FDA alert: Supplements sold on Amazon may be poison or drugs

An FDA review of dietary supplements purchased online and labeled as tejocote root found that samples contained toxic yellow oleander—a poisonous plant that can be fatal to humans. A separate review of “energy enhancing” supplements purchased through Amazon found that many contain “undeclared and potentially harmful active pharmaceutical ingredients.” Here’s what you should know, and what to do if you’ve taken adulterated supplements. 

Toxic yellow oleander mislabeled as tejocote root supplement

Last week, the US Food and Drug Administration issued a warning to consumers about tejocote root (Crataegus mexicana) supplements, particularly those purchased online through third-party retailers like Amazon and Etsy. An analysis of nine such products revealed that all nine were labeled as tejocote but are actually toxic yellow oleander (Cascabela thevetia), a potentially fatal poison that can cause “neurologic, gastrointestinal, and cardiovascular adverse health effects,” including convulsions and lethargy, diarrhea, hypertension, and in severe cases, coma. 

Tejocote root is often marketed as a weight-loss supplement and has found a surge in popularity in recent years, partly because the brand name Alipotec is often promoted by online influencers through social media platforms. Though just a single listing on Amazon has hundreds of five-star reviews and multiple reviews that attribute significant weight loss and other results to taking tejocote root, it is poorly researched for weight loss and is associated with cardiotoxicity (damage to the heart or cardiovascular system) in several case studies. 

The FDA’s warning to consumers is a serious one, as the practice of substituting lethal yellow oleander in tejocote root products appears to be widespread. In 2022, a 23-month-old child who consumed their mother’s weight-loss supplement was poisoned by yellow oleander that was sold as tejocote root. In its statement, the FDA says it “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.”

Amazon’s role in distributing harmful products

Despite this week’s warning from the FDA, many of the “tejocote root supplements” identified as yellow oleander are still available for sale on Amazon. In an unrelated action, the online retailer also received a warning letter from the FDA in December 2023 for selling “energy boosting” supplements that contain sildenafil or tadalafil, the active ingredients in the drugs Viagra and Cialis. The risks of taking sildenafil include irregular heartbeat, heart attack, stroke, and death. Tadalafil can cause hearing loss, blindness, irregular heartbeat, and sudden cardiac death. 

Because these male virility supplement products don’t list these pharmaceutical ingredients on the packaging, the FDA identified them as “misbranded drugs” and “unapproved new drugs,” and warned Amazon that it was “responsible for introducing or delivering these products for introduction into interstate commerce,” a violation of the Food, Drug, and Cosmetic Act. 

Supplements should be better regulated—especially online

The world of dietary supplements is a poorly regulated one, and even diligent consumers who research ingredients lists and efficacy studies can be harmed by manufacturers who omit information from product packaging. CSPI has long urged agencies and Congress to do more to protect consumers from mislabeled, untested, and illegally marketed supplements. 

In 2018, CSPI president and executive director Dr. Peter Lurie called on Congress and the FDA to do more to protect consumers from supplements contaminated with pharmaceutical drugs:

The agency could pick up its pace issuing warning letters and taking other enforcement actions (its last warning letter for a tainted dietary supplement was in 2009, despite detecting hundreds of tainted products since then). And Congress could require pre-market third-party testing of supplements—particularly of supplements advertised as weight loss, sex enhancement, or body building aids—to assure that they don’t contain unsafe or unlabeled ingredients.

In 2020 alone, CSPI issued statements urging the FDA to be more forceful in regulating unapproved drugs—like tianeptine—as well as multiple supplements that claimed to cure COVID-19; the same year, Laura MacCleery, then-policy director at CSPI, testified before the Senate Committee on Commerce, Science and Transportation on the topic of protecting Americans from COVID-19 scams.

More recently, Balance of Nature, a so-called whole food supplement brand that illegally advertised its products as a cure for everything from diabetes to multiple sclerosis, was ordered by a Utah court to stop production and sales until it complies with FDA regulations. Unfortunately, this level of enforcement is relatively rare, and the sheer volume of untested, misleadingly advertised supplements available to consumers only continues to grow. 

For too long, kids and teenagers have been able to purchase weight-loss and muscle-building supplements over the counter or online. The FDA has repeatedly warned that these supplements are often shown to be ineffective, and worse, many may be laced with dangerous chemicals, such as pharmaceuticals, steroids, and stimulants. In October 2023, New York Governor Kathy Hochul signed into law a CSPI-endorsed bill banning the sale of supplements for weight loss or muscle-building to minors in the state.

What to do if you have taken an adulterated supplement

Samples of these products, purchased from Amazon, Etsy, and online supplement retailers, were identified as yellow oleander in the FDA’s investigation:

• Alipotec Tejocote Root
• Nutraholics ELV Tejocote Root
• ELV Nutraholics Mexican Tejocote Root
• ELVPOTEC Tejocote Root
• Science of Alpha Mexican Tejocote Root 
• Niwali Raiz de Tejocote
• Tejocotex 
• ELV Alipotec Raiz de Tejocote 

If you have purchased any of these supplements, stop taking them immediately. The FDA recommends contacting your healthcare provider at once, and adds that, “Even if these products have not been used recently, consumers should still inform their healthcare provider about which product they took, so that an appropriate evaluation may be conducted.” 

If you are experiencing adverse health effects from consuming a supplement—whether it is on the list above or not—call 9-1-1 or get emergency medical help right away. If you have concerns about supplements you’ve taken, contact your healthcare provider and your state poison control center. 

When and how to dispose of adulterated supplements

Consumers who have purchased tejocote root supplements or other products and suspect or experience adverse health effects can file a MedWatch Online Voluntary Reporting Form, using the Consumer/Patient portal on the linked page. Keep the product and its packaging until instructed to submit it to the FDA for assessment or throw it away. Until then, keep the product stored safely away from children and pets.

After filing a MedWatch report, you may be asked to send your remaining product to the FDA for evaluation. A representative will contact you with information if this is the case.

If you are instructed by your doctor, pharmacist, or poison control center to dispose of the product, follow the instructions provided to you. If you do not receive instructions for safe disposal, follow these steps:

1.    Drop the product off at a drug take-back site. Find an authorized drug collection site near you or call the DEA Diversion Control Division Registration Call Center at 1-800-882-9539 for more information about these collection sites.

2.    If a drug take-back site is not available, check the FDA flush list. Some medications, like opioids, are extremely dangerous when misused or abused. These medications are better flushed than stored where children, pets, or other adults in your home can accidentally ingest them. Search the FDA flush list for your medication and follow the guidelines when disposing of your unused medications and supplements. 

3.    If you have been instructed to dispose of your product, and no take-back site is available, and your medication is not on the FDA flush list, then prepare it for disposal at home as follows:

• Mix the medicines into something unpalatable, like used coffee grounds, dirt, or even kitty litter.
• Place the mixture in a zip-top plastic bag. Consider double bagging.
• Throw the bag away in your trash at home. Do not throw it into the recycling or into public trash bins.
• If the container for your disposed product includes personal info, use a Sharpie to black out your name, address, and other identifying information, or remove and destroy the label separately.