How to tackle PMTA as a small business
With the PreMarketing Tobacco Application deadline quickly approaching, as a small ENDS business you may be wondering how to deal with PMTA.
We believe that increasing regulation such as the PMTA is a positive move for a safer e-cigarette industry, but the application process can be costly, and so small business owners may feel that they have no choice other than to close their business. However, there are some options which could make the cost easier to bear as an independent ENDS company.
Here are three ways to reduce the cost of making a PreMarket Tobacco Application and some tips to help you improve your chances of having your application approved by the FDA.
What is PMTA and how will it affect your small business?
The PreMarketing Tobacco Application is required for any new tobacco product seeking to market its products. If a PMTA is successful, the FDA will grant a marketing order which authorises e-cigarette manufacturers and other tobacco companies to market their product as deemed appropriate.
In order for a PMTA submission to be successful, it must demonstrate that the product is in the interest of protecting public health by detailing the risks and benefits of the product, whether it will help smokers to choose an alternative product and the manufacturing, packaging and design process of the product.
The PMTA should include:
- Full reports of all information published which shows the health risks of the tobacco product and whether the product presents less risk than other tobacco products.
- A full statement of the components, ingredients, additives and properties of the product.
- A full description of the methods used in the manufacturing, processing and packing and installation.
- Evidence that the product meets the tobacco product standard, any information regarding deviation from a standard, samples of the product and its proposed labelling.
Utilise information efficiently
ENDS products which were on the market before February 2007 are exempt from PMTA. If your product was released before then, you won’t need to make a pre-marketing application.
If your products were released after February 2007 but have identical ingredients to a product which was released before that date, or are comparable to a product with an existing PMTA order, you may be able to make a case for your products to be “grandfathered in”.
You could also utilise data from one product for another (for example, if they had some of the same ingredients) in order to reduce the number of studies and tests required. This is called bridging, and while scientific rationale must be used to justify doing this, it may be helpful in reducing the amount of data you need to gather and therefore your costs.
Ensure that your products comply with the FDA regulations
The FDA are concerned about the marketing of ENDS and are particularly strict about tobacco products which proclaim to be healthy or may appeal to children, for example using colourful packaging designs or looking similar to food or drink packaging.
While you will still need to submit a PMTA, ensuring that your products already comply with the FDA regulations will reduce the risk of your application being rejected and having to go through the process, and its costs, again.
Make a financial plan
While the PMTA process can be expensive, it can also benefit your company in the long run as you’ll be able to keep selling your products, and will likely have less competition from other small businesses who chose not to proceed with a PMTA.
It’s also true that you won’t know how much it will cost and if you can find a way to afford it until you actually calculate the numbers – you may find that once you know the costs involved, you are able to plan your finances accordingly.
Get help and guidance from PMTA experts
As a dynamic business, we understand the value that independent, responsible e-cigarette manufacturers bring to the industry. We provide a simple, seven step road map to help guide your small business through the process of the PMTA, and provide a turn-key service including testing, conducting scientific studies and creating a product strategy to minimise both the cost of the PMTA and the risk of your application being rejected.
Ultimately, the FDA’s goal is to create a safer environment for American citizens and promote better health, which is a good thing. While the impact on smaller companies may be bigger than on large corporations, the costs can be navigated to allow small e-cigarette businesses to continue trading.
If you need help with your PreMarketing Tobacco Application, we can help. Click here to learn more about how we can help you through the process and the services we can provide to give your submission the best chance of being approved.