Two Importers Receive Warning Letters for Lack of FSVP

FDA issued Warning Letters to two import companies for not having FSVP programs in place for the products they import.

Green Food Ingredients, LLC of Burr Ridge IL did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity or activities in accordance with 21 CFR 1.506(d).

HK Produce Group Inc. DBA Y2S Trading Inc. of  Long Island City, NY 11101 received an inspection was initiated, in part, based on FDA samples finding Listeria monocytogenes (L. monocytogenes), a human pathogen, in four (4) entries of fresh enoki mushrooms.  Inspectors found the company did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the foods imported.

"This inspection was initiated, in part, based on FDA samples finding Listeria monocytogenes (L. monocytogenes), a human pathogen, in four (4) entries of fresh enoki mushrooms, three (3) of which were from (b)(4) located in (b)(4) and one (1) from (b)(4) located in (b)(4). The samples were collected from entries B7S-2105311-2, 677-0332940-8, 677-0332919-2 and B7S-2106092-7, all imported by your firm. We placed fresh enoki mushrooms from (b)(4) under Import Alert (IA) #99-23 “Detention Without Physical Examination of Produce Due to Contamination With Human Pathogens,” on July 20, 2021 and IA #99-35 “Detention Without Physical Examination of Produce That Appears To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” on November 1, 2021. "

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-food-ingredients-llc-616669-10212021
WARNING LETTER
Green Food Ingredients, LLC

Gogi Berry Snacks Recalled After State Lab Finds Undeclared Sulfites

BCS International Corp. Long Island City, NY, is recalling its 4.5 ounce, 6 ounce and 9 ounce containers and 5 pound packages of “Dr. Snack Goji Berry” food treats because they contained undeclared sulfites.  The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in “Dr Snack Goji Berry” which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics.  Analysis of the “Dr. Snack Goji Berry” revealed they contained 13.6 milligrams per serving.

CFR Title 21 Chapter I Subchapter B Part 130 Subpart A § 130.9 
(a) Any standardized food that contains a sulfiting agent or combination of sulfiting agents that is functional and provided for in the applicable standard or that is present in the finished food at a detectable level is misbranded unless the presence of the sulfiting agent or agents is declared on the label of the food. A detectable amount of sulfiting agent is 10 parts per million or more of the sulfite in the finished food.

FARP 
"Sulfites are also prohibited from certain uses in the U.S. Sulfites may not be used in products such as meats that serve as a good source of vitamin B1 because sulfites can scavenge that vitamin from foods. In 1986, following the identification of numerous cases of sulfite-induced asthma occurring on ingestion of green or fruit salads treated with sulfites, FDA prohibited the use of sulfites on fruits and vegetables intended to be served raw or presented fresh to the public (Fed. Regist. 51:25021-25026, 1986). The only exception is sulfite use on minimally processed potatoes sliced or shredded for frying where sulfite use is still permitted (although FDA has a long-standing, though never finalized, proposal to ban that use also). Sulfite use as a fungicide during the shipment of fresh table grapes is regulated by the U.S. Environmental Protection Agency, but the concentration of SO2 residues on the table grapes as consumed must be <10 ppm total SO2."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bcs-international-corp-issues-alert-undeclared-sulfites-dr-snack-goji-berry
BCS International Corp. Issues Alert on Undeclared Sulfites in “Dr. Snack Goji Berry”
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 21, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared sulfites
Company Name:  BCS International Corp.
Brand Name:  Dr. Snack
Product Description:  Goji berry

Frozen Chopped Spinach Recalled After Testing Finds Listeria

Frozen Food Development is voluntarily recalling specific lots of Lidl branded 12-ounce packages of Frozen Chopped Spinach because the product has the potential to be contaminated with Listeria monocytogenes.  The potential for contamination was noted after routine testing revealed the presence of Listeria monocytogenes in 12-ounce packages of Lidl Frozen Chopped Spinach.  The production of the product has been suspended while FDA and Frozen Food Development continue to investigate the source of the problem.  The recalled Frozen Chopped Spinach was distributed in Lidl retail stores in GA, SC, NC, VA, MD, DE, NY, NJ, and PA.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/frozen-food-development-recalls-lidl-branded-chopped-spinach-because-possible-health-risk
Frozen Food Development Recalls Lidl Branded Chopped Spinach Because of Possible Health Risk
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 19, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Listeria Monocytogenes
Company Name:  Frozen Food Development
Brand Name:  Lidl
Product Description:  Frozen Chopped Spinach

