FDA Issued Warning Letter to CA Food Warehouse and Repack Facility for Rats, Cats, Bats and Bugs

FDA issued a Warning Letter to Gold Coast Distributors of Stockton, CA, an ambient and frozen warehouse and re-packing facility.  FDA determined the food products packaged and/or held in your facility are adulterated.  In short, lots of rats, cats, bats, and bugs.  And throw some mislabeled product on top for good measure.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gold-coast-distributors-inc-dba-shah-distributors-635805-11022022
WARNING LETTER
Gold Coast Distributors Inc. dba Shah Distributors

MARCS-CMS 635805 — NOVEMBER 02, 2022

Recipient:
Mr. Sourabh Roy
CEO
Gold Coast Distributors Inc. dba Shah Distributors
2325 W. Charter Way
Stockton, CA 95206-1135
United States

Issuing Office:
Division of Human and Animal Food Operations West V
United States

WARNING LETTER
WL 635805

Dear Mr. Roy:

The United States Food and Drug Administration (FDA) inspected your ambient and frozen warehouse and re-packing facility, located at 2325 W. Charter Way, Stockton, CA 95206, from May 09-27, 2022. During our inspection of your facility, the FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). At the conclusion of the inspection, the FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. In addition, during the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent, insect, or cat filth present all throughout your facility.

Guidance - Retail Establishments Using Farms and Farmers' Markets Considering 'Approved' Requirement

AFDO (Association of Food and Drug Officials) released guidance for retail establishments who wish to buy food from farmers.  In the Food Code, it states that retail establishments should use a vendor that is an "approved" source.

"The definition of “approved” in the 2017 Food Code 1-201.10(B) says it “means acceptable to the regulatory authority based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.” Paragraph 3-201.11(a) states “food shall be obtained from sources that comply with law”."

So if a restaurant wants to buy produce from a small farmer or a farmers' market, it is permissible, but whether one should may not be an easy question to answer.

The AFDO guidance states:

"Produce (RACs) sourced directly from a farm, from a farmer’s market, or grown by the retail establishment, can be considered an “approved” source at retail unless there are factors that call into question such a conclusion, for example, evidence of contamination, microbial contamination through surveillance testing, or foodborne illness outbreaks."

In the end, the onus is responsibility of the retail establishment,

"Buyers for retail establishments should ensure produce sourced directly from farms or farmer’s market vendors are following safe food handling practices. Current resources can be used to help buyers when selecting their local produce. Due diligence on the buyer’s side is important." 

So while the vendor may not have a GAP inspection, you can still permitted to use produce from them.  One thing you can do is ask if they have attended Produce Safety Growers Training.  You can get to know the farmer....ensure they are following practices, complete your own inspection.

Iowa State has an often referenced checklist for retail purchasing that you can use.

Checklist for Retail Purchasing of Local Produce (iastate.edu)

USDA has a more comprehensive document that was put together for school districts
https://theicn.org/resources/179/produce-safety/105766/verifying-on-farm-food-safety-fact-sheet.pdf

https://www.afdo.org/wp-content/uploads/2022/05/Updated-AFDO-Retail-Produce-Guidance-Formatted.pdf
AFDO Guidance for Interpretation of Approved Source as it relates to Retail Food Establishments and the Produce Safety Rule

With the passage of the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), the FDA has adopted 21 CFR 112 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (referred to as the Produce Safety Rule). The Produce Safety Rule is complex and has led to many questions from the state and local regulatory food safety jurisdictions as to how it may impact the interpretation of the “approved” source at the retail level. This guidance document will help clarify the issues surrounding fresh produce, which are Raw Agricultural Commodities (RACs) that are locally grown, sourced, and sold in retail food establishments.

Question:
Regulatory authorities ask if produce (RACs) from any source, including farmer’s markets or direct from the farm, is considered an “approved” source for retail?

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