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.

The New Food Safety Concern for Summer - Cyclospora

Cases of Cyclosporiasis (infection from the parasite Cyclospora) have been increasing in the US, and we have seen an increase coming from domestically grown produce, while imported produce has been historically the primary issue.  Last month, CDC reported a large outbreak of Cyclospora where imported broccoli may have been the source.

Currently, there is an ongoing outbreak in the Houston, TX area.  A source has not yet been identified, although one would expect it to be related to the consumption of fresh produce, especially those items that cannot be vigorously washed....items such as .fresh cilantro, pre-packaged salad mix, raspberries, basil, snow peas, and mesclun lettuce.

In CDC MMWR article released this week, an Florida outbreak of Cyclospora linked to bagged salad is covered with a discussion how cases have been increasing over the past year.

The symptoms They usually begin about 1 week after exposure. If the infection is not treated, symptoms can last for several weeks to a month or more. Symptoms may include the following:

• Frequent bouts of watery diarrhea (the most 
• common symptom)
• Loss of appetite and weight
• Cramping, bloating, and/or increased gas
• Nausea (vomiting is less common)
• Fatigue
• Low-grade fever

https://publichealth.harriscountytx.gov/Portals/27/Documents/News/Cyclosporiasis_SM.pdf
Harris County Public Health
FOR IMMEDIATE RELEASE
July 7, 2023
Cyclospora Cases on the Rise in Harris County
HCPH urges residents to take protective measures to prevent gastrointestinal illness
HOUSTON — Harris County Public Health (HCPH), the Houston Health Department and Fort Bend
County Health & Human Services, have received reports of an increased number of Cyclospora
infections within their jurisdictions and urge people to use caution this summer while cooking and
spending time outdoors.

Imported Soup Base Recalled for Undeclared Milk

Ziyad Brothers Importing of Cicero, IL, is recalling its 35.2 fluid ounce packages of Ziyad Brand Jameed Soup Starter because it does not declare milk.  The recall was initiated after it was discovered during a routine internal company review that the product was distributed in packaging that disclosed the presence of “lactic casein powder” in the ingredient list but it did not further clarify that this ingredient is derived from “milk.”

The product itself is made with a sheep yogurt base, which is not dairy.  However the lactic casein powder was derived from milk.  Product was imported from Jordan.  The importer in this case, needs to conduct a hazard analysis as part of the FSVP - Foreign Supplier Verification Program, and should have determined this ingredient as an allergen as part of that analysis.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ziyad-brothers-importing-issues-allergy-alert-undeclared-milk-jameed-soup-starter
Ziyad Brothers Importing Issues Allergy Alert on Undeclared Milk in Jameed Soup Starter
Summary
Company Announcement Date:  July 07, 2023
FDA Publish Date:  July 07, 2023
Product Type:  Food & Beverages  Soup
Reason for Announcement:  Undeclared milk
Company Name:  Ziyad Brothers Importing
Brand Name:  Ziyad
Product Description:  Jameed Soup Starter

NY Firm Recalls Mispackaged Blintzes Resulting in Undeclared Milk

MilMar Food Group LLC, of Goshen, NY is recalling 1200 units of Spring Valley Potato Blintzes, because it may contain undeclared milk.  A voluntary recall was initiated after it was discovered through a consumer complaint that product containing milk was potentially packed into packaging that did not reveal the presence of milk. Subsequent investigation revealed that the potential problem was caused by a temporary breakdown in the company’s packing processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/milmar-food-group-llc-issues-allergy-alert-undeclared-milk-spring-valley-potato-blintzes?utm_medium=email&utm_source=govdelivery
Milmar Food Group LLC Issues Allergy Alert on Undeclared Milk in Spring Valley Potato Blintzes
Summary
Company Announcement Date:  July 06, 2023
FDA Publish Date:  July 06, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk
Company Name:  MilMar Food Group LLC
Brand Name:  Spring Valley
Product Description:  Potato Blintzes

Imported Sheep Milk Cheese Recalled Due to Potential Listeria Contamination

Estancia Holdings of Cumming, GA is recalling one Lot of Tome Corse Sheep Ottavi due to a potential contamination of Listeria monocytogenes. Estancia Holdings was notified by the French supplier that a wheel they received may be contaminated with Listeria Monocytogenes.

