The Study
A hard look at FDA's review of GRAS notices.
This study just counted how many times the FDA said 'okay,' 'not enough info,' or 'we stopped looking' at food safety notices. It doesn't prove anything is safe or unsafe — it just tells us what the FDA wrote down.
Analysis score
Maximum 5 for a narrative review.
Where the score came from
Companies can tell the FDA their new food ingredients are safe without waiting for approval. The FDA checks their paperwork and says either 'okay', 'not enough info', or 'you withdrew it'.
Where does this study sit?
Reviews of RCTs (Meta-analyses)
Max 100Randomized Trials
Max 90Reviews of Cohort Studies
Max 85Cohort Studies
Max 72Reviews of Case-Control Studies
Max 63Case-Control Studies
Max 58Cross-Sectional & Case Series
Max 50Expert Opinion
Max 51 / 100
Quality score
Based on clinical experience or non-systematic literature reviews. The lowest level of evidence as they are most susceptible to bias and personal perspective.
Key takeaways
Summary
Based on the study abstract and findings.
- 1Even though many notices were rejected or withdrawn, almost all approved ones had no safety issues reported, and no public health problems have been linked to the system since 1997.
- 2Out of 528 cases: 393 got 'okay', 17 got 'not enough info', 84 were pulled by companies.
- 322 of the pulled ones came back and got 'okay'.
- 4Only 4 had safety worries, and 3 of those got 'okay' later.
Score breakdown, methodology, conflicts of interest, evidence analysis & raw study data
Publication
Journal
Regulatory toxicology and pharmacology : RTP
Year
2016
Authors
A. Roberts, L. Haighton
Not medical advice. For informational purposes only. Always consult a qualified healthcare professional before making health decisions.