Lead in pharmaceutical products and dietary supplements
John F Kauffman1, Benjamin J Westenberger, J David Robertson
1U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Sciences, Division of Pharmaceutical Analysis, 1114 Market St., St. Louis, MO 63101, USA. John.Kauffman@fda.hhs.gov
Regulatory Toxicology and Pharmacology : RTP
|May 1, 2007
Summary
This study measured lead in 45 pharmaceutical products. While lead levels were below current limits, they may pose risks, suggesting a need for stricter pharmaceutical lead limits.
Area of Science:
- Environmental Science
- Toxicology
- Pharmaceutical Science
Background:
- Lead exposure is a significant public health concern due to its adverse effects on both children and adults.
- Existing tolerable lead limits in pharmaceutical substances are high and vary widely, potentially allowing for unsafe exposure levels.
Purpose of the Study:
- To quantify lead concentrations in commonly used pharmaceutical products.
- To evaluate the potential health risks associated with lead exposure from these medications.
- To advocate for updated, stricter regulatory limits for lead in pharmaceuticals.
Main Methods:
- Inductively-coupled plasma mass spectrometry was employed to measure lead concentrations.
- Analysis covered 45 different pharmaceutical products.
- Lead exposure was estimated based on average daily dosage.
Main Results:
- Six of the 45 products exceeded 100 parts per billion (ppb) lead, with a maximum concentration of 500 ppb.
- The average daily lead intake from all products was 0.22 micrograms, minimally impacting adult blood lead levels (<1%).
- Five products exceeded the 1 microgram per day lead delivery threshold.
Conclusions:
- Pharmaceutical products examined had lead levels below current regulatory standards.
- Despite being below current limits, lead exposure from pharmaceuticals warrants concern due to established low-level toxicity.
- There is a critical need for uniform, lower lead limits in pharmaceuticals that align with current manufacturing capabilities to minimize consumer exposure.
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