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The Link Between Employee Training & FDA Tobacco Compliance

In this video, Jacob will discuss how important employee training is to ensure compliance with the U.S. Food and Drug Administration's (FDA) regulations for tobacco and vape businesses. Click the play button above to hear more from Jacob.

Whether purely a retail business or a tobacco product manufacturer, no business in the tobacco and vape industry today is immune to the benefits, and often the requirement, to thoroughly train all employees.

Certainly, retailers have long understood the need for staff-wide training in not only the law, but in best practices related to age verification, product safety, returns, and other aspects of retail operations. However, there is a growing expectation within FDA that all tobacco and vape businesses, whether retail or manufacture (or some combination), train employees in their lawful operations and compliance obligations.

This includes an increasing array of mandatory training, particularly with the proposed new Tobacco Product Manufacture Practice rule (TPMP for short), which requires training (and complete training records) for all employees engaged in any of the steps involved in the manufacturing and distribution process for both bulk and finished tobacco products.

Our firm has long since advocated thorough employee training as a best practice and a risk reduction strategy for tobacco and vape businesses, however, this “recommendation” is increasingly turning into a rule for most tobacco and vape businesses. TPMP, for example, will require, among other items:

  1. Identification of specific manufacturing process employee roles

  2. Training for all manufacturing processes (including raw materials intake, manufacturing, all the way through to packaging and distribution)

  3. Role-specific employee authorizations following training

  4. Records of all employee training and refresher training sessions

While retailers have plenty of experience training employees in the many laws and regulations at both the state and federal levels which apply to retail operations, the growth of training requirements for all tobacco and vape operation types warrants taking a second look at your company’s own operations and determining whether you have an adequate training program in place, and whether upcoming regulations will require additional (or expanded) training programs.

As always, our advice is to make employee training a component of an overall internal compliance program with related Standard Operating Procedures (SOPs) to take the guesswork out of compliance. Soon, for many business types, this will be a requirement – therefore, the sooner your business gets started the better.

Need help building your FDA training program? Have additional questions? Interested in learning more about our consultation process? Give our office a call today at (917) 546-6997.

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