Tomme Corse Ottavi is is a raw sheep's milk with a natural, taupe-colored rind that takes on a light white or orange-colored bloom from natural bacteria which flourish in the aging caves, where the cheese matures from 6 to 8 months. Product is from Ghisonaccia, a coastal region of Eastern Corsica.
Adapted from Source - https://chefshop.com/Tomme-Corse-Ottavi-Cheese-P7154.aspx

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/estancia-holdings-recalls-tome-corse-sheep-ottavi-due-potential-listeria-monocytogenes-contamination
Estancia Holdings Recalls Tome Corse Sheep Ottavi Due to Potential Listeria monocytogenes Contamination
Summary
Company Announcement Date:July 05, 2023

FDA Publish Date:July 05, 2023

Product Type:Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Potential Foodborne illness

Company Name: Estancia Holdings

Brand Name:  Fromager Affineur

Product Description:  Tome De Brebis Sheep Milk Cheese

Gluten Free Waffles Recalled After Mislabeling Issue with Gluten Containing Product

Van’s International Foods (“Van’s” or “the Company”) is voluntarily recalling certain packages of Van’s Gluten Free Original Waffles, because they may contain undeclared wheat.  The recall was initiated after it was discovered that wheat-containing product was distributed in packaging that did not reveal the presence of wheat. Subsequent investigation indicates that the problem was caused by the inclusion of a limited number of cartons for Van’s Gluten Free Original Waffles with a pallet of cartons intended for wheat containing products. Immediate steps were taken to prevent recurrence.

As part of  being in compliance with the Preventive Controls regulations, the company would have an allergen preventive control for labeling.  A difficulty here is that someone improperly stored pre-labeled cartons on the wrong pallet, perhaps these cartons were from a previous production run, and at the end of that production run, the remaining unused cartons were returned back to the label storage area and improperly placed on the pallet of gluten-containing cartons.  It is easy to see how a box or two of cartons on the pallet could have been missed, even if there were some checks in place at the point of labeling.  The allergen preventive control at the point of labeling needs to address this type of situation.  This could include an entire pallet check, a control component for the return of unused labels, and/or an inline bar code reader.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/urgent-food-recall-vans-gluten-free-original-waffles-due-potential-presence-undeclared-wheat
Urgent Food Recall of Van’s Gluten Free Original Waffles Due to Potential Presence of Undeclared Wheat Allergen
Summary
Company Announcement Date:  July 03, 2023
FDA Publish Date:  July 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Wheat
Company Name:  Van’s International Foods
Brand Name:  Van’s
Product Description:  Gluten Free Original Waffles

Breakfast Sandwich Cookies Recalled for Undeclared Peanuts

Mondelēz Global LLC announced today a voluntary recall of two varieties of belVita Breakfast Sandwich products [cookies], manufactured in the United States and sold nationwide, due to the possibility that the products may contain undeclared peanut resulting from cross-contact on a single manufacturing line. The company "became aware of this issue during an internal manufacturing inspection, when [they] found the potential presence of peanut protein residue on the line used to make these products. There have been three unconfirmed reports of possible allergic reaction to date related to these products."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mondelez-global-llc-conducts-voluntary-recall-two-varieties-belvita-breakfast-sandwich-products-sold
Mondelēz Global LLC Conducts Voluntary Recall of Two Varieties of belVita Breakfast Sandwich Products Sold in the United States Due to Undeclared Peanut Allergen
Summary
Company Announcement Date:  July 03, 2023
FDA Publish Date:  July 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared peanuts
Company Name:  Mondelez Global LLC
Brand Name:  belVita
Product Description:  Breakfast sandwich products

