Guideline / position statementindependent cross-checkfull text checked I-CHK-03 standard review
US withdrawal of arsenic drugs for poultry
Arsenic-based Animal Drugs and Poultry (FDA web page, last updated 29 April 2022)
Overview
US Food and Drug Administration. FDA 2022
Arsenic-based poultry drugs were withdrawn in the US between 2013 and 2015.
Does the study support the specific claim? Partly · Methodological quality: not applicable
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Regulatory status of arsenical drugs in US poultry
- How was the study done?
Regulatory information page
- How many people, animals or samples were studied?
Not applicable; US poultry
- What was actually found?
Alpharma voluntarily suspended sale of 3-Nitro (roxarsone); Federal Register 22 Nov 2013 withdrawal of approvals for carbarsone and roxarsone; on 27 Feb 2014 Zoetis withdrew the 3-Nitro application and sponsors withdrew approvals for arsanilic acid and carbarsone; nitarsone (Histostat) approval withdrawal requested by end of 2015, not available from the 2016 season.
- How large was the observed effect?
Not applicable
- What do the results mean in everyday life?
US chicken is no longer raised with these drugs.
- What are the study's limitations?
Page does not cover other countries
- What does it say about Elawady's specific claim?
Confirms the claim is historical.
- Do the results apply to Germany and Europe?
EU: roxarsone not authorised (secondary sources date this to 1999; primary instrument not verified).
- What can explicitly not be concluded from this study?
Says nothing about Egypt.
Scientific in-depth review
1. Full reference
- Authors
- US Food and Drug Administration
- Journal
- FDA
- Year
- 2022
- Identifier
- Verification
- verified – Fetched 2026-10-25: https://www.fda.gov/animal-veterinary/product-safety-information/arsenic-based-animal-drugs-and-poultry
- Retracted
- no
- Corrections
- none
- Extent checked
- full text
- Conflicts of interest and funding
Not applicable
2. Research question
Regulatory status of arsenical drugs in US poultry
3. Study design and population
- Study design
- Guideline / position statement – Regulatory information page
- Population
US poultry
- Country
USA
- Period
2011-2015 actions
- Sample size
Not applicable
- Inclusion and exclusion criteria
Not applicable
4. Methods and endpoints
- Exposure / intervention
Roxarsone, nitarsone, arsanilic acid, carbarsone
- Comparator
Not applicable
- Endpoints
Approval status
- Statistical methods
Not applicable
5. Actual results
- Results
Alpharma voluntarily suspended sale of 3-Nitro (roxarsone); Federal Register 22 Nov 2013 withdrawal of approvals for carbarsone and roxarsone; on 27 Feb 2014 Zoetis withdrew the 3-Nitro application and sponsors withdrew approvals for arsanilic acid and carbarsone; nitarsone (Histostat) approval withdrawal requested by end of 2015, not available from the 2016 season.
- Absolute risks
Not applicable
- Authors' conclusion
Not applicable
6. Strengths
- Primary regulator
7. Weaknesses
- Page does not cover other countries
8. Risk of bias
- Orienting tool
- none applicable
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- not assessable
- Rationale
Regulatory source.
9. Assessment of the statistical interpretation
Not applicable.
10. Relevance to the specific claim
11. Independent contrary findings
Not applicable.
12. Transferability to Germany and Europe
EU: roxarsone not authorised (secondary sources date this to 1999; primary instrument not verified).
13. Overall methodological judgement
Confirms archive "until recently" for US.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | not applicable |
| Risk of bias | not assessable |
| Precision of results | not applicable |
| Directness | direct |
| Reproducibility | unknown |
| Consistency with the overall evidence | unknown |
| Regional transferability | low |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Status in Egypt.
15. Linked fact checks
- Chickens were fed arsenical drugs (roxarsone) that raise carcinogenic inorganic arsenic in chicken meat and in consumers. – Studies contradicting or limiting the claim