In a competitive market, one leading e-nicotine delivery system (ENDS) company faced critical regulatory hurdles regarding the underage use of their innovative vape products. Simultaneously, the company grappled with the escalating issue of counterfeit products, threatening to undermine their market success. Deployment of a Systech solution, not only caused Minors' usage of their products drastically decreased, averting the risk of a US ban, it provided comprehensive global visibility and minimized the commercial impact of counterfeits. The company’s 300 million serialized units are now safely distributed to 500,000 plus retailers.
Addressing Underage Use
Recognizing the urgency of curbing underage usage, the ENDS company initially implemented a non-standard serialization and track-and-trace program to identify retail outlets involved in selling their products to teenagers. However, this system encountered frequent errors and duplications, necessitating a more robust solution. UniTrace®, part of the Systech Brand Protection Suite, was deployed, enabling the company to track vape devices and pods throughout the supply chain. With over 300 million serialized units supported annually and seamless integration with customer complaint data, the company swiftly identified retailers selling to minors and promptly responded to parental concerns.
Countering Counterfeit Products:
Following the company's marketing success, counterfeit versions of their devices and pods flooded the market, creating an immediate need for proactive measures. To combat this threat, the ENDS company employed GS1-compliant serialization across their US contract manufacturers, covering 23 production lines. Additionally, UniSecure®, another component of the Systech suite, enabled authentication, ensuring the integrity of their products and mitigating the adverse effects of counterfeits. Camera installations on the packaging line facilitated real-time authentication and scanning, swiftly identifying fake products and fostering collaboration through shared notes.
By leveraging the Systech platform, the ENDS company successfully identified and addressed the distribution of their devices to underage users. Serialization efforts allowed for end-to-end traceability, tracking products from shipment through distribution centers to specific retail outlets. This achievement not only reduced product usage by minors but also safeguarded the brand from potential bans in well-regulated markets like the U.S. Furthermore, the company's adherence to FDA Premarket Tobacco Product Applications submission guidelines was ensured through robust serialization and traceability validation.
Through the implementation of Systech's UniSecure and UniTrace solutions, the ENDS company effectively addressed regulatory challenges related to underage usage and countered the proliferation of counterfeit products. The comprehensive serialization, track and trace capabilities, and real-time authentication measures enabled the company to protect its brand integrity, comply with FDA guidelines, and maintain a robust market presence.
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
