Three Years of FDA Testing and the Products Keep Coming: What the Tejocote Case Teaches Supplement Brands

In our coverage of the FDA's spiking crackdown this spring, we made the case that honest supplement brands get caught by failures in their supply chain rather than by their own conduct. There is no cleaner illustration of that than the FDA's ongoing yellow oleander alert.

On September 17, 2026, the FDA added three more products to it. A state laboratory partner tested one product through the agency's Laboratory Flexible Funding Model and the FDA tested two others. All three were found to contain toxic yellow oleander.

That alert has now been running for three years.

What the FDA Found

The FDA has determined that certain products labeled as tejocote (Crataegus mexicana) root or Brazil seed are adulterated because they contain yellow oleander instead of the labeled ingredient. Yellow oleander is a poisonous plant native to Mexico and Central America.

The agency warns that consuming it can cause neurologic, gastrointestinal, and cardiovascular adverse health effects that may be severe, or even fatal.

Yellow oleander is the longest-running botanical substitution case on the FDA's books right now, and the agency is still finding new products three years in.

The Timeline Tells the Story

The case began with a September 2023 CDC report identifying tejocote root products substituted with yellow oleander. The FDA opened an investigation to sample and test additional tejocote root products, and it has been adding products to the alert ever since: March 2024, April 2024, September 2024, December 2024, November 2025, March 2026, and September 2026.

The agency's concern extends past the products it has already named. The FDA has stated it is concerned that other products marketed as tejocote root, including under names such as Crataegus mexicana, Raiz de Tejocote, and Mexican Hawthorn, may contain yellow oleander.

If you formulate with that ingredient or anything sold under those names, the FDA has told you in advance where it is looking.

The Part of the Alert Most Brands Skip

Read the recall status column in the FDA's product table. It is the most instructive part of the document, and it describes four very different outcomes:

Firm Response in the FDA Table	What It Signals	Practical Consequence
Initiated a voluntary recall	Reachable firm, functioning recall process	Product removed, cooperation documented
Declined to recall, removed listings	Firm present but resisting	Listings pulled by the platform, product may persist elsewhere
Has not committed to a recall	Firm contacted, no corrective action	Product stays in the FDA's public alert indefinitely
FDA unable to contact firm	No reachable responsible party	Nothing the agency can compel; the listing does the work

Nearly every product named in the alert was sold through a marketplace: Amazon, eBay, Etsy, or a direct-to-consumer website. The FDA has said it is actively working with the third-party platforms where these products are sold.

An unreachable seller, an offshore supply chain, a marketplace listing, and a botanical that looks like another botanical once it is dried and powdered. That is the modern supplement risk profile, and it is the exact scenario that pulls honest brands into an FDA action they did not create.

Why Identity Testing Is the Whole Ballgame

Under 21 CFR Part 111, dietary supplement manufacturers must establish the identity of incoming dietary ingredients. That requirement exists precisely for cases like this one.

A supplier certificate of analysis stating "tejocote root" is not identity testing. It is a supplier's assertion. Dried and milled botanical material is difficult to distinguish visually, and an adulterator who is willing to substitute a toxic species is also willing to issue a COA that says whatever the buyer wants it to say.

Species-level confirmation is what actually catches substitution: DNA barcoding, HPTLC, or a validated chemical marker method appropriate to the botanical. Brands that manufacture through contract facilities should confirm which method their co-manufacturer uses, on which lots, and whether they receive the raw data or only a pass/fail summary.

What Supplement Brands Should Do Now

These requirements apply uniformly wherever you manufacture, distribute, or sell. There is no geographic exception and no grace period based on company size.

•    Treat botanical identity as a laboratory question, not a paperwork question. Verify that identity testing is being performed on every incoming lot, at the species level, by a method capable of detecting substitution.

•    Build a look-alike watch list. Any botanical with a regional common name, a cheaper or more potent lookalike, and a supply chain running through a single region deserves elevated testing frequency. Tejocote is one example, not the only one.

•    Qualify suppliers you can actually reach. The note about the FDA being unable to contact a firm appears repeatedly in this alert. Document a verified physical address, a named contact, and a responsive communication channel for every raw material supplier and contract manufacturer. If you cannot reach a supplier during a recall, neither can the agency.

•    Put testing and indemnification into your contracts. Supplier and co-packer agreements should include cGMP compliance representations, audit rights, the right to require third-party testing, and indemnification provisions. Brands without those terms have limited recourse when a supplier fails.

•    Rehearse your recall process before you need it. The firms that came through this alert best are the ones that acted quickly and publicly. The ones that stalled are still listed on an FDA public advisory years later.

Surveillance Capacity Is Growing, Not Shrinking

One detail in the September update deserves attention. One of the three newly added products was identified by a state laboratory partner working through the FDA's Laboratory Flexible Funding Model, not by the FDA itself.

That is the agency extending its testing reach through state labs. For supplement brands, the practical reading is straightforward: more products are going to be tested, by more laboratories, more often. Plan for more alerts, not fewer.

How Bustos Law Group Protects Supplement Brands

Bustos Law Group provides comprehensive FDA legal services for dietary supplement brands nationwide, including supplier qualification reviews, contract drafting and negotiation, label and ingredient reviews, Warning Letter response strategy, and recall management.

With a 95% Warning Letter resolution rate and a dedicated team of food and supplement experts, the firm helps honest brands build the legal infrastructure that protects them from supply chain failures they did not cause.

Botanical substitution is not slowing down, and the FDA's testing capacity is expanding. Schedule a consultation with Bustos Law Group to review your supplier qualification and identity testing program before a substitution becomes your recall.

Sources: U.S. Food and Drug Administration (FDA.gov) | Centers for Disease Control and Prevention (CDC.gov)

This blog is for informational purposes only and does not constitute legal advice. For guidance specific to your business, contact Bustos Law Group.