NCHR Testimony on Non-Prescription Nicotine Mouth Spray

Nina Zeldes, National Center for Health Research, September 18, 2019

My name is Nina Zeldes and I am a Senior Fellow at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers.  We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

Thank you for the opportunity to share our views.

As a colleague of the campaign for Tobacco-Free Kids and other members of Partners for Effective Tobacco Policy, we of course agree with other members of the coalition that effective smoking cessation treatments are needed.  However, to our knowledge, we are the only member of the coalition that has analyzed the data for this specific product and as a result of our analysis we are very concerned about its safety and efficacy

This nicotine mouth spray has already been approved in several other countries, but that doesn’t mean that it is good product for the U.S. We already have a major problem with addiction from nicotine delivery systems, such as e-cigarettes, especially among teens.  If we’ve learned anything from the Juul and vaping epidemic, it is that anything that delivers nicotine over the counter or online can be misused.

Making this product available in the U.S., especially over-the-counter, is obviously of concern.  It is important that we do not assume any nicotine product to be safe and effective for smoking cessation, unless there is clear evidence it is.

Only one study examined the efficacy of this treatment in an over-the-counter setting.  Only 3.4% of participants using the nicotine mouth spray continued to not smoke at the end of the study, compared to 1.2% using the placebo.  This 2.2% difference is not clinically meaningful. The rest continued to smoke, and 79% smoked while also using this “cessation” product.

The risks of this ineffective treatment include dependence, misuse, or abuse and other adverse events. Cases have been documented in the post-market adverse events reporting systems, and because these are voluntary reporting systems, they underestimate the actual incidence.

The reported difficulties with locking, unlocking and priming may also increase the risk for accidental exposure to non-users.  Additionally, this product is similar to e-cigarettes in that it is easy for people to lose track of how much they have consumed until the container is empty.  This may lead to people ingesting much more nicotine than intended – or that is safe.

The label comprehension study also raised concerns that participants did not understand or were not aware of the label. This reduces the likelihood that the product will be used safely.

There already are FDA-approved nicotine replacement products available, both over-the-counter and by prescription.  All seem to be more effective than this new product.  A new treatment, particularly one that could increase addiction to nicotine, should not be approved unless it has demonstrated proven benefits that outweigh the risks.  This product does not.

Thank you for your time.