How does the FDA check if new food ingredients are safe?
A hard look at FDA's review of GRAS notices.
Not medical advice. For informational purposes only. Always consult a healthcare professional. Terms
Surprising Findings
Only four of 528 notices raised safety concerns, and three were later approved with more data.
People assume self-declared ingredients are risky or unchecked—but the data shows the FDA flagged very few safety issues, and most were resolved.
Practical Takeaways
When you see a new ingredient on a food label, remember: it may have been self-declared safe by the company, not approved by the FDA.
Not medical advice. For informational purposes only. Always consult a healthcare professional. Terms
Surprising Findings
Only four of 528 notices raised safety concerns, and three were later approved with more data.
People assume self-declared ingredients are risky or unchecked—but the data shows the FDA flagged very few safety issues, and most were resolved.
Practical Takeaways
When you see a new ingredient on a food label, remember: it may have been self-declared safe by the company, not approved by the FDA.
Publication
Journal
Regulatory toxicology and pharmacology : RTP
Year
2016
Authors
A. Roberts, L. Haighton
Related Content
Claims (6)
Food companies can decide for themselves that a new ingredient is safe to put in food, without asking the FDA for approval or telling the public how they made that decision.
Out of 17 food ingredient safety reviews that couldn't be approved, most were turned down not because they were dangerous, but because the companies didn't provide enough proof that scientists generally agree they're safe.
Out of 528 times companies asked the FDA if their food ingredients were safe, the FDA said it had no concerns in 393 cases, couldn't confirm safety in 17 cases, and 84 companies decided to pull their requests on their own.
The FDA turned down 17 food safety notices because they didn’t have enough info. Only four of those had real safety worries, and three of those got approved later after the companies gave more data.
Since 1997, the FDA’s shortcut for approving food ingredients hasn’t been linked to any known health problems in the public.