FDA Issues Warning About Certain Supplements Substituted with Toxic Yellow Oleander (January 2024)

What is the problem?

  • FDA analysis has determined that certain dietary supplements labeled as tejocote (Crataegus mexicana) root or Brazil seed are adulterated because they were tested and found to be substituted with yellow oleander (Thevetia peruviana), 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 that were labeled as tejocote or Brazil seed are actually toxic yellow oleander.

Tested Products

As of 1/26/2024, the FDA tested as many as 18 samples, representing the products listed below, and found them to contain yellow oleander:

SELLING
FIRM
BRAND WEBSITE
PURCHASED FROM
PRODUCT RECALL
STATUS
World Green Nutrition Inc. / Alipotec Green ELV Nutrition brand Elv Control Herbal Supplement (capsules) Amazon.com

Independent Distributor (Alipotec)

Green ELV Nutrition Herb Control - Herbal Supplement Capsules
Recall Initiated
Alipotec South TX

World Green Nutrition, Inc.

ALIPOTEC ELV Mexican Tejocote Root alipotecus.com
ELV Alipotec brand Raiz de Tejocote
Recall Initiated
Amazon.com nwl NUTRA Mexican Tejocote Root Amazon.com
nwl NUTRA Mexican Tejocote Root
Recall Initiated by seller
Global Mix Inc.  EVA NUTRITION Mexican Tejocote Root Eva-nutrition.com
EVA NUTRITION Mexican Tejocote Root
Recall Initiated
Sunset Sales +  ELV King All Natural Tejocote Root

ELV King Tejocote Root Raiz de Tejocote

Amazon.com
ELV King All Natural Tejocote Root
ELV King Tejocote Root Raiz de Tejocote
Declined to recall, removed listings
ALIPOTEC RAIZ DE TEJOCOTE ALIPOTEC Tejocote Root Dietary Supplement Pieces alipotectejocote.com
Tejocote Root Dietary Supplement Pieces
FDA unable to contact firm
Natural Supplements, LLC Science of ALPHA Mexican Tejocote Root Tejocotemexican.com
Science of ALPHA Mexican Tejocote Root
Recall Initiated
H and Natural H & Natural Tejo Root Raiz de Tejocote

H & Natural Brazil Seed

Handnatural.com
H & Natural Tejo Root Raiz de Tejocote
H & Natural Brazil Seed
Recall Initiated
Backstage CTC Seller ALIPOTEC Tejocote Root Raiz de Tejocote Amazon.com
Alipotec Tejocote Root Raiz de Tejocote
Recall Initiated by seller
Amazon.com ALIPOTEC Tejocote Root Dietary Supplement Pieces

Nutraholics ELV Tejocote Root Dietary Supplement Pieces

Nutraholics ELV Nutraking Mexican Tejocote Root Supplement Pieces

ALIPOTEC Tejocote Root

Amazon.com
ELVPOTEC brand Tejocote Root
Alipotec brand Tejocote Root
ELV Nutraholics brand Mexican Tejocote Root
Alipotec brand Tejocote Roo
Declined to recall, removed listings
Global Mix, Inc. Niwali Raiz de Tejocote

Science of Alpha Mexican Tejocote Root

Etsy.com
Niwali brand Raiz de Tejocote
Science of Alpha brand Mexican Tejocote Root
Recall Initiated
Innovacion Natural, LLC ALIPOTEC Tejocote Root Dietary Supplement Pieces Innovacionnatural.com
Alipotec brand Tejocote Root
FDA unable to contact firm
Pastor-Villareal, Inc.  Tejocotex Tejocote Root Amazon.com
Tejocotex brand Dierary Supplement
Declined to recall, removed listings

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. As of 1/26/2024, the FDA tested as many as 18 samples, representing the products listed above, and found them to contain yellow oleander.

Based on the FDA’s sampling and testing results thus far, the FDA is also concerned that other products marketed as tejocote root (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.

 

Continue at:  https://www.fda.gov/food/alerts-advisories-safety-information/fda-issues-warning-about-certain-supplements-substituted-toxic-yellow-oleander-january-2024

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See: https://manoxblog.com/2024/05/26/michael-sassano-ceo-at-somai-pharmaceuticals-walks-us-through-how-clarity-and-standards-can-help-the-cbd-industry-to-thrive/

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