In a strongly-worded statement, the Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced the agency is taking steps to curtail what it called the “epidemic” of e-cigarette use among teenagers.
Among other actions, the FDA is looking closely at flavored e-cigarettes, saying they “play an important role in driving the youth appeal.” As part of that examination, the agency is “seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.”
It can take time for the dust to settle on such regulatory changes, but these and other increased e-cig regulations could require companies to pull product from the shelves nationwide. With intense regulatory and media scrutiny at play, that means the retrieval process must be swift and accurate. Companies will likely need a robust, specially-trained field force that can be deployed to retailers from large chains to small independent and nontraditional outlets. Relying on retailers to remove the product themselves often results in “shelf-sweeping,” where entire brands are removed to avoid spending man hours sorting through those that comply and those that no longer do. Companies must also be prepared to manage secure chain of custody and documentation procedures, all while capturing critical data at every stage of the process.
Another aspect to consider is the difficulty in shipping the product back or destroying it in the field. Some retailers will bypass shipping instructions and fail to provide a certificate of destruction. When it comes to products made with hazardous materials, including those containing lithium-ion batteries, lack of documentation can put manufacturers in hot water with regulators who are already watching closely.
Above all, any time products are prohibited by new regulations, every single item must be pulled from shelves. Doing otherwise can leave manufacturers vulnerable to fines, legal liability, negative press coverage, and – ultimately – brand damage.
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