Tianeptine (aka Drug Store Heroin) and the Supplement Industry

An article in Natural Products Insider discusses tianeptine, aka drug store heroin, and the connection being made to the supplement industry.  Tianeptine, an antidepressent, and according to the Cleveland Clinic, "It enhances a person’s mood by binding to the brain’s opioid receptors — just like heroin, morphine and other narcotics. Experts quickly discovered that it was highly addictive, as patients began doctor-shopping for more and were developing withdrawals after abruptly stopping it.” The U.S. Food and Drug Administration (FDA) has never approved tianeptine to treat depression or any other condition. Tianeptine also never earned a Generally Recognized as Safe (GRAS) designation, a label the FDA puts on some chemicals and food additives.  But some companies found a legal loophole that allowed them to put tianeptine in products labeled as “dietary supplements.” That’s why you can still find it on store shelves today. Tianeptine appears in various so-called supplements, often those sold at convenience stores and gas stations. ""

Further, "The FDA doesn’t strictly regulate dietary supplements or approve them before they’re sold. But they have tracked down and sent warning letters to companies that sell tianeptine products. And some states have banned tianeptine, including: Alabama. Georgia. Indiana. Kentucky. Michigan. Mississippi. Ohio. Tennessee.

So the article discusses the impact on the supplement industry, which is far less regulated than the medical industry and even the food industry.  I don't agree in that this does not further damage the supplement industry, but provides another indicator of how unregulated the industry is.


Natural Products Insider
https://www.naturalproductsinsider.com/supplement-regulations/tianeptine-sales-besmirch-supplement-industry-s-reputation-but-who-is-really-at-fault-?
Tianeptine sales besmirch supplement industry’s reputation, but who is really at fault?
A shadowy network supplies products featuring illegal drugs that are sold in convenience and liquor stores and smoke shops. Is that the fault of the dietary supplement industry?
Hank Schultz
January 12, 2024

NJ CEA Farm Recalls Spinach After State Lab Finds Listeria

BrightFarms has issued a voluntary recall of spinach grown by its supplier Element Farms in their Pompton Plains, New Jersey farm and distributed under the BrightFarms brand because the spinach has the potential to be contaminated with Listeria monocytogenes. Due to potential cross-contamination, BrightFarms is also issuing a voluntary recall of a limited quantity of four salad kit products (shown below) from its Selinsgrove, PA facility.  The recall of spinach was initiated after routine sampling conducted by Element Farms yielded a positive result for Listeria monocytogenes. Due to potential cross-contamination at BrightFarms’s Selinsgrove, Pennsylvania facility, BrightFarms is also recalling a limited quantity of four select salad kit products. No positive test results or reported illness have been received on those products, to date.  As a result of today’s recall, the company has temporarily suspended distribution of Element Farms grown spinach.

This product is grown as under CEA, or Controlled Environmental Agriculture.  From the Element Farms website, the company "is a sustainable farm based in Lafayette, NJ." They  grow the " greens hydroponically  and without pesticides in a controlled-agriculture environment".  The "greens start out in a sterile soil/peat moss and then are moved to large ponds of ultra-filtered water to grow hydroponically".

Interesting is this from the website:
Do I need to wash your greens?

No. Our greens are grown indoors without pesticides, herbicides, and fungicides, and away from the outdoor contaminants that plague field farmers. We personally don’t wash our greens before eating--that’s another benefit to growing them in an ultra-pure environment--but you’re always welcome to. We don’t pre-wash our greens so they stay as fresh as can be in your clamshell.
A note on other brands’ triple-washed greens: triple-washed greens are most often washed in a chlorine solution and should be washed again at home before eating."

The question here is how did Listeria get into the production system.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/brightfarms-recalls-spinach-and-salad-kits-because-possible-health-risk-result-supplier-element
Brightfarms Recalls Spinach and Salad Kits Because of Possible Health Risk as a Result of Supplier Element Farms Recall
Summary
Company Announcement Date:  January 17, 2024
FDA Publish Date:  January 17, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Foodborne Illness-Listeria monocytogenes
Company Name:  BrightFarms
Brand Name:  BrightFarms
Product Description:  Spinach and Salad Kits

Imported Indian Ingredient Recalls for Undeclared Wheat Even Though Stated on Precautionary Label

Kinjin Food Pvt. Ltd. Maharashtra, India is recalling its 50 gm, 100 gm, 200 gm & 500 gm, 1 Kg packages of "Asafoetida” Vandevi Yellow powder because they may contain undeclared traces wheat.  The recall was initiated after it was discovered that the product was being manufactured at a plant which also processed wheat products and therefore, there may be a possibility that the product may contain undeclared traces of wheat and the packaging did not mention the presence of traces of wheat as per the declaration required under labelling requirements of FSMA. Subsequent investigation indicates the problem was caused due to misunderstanding of the precautionary labelling done on the product however not as per the labelling requirement of FSMA.

So basically, the foreign company producing the product thought it was acceptable to have trace amounts in the product (a function of inadequate cleaning / product protection) if they had the precautionary label on the product.  As we know, the Precautionary Label does not allow one to process without adequate allergen controls.

