrium pH would be a concern.  Yes, achieving the proper pH is need, and if they were not doing that it is an issue, however, this would not have been classified as a what we normally view as an  acidified food.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/brewing-market-coffee-682451-04252024
WARNING LETTER
Brewing Market Coffee
MARCS-CMS 682451 — April 25, 2024

NC Firm Recalls Snack Mix After Mispacking Issue Results in Undeclared Allergens

Truly Good Foods, Charlotte, NC, is recalling its 3.25-ounce packages of Grabeez The Big Cheese Snack Mix cups with a Best Before 041625 because they contain undeclared almonds and cashews.  The recall was initiated on September 23, 2024 after a customer noticed an incorrect cup. The firm discovered that the tree nut-containing product was distributed in mislabeled packaging that did not reveal the presence of almonds and cashews. The product inside the cup could be Healthy Trails Mix which contains raisins, sunflower seeds, almonds, pumpkin seeds, and cashews.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/truly-good-foods-issues-allergy-alert-undeclared-almonds-and-cashews-grabeez-big-cheese-snack-mix
Truly Good Foods Issues Allergy Alert on Undeclared Almonds and Cashews in Grabeez The Big Cheese Snack Mix 3.25 oz Cup
Summary
Company Announcement Date:  September 24, 2024
FDA Publish Date:  September 25, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Almonds and Cashews
Company Name:  Tropical Nut & Fruit d.b.a. Truly Good Foods
Brand Name:  Grabeez
Product Description:  Trail Mix with peanuts, pretzels, and crackers.

Pennsylvania Pet Food Establishment Recalls Raw Dog Food After Testing Finds Salmonella and Listeria

FDA issued a health alert about dog food sold by a Pennsylvania Company, Lystn, LLC d.b.a./ANSWERS Pet Food. for potential Salmonella and Listeria contamination. This comes after samples collected by the U.S. Food and Drug Administration were reported to have tested positive for the presence of Salmonella and Listeria monocytogenes.   The FDA collected and tested unopened retail samples of products after receiving three consumer complaints of illness in dogs that ate the products.

The lots referenced below were distributed throughout the United States in retail stores and direct online sales. No illnesses associated with these lots have been confirmed.

According to the website, the food is fermented and this fermentation is supposed to help protect against pathogens.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/answers-pet-food-voluntarily-withdrawals-certain-limited-lots-beef-and-chicken-dog-foods-due
ANSWERS Pet Food Voluntarily Withdrawals Certain Limited Lots of Beef and Chicken Dog Foods Due to Potential Salmonella and Listeria
Summary
Company Announcement Date:  September 22, 2024
FDA Publish Date:  September 23, 2024
Product Type:  Animal & Veterinary  Food & Beverages  Pet Food
Reason for Announcement:  Due to Potential Salmonella and Listeria
Company Name:  Lystn, LLC. d.b.a. ANSWERS
Brand Name:  ANSWERS
Product Description:  Beef and Chicken Dog Foods