BOTREG and BAER: Source Selection Determines Whether Botanical Substitution Is Visible in the US Regulatory Record
Year: 2026
Type: preprint
Abstract: Botanical substitution, the sale of one plant labeled as another, is a recognized hazard in dietary supplements, yet it is unclear how much of it the public regulatory record reveals. We introduce BOTREG, an open package that retrieves five US regulatory sources with guards against three silent failure modes, and BAER, the Botanical Adulteration Event Record derived from it. A production run screened 247,005 records (2004–2026) from openFDA food and drug enforcement, the CFSAN Adverse Event Reporting System (CAERS), the California Proposition 65 register, and FDA alerts and advisories. 9,803 records (3.97%) mentioned a botanical, yielding 11,636 record–botanical events across 160 taxa; 83.54% resolved to exact species-level GBIF matches. Explicit species substitution appeared only in FDA advisories: one finding, tejocote substituted with yellow oleander, recorded as three events, two of them species-level. The 246,938 enforcement, adverse-event and Proposition 65 records contained none, under two vocabularies, one of them extended with the species from that very case. An audit of the advisory parser found that a title filter had excluded a second advisory stating substitution, so even the advisory count is a floor. Enforcement instruments record hazards; advisories record what a product turned out to be. A botanical adulteration record built from enforcement endpoints alone will therefore report zero substitution, and that zero is an artifact of source selection. CAERS supplied 70.0% of events, and 75.5% of events stated no adulteration type.
Source: ChemRxiv
Authors: Oshoma Erumiseli, Bila Hassan Ali, Dauda Garba
Institutions: Veritas University, University of Abuja
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7221795771