Nicotine Salts: What They Are and Why They Matter

When developing a nicotine product, the choice between freebase nicotine and nicotine salts plays a critical role in the overall experience, stability, and regulatory compliance of your product. While both forms deliver nicotine, they behave very differently, chemically, biologically, and commercially.

What Are Nicotine Salts?

Nicotine salts are a form of nicotine that more closely resemble the natural state of nicotine found in tobacco leaves. They are created by combining freebase nicotine with an acid, such as benzoic, lactic, or citric acid, resulting in a more stable molecule. This stabilisation alters the pH of the formulation, which can reduce harshness and improve sensory appeal.

Why Are They Used?

Freebase nicotine, while commonly used in traditional e-liquids and pouches, has a higher pH level, making it more alkaline. This alkalinity can cause a harsher throat hit, particularly at higher nicotine concentrations. Nicotine salts, by contrast, allow for:

• Higher nicotine strengths with a smoother user experience
• Faster absorption for a cigarette-like “hit”
• Improved consumer satisfaction in oral and inhaled formats

This makes nicotine salts especially beneficial for:

• New users seeking a less harsh experience
• Product developers aiming for a premium user profile
• Brands targeting adult smokers seeking harm reduction alternatives

Different Acids, Different Effects

The type of acid used affects not just pH, but also nicotine bioavailability, taste, and even shelf stability. For example:

• Benzoic acid: Common in pod-style e-liquids, helps smooth inhalation and improves absorption.
• Lactic acid: Often used in pouches and other oral formats for a more neutral profile.
• Citric or malic acids: Used to modify taste and impact the overall user sensory experience.

Each acid can influence how the nicotine salt behaves under storage conditions, how it is released in the body, and how it performs in analytical testing.

Why It Matters for Testing and Compliance

Nicotine salts change the physicochemical behaviour of your product, which has direct implications for regulatory testing and submission strategy:

• Stability testing: The salt form may degrade differently under ICH conditions compared to freebase.
• Impurity profiling: Salt-acid reactions can introduce new peaks requiring method refinement.
• Bioavailability and pharmacokinetics: May vary depending on acid selection, impacting regulatory claims.
• Classification implications: In some jurisdictions, formulation may influence whether the product is regulated as a medicinal or consumer item.

For these reasons, nicotine salt-based products often require bespoke method development, robust characterisation, and a clear rationale in regulatory submissions (e.g., PMTA, MAA).

How Broughton Can Help

At Broughton, we bring together formulation chemists, regulatory strategists, and analytical scientists to provide an end-to-end solution:

• Evaluate formulation options and recommend optimal acid/nicotine pairings
• Develop and validate analytical methods that accommodate nicotine salt characteristics
• Perform impurity profiling and stability studies aligned with ICH, FDA, and MHRA expectations
• Support regulatory justification for salt selection within PMTA, MAA, or EU submissions

Summary

Nicotine salts are not just a formulation trend, they are a critical factor in how your product performs, how it is perceived, and how it is regulated. Choosing the right salt form, and validating it through scientifically robust data, can accelerate your path to market while building consumer trust.

Want to optimise your formulation and streamline your regulatory journey?  Explore our Nicotine Testing Services.