FDA Acknowledges There Is Alignment of 3rd Party Audit Standards with FSMA Regulations

FDA released results of their evaluation of 3rd party audit standards to assess whether those standards are in alignment with FDA FSMA regulations.  FDA finding of alignment indicates that the relevant technical components of the PC Human Food or Produce Safety rules have been addressed.  

Why is this important?  "Under FSMA, the PC Human Food rule, Preventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule – allow for third-party audits to be used as supplier verification activities."  As is common industry practice, "Buyers and others in the food supply-chain often use third-party audits to assess the quality and safety of a product. "  So, "a finding of third-party audit standards alignment with the FSMA regulations could help give importers and receiving facilities confidence that the standards used to audit their suppliers adequately address applicable FDA food safety requirements. This information, along with results of a firm’s audits, also could help inform the FDA in determining risk prioritization and resource allocation."

So these audit standards were found to be in alignment:

Preventive Controls for Human Foods (PCHF)

• BRC Global Standard Food Safety plus the Global Standard Food Safety, Issue 9, Interpretation Guideline
• FSSC 22000 Scheme 5.1 for Food Manufacturing plus the FSSC 22000 Version 3 FSMA PCHF Report Addendum
• SQF Food Safety Code: Food Manufacturing, Edition 9 plus the SQF Addendum for the Preventive Controls for Human Food

Produce Safety Rule (PSR)

• GLOBALG.A.P. Integrated Farm Assurance – All Farm Base-Crops Base – Fruit and Vegetables Checklist. Version 5.4-1-GFS plus the GLOBALG.A.P. Food Safety Modernization Act Produce Safety Rule Add-on Module Version 1.3

https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-alignment-findings-voluntary-pilot-program-evaluate-third-party-food-safety-standards
The FDA Announces Alignment Findings from Voluntary Pilot Program to Evaluate Third-Party Food Safety Standards

Constituent Update

July 17, 2023

Today, the U.S. Food and Drug Administration (FDA) is announcing the findings from the voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations issued to implement the FDA Food Safety Modernization Act (FSMA) - the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules.

Frozen Fruit Bars Recalled for Undeclared Allergens

Dreyer’s Grand Ice Cream, Inc. is voluntarily recalling a limited number of its Outshine No Sugar Added Strawberry Fruit Bars that may contain an undeclared milk allergen.   The company is recalling this product because it may contain trace amounts of milk. Although the investigation is ongoing, they believe a faulty valve allowed trace levels of milk to be introduced into the product.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dreyers-grand-ice-cream-inc-issues-allergy-alert-undeclared-milk-outshine-no-sugar-added-strawberry
Dreyer’s Grand Ice Cream, Inc. Issues Allergy Alert on Undeclared Milk in Outshine No Sugar Added Strawberry Fruit Bars in 6 Count Pack
Summary
Company Announcement Date:  July 17, 2023
FDA Publish Date:  July 18, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk allergen
Company Name:  Dreyer’s Grand Ice Cream, Inc.
Brand Name:  Outshine
Product Description:  No Sugar Added Strawberry Fruit Bars

DC Establishment Recalls Tubs of Spicy Hummus for Undeclared Sesame After Incorrect Lid Applied

Cava Foods, Inc., a subsidiary of Cava Group, Inc. in Washington D.C., is issuing a voluntary recall of one lot of its packaged CAVA Spicy Hummus due to the potential for the product to contain undeclared sesame, which is a food allergen.   CAVA voluntarily initiated the recall after a single retail store notified the company that packaging lids for CAVA Spicy Labneh (which do not declare sesame as an ingredient) were applied to containers of Spicy Hummus, which contains sesame, a common allergen. The wrong lid was applied to a limited number of Spicy Hummus containers by a third-party supplier.

