In support of regulators’ emphasis on a “science-based approach,” for twenty years we have taken the extra step to publish in high-impact, scholarly journals. Our new report explores if/ where/ how/ why journal articles ARE the gold standard.
Reference: Defining a “Science-Based Approach” Based on U.S. Government Agency Applications, Access
A Frequently Cited Regulatory Term
For nearly twenty years, we have framed food fraud prevention work around the idea that agencies refer to a “science-based approach.” It is language used to justify recommendations, to press for stronger vulnerability assessments, and to argue that a countermeasure deserves adoption. This phrase had not been tested directly, so it was worth reviewing whether it carries defined evidentiary weight or functions primarily as regulatory language. That question led to our new Food Fraud Insight Report (FFIR) on Defining a “Science-Based Approach” Based on U.S. Government Agency Applications. The review traced the term across food safety, food fraud, and food defense provisions alike, and found the identical pattern in each: Congress and federal agencies invoke the phrase as a binding requirement, yet no U.S. food statute defines what evidence actually satisfies it. The requirement is stated in statute. A definition of the evidentiary standard required to satisfy it is not provided.
What a Peer-Reviewed Journal Article Actually Requires
The gap is filled by U.S. information-quality law (U.S. Information Quality Act, IQA), and the picture it presents is more demanding than most assume. A peer-reviewed, refereed scholarly journal article is not simply a report someone writes and posts online. It is evaluated by qualified, independent specialists in the field, who assess the methodology, the evidence, and the conclusions before publication is permitted. Multiple reviewers must sign off. Revisions are typically required, sometimes over several rounds. Many submissions are rejected outright. The journal itself carries a track record, measured by impact factor, and the strongest journals are indexed in the Scopus database, which functions as a quality filter of its own. This process can take months, sometimes years, and industry professionals often find it overwhelming in its level of detail. That reaction is understandable, but it misses the point entirely. The scrutiny is not a flaw in the system. It is the entire mechanism by which a claim earns the label “science-based” in the first place.
The Application of Peer-Reviewed Evidence in Federal Practice
Here is the answer to the original question. In its GRAS (Generally Regarded As Safe) scientific memorandum, FDA states that “the usual mechanism to establish that scientific information is generally available is to show that the information is published in a peer-reviewed scientific journal.”[1] The same memorandum shows FDA dismissing two unpublished, industry-funded studies as irrelevant to a federal determination. No agency requires a journal article as the only acceptable evidence. But the pattern is consistent: unreviewed reports, however well produced, do not carry the same weight, and agencies are not obligated to treat them as if they do. For anyone proposing a new method, a new countermeasure, or a change to established practice, that consistency matters most, because federal policy explicitly demands more rigorous review precisely where a concept is new or would change prevailing practice.[2] The overwhelming detail that frustrates a fast reader is exactly what a regulator, an auditor, or a skeptical peer is looking for. The citation is not decoration. It is the price of admission.
A “science-based approach” is a defined evidentiary standard, not merely an assertion offered without support. Peer-reviewed publication remains its clearest expression, and the intensity of that process is exactly what gives it value.
Takeaway Points
- A “science-based approach” is not just a buzzword. It’s a burden of proof, and a peer-reviewed journal article is still the clearest evidence that the burden has been met.
- Our review found that U.S. food-related agencies treat peer-reviewed publications as the usual proof of scientific legitimacy and have dismissed unpublished studies as irrelevant.
- For important research and guidance, such as a new prevention method or a significant change in practice, pursue peer-reviewed publication – it is the strongest support available.
Reference:
Defining a “Science-Based Approach” Based on U.S. Government Agency Applications, (2026); Food Fraud Insight Report (FFIR) series, Author: John W SPINK, Food Fraud Prevention Academy, URL to full report: https://foodfraudpreventionthinktank.com/wp-content/uploads/2026/07/FFIR-Defining-Science-Based-Approach-v5.pdf
End Notes:
[1] FDA/CFSAN Memorandum, “Regulatory status and review of available information pertaining to 1,3-dimethylamylamine (DMAA),” Oct. 3, 2016.
[2] Office of Management and Budget, Final Information Quality Bulletin for Peer Review, M-05-03 (Dec. 16, 2004), §II.
[Note: This project was led and directed by John W. Spink, PhD. Human-directed and human-reviewed AI support was provided by ChatGPT, Claude.ai, NotebookLM (Google), Grammarly, and EndNote.]