i- In January of this year, FDA testing revealed the presence of toxic yellow oleander (Thevetia peruviana) in a number of dietary supplements containing Crataegus mexicana, which the supplements refer to as tejocote root, and in one case as “brazil seed.” We note that Crataegus mexicana can also be referred to by other names such as “Mexican hawthorn,” although none of the products that have been identified as contaminated use that name. Many of these products are advertised as weight loss supplements. The FDA testing followed the lead of an earlier Centers for Disease Control (CDC) investigation, which also revealed yellow oleander contamination in tejocote supplements.
- FDA continues to receive adverse event reports. Many of the sellers have not recalled their product, so there are significant concerns that some of these products remain on the market. FDA states that yellow oleander can cause severe, or even fatal, neurologic, gastrointestinal, and cardiovascular adverse health effects.
- While FDA has mandatory recall authority where a product is adulterated or misbranded and there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death, it has not yet instituted any mandatory recalls and has instead worked to remove listings for these products and/or facilitate voluntary recalls.
Adverse Reports Related to Certain Tejocote Root Dietary Supplements Continue
Wednesday, March 13, 2024