Here is another recall related to mislabeling where a lid label is applied to the wrong product.  Seems like an easy enough issue to prevent through development and implementation of a good Allergen Preventive Control.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cava-foods-inc-subsidiary-cava-group-inc-issues-allergy-alert-undeclared-sesame-cava-spicy-hummus
Cava Foods, Inc., a Subsidiary of Cava Group, Inc. Issues Allergy Alert for Undeclared Sesame in Cava Spicy Hummus
Summary
Company Announcement Date:  July 17, 2023
FDA Publish Date:  July 18, 2023
Product Type:  Food & Beverages Prepared Food  
Reason for Announcement:  Undeclared sesame allergen
Company Name:  Cava Foods, Inc.
Brand Name:  CAVA
Product Description:  Spicy Hummus, 8 oz tub

Ohio Firm Recalls Cashew Butter After Product Found to Contain Peanuts or Almonds

Heinen’s of Warrensville Heights, OH is voluntarily recalling Heinen’s Fresh Ground Cashew Butter, due to the possibility that it may contain undeclared Peanuts or Almonds.  The recall was initiated after it was discovered that product containing Peanuts or Almonds was distributed in Fresh Ground Cashew Butter Containers that did not reveal the presence of additional allergens. Subsequent investigation indicates that this was isolated to a single distributed Sell By Date of 8/27/23

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/heinens-issues-allergy-alert-undeclared-peanuts-and-almonds-heinens-fresh-ground-cashew-butter
Heinen’s Issues Allergy Alert on Undeclared Peanuts and Almonds in Heinen’s Fresh Ground Cashew Butter
Summary
Company Announcement Date:  July 13, 2023
FDA Publish Date:  July 17, 2023
Product Type:  Food & Beverages  Butter/Butter Product
Reason for Announcement:  Undeclared peanut and almond allergens
Company Name:  Heinen’s
Brand Name:  Heinen’s
Product Description:  Fresh Ground Cashew Butter

Ingredient Supplier of Batter Recalls 6 Million Pounds of Product Due to Salmonella Potential

Newly Wed Foods, an ingredient supplier is recalling 6 million pounds of batters/breaders due to Salmonella. This recall will not be listed on the normal recall page because it is not product that is sold to the consumer. Rather, it is posted on the Enforcement Report page - Enforcement Report (fda.gov). Batter and breader are used in breading applications for foods that will be cooked, generally fried.

California Recall of Asian Chopped Salad Due to Undeclared Allergens Packed With Wrong Condiment Pack

In California, Braga Fresh is recalling a single production run of 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kit 12oz bag purchased from Whole Foods Markets stores.  The product is being recalled because it contains incorrect condiment ingredients resulting in undeclared milk and egg that was not listed on the product label.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/braga-fresh-issues-precautionary-recall-365-whole-foods-market-brand-organic-asian-inspired-chopped
Braga Fresh Issues Precautionary Recall of 365 By Whole Foods Market Brand Organic Asian Inspired Chopped Salad Kit 12oz Bag Due to Potential Presence of Undeclared Allergens
Summary
Company Announcement Date:  July 11, 2023
FDA Publish Date:  July 12, 2023
Product Type:  Food & Beverages  Prepared Food  
Reason for Announcement:  Undeclared milk and egg allergens
Company Name:  Braga Fresh
Brand Name:  365 By Whole Foods Market
Product Description:  Potential or Undeclared Allergen - milk and egg

Thinking of Taking a Cruise - Norovirus Cases from 1st Half of 2023 On Course for Most Cases in over a Decade

The Vessel Sanitation Program (VSP) requires cruise ships to log and report the number of passengers and crew who say they have symptoms of gastrointestinal illness. Learn more about illnesses and outbreaks reported to VSP and find information about outbreaks of gastrointestinal illness on cruise ships.

In the first half of 2023, there were 13 reports of ships with Norovirus cases where roughly 3 to 5% of passengers and 1 to 2% of staff became infected.  In 2022, there were 4 cases and in 2021, there was only one case.  We would have to go back to 2012 where there were more cases for the entire year (16) to be more than seen in the first half of this year.

