September 13, 2021
What does this finding mean for manufacturers and consumers?
On May 4, 2021, a test laboratory filed a citizen's petition with the U.S. Food & Drug Administration (FDA) reporting the detection of benzene — a substance classified as carcinogenic by multiple health agencies — at concentrations up to 6.26 parts per million in specific batches of aerosolized sunscreen products produced by multiple manufacturers. This petition was the second report in recent months related to ppm levels of benzene in skin care products. In response, two manufacturers of products identified in the May 4th petition, Johnson & Johnson Consumer Inc. and CVS Health Corp., have issued voluntary recalls of the identified sunscreen products.
Benzene is a petroleum-derived liquid that has been well-studied and used industrially for decades and is present in the environment from both natural and human sources. Although the source of the benzene contamination detected in the tested aerosolized sunscreen and hand sanitizer products has not yet been identified, levels of contaminants can be introduced to products such as hand sanitizer and sunscreen at one or more stages of a product's lifecycle, including through
- Use of contaminated raw materials or formation of byproducts in manufacturing.
- Introduction of contaminants during processing or storage, such as in a storage tank that was not properly cleaned between uses.
- Leaching of contaminants from packaging materials or other materials in direct contact with the product during manufacturing, shipping, or storage.
- Formation of contaminants through degradation of product components, during shipping, storage, or as a result of unusual or unexpected exposure to environmental conditions.
Importantly, the presence of a contaminant in a product does not necessarily indicate an unacceptable health risk with use of the product. Established regulatory thresholds (e.g., conditionally restricted FDA limit of 2 ppm benzene as a residual solvent in drug products) can provide guidance on acceptable levels of common contaminants such as benzene in certain products. However, a variety of product use factors determine the toxicological risks, including exposure route, amount and frequency of use, and duration of use.
How Exponent Can Help
Detected concentrations of contaminants in consumer products (e.g., skin care products and pharmaceuticals), environmental samples (e.g., drinking water and soil), and biological samples (e.g., blood), can vary from percentage levels to increasingly trace amounts. With the capabilities of analytical chemistry techniques being able to detect contaminants at the parts-per-million and parts-per-trillion level, the key question becomes: what level is relevant? When contaminants are detected in a product, manufacturers must decide whether and how to respond, often with limited information and in the context of an evolving regulatory framework. Our chemists, engineers, and toxicologists have experience assisting clients with the following questions across a broad array of contaminants:
- How much is present, and where did it come from?
- What are the potential health risks with exposure to the contaminant at a given level?
- How do you minimize contamination and mitigate that risk?
We can help to identify and mitigate risks by identifying sources of contaminants and implementing quality measures designed to minimize the contaminant levels below relevant regulatory and toxicity thresholds.