As the tobacco industry continues to evolve, regulations have become more stringent, requiring manufacturers to provide comprehensive data on their product’s safety and efficacy. Here are some tips to ensure the success of your modern oral nicotine pouch testing.

Find a Trustworthy Consultant & Lab

If you’re going to have a new product on the market like white pouches, you’re going to need to do a premarket tobacco application (PMTA), and it is a good idea to do preliminary testing before that. Before beginning the PMTA, it is important to have a consultant, or someone in-house who is knowledgeable about developing studies for FDA submission. McKinney Specialty Labs works with a lot of excellent consultants and can help with recommendations.

It is crucial to ensure that the lab used for testing has developed specific methods for the pouch matrix, which is different from other tobacco products. Manufacturers must vet the lab they use and be transparent about the full list of ingredients used in the product. Failing to do so may lead to inaccurate results and PMTA failures. In some cases, manufacturers have had to restart their studies entirely because of ingredients that were not considered carefully enough, or even inconsistencies between batches.

Necessary Studies & Testing

When submitting a PMTA, stability studies are strongly recommended. These studies assess a product’s shelf life and evaluate how it responds to various conditions such as temperature, humidity, and light. By doing so, manufacturers can determine the product’s expiration date, which is critical information for regulators and consumers.

In addition to stability studies, batch testing is essential to ensure product consistency. Typically, three batches of each SKU should be tested to show consistency in production. Failure to do so may result in inconsistent batches, inaccurate results, and the need to restart studies.

A pilot study should be done immediately to test the basic parameters of the pouches, such as nicotine concentration and dissolution. Starting the testing process sooner, rather than later, is important, as stability studies can take time. The journey to market typically starts with pilot studies, followed by stability studies, clinical studies, and PMTA submission. The timeline depends on how long the product’s shelf life is expected to be.

Contact Us

McKinney Specialty Labs offers extensive testing for smokeless tobacco products including snus, snuff, and pouches, as well as many varieties of tobacco-free nicotine pouches, often referred to as white pouches. To learn more about our services, contact us or visit our Nicotine Testing website.

Scott Mayo

Client Program Manager, III