FDA Issues Draft Guidance on Action Levels of Lead in Food For Babies and Young Children

FDA issued Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry. This document presents "the background and rationale for FDA’s action levels for lead in processed food intended for babies and young children:

• 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient root vegetables), mixtures (including grain and meat-based mixtures), yogurts, custards/puddings, and single-ingredient meats;
• 20 ppb for root vegetables (single ingredient); and
• 20 ppb for dry infant cereals

"These action levels reflect levels of lead at which FDA may regard the food as adulterated"

This Draft Guidance comes after a push to establish limits for heavy metals in baby food.

Lead is a challenge with regard to growing and processing food.  From the guidance, 

"Lead is widely present in the environment due to both its natural occurrence and to human activities that have introduced it into the environment. Because lead may be present in environments where food crops used to make food intended for babies and young children are grown, various foods may contain small amounts of lead. Potential sources of lead in food include contaminated soil where crops are grown, contaminated water, atmospheric deposition from industrial activities, and old lead-containing equipment used to process food. As a result of  the first three sources, agricultural crops (e.g., root vegetables) can take up lead from contaminated soil and contaminated soil may be deposited on plant surfaces (e.g., leafy vegetables and cereal grains). Studies suggest that manufacturers may be able to reduce lead levels in food by using practices such as thoroughly peeling root vegetables and thoroughly washing fruits and vegetables, particularly leafy vegetables (Refs. 3, 4, 5, 6). It is possible in some cases for manufacturers who have found elevated lead levels in sources of food intended for babies and young children to choose sources of food or food ingredients with lower lead levels or no detectable lead. Manufacturers could also consider increased testing of ingredients or finished products that are historically known to contain elevated lead levels; this is particularly important for ingredients or finished products intended for babies and young children. Additionally, manufacturers could consider examining their facilities, processes, and equipment to ensure that they are not contributing to lead in their products (Refs. 7, 8)." 

WA Firm Recalls Chocolate-Coated Cashews For Undeclared Peanuts Due to Supplier Issue

SkinnyDipped® of Seattle, WA is voluntarily recalling a limited quantity of SkinnyDipped® Dark Chocolate Cocoa Almond 3.5oz and SkinnyDipped® Dark Chocolate Salted Caramel Cashew 3.5oz due to an undeclared peanut allergen in an ingredient from a raw material supplier.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/skinnydippedr-issues-allergy-alert-undeclared-peanuts-limited-number-skinnydippedr-dark-chocolate
SkinnyDipped® Issues Allergy Alert on Undeclared Peanuts in a Limited Number of SkinnyDipped® Dark Chocolate Nut Products
Summary
Company Announcement Date:  January 20, 2023
FDA Publish Date:  January 23, 2023
Product Type:   Food & Beverages  Snack Food Item
Reason for Announcement:  Undeclared peanut allergen
Company Name:  SkinnyDipped
Brand Name:  SkinnyDipped
Product Description:  Dark Chocolate Cocoa Almond & Dark Chocolate Salted Caramel Cashew

USDA Updated Organic Regulations to Help Reduce Fraud

USDA issued a rule for organic food titled, National Organic Program (NOP); Strengthening Organic Enforcement..This rule is designed "to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products. The amendments protect integrity in the organic supply chain and build consumer and industry trust in the USDA organic label by strengthening organic control systems, improving farm to market traceability, and providing robust enforcement of the USDA organic regulations."

The reason, as stated in the Executive Summary, "The absence of direct enforcement over some entities in the organic supply chain, in combination with price premiums for organic products, has created the opportunity for organic fraud."  When we think of food fraud, olive oil and honey come to mind.  But the organic food supply chain has offered the greatest opportunities because of these shortcomings.

The rule can be found here - https://www.federalregister.gov/documents/2023/01/19/2023-00702/national-organic-program-nop-strengthening-organic-enforcement

From the Executive Summary:

"This rulemaking strengthens enforcement of the USDA organic regulations through several actions mandated by the Agriculture Improvement Act of 2018:

Health Alert Issued After A Supplier Substitution for Gravy Results in Undeclared Wheat Allergen

U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to concerns that the gravy component of ready-to-eat Hy-Vee beef pot roast entrée products may contain wheat, a known allergen, which is not declared on the finished product label. A recall was not requested because the products are no longer available for purchase.

The problem was discovered when the establishment identified that they received a substitute gravy mix from their spice supplier that includes wheat, whereas the normal gravy mix does not. The establishment notified FSIS that the label on the back of the product does not list wheat contained in the substitute gravy mix.

A reminder for the need for the Food Safety Team to review supplier changes / substitutions.

https://www.fsis.usda.gov/recalls-alerts/fsis-issues-public-health-alert-ready-eat-hy-vee-beef-pot-roast-entree-products-due
FSIS Issues Public Health Alert for Ready-To-Eat Hy-Vee Beef Pot Roast Entrée Products due to Misbranding and an Undeclared Allergen

Federal Agencies Investigate Listeria Outbreak Linked to Enoki Mushrooms - Importers Doing Too Little?

FDA and CDC are conducting an investigation into a Listeria outbreak linked to Enoki Mushrooms distributed by Utopia Foods, Inc. of Glendale, New York.  There are 3 cases, with the three people being hospitalized.

