FDA issues warning about toxic yellow oleander in tejocote root products

The FDA has been investigating certain supplements since September and has found some tejocote root products to be substituted with toxic yellow oleander, which can cause serious reactions and death.

Most of the products are sold online. As of April 4, the Food and Drug Administration had received reports of “adverse events” from people who ingested products labeled as tejocote root. At least one serious event has been reported in relation to Green ELV Nutrition brand Elv Control Herbal Supplement capsules. The capsules have been added to the FDA’s list of products that have been found to have toxic yellow oleander.

“The agency is reminding consumers to avoid these products (certain tejocote root products) because they contain toxic yellow oleander and can cause neurologic, gastrointestinal and cardiovascular adverse health effects that may be severe, or even fatal,” according to the FDA’s warning.

Some of the products have been recalled, but seven suppliers have refused to recall their products. Therefore, the FDA is concerned that products containing toxic yellow oleander remain on the marketplace. The FDA is evaluating additional regulatory pathways to remove all identified products from the marketplace. The agency has the authority to force recalls but it has not imposed such recalls on the identified firms. 

The complete list of products can be found in the chart below.

Some products may have tejocote listed as Crataegus mexicana root or Brazil seed. 

“Yellow oleander is 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,” according to the FDA’s warning.

Recommendations

• 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.

Who to contact

Health care professionals, patients and consumers are encouraged to report complaints and cases of exposure and adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

To report a complaintor adverse eventsuch asillness or serious allergic reaction, you can

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to FDA.

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)		Recall Initiated
Alipotec South TXWorld Green Nutrition, Inc.	ALIPOTEC ELV Mexican Tejocote Root	alipotecus.com		Recall Initiated
Amazon.com	nwl NUTRA Mexican Tejocote Root	Amazon.com		Seller declined to recall, removed listings
Global Mix Inc.	EVA NUTRITION Mexican Tejocote Root	Eva-nutrition.com		Declined to recall
Sunset Sales +	ELV King All Natural Tejocote RootELV King Tejocote Root Raiz de Tejocote	Amazon.com		Declined to recall, removed listings
ALIPOTEC RAIZ DE TEJOCOTE	ALIPOTEC Tejocote Root Dietary Supplement Pieces	alipotectejocote.com		FDA unable to contact firm
Natural Supplements, LLC	Science of ALPHA Mexican Tejocote Root	Tejocotemexican.com		Declined to recall
H and Natural	H & Natural Tejo Root Raiz de TejocoteH & Natural Brazil Seed	Handnatural.com		Recall Initiated
Backstage CTC Seller	ALIPOTEC Tejocote Root Raiz de Tejocote	Amazon.com		Recall Initiatedby seller
Amazon.com	ALIPOTEC Tejocote Root Dietary Supplement PiecesNutraholics ELV Tejocote Root Dietary Supplement Pieces Nutraholics ELV Nutraking Mexican Tejocote Root Supplement Pieces ALIPOTEC Tejocote Root	Amazon.com		Declined to recall, removed listings
Global Mix, Inc.	Niwali Raiz de TejocoteScience of Alpha Mexican Tejocote Root	Etsy.com		Declined to recall
Innovacion Natural, LLC	ALIPOTEC Tejocote Root Dietary Supplement Pieces	Innovacionnatural.com		FDA unable to contact firm
Pastor-Villareal, Inc.	Tejocotex Tejocote Root	Amazon.com		Declined to recall, removed listings

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