Nitrosamines: Understanding Their Causes, Health Risks, and How to Prevent Them

Nitrosamines continue to draw attention across multiple industries—especially pharmaceuticals, food production, and chemicals—due to their potential health risks and complex formation pathways. At Ellutia, we believe that clear understanding combined with robust detection strategies is the best way forward.

In this blog, we take a deeper look at what causes nitrosamines to form, their associated health risks, and how both industries and individuals can take steps to reduce exposure. With advanced detection tools like Ellutia’s ATNA and 800 Series TEA, tackling this issue is more achievable than ever.

Nitrosamines typically form when nitrites react with amines—two common chemical components found in food, pharmaceuticals, and industrial environments. These reactions are especially likely under high heat, acidic conditions, or in the presence of specific catalysts.

1. Nitrosamine formation in food and beverages: 

Nitrosamines can form during the curing, smoking, or cooking of meats—especially when nitrite preservatives come into contact with proteins. Common culprits include:

• Bacon, sausages, and hot dogs

• Smoked fish

• Certain cheeses and dairy products

• Beer and other fermented beverages

High temperatures (such as grilling or frying) can accelerate this reaction, increasing the likelihood of nitrosamine presence.

2. Nitrosamine formation during industrial processes: 

Industrial sources include:

• Tobacco processing

• Rubber and plastic manufacturing

• Cosmetics and personal care products

• API synthesis in pharmaceuticals

Workers in these settings may face occupational exposure, making air monitoring and workplace safety practices essential.

Exposure to nitrosamines has been linked to a range of serious health risks—most notably, their carcinogenic effects. These compounds are classified as potent carcinogens, with studies showing associations with several forms of cancer, including:

• Stomach

• Liver

• Bladder

• Oesophageal cancers

Beyond cancer, nitrosamine exposure has also been associated with:

• Liver and kidney damage

• Respiratory issues

• Developmental disorders in infants

Case Study: Valsartan Contamination and Its Impact

The nitrosamines found in pharmaceutical drugs, such as NDMA and NDEA, exhibit genotoxic and tumorigenic properties, often targeting similar organs across a range of species in laboratory studies. One of the most prominent examples is the contamination of valsartan, a commonly prescribed blood pressure medication.

According to findings from the US FDA, coupled with cancer potency assessments by California Proposition 65 and the US Environmental Protection Agency (EPA), long-term use of nitrosamine-contaminated drugs has been shown to significantly increase cancer risk, raising substantial concerns for patient safety and public health.

To read the full study and risk assessment, read the paper Estimated Cancer Risks Associated with Nitrosamine Contamination in Commonly Used Medications

Governments and industry bodies have responded with tight regulations and evolving best practices.

Regulatory Actions

• EMA and FDA have established strict permissible daily intake limits (as low as 18 ng/day for NDMA).

• ICH M7(R1) classifies nitrosamines as Class 1 impurities, requiring evaluation and control in all human-use pharmaceuticals.

How Ellutia Supports Compliance

Ellutia has developed the Automated Total Nitrite Analyser (ATNA)—a purpose-built solution for nitrite detection down to low parts-per-billion (ppb) levels. This is a critical tool for:

• Monitoring raw material and excipient purity

• Assessing reaction conditions in synthesis

• Reducing nitrosamine formation risk at the source

Our 800 Series Thermal Energy Analyser (TEA) complements this by offering unparalleled sensitivity and selectivity for nitrosamines in trace quantities, helping laboratories stay compliant and confident.

Even outside industrial settings, individuals can reduce personal nitrosamine intake through simple lifestyle choices:

• Choose nitrite-free or minimally processed meats

• Avoid charring or overcooking protein-rich foods

• Minimise use of cosmetics with DEA, TEA, or other nitrosamine-forming ingredients

• Avoid second-hand tobacco smoke and vapor products

While regulatory measures help reduce contamination at scale, informed choices at the consumer level are also valuable.

Innovation is key. At Ellutia, we're continuing to push boundaries with:

• New analytical techniques to quantify nitrosamines and nitrite precursors

• Integration of automated workflows to streamline compliance testing

• Collaboration with regulatory bodies to ensure alignment and foresight

As research evolves, we remain committed to providing high-precision instruments that meet the needs of today—and anticipate the challenges of tomorrow.

Understanding the chemistry and consequences of nitrosamines is essential to public and product safety. Through the use of effective prevention strategies, regulatory compliance, and advanced detection instruments like Ellutia’s ATNA and GC-TEA, industries can meet their safety obligations and deliver peace of mind to consumers.. If you are experiencing difficulties with the monitoring the nitrosamine levels in your products, please feel free to reach out to one of our experts who can help understand your challenge and work with you to find a suitable solution.