Organic Mac n' Cheeze (Fake Cheese) Recalled After Third Party Testing Finds Milk Allergen

Amy’s Kitchen of Petaluma, California is initiating a voluntary Class I recall of Lot 60J0421 of the Vegan Organic Rice Mac & Cheeze due to the potential of having trace amounts of milk, which is not declared on the product label.  The recall was issued "After receiving a test result from a third-party laboratory indicating one of the meals in the lot contained trace amounts of milk protein,"

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amys-kitchen-voluntarily-issues-allergy-alert-undeclared-milk-single-lot-vegan-organic-rice-mac
Amy’s Kitchen Voluntarily Issues Allergy Alert on Undeclared Milk in a Single Lot of Vegan Organic Rice Mac & Cheeze
Summary
Company Announcement Date:  January 19, 2022
FDA Publish Date:  January 19, 2022
Product Type:  Food & Beverages  Organic Food / Home Grown   
Reason for Announcement:  Undeclared Milk
Company Name:  Amy’s Kitchen
Brand Name:  Amy’s
Product Description:  Amy’s Vegan Organic Rice Mac & Cheese

FDA Issue Report on Salmonella Outbreak Linked to Leafy Greens from Indoor Growing Facility

FDA released their report on a 2021 Salmonella outbreak that was linked to packaged leafy greens produced at a Controlled Environmental Agriculture (CEA) indoor hydroponic operation [a fancy indoor greenhouse].  The outbreak occurred in July and August of 2021 and was caused by Salmonella Typhimurium which infected 31 people and resulted in 4 hospitalizations.

One would think that product produced in a controlled setting would be free from pathogens.  However, there were many opportunities for contamination and a lack of control.  And an indoor greenhouse is not much different than a processing facility where controls are needed.  While a definitive source was not found, here is a brief summary of some of the issues"

• The operation stored its nutrient-rich growth media used in an outdoor location that was not adequately protected from potential sources of contamination such as animal intrusion, bird droppings, or water runoff.
• The use of production pond water, while not intended to be an issue with leafy greens final product, but control of the water was questioned and there were inadequate controls for the water itself, with FDA isolating a different strain of Salmonella (not the one involved in the outbreak.
• Harvesting equipment lacked adequate control, and condensate with the facility.
• Inadequate validation support for cooling greens after packaging.
• Issues with storm water retention pond in close proximity to the facility (25ft).  This pond did test positive for the outbreak strain.
• The firm did not adequately document that cleaning and sanitizing of equipment, tools, and buildings used in growing operations is routinely conducted in accordance with the firm’s procedures

FDA highlighted the recommendations that focused on the need to better understand the microbial risks and put in place better controls.
The full report can be found here - https://www.fda.gov/media/155402/download

Investigation Report: Factors Potentially Contributing to the  Contamination of Packaged Leafy

Greens Implicated in the Outbreak of Salmonella Typhimurium During the Summer of 2021

https://www.fda.gov/media/155402/download

Peppermint Baking Chips Recalled for Allergens After Packing Error by Co-Packer

Lily’s Sweets, is voluntarily recalling 18,855 cases of 7-ounce Peppermint Flavor Baking Chips due to the presence of soy lecithin.  "The error was discovered after consumers contacted the company and reported finding the white candy pieces mixed with Lily’s Peppermint Flavor Baking Chips. We have determined that the error occurred at a co-manufacturer. The white disc-shaped candy pieces contain soy lecithin, sugar, and other ingredients that are not present in Lily’s Peppermint Flavor chips." 

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lilys-sweets-voluntarily-recalls-lilys-peppermint-flavor-baking-chips-due-undeclared-presence-soy
Lily’s Sweets Voluntarily Recalls Lily’s Peppermint Flavor Baking Chips Due to Undeclared Presence of Soy Lecithin
Summary
Company Announcement Date:  January 14, 2022
FDA Publish Date:  January 14, 2022
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared soy lecithin
Company Name:  Lily’s Sweets
Brand Name:  Lily’s
Product Description:  Peppermint Flavor Baking Chips

Review Article - Kombucha

In this months Journal of Food Science , a review of Kombucha was published titled, Kombucha: A review of substrates, regulations, composition, and biological properties (Jan 2022). The article is a good review of what we know, and what we don't know, about the increasing popular drink Kombucha.

