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FDA issues warning about certain supplements with toxic yellow oleander

2024-01-24 Food Safety News

Tag: 2024 recalls

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The Food and Drug Administration (FDA) has issued a warning about certain tejocote root supplements substituted with toxic yellow oleander.

FDA analysis has determined that certain dietary supplements labeled as tejocote (Crataegus mexicana) root because they were tested and found to be substituted with yellow oleander (Cascabela thevetia), a poisonous plant native to Mexico and Central America and a toxic substance of concern to public health officials.

Ingestion of yellow oleander can cause neurologic, gastrointestinal and cardiovascular adverse health effects that may be severe, or even fatal. Symptoms may include nausea, vomiting, dizziness, diarrhea, abdominal pain, cardiac changes, dysrhythmia and more.

The FDA’s warning has prompted World Green Nutrition, Inc. to recall Elv Alipotec brand Mexican Tejocote Root Supplement Pieces (Raiz De Tejocote Mexicano Suplemento En Trozos), NET. WT, 0.3 0Z (7g), due to the presence of yellow oleander in the product. The full recall can be found here.

The products subject to the warning are typically sold online through third-party platforms.

Tested Products:

To date, the FDA has tested 9 samples, representing the 9 different products listed below, and found them to contain yellow oleander. Tejocote root dietary supplements that were sampled and determined by the FDA to be substituted with toxic yellow oleander:

SELLING FIRM BRAND WEBSITE PURCHASED FROM PRODUCT
Amazon.com Alipotec Tejocote RootNutraholics ELV Tejocote RootELV Nutraholics Mexican Tejocote RootELVPOTEC Tejocote Root Amazon.com ELVPOTEC brand Tejocote RootAlipotec brand Tejocote RootELV Nutraholics brand Mexican Tejocote RootAlipotec brand Tejocote Roo
Global Mix, Inc. Science of Alpha Mexican Tejocote RootNiwali Raiz de Tejocote Etsy.com Niwali brand Raiz de TejocoteScience of Alpha brand Mexican Tejocote Root
Innovacion Natural, LLC Alipotec Tejocote Root Innovacionnatural.com Alipotec brand Tejocote Root
Pastor-Villareal, Inc.  Tejocotex Amazon.com Tejocotex brand Dierary Supplement
Alipotec South TXWorld Green Nutrition, Inc. ELV Alipotec Raiz de Tejocote alipotecus.com ELV Alipotec brand Raiz de Tejocote

The FDA is advising consumers to stop using and dispose of these products.

The FDA advises consumers who have taken any of these products of concern to contact their health care provider immediately.  Even if these products have not been used recently, consumers should still inform their health care provider about which product they took, so that an appropriate evaluation may be conducted.

Call 9-1-1 or get emergency medical help right away if you or someone in your care has serious side effects from these products. Contact your healthcare provider if you or someone in your care recently ingested these products and have health concerns. Consumers can also contact the state poison control center.

Background:

In Sept. 2023, the Centers for Disease Control and Prevention (CDC) published a report of several tejocote root products found to be substituted with toxic yellow oleander. based on this report, the FDA initiated an investigation to sample and test additional tejocote root products. To date, the FDA has tested 9 samples, representing the 9 different products listed above, and found them to contain yellow oleander. Additional sample analysis is pending.

based on the FDA’s sampling and testing results thus far, the FDA is also concerned that other products marketed as tejocote (including with other names such as Crataegus mexicana, Raiz de Tejocote, and Mexican Hawthorn) may contain yellow oleander. Consuming yellow oleander can cause severe adverse health effects and be potentially fatal.

The FDA is actively working with the third-party platforms wher these products are sold.

The FDA’s investigation is ongoing, and the FDA will continue to provide information on any further actions as it becomes available. Products may be added to this advisory. The FDA is working to further address the concerns related to these products and monitoring the market for adverse events, product complaints, and other emerging issues.

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