What is Asafoetida?  From bon appetit, "It is essentially a gum resin extracted from ferula, an herb in the celery family. It is usually available as a coarse yellow powder and smells like boiled eggs because of its sulfur compounds—which explains one of its other nicknames, devil’s dung. But don’t be put off by the pungency. When used properly, a pinch of hing supercharges every other spice in the pan, like salt but in a funkier way (and without any sodium)."

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kinjin-food-pvt-ltd-maharashtra-india-issues-allergy-alert-undeclared-wheat-traces-vandevi
Kinjin Food Pvt Ltd, Maharashtra, India Issues Allergy Alert on Undeclared Wheat Traces in "Vandevi Asafoeitida Yellow Powder"
Summary
Company Announcement Date:  January 10, 2024
FDA Publish Date:  January 17, 2024
Product Type:  Food & Beverages
Reason for Announcement:  May contain undeclared wheat traces.
Company Name:  Kinjin Food Pvt. Ltd.
Brand Name:  Vandevi
Product Description:  Asafoetida Yellow Powder in 50 gram, 100 gram, 200 gram, 500 gram, and 1 kilogram packages.

Hawaii Retailer Recalls Mislabeled Nut Brownies With Undeclared Peanuts

Big Island Candies of Hilo, Hawaii is voluntarily recalling 120 boxes of their Makana Brownie Assortment Box (batch 60) purchased from its Ala Moana Store because the product contains undeclared peanuts.  A portion of the box may contain Milk Chocolate Covered Peanut Butter Brownies instead of Milk Chocolate Covered Macadamia Nut Brownies. The label does not depict peanut as a key ingredient.  This recall was initiated as a result of information received by a consumer who had an adverse reaction. To date, no other incidents have been reported. Subsequent investigation indicates the problem was caused at the packing and labeling stage and was limited to batch 60 of this item.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/big-island-candies-issues-allergen-alert-undeclared-peanuts-makana-brownie-assortment
Big Island Candies Issues Allergen Alert on Undeclared Peanuts in “Makana Brownie Assortment”
Summary
Company Announcement Date:  January 16, 2024
FDA Publish Date:  January 17, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Contains undeclared peanuts
Company Name:  Big Island Candies
Brand Name:  Big Island Candies
Product Description:  Brownie Assortment

CA Company Recalls Aged Cotija Mexican Grating Cheese After State Lab Finds Listeria

Rizo Lopez Foods, Inc. of Modesto, CA is recalling 344 cases of Aged Cotija Mexican Grating Cheese (8oz) because it has the potential to be contaminated with Listeria monocytogenes.  The recall was a result of a routine sampling program by the Hawaii State Department of Health’s Food and Drug Branch on Wednesday, January 3rd which revealed that the finished product contained the bacteria.

To date, no confirmed illnesses related to this product have been reported.

Aged Cotija Mexican Grating Cheese (8oz) was distributed nationwide through distributors.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rizo-lopez-foods-inc-recalls-aged-cotija-mexican-grating-cheese-8oz-because-possible-health-risk
Rizo Lopez Foods, Inc. Recalls Aged Cotija Mexican Grating Cheese (8oz) Because of Possible Health Risk
Summary
Company Announcement Date:  January 11, 2024
FDA Publish Date:  January 11, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential Listeria monocytogenes contamination.
Company Name:  Rizo Lopez Foods, Inc.
Brand Name:  Rio Bros California Creamery
Product Description:  Aged Cojita Mexican Grating Cheese

CA Company Recalls Jelly Bars Due to Potential Choking Hazard

U.S. Trading Company of Hayward, CA is recalling Dragonfly jelly bars because it contains konjac powder and may present a choking hazard.  The recall was initiated after New York State Agriculture Department of Agriculture and Markets collected a sample of the jelly containing Konjac. Based upon the products containing the ingredient konjac and the dimensions, FDA has determined that the products present a choking hazard.

Konjac and its consequent texture and consistency could pose a choking hazard to small children as well as adults with functional and/or anatomic abnormalities.  The recalled Jelly bars were distributed to retailers Nationwide.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/us-trading-company-hayward-ca-recalling-dragonfly-jelly-bars-because-it-contains-konjac-powder-and
U.S. Trading Company of Hayward, CA is Recalling Dragonfly Jelly Bars Because it Contains Konjac Powder and May Present a Choking Hazard
Summary
Company Announcement Date:  January 11, 2024
FDA Publish Date:  January 11, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Product contains konjac powder and may present a choking hazard.
Company Name:  U.S. Trading Company
Brand Name:  Dragonfly
Product Description:  Jelly Handbag and Jelly Backpack containing Jelly Bars

Quaker Oats Company Expands Recall to Include Cereals and Snack Bars Due to Potential Salmonella Contamination

The Quaker Oats Company expanded their  December 15, 2023 recall of granola products due to potential Salmonella contamination to include additional cereals, bars and snacks.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/update-quaker-issues-revised-recall-notice-additional-products-due-possible-health-risk
Update: Quaker Issues Revised Recall Notice with Additional Products Due to Possible Health Risk
Summary
Company Announcement Date:  January 11, 2024
FDA Publish Date:  January 11, 2024
Product Type:  Food & Beverages
Reason for Announcement:  Potential for Salmonella contamination
Company Name:  The Quaker Oats Company
Brand Name:  Multiple brand names
Product Description:  Cereal, bars, and snacks

FDA Issues First Annual CORE Report Summarizing FDA Investigations Into Foodborne Outbreaks

The FDA issued the first CORE (Coordinated Outbreak Response & Evaluation Network) annual report summarizing the investigations of foodborne outbreaks and adverse events in FDA-regulated human foods for the 2022 calendar year.

