From today’s American Association for Justice’s TRIAL magazine, FDA focusing on e-cigarette use by minors (see blue text below) –
Top Story
FDA releases new action plans for medical devices, e-cigarettes
May 2018 – Kate Halloran
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The FDA recently announced action plans for medical device safety and reducing sales and marketing of e-cigarettes to children under 18. The “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” outlines the agency’s priorities for addressing safety for the more than 190,000 devices that it regulates, and its Youth Tobacco Prevention Plan aims to hold manufacturers and distributors accountable for illegally selling these devices to children.
The FDA recently announced action plans for medical device safety and reducing sales and marketing of e-cigarettes to children under 18. The “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” outlines the agency’s priorities for addressing safety for the more than 190,000 devices that it regulates, and its Youth Tobacco Prevention Plan aims to hold manufacturers and distributors accountable for illegally selling these devices to children.
The medical device action plan highlights five areas: creating a patient safety net, improving the postmarket process for safety-related changes, encouraging development of safer devices, improving device cybersecurity, and enhancing the “total product life cycle” approach to device safety within the FDA.
Many of the plan’s objectives illustrate the role that technology will play in medical device oversight. For example, the patient safety net will rely on the National Evaluation System for Health Technology (NEST), which is run by the nonprofit Medical Device Innovation Consortium. NEST’s goal is to collect electronic health data from a variety of sources—such as medical records, device registries, and patient complaints—to share real-time data among providers and the agency to expose adverse events and safety issues more quickly. As part of its action plan, the FDA intends to devote more resources to its role in NEST and to seek additional funding for the system.
Another example is device cybersecurity, which has garnered increased scrutiny as more medical devices integrate internet-based features that place the device and the patient at risk when there are software vulnerabilities. The FDA’s plan includes possibly adding premarket cybersecurity requirements for medical device manufacturers, such as having to build into devices the ability to update software and address cybersecurity threats and having to disclose to the agency an inventory of the software in a device as part of the premarket submission process—information which also must be made available to the public. Other potential changes include updates to premarket guidance on protecting against cybersecurity risks that pose a danger to patients, developing standards for timely disclosing risks, and creating a separate entity that would oversee device cybersecurity and the response process with manufacturers when a risk is identified.
The agency also announced steps it is taking to address marketing and sales of electronic nicotine delivery systems (ENDS)—often called e-cigarettes—to minors. As part of a ramped-up Youth Tobacco Prevention Plan, the FDA is targeting e-cigarette use among minors to reduce nicotine addiction and to reduce the transition to traditional tobacco products in the next generation. The use of e-cigarettes—known as vaping—has become especially popular with teenagers, partly due to the discreet nature of the devices, which can resemble a USB drive, and the fruit and candy flavors of the liquid used in the devices.
A critical component of the FDA’s plan is increasing enforcement actions against companies that improperly market and sell e-cigarettes to children. One company, JUUL, has become a particular focus: Since March, the agency has sent JUUL 40 warning letters over its sales to minors and has requested documents about the company’s marketing tactics, health and behavioral research that it has conducted on its products, and information about whether design features or ingredients appeal to certain demographics.
Lawrenceville, N.J., attorney Domenic Sanginiti, who handles e-cigarette cases, noted that regulatory efforts initiated when e-cigarettes became popular left a loophole that has impacted minors. “When the FDA extended its tobacco regulation arm to include e-cigarettes, the industry was put on notice that selling and marketing to children under 18 would be banned. The FDA did not, however, issue a similar ban regarding the use of flavors known to appeal to children and young adults—as it did for cigarettes in 2009.” Sanginiti explained that as a result, products that would appeal especially to children “flooded