Kombucha is a beverage traditionally obtained by the fermentation technique of tea with added sugar by a SCOBY (symbiotic culture of bacteria and yeast).

The article discusses the evolution of Kombucha to include additional substrates.  This type of research is good to have for those who push the boundaries of this fermented product.  The article also details many of the benefits, but points out "According to literature data, there are many benefits attributed to kombucha, however, it is important to emphasize that the studies are carried out predominantly in animals, or in vitro in cell cultures of animals or humans, with no evidence yet to support these benefits to human health (Kapp & Sumner,2019). Still, despite not being able to receive any official claims about its health effects, kombucha can be considered a high-value food product in a healthy diet (Jayabalan et al.,2014)."

There is still a lot of research needed to better understand the science - organisms involved in the ferementation, the benefits to human health, and potential toxic affects.

IFT Journal of Food Science
https://ift.onlinelibrary.wiley.com/doi/epdf/10.1111/1750-3841.16029
Kombucha: A review of substrates, regulations,composition, and biological propertiesJeniffer Ferreira de Miranda1Larissa Fernandes Ruiz1Cíntia Borges Silva1Thais Matsue Uekane1Kelly Alencar Silva1Alice Gonçalves Martins Gonzalez1Fabrício Freitas Fernandes2Adriene Ribeiro Lima

Abstract:

NC Company Expands Recall of Cream Puffs Due to Metal Fragments

A NC food company is expanding their late December recall  of chocolate covered cream puffs for potential metal fragments.  "Poppies International, Inc. of Battleboro, NC is expanding their voluntary recall to include the Taste of Inspirations Crème Puffs 30ct container, UPC 7 25439 99597 9, Lot # L2I5021 Best Before Date 06/08/23 that were made during December 7-10, 2021, due to the possible presence of small metal fragments. The issue was discovered during production. To date no injuries or incidents have been reported in connection with the recalled items."


FDA Recall Notice
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/poppies-international-expands-voluntary-recall-chocolate-enrobed-and-cream-puff-products-due
Poppies International Expands Voluntary Recall of Chocolate Enrobed and Cream Puff Products Due to Presence of Metal
Summary
Company Announcement Date:  January 10, 2022
FDA Publish Date:  January 11, 2022
Product Type:  Food & Beverages
Reason for Announcement:  Possible presence of small metal fragments.
Company Name:  Poppies International, Inc.
Brand Name:  Taste of Inspirations
Product Description:  Cream Puffs

FDA Revokes Standard of Identity for French Dressing

FDA is revoking the Standard of Identity for French Dressing. The Standard, initially established in 1950 and modified over time. "The French dressing standard allowed for certain flexibility in manufacturers’ choice of oil, acidifying ingredients, and seasoning ingredients. Tomatoes or tomato-derived ingredients were among the seasoning ingredients permitted, but not required. Amendments to the standard since 1950 have permitted the use of additional ingredients, such as any safe and suitable color additives that impart the color traditionally expected (39 FR 39543 at 39554-39555"

"Most, if not all, products currently sold under the name “French dressing” contain tomatoes or tomato-derived ingredients and have a characteristic red or reddish-orange color. They also tend to have a sweet taste. Consumers appear to expect these characteristics when purchasing products represented as French dressing. Thus, it appears that, since the establishment of the standard of identity, French dressing has become a narrower category of products than prescribed by the standard. These products maintain the above characteristics without a standard of identity specifically requiring them." Plus there are variations in fat (oil).

So basically, the Standard of Identity is not needed.   "Therefore, after considering the petition and related information, through the proposed rule, we tentatively concluded that the standard of identity for French dressing no longer promotes honesty and fair dealing in the interest of consumers consistent with section 401 of the FD&C Act and proposed to revoke the standard of identity for French dressing. The preamble to the proposed rule also noted that the proposed revocation is consistent with section 6 of Executive Order 13563, “Improving Regulation and Regulatory Review” (January 18, 2011), which requires agencies to periodically conduct retrospective analyses of existing regulations to identify those “that might be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them” accordingly."