"The FDA’s CORE Network was established in 2011 with the mission to find, stop, and aid in the prevention of foodborne illness outbreaks. This is accomplished through disease surveillance, outbreak response, post-response activities, and collaboration with CDC and state and local public health agencies. Every year, CORE evaluates and responds to numerous foodborne outbreaks related to FDA-regulated products."

"In 2022, CORE evaluated 65 incidents, responded to 28, and issued advisories for 11. These numbers show a slight increase in the number of incidents evaluated in recent years, with 59 incidents evaluated, 19 responses, and 10 advisories issued in 2021. The investigations in 2022 included E. coli, Cronobacter, hepatitis A virus, Listeria monocytogenes, and Salmonella which were linked to a variety of products, including produce, dairy, and fish."

The 2022 annual report highlights a few noteworthy outbreaks from 2022: Listeria monocytogenes linked to enoki mushrooms, Salmonella linked to cantaloupe, and Salmonella linked to peanut butter.

In our reporting, we summarized the FDA findings of these noteworthy outbreaks: 

Salmonella in Cantaloupe (August 2022) - The investigation did not find a definitive source for the Salmonella strain found in the outbreak, although a common  packinghouse was identified.  The report does give some broad recommendations that packing houses, as well as farms, should be following.   Key among these, from my perspective, developing written procedures (SOPs) for the operation based upon reducing risk and then following these procedures with documentation.  It seems that this was the biggest knock against the firm in this investigation.

Salmonella in Peanut Butter (May 2022)  Inspectors found "found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation" and "failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule"  The biggest issue was related to positive tests in the facility and the corrective action that was taken,  FDA finished the report stating the concern that Salmonella may be a resident contaminate within the facility and that broader measures are needed.

FDA published a strategy summary to prevent Listeria from Enoki mushrooms. 

The report provides links to the other FDA actions related to outbreaks.

LINK to report.

https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-core-2022-annual-report-investigations-foodborne-outbreaks-and-adverse-events-fda
FDA Releases the CORE 2022 Annual Report: Investigations of Foodborne Outbreaks and Adverse Events in FDA-Regulated Foods

FDA and CDC Provide Update on Lead-in-Apple Sauce Contamination - Additional Reported Cases and the Finding of Chromium in Product

In a January 5, 2024 update to the lead contamination issue linked to cinnamon apple sauce product produced in Ec . and sold under the WanaBana Brand as well as by retailers Schnucks and Weis in the US, CDC is reporting that there are 321 reported cases. FDA states that as of Jan, 8, 2024, 87 of these cases have been confirmed. These cases range from zero and 53 years of age and the median age is one year old. (CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after November 2022. As of January 5, CDC has received reports of 86 confirmed cases, 209 probable cases, and 26 suspected cases for a total of 321 cases from 38 different states through their reporting structure.)

FDA is also reporting that in their testing of the recalled products and the cinnamon collected from the Austrofoods facility, the agency has found chromium. People who ate recalled products, especially if they had elevated blood lead levels, may have been exposed to chromium.

From the FDA report, "Chromium is a naturally occurring element. It is an essential trace nutrient important to the diet that exists predominantly in two forms, chromium (III) and chromium (VI). Chromium (VI) is more toxic than chromium (III). Due to limitations in available testing methods, FDA was not able to definitively determine the form of chromium in the cinnamon apple puree sample (i.e., whether the chromium present is chromium (III) or chromium (VI)). The lead-to-chromium ratio in the cinnamon apple puree sample is consistent with that of lead chromate (PbCrO4) (which contains chromium (VI)), but this is not a definitive indicator that lead chromate or chromium (VI) (the more toxic form of chromium) was present. Information on the health effects of eating food contaminated with chromium (VI) are limited. The chromium in lead chromate may also be converted to chromium (III) (the less toxic form of chromium) due to the acidity of the applesauce and the stomach."

This was first reported in October of 2023 and FDA/CDC have provided updates over time.

https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-chromium-levels-cinnamon-applesauce-pouches-november-2023
Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches (November 2023)
Current Update
January 9, 2024

As of January 8, 2024, FDA has received 87 confirmed complaints/reports of adverse events potentially linked to recalled product. To date, confirmed complainants, or people for whom a complaint or adverse event was submitted and met FDA’s complainant definition, are between zero and 53 years of age and the median age is one year old.