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LEGAL ALERT

EDITOR'S NOTE


FDA has issued an advisory asserting that certain dietary supplement products labeled as containing or consisting of tejocote (Crataegus Mexicana) root, instead contain seeds of the yellow oleander (Cascabela thevetia). Yellow oleander seeds contain cardiac glycosides, which can cause severe adverse health effects if consumed. This advisory follows an associated CDC report and a similar advisory to consumers regarding products labeled as nuez de la India, both published in September 2023.


At present World Green Nutrition has issued a recall of one product for the presence of yellow oleander. 

FDA Issues Warning About Certain Tejocote Root Supplements Substituted with Toxic Yellow Oleander

Audience

  • All consumers



What is the problem?

  • FDA analysis has determined that certain dietary supplements labeled as tejocote (Crataegus mexicana) root are adulterated 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. In other words, the tested products are labeled as tejocote but are actually toxic yellow oleander.
  • 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.
  • These products are typically sold online through third-party platforms.


Tested Products

To date, the FDA has tested 9 samples, representing the 9 different products, 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.


Recommendations for consumers

  • 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.


Summary and Scope of the Problem

In September 2023, the Centers for Disease Control and Prevention 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.


Actions

The FDA is actively working with the third-party platforms where 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.


Read more...

The American Herbal Products Association (AHPA) distributes dietary supplement regulation and enforcement news as Legal Alerts. The information presented in Legal Alerts represents the views and opinions of the original authors of the content and does not necessarily represent the views or opinions of AHPA. Distribution of dietary supplement regulation and enforcement news as a Legal Alert does not constitute AHPA endorsement of the content or legal advice. Please direct any questions about Legal Alerts to communications@ahpa.org.

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