OR Food Establishment's Use of Outdated Packaging Leads to Unlabeled Sesame Issue

Betty Lou’s Inc., McMinnville, OR is recalling 1.5oz (42g) packages of Betty Lou’s Brand Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds, BB 08MAY24 1283, due to undeclared sesame allergen. The recall was initiated after it was discovered by a regular Betty Lou’s Inc. internal review, an old version roll of packaging was used during production, and product containing sesame was distributed in packaging that did not reveal the presence of sesame.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/betty-lous-inc-issues-allergy-alert-undeclared-sesame-paleo-java-nuts-about-energy-balls-cacao
Betty Lou’s Inc. Issues Allergy Alert on Undeclared (Sesame) in Paleo Java Nuts About Energy Balls With Cacao, Coffee & Pumpkin Seeds
Summary
Company Announcement Date:  July 10, 2023
FDA Publish Date:  July 11, 2023
Product Type:  Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared sesame allergen
Company Name:  Betty Lou’s Inc.
Brand Name:  Betty Lou’s
Product Description:  Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds

FDA Releases List of Chemicals Not Allowed in Foods and Chemicals Under Review

The FDA released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review.
 

This week, FDA issued Warning Letters to a number of companies that were selling products with Delta-8 Tetrahydrocannabinol (Delta-8 THC), an isomer of Delta-9 THC, the intoxicating component found in marijuana. many of these products look like snacks or candies and can be an issue for children mistakenly eating. 

This is a good reference for chemicals in question.

Post-market Determinations that the Use of a Substance is Not GRAS

• 4-androstenedione
• Arimistane
• Betel nut (Areca catechu)
• Caffeinated alcoholic beverages (CABs)
• Cannabidiol (CBD)
• Delta-8-tetrahydrocannabinol  (THC)
• 1,3-dimethylamylamine  (1,3-DMAA)
• Ginkgo biloba
• Kava
• Melatonin
• Picamilon

List of Select Food Ingredients and Food Contact Substances Currently Under FDA Review

• Authorized PFAS: Certain Short-Chain Per- and Polyfluoroalkyl Substances (PFAS) Food Contact Substance
• Authorized PFAS: Uses of other Per- and Polyfluoroalkyl Substances (PFAS) in food contact applications Food Contact Substance
• Brominated-Vegetable-Oil (BVO)  - Food Additive
• Irgafos 168 - Food Contact
• Partially Hydrogenated Oil (PHO) - food additive
• Phthalates - Food contact
• Red Dye No. 3 - Color Additive
• Titanium Dioxide - Color Additive

List of Select Contaminants Currently Under FDA Review

• Arsenic - Environmental Contaminant
• Cadmium - Environmental Contaminant
• Lead - Environmental Contaminant
• 4-MEI Methylimidazole CAS Number 822-36-6 - Process contaminant in some caramel colors and flavors, and in some foods and beverages during the normal cooking process
• Mercury - Environmental Contaminant
• 3-Monochloropropane-1,2-diol (MCPD) esters and Glycidyl Esters (GE)  - Process contaminants that can occur in refined edible oils, such as vegetable oils, and foods made with these oils, including infant formula
• Per- and Polyfluoroalkyl Substances (PFAS) - Environmental Contaminant
• Thallium - Environmental Contaminant

https://www.fda.gov/food/cfsan-constituent-updates/fda-update-post-market-assessment-certain-food-ingredients
FDA Update on Post-market Assessment of Certain Food Ingredients

Constituent Update

July 12, 2023

Today, the U.S. Food and Drug Administration (FDA) released a public inventory of certain food ingredients that the agency has determined to have unsafe uses in food because they are unapproved food additives and lists of select chemicals currently under the agency’s review. The FDA also released a Conversations with experts about the agency’s work to enhance the assessment of ingredients in foods on the market. These resources are intended to provide more insight on the FDA’s post-market assessments.