The distributor did issue a recall and then expanded that recall.

There has been plenty of concern about the Listeria risk in enoki mushrooms.  The question has to be asked if these importers are doing enough to ensure that their product is safe.

Case Counts
Total Illnesses: 3
Hospitalizations: 3
Deaths: 0
Last illness onset: October 8, 2022
States with Cases: CA (1), MI (1), NV (1)
Product Distribution: Nationwide


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-enoki-mushrooms-november-2022
Outbreak Investigation of Listeria monocytogenes: Enoki Mushrooms (November 2022)

Alfalfa Spouts Recalled After FDA Testing Finds STEC (Shiga toxin producing E.coli)

Fullei Fresh is voluntarily recalling Alfalfa Sprouts due to the detection of Shiga toxin producing E.coli (STEC.)    It was detected upon sampling of finished product by the FDA.  The company stated that "STEC is a bacterial strain that is not part of our routine microbial testing conducted in compliance with the FDA’s Produce Safety Rule Subpart M on every lot we produce."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fullei-fresh-issues-correction-alfalfa-sprout-recall-because-possible-health-risk
Fullei Fresh Issues Correction on Alfalfa Sprout Recall Because of Possible Health Risk
Summary
Company Announcement Date:  January 17, 2023
FDA Publish Date:   January 17, 2023
Product Type:  Food & Beverages
Reason for Announcement:   Contamination with shiga toxin-producing E. coli
Company Name:  Fullei Fresh
Brand Name:  Fullei Fresh
Product Description:  Alfalfa Sprouts

NJ Firm Recalls Peanut Butter Hot Chocolate for Undeclared Peanuts

Updated on 1/23/23 **A previous version of this press release issued on 1/18/2023. This press release was updated to identify the single unit serving size as “single serve coffee pods”.**

Corim Industries Issues Allergy Alert on Undeclared Peanuts in Peanut Butter Hot Chocolate | FDA

A New Jersey firm is recalling its Peanut Butter Hot Chocolate for undeclared peanuts.

According to the release, "The recall was initiated after it was discovered that a replacement flavoring ingredient from a different supplier may have trace levels of peanut that was not declared on bulk label or finished product label to downstream partners. However, testing conducted by Corim indicated that the levels may be below the limit of detection. The firm’s subsequent investigation identified the root cause as a temporary breakdown in the company's supplier documentation process. The process has been corrected and the company has instituted additional safety checks and corrective actions, including discontinuing the use of this particular flavoring ingredient."

So the peanut butter flavor was provided by a non-peanut-containing ingredient.  However. due to a supplier change, this new flavor ingredient may have contained peanut.  My question is, since the label states peanuts, why not use real peanuts?  This may be due to the firm not wanting to introduce peanut allergens into their operation.  I can't imagine someone who is allergic to peanuts actually taking a chance by consuming this product because peanut allergens are not listed.




https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/corim-industries-issues-allergy-alert-undeclared-peanuts-peanut-butter-hot-chocolate
Corim Industries Issues Allergy Alert on Undeclared Peanuts in Peanut Butter Hot Chocolate
Summary
Company Announcement Date:  January 18, 2023
FDA Publish Date:  January 18, 2023
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared Peanut Allergen
Company Name:  Corim Industries
Brand Name:  Cocoa de Aroma, Smart Sips and more
Product Description:  Peanut butter hot chocolate products
Company Announcement

NY Distributor of Enoki Mushrooms Expands Recall

Utopia Foods Inc of Glendale, NY, is expanding the recall of its December 2022 recall of enoki mushrooms (because they have the potential to be contaminated with Listeria monocytogenes to include product with Best by dates “Best before 03/02/2023” or “Best before 03.09.23” which were distributed between January 6th to January 13th, 2023.

The potential contamination was initially found through routine sampling conducted in the State of Missouri  that revealed the presence of Listeria monocytogenes in the 200g packages of “Enoki Mushrooms”.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/utopia-foods-expands-recall-enoki-mushrooms-because-possible-health-risk
Utopia Foods Expands Recall on “Enoki Mushrooms” Because of Possible Health Risk
Summary
Company Announcement Date:  January 13, 2023
FDA Publish Date:  January 13, 2023
Product Type:  Food & Beverages  Produce
Reason for Announcement:  Listeria monocytogenes
Company Name:  Utopia Foods Inc.
Brand Name: Utopia Foods Inc
Product Description:  Enoki Mushrooms

USDA Issues Health Alert for Frozen Cooked Swai Fish

USDA is issuing a public health alert because A & S Produce Inc., a Vernon, Calif. establishment conducting business as Greenland Food Company, produced and distributed fully cooked, frozen swai fried fish cutlet products without the benefit of federal inspection. A recall was not requested because the products are no longer available for purchase.  The products involved in this public health alert do not bear the establishment number or a USDA mark of inspection. These items were sold at retail locations in California and through online sales.  FSIS discovered the problem when it was conducting surveillance at an online retailer and found FSIS-regulated products without a USDA mark of inspection.

USDA has regulatory authority for inspection of Siluriformes.  But Siluriformes, as a group, are more than just catfish.  Here is a listing: