FDA Warning Letter to Company Selling THC Gummies Highlights Growing Concern

FDA issued a Warning Letter to a Florida company that sells THC Gummies.  FDA focused on those products containing Delta-8 THC, but this and other cannabinoids are not allowed for food use.

"We note that your firm sells food products that contain cannabinoids other than Delta-8 THC. We know of no basis to conclude that any use in food of a cannabinoid, plant derived or otherwise, would be safe and lawful. For some cannabinoids, such as Delta-8 THC, the available data raise serious concerns about potential harm. For other cannabinoids, there is little or no available information concerning the safety of their use in food. No cannabinoid, plant derived or otherwise, is approved for any use in food as a food additive. Moreover, we know of no basis to conclude that any intended use in food of any cannabinoid satisfies the criteria for eligibility for GRAS status.

There was not inspection, as it appears, but this was from information obtained from the company's internet site.

The "U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address stnrcreations.com in March 2025 and determined that you take orders there for various human food products, which you represent as containing Delta-8 tetrahydrocannabinol (THC). FDA has determined that your products, STNR Delta-8 and Delta-9 Gummies in various flavors, STNR Delta-8 and Delta-9 Candy Clusters Nana Berry Gummies, STNR Delta-8 Gummies in various flavors, STNR Delta-8 and Delta-9 Cookies in various flavors, and STNR Delta-8 and Delta-9 Brownies in various flavors, are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce adulterated food into interstate commerce under section 301(a) of the Act, 21 U.S.C. § 331(a)."

FDA states that there is an increasing amount of companies selling such products, and it is a concern.

FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products, including for your Delta-8 and Delta-9 Watermelon Lemonade product specifically; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children

So what is Delta-8 THC and how does it differ from what we normally consider THC from marijuana?  This was a nice summary article in Forbes (https://www.forbes.com/health/cbd/delta-8-vs-delta-9/)

"Delta-8 THC is a naturally-occurring cannabinoid (a type of chemical in marijuana) in the cannabis sativa plant. However, as delta-8 typically occurs in relatively low quantities in the plant, the delta-8 found in retail CBD or cannabis products is often synthetically developed through a process of chemically converting CBD into delta-8.

Delta-8 and delta-9 THC produce similar psychoactive effects, but the effects from delta-8 are less potent. This is a result of the way delta-8 binds to the body’s endocannabinoid system (ECS), which regulates many functions in the central nervous system, including emotional and cognitive processing behavior, mood and more. Delta-8 binds to this system via a double bond structure in a particular carbon, which creates the psychoactive intoxicating effect, but to a lesser degree compared to delta-9.

“Delta-8 is a cannabinoid (cannabis-like molecule) that is very similar to the main active ingredient of regular cannabis, delta-9,” says Peter Grinspoon, M.D., a physician at Massachusetts General Hospital, instructor at Harvard Medical School, cannabis specialist and author of Seeing Through the Smoke: Cannabis: An Expert Doctor Untangles the Truth About Cannabis. “It functions by triggering our cannabinoid receptors in the same way that cannabis does.”

However, it’s worth noting that due to delta-8’s low natural presence in the cannabis sativa plant, artificially produced formulations of delta-8 may expose users to higher levels of the cannabinoid than they’d experience when using non-synthetic CBD. Additionally, commercially sold delta-8 and products containing delta-8 aren’t regulated by the U.S. Food and Drug Administration (FDA), meaning the chemical process by which the cannabinoids are made and the sanitary standard of the factories in which they’re made are also unregulated, potentially exposing users to unwanted risk and harm, according to the FDA."

FDA Warning Letters
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stnr-creations-llc-698700-07162025

STNR Creations, LLC
MARCS-CMS 698700 — July 16, 2025

MN Produce Distributor Recalls Fresh Cut Cantaloupe After Testing Finds Listeria

Wholesale Produce Supply of Minneapolis, Minnesota is recalling fresh cut/processed cantaloupe, because it has the potential to be contaminated with Listeria monocytogenes.  The recall was the result of a routine sampling program by the company which revealed that the finished products potentially contained bacteria. Wholesale Produce Supply has suspended production and distribution of the affected lots as the company continues their investigation as to what caused the problem.  
No illnesses have been reported to date.

This indicates that the environmental sampling program found Listeria and the company has decided to recall product as part of their corrective action.

Fresh Cut Cantaloupe was sold to distributors in Nebraska, North Dakota and Wisconsin, who may have distributed into other states under the “Harvest Cuts” and “Fresh and Finest” brand at traditional grocery locations.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wholesale-produce-supply-minneapolis-minnesota-recalling-fresh-cutprocessed-cantaloupe-because-it
Wholesale Produce Supply of Minneapolis, Minnesota is Recalling Fresh Cut/Processed Cantaloupe, Because it has the Potential to be Contaminated With Listeria Monocytogenes
Summary
Company Announcement Date:  September 29, 2025
FDA Publish Date:  September 29, 2025
Product Type:  Food & Beverages  Fruit/Fruit Product
Reason for Announcement:  Potential to be contaminated with Listeria monocytogenes
Company Name:  Wholesale Produce Supply, LLC.
Brand Name:  Wholesale Produce Supply, LLC.
Product Description:  Fresh Cut Cantaloupe

Listeria Outbreak with 20 cases and 4 Deaths Linked to RTE Pasta

The FDA, USDA and CDC with state and local partners, are investigating illnesses in a multistate outbreak of Listeria monocytogenes infections linked to prepared meals. There have been 20 cases with 19 being hospitalized and 4 deaths.

Case Counts
Total Illnesses: 20
Hospitalizations: 19
Deaths: 4
Last Illness Onset: September 11, 2025
States with Cases: CA, FL, IL, IN, LA, MI, MN, MO, NC, NV, OH, SC, TX, UT, VA
Product Distribution: Nationwide

The pasta supplier, Nate’s Fine Foods of Roseville, CA, does not sell affected products direct to retail. On September 25, 2025, the supplier of the affected pasta, recalled certain lots of pre-cooked pasta including fettucine, linguine, and farfalle (bowtie), after a sample of linguine pasta collected and tested by FreshRealm tested positive for Listeria monocytogenes. FreshRealm recalled linguine and meatball product which was under the Marketside (Walmart) brand. Additional product recalled include Marketside Grilled Chicken Alfredo with Fettuccine 12.3 oz – best-by date of June 26, 2025, or prior; Marketside Grilled Chicken Alfredo with Fettuccine 32.8 oz – best-by date of June 27, 2025, or prior; Home Chef Chicken Fettuccine Alfredo 12.5 oz – best-by date of June 19, 2025, or prior; and TRADER JOE’S CAJUN STYLE BLACKENED CHICKEN BREAST FETTUCINE ALFREDO” with “best if used by” dates 9/20/2025, 9/24/2025, or 9/27/2025.

The contaminated ingredient was found in response to the investigation, "FreshRealm Inc., began testing individual ingredients used to produce their Marketside-brand linguine with beef meatballs & marinara sauce meal, and the company’s ingredient testing of linguine pasta samples were confirmed positive for Listeria monocytogenes by FreshRealm’s contracted lab. On September 27, 2025, FDA was informed by FreshRealm that whole genome sequencing performed by the company’s contracted lab confirmed the linguine sample is positive for the same strain of Listeria that was detected in the company’s chicken alfredo meals, which were recalled on June 17, 2025. It is also the same strain of Listeria that is linked to causing illnesses in this outbreak."

Being a USDA regulated facility, the company is not subject to Preventive Controls, and with that, does not have to have a Supply Chain Preventive Control, which would be a must for the type of product (heat and serve which is ready-to-eat).   As this is the case, the processor would have recognized Listeria as hazard on the incoming RTE pasta (as well as other ingredients) and would have ensure that the supplier had an active Listeria Control Program.  

As for the pasta supplier, they do operate under Preventive Controls and would definitely need to have a Sanitation Preventive Control to ensure that recontamination does not occur after pasta preparation.   Pasta preparation require boiling pasta which would eliminate Listeria, however, it can be recontaminated in the post-process environment.  With a Sanitation Preventive Control, monitoring and verification steps would be present for ensuring the food contact surfaces and the overall post-process environment were free from Listeria.   This was not the case with this facility however.

Unfortunately, the continued push for RTE meals requires more attention by companies producing that product.  If this had been a product to be cooked, the likelihood of illnesses would have been reduced or eliminated.   This however, would not eliminate the needs for Listeria controls because one would still need to be concerned about undercooking.


https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-prepared-pasta-meals-june-2025
Outbreak Investigation of Listeria monocytogenes: Prepared Pasta Meals (June 2025)
Do not eat or serve certain meals containing pre-cooked pasta. FDA’s investigation is ongoing.

Products:

On September 25, 2025, the supplier of the affected pasta, recalled certain lots of pre-cooked pasta including fettucine, linguine, and farfalle (bowtie), after a sample of linguine pasta collected and tested by FreshRealm tested positive for Listeria monocytogenes.

Freeze Dried Products Recalled for Metal Foreign Material After Complaint

Tru Fru, LLC, Salt Lake City, UT, announced that its third-party manufacturer, Georgia Nut Company (GNC) issued a voluntary recall of specific varieties of Tru Fru Freeze Dried products due to the potential presence of metal in the product. The recall was initiated upon receiving a report from a consumer alerting the company to this matter.

There have been no reported cases of injury or illness to date.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/georgia-nut-company-gnc-third-party-manufacturer-tru-fru-llc-issues-voluntary-recall-specific
Georgia Nut Company (GNC), Third-Party Manufacturer for Tru Fru, LLC Issues Voluntary Recall of Specific Varieties of Tru Fru Freeze Dried Products Due to Potential Presence of Metal in Product
Summary
Company Announcement Date:  September 26, 2025
FDA Publish Date:  September 29, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Due to potential presence of metal in the product.
Company Name:  Georgia Nut Company
Brand Name:  Tru Fru
Product Description:  Freeze Dried Fruit snacks

Corn Dogs and Sausage on Stick Products Recalled for Foreign Material - Wood

The Hillshire Brands Company, a Haltom City, Tex. establishment, is recalling approximately 58,000,000 pounds of corn dog and sausage on a stick products that may be contaminated with extraneous material, specifically pieces of wood embedded in the batter.  The problem was discovered after the establishment received multiple consumer complaints, five of which involved injuries. The Hillshire Brands Company conducted an investigation and determined that the wooden sticks entered the production process prior to product battering. 

In this case, wood used for the sticks has made its way into the process to end up as a foreign material.  So perhaps rework?

https://www.fsis.usda.gov/recalls-alerts/hillshire-brands-company-recalls-corn-dog-and-sausage-a-stick-products-due-possible
The Hillshire Brands Company Recalls Corn Dog and Sausage On A Stick Products Due To Possible Extraneous Matter Contamination

FSIS Announcement

WASHINGTON, September 27, 2025 – The Hillshire Brands Company, a Haltom City, Tex. establishment, is recalling approximately 58,000,000 pounds of corn dog and sausage on a stick products that may be contaminated with extraneous material, specifically pieces of wood embedded in the batter, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

Imported Dried Bean Curd Recalled for Undeclared Wheat Allergen

Gansu Zhaofeng Agricultural Development Co., Ltd.in Hui County Industrial Concentration Zone, Longnan City, Gansu Province has voluntarily recalled 500g/bag G&L FOOD Dried Bean Curd for failing to declare the allergen wheat.   The recall was initiated after feedback from an FDA inspection that the product's label did not indicate wheat, a component of soy sauce, as an allergen.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gansu-zhaofeng-agricultural-development-co-ltd-voluntarily-recalling-its-dried-bean-curd-due
Gansu Zhaofeng Agricultural Development Co., Ltd. Is Voluntarily Recalling Its Dried Bean Curd Due to Undeclared Wheat
Summary
Company Announcement 

Date:  September 26, 2025FDA 

Publish Date:  September 27, 2025

Product Type:  Food & Beverages

Reason for Announcement:  Undeclared wheat allergen

Company Name:  Gansu Zhaofeng Agricultural Development Co., Ltd.

Brand Name:  G&L Food

Product Description:  Dried Bean Curd

Another Cinnamon Recall Due to Elevated Lead Contamination

SLR Food Distribution of Hicksville, NY is recalling Wise Wife brand Cinnamon, because it has the potential to be contaminated with elevated levels of lead.  The recall was the result of an analysis conducted by the United States Food and Drug Administration that revealed the product contained elevated levels of lead. The last sales order of the product was distributed on 6/28/25 and the product is no longer being sold by SLR Food Distribution, Inc.

For companies importing cinnamon, lead must be considered on the hazard analysis as part of the FSVP for that item.

Wise Wife brand Ground Cinnamon was distributed to retailers located (NJ, NY, FL, MD, MN, OK, OH) between 02/15/2024 and 06/28/2025.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/slr-food-distribution-inc-recalls-wise-wife-brand-ground-cinnamon-because-possible-health-risk
SLR Food Distribution, Inc. Recalls Wise Wife Brand Ground Cinnamon Because of Possible Health Risk
Summary
Company Announcement Date:  September 26, 2025
FDA Publish Date:  September 26, 2025
Product Type:  Food & Beverages  Spices, Flavors & Salts
Reason for Announcement:  Potential to be contaminated with elevated levels of lead
Company Name:  SLR Food Distribution
Brand Name:  Wise Wife
Product Description:  Cinnamon powder

Aroma Candles - Are Wax Melt (non-burning) Better than Regular Candles? No

I know that there are some big aroma candle users out there, so this is for you.  A recently released study showed that aroma wax melts (perfumed wax heated to the point of melting to release the 'aromas') produce more health impacting chemicals similar to those produce by a diesel engine...not that many are have a diesel engine to improve relaxation while sitting in a soothing bath with rose pedals. (This is too close to my ongoing fear of getting picked off by a speeding forklift in some overly dark warehouse).

"Our findings reveal that terpenes released from scented wax melts react with indoor atmospheric ozone (O3) to initiate new particle formation (NPF) events, resulting in significant indoor atmospheric nanoparticle concentrations (>106 cm–3) comparable to those emitted by combustion-based scented candles, gas stoves, diesel engines, and natural gas engines. We show that scented wax melt-initiated NPF events can result in significant respiratory exposures, with nanoparticle respiratory tract deposited dose rates similar to those determined for combustion-based sources."

So there you go, don't be buying one of those fancy plug-in wax melts. You can get the same terpene high with those cheap burning aroma candles and at least get the flickering flame.

While this work focused on wax melts, I would guess the same would apply for those plug-in scented oil units that have become popular.

As for me, I have gone unscented.  I think about all those chemicals added to provide some artificial smell....like laundry detergent, or worse yet, drier sheets.  Clean is the absence of smell.  As a former boss used to say, don't use agents that mask the smell, because if not properly clean, we want to know.

Environmental Science & Technology LettersVol 12/Issue 2
https://pubs.acs.org/doi/full/10.1021/acs.estlett.4c00986
Flame-Free Candles Are Not Pollution-Free: Scented Wax Melts as a Significant Source of Atmospheric Nanoparticles
Satya S. PatraJinglin JiangJianghui LiuGerhard SteinerNusrat Jung*Brandon E. Boor*

Abstract

PA Firm Recalls Cheese After Listeria Positive Sample

Goot Essa LLC of Howard, PA is recalling one lot totaling 64 pounds, batch 33, of its Goot Essa brand Der Mutterschaf Cheese because it has the potential to be contaminated with Listeria monocytogenes.  

The potential for contamination was noted after routine testing by the company revealed the presence of Listeria monocytogenes in one sample from the batch. Sampling of similar batches revealed no contamination. Goot Essa will work closely with the FDA to conclude the investigation.

It appears that good corrective action limited this to one lot.

Goot Essa brand Der Mutterschaf Cheese was distributed to 7 customers in New Jersey, Virginia, Connecticut, and Montana and it was distributed through retail stores and restaurants.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/goot-essa-recalls-der-mutterschaf-cheese-because-possible-health-risk
Goot Essa Recalls Der Mutterschaf Cheese Because of Possible Health Risk
Summary
Company Announcement Date:  September 19, 2025
FDA Publish Date:  September 25, 2025
Product Type:  Food & Beverages  Cheese/Cheese Product
Reason for Announcement:  Potential contamination with Listeria monocytogenes
Company Name:  Goot Essa LLC
Brand Name:  Goot Essa
Product Description:  Der Mutterschaf Cheese