Change in Nut Mix Ingredient Leads to Recall of Party Mix Due to Undeclared Walnuts

Fry Daddy’s Brand of Walker, Michigan is voluntarily recalling its Party Mix in all flavors and sizes due to undeclared walnuts.  "This occurred due to a change to the deluxe mixed nuts removing hazelnuts and pistachios and adding walnuts to the party mix. The recall was initiated after it was discovered that the product containing walnuts was distributed in packaging that did not reveal the presence of walnuts. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fry-daddys-brand-issues-allergy-alert-undeclared-walnut-all-party-mix-products
Fry Daddy’s Brand Issues Allergy Alert on Undeclared Walnut in all Party Mix Products
Summary
Company Announcement Date:  June 30, 2023
FDA Publish Date:  July 03, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared walnuts
Company Name:  Fry Daddy’s Brand
Brand Name:  Fry Daddy
Product Description:  Party Mix

FDA Issues Warning Letter to OH Bakery

FDA issued a Warning Letter to an Ohio Bakery for the following issues:

Lack of Allergen Preventive Control for Sesame

• The "facility’s written hazard analysis for the buns did not consider allergen cross-contact at all steps where your sesame seed buns and non-sesame seed buns are made on shared equipment (e.g., “(b)(4),” “Baking,” “Depanning,” “Cooling,” and “(b)(4)”). Your facility manufactures at least 21 bun products that contain allergens (such as wheat, soy, and sesame); products containing different allergen profiles (i.e., with or without sesame seeds) are processed on shared equipment and using shared utensils on the same production day."
• The facility did "not adequately controlling the hazard of allergen cross-contact during our inspection. FDA investigators observed apparent sesame residue on the “(b)(4) conveyor” after sanitation had been completed for the changeover from a sesame seed bun batch to a non-sesame seed bun batch produced on shared equipment. Our investigators observed sesame seeds immediately after the buns were depanned, which you consider to be part of the bun cooler. When this was pointed out by the investigators, the non-sesame seed bun was already traveling along the conveyor with sesame seed residue still present even though an employee was trying to clean it."

Lack of Sanitation Preventive Control in Post-Process Environment

• "Did not appropriately evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control in your RTE bun products, as required by 21 CFR 117.130(a)(1). Your facility’s written hazard analysis considered biological contamination from the environment at certain post-baking steps but did not identify it as requiring a preventive control at processing steps such as “Depanning,” “Cooling,” “(b)(4), and Packaging.” Your RTE buns are exposed to the environment prior to packaging where they could be contaminated with environmental pathogens such as Salmonella and Listeria monocytogenes." 
• The "investigators observed several instances where you did not record sanitation activities at the post-baking steps in your process and did not take corrective actions when sanitation was not performed. Our review of your “Master Sanitation Schedule” records from June 3, 2022, through January 6, 2023, found that you did not record sanitation activities at the frequency for which they should occur. When asked by our investigators about the missing sanitation records, your Senior Engineer stated if there was no record then sanitation did not happen."

Lack of Corrective Action to Environmental Samples

• During the investigators’ review of your environmental monitoring records, it was noted that you have had at least four instances in the not ready-to-eat areas in your facility where you had either a suspected positive or confirmed positive for Listeria with no further action taken.

Pest Control

• At least one live mouse was observed between pallets of (b)(4) bags of (b)(4) brand Pure Granulated Sugar in the warehousing area. Eight incidents of rodent activity were documented in the shipping area, tray washing room, boiler room, and break room by your pest control operator between the period of May 18, 2022, to January 18, 2023, including rodent activity on January 4 and January 18, 2023, in the warehousing area where FDA investigators observed a live rodent during the inspection.
• Apparent rodent excreta pellets (AREPs) were observed on pallets and flooring in the warehousing areas"

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/schwebel-baking-company-653005-06092023

FDA Warning Letter
Schwebel Baking Company

MARCS-CMS 653005 — JUNE 09, 2023