Ethylene Glycol and Diethylene Glycol: Critical Concerns for OTC and Dietary Supplement Manufacturers
Why Ethylene Glycol and Diethylene Glycol Matter
Ethylene glycol (EG) and diethylene glycol (DEG) are toxic industrial chemicals that have no place in consumer health products. Unfortunately, products ranging from cough syrups to dietary supplements have been found to contain these contaminants, often with tragic consequences. Multiple incidents occurred in the past when EG or DEG, sometimes substituted for pharmaceutical-grade glycerin or propylene glycol, entered finished products through adulterated or misrepresented bulk excipients. In 2022, EG/DEG‑contaminated acetaminophen syrup was linked to child deaths from acute kidney injury. Similar incidents in Haiti and multiple countries have resulted in additional fatalities. Between 2022–2023, tainted cough and cold syrups in at least seven countries caused more than 300 deaths.
For brand owners and manufacturers, these incidents highlight the urgent need for proactive testing and supply chain oversight.
FDA Guidance: What You Need to Know
The FDA has issued clear expectations for manufacturers1:
- Mandatory Testing of High‑Risk Excipients: Ingredients such as glycerin, sorbitol solution, maltitol solution, and propylene glycol must be tested for EG and DEG contamination before use.
- Validated Analytical Methods: Companies are expected to employ robust, validated methods such as GC-MS capable of detecting trace levels of EG and DEG.
- Supply Chain Accountability: Documentation and verification of excipient integrity are required, not optional.
For OTC and dietary supplement manufacturers, this means compliance is no longer a competitive advantage, it’s an expectation demanded simultaneously by regulatory agencies seeking product safety and truthful labeling, consumers who increasingly scrutinize quality and transparency, retailers and e‑commerce platforms that require documented compliance to protect their own brands, and industry innovators who view robust quality systems as the minimum foundation for responsible product development.
Why OTC and Supplements Are Especially Vulnerable
Unlike prescription drugs, OTC and dietary supplement products often face unique challenges in safeguarding against contamination. Their diverse formulations, reliance on global supply chains, and consumer-facing positioning make them particularly exposed to risks like EG and DEG adulteration. Understanding these vulnerabilities is critical for brand owners and manufacturers who want to protect both compliance and consumer trust:
- Global sourcing: Many excipients are imported, sometimes from regions with less stringent oversight.
- Complex blends: Supplements often contain multiple excipients, increasing the risk of adulteration.
- Consumer trust: Contamination incidents can devastate brand reputation, particularly in products marketed for children or wellness.
Best Practices for Brand Owners and Manufacturers
Preventing EG and DEG contamination is essential for protecting consumers, preserving brand trust, and strengthening long‑term business resilience. For OTC and dietary supplement companies, the stakes are high: one contamination incident can trigger recalls, regulatory penalties, and lasting damage to consumer trust.
To mitigate risk and demonstrate leadership in safety, manufacturers should adopt a proactive, layered approach that goes beyond minimum requirements:
- Audit and qualify suppliers rigorously, don’t rely solely on certificates of analysis.
- Implement routine EG/DEG testing for all high‑risk excipients, even if suppliers claim compliance.
- Maintain transparent documentation to satisfy FDA inspections and reassure stakeholders.
- Develop rapid response protocols for recalls or contamination events to protect consumers and brand equity.
The Business Case for Vigilance
Routine screening helps manufacturers avoid costly recalls, protect consumers, and strengthen their market position. Companies that build robust safety systems around EG/DEG monitoring may have meaningful financial and reputational benefits, including:
- Reduced Liability Exposure
Early detection prevents contaminated batches from reaching the market, avoiding multimillion‑dollar recall events. Per SEC filings, a single nationwide OTC recall may cost $2–$5M in logistics, destruction, legal fees, and retailer penalties costs that routine EG/DEG testing can prevent.
- Lower Testing Costs Through Centralized Programs
Consolidating EG/DEG testing into a structured program can reduce per‑test costs by 20–40% compared to ad‑hoc or emergency testing. For high‑volume manufacturers, this can translate to significant savings, depending on testing frequency.
- Leadership Position in a Competitive Market
Brands that adopt rigorous EG/DEG controls differentiate themselves in the OTC and supplement space, positioning as reliable partners for retailers and preferred choices for consumers.
Ensuring Confidence Through Advanced Testing
Eurofins Supplement & OTC Testing in Madison, WI has developed a GC‑MS method specifically designed to deliver accurate, reliable detection of EG and DEG in OTC products and dietary supplements. GC‑MS provides the sensitivity and selectivity needed to identify these compounds even in complex formulations, and the use of stable‑isotope internal standards ensures consistent, dependable results by correcting for variability throughout the process. Together, these elements make our method a highly reliable tool for protecting product quality and ensuring consumer safety.
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