ESCP / Food & Water Watch 2021 — FDA Letter: Pb and As in US Retail Balsamic Vinegars
The Empire State Consumer Project (ESCP) and Food & Water Watch submitted this letter to FDA in May 2021 reporting third-party lab testing of 24 commercially available vinegar and vinegar-reduction products purchased in the United States. The letter is a citizen petition pressing FDA to establish limits and warning requirements for Pb and As in vinegar products. This is a B-tier source: the underlying test data are from a commissioned lab (methodology not fully described), the sampling is non-random and advocacy-motivated, and the document is not peer-reviewed. However, the concentration values reported are substantial and broadly consistent with peer-reviewed literature on balsamic vinegars; the filing is public FDA record and has regulatory process significance for the US condiment category.
Key numbers
24 samples total (vinegars, reductions, glazes). 21 of 24 were balsamic or balsamic-type products. All positive-testing samples were imported from Italy, Greece, or Spain.
Arsenic (total As — speciation not reported):
- 11 of 24 samples contaminated with As or Pb; 7 tested positive for both
- As range in positive samples: 70 to 1,040 ppb (µg/kg)
- Mean As across positive balsamic samples: 287.91 ppb
- At 1 tablespoon (15 mL) serving, mean As intake = 4.32 µg; at maximum (1,040 ppb), one tablespoon delivers ~15.6 µg tAs
- FDA MCL for bottled water: 10 ppb. The maximum balsamic As found (1,040 ppb) is 104× higher per volume.
- Note: This is total arsenic; speciation between iAs and organic As not performed. ESCP comparison to water MCL (iAs-specific) is analytically imprecise.
Lead (Pb):
- Pb range in positive samples: 68.6 to 127 ppb
- 10 of 21 balsamic products (47.6%) tested positive for As or Pb
- All Pb-positive samples were balsamics imported from Italy, Greece, or Spain
- California Prop 65 limit for Pb in balsamic vinegar: 34 ppb (corresponding to 0.5 µg/day at 15 mL serving). ESCP found all Pb-positive samples exceeded this threshold (range 68.6–127 ppb, i.e., 2× to 3.7× above Prop 65 threshold).
- Context: two brands previously found clean in 2002 Environmental Law Foundation testing registered the highest As (1,040 ppb) and Pb (106 ppb) in this 2021 testing.
Regulatory context cited:
- California AG database listed 24 Prop 65 warning notices for balsamic vinegar Pb as recently as 2020
- FDA Closer to Zero program announced but does not include vinegar products
- FDA Total Diet Survey does not include vinegar
Methods
Commissioned third-party laboratory testing (specific lab not identified in the letter; results in attached spreadsheet referenced but not reproduced in the letter text). Sample prep and analytical method not described. As and Pb reported as ppb values. No LOD/LOQ stated. No certified reference material validation reported. This is the primary methodological weakness of this source: the testing was conducted for advocacy purposes without full method disclosure.
Implications
Certification: This source provides the most recent (2021) and most alarming US-market data on balsamic vinegar Pb and As. Even accepting methodological caveats, the magnitude of As values (up to 1,040 ppb tAs) in balsamic reductions is far higher than peer-reviewed data for balsamic vinegars from Greece or Turkey (where max As was 26 ppb in Karavoltsos 2020). The difference likely reflects the concentration effect in reductions and glazes versus standard balsamic vinegar. HMT&C should treat balsamic reductions/glazes as a distinct higher-risk subcategory from standard balsamic vinegar for As and Pb.
Courses: Illustrates that US regulatory frameworks contain a significant gap: no FDA As or Pb limits for vinegar, no inclusion in Total Diet Survey. Prop 65 warning applies only in California. The ESCP filing is an example of NGO data driving regulatory attention.
App: This source does not provide sufficient methodological detail to anchor ppb values in the contamination_profile for vinegar; it should be used as corroboration for balsamic-reduction/glaze as a high-risk format rather than as a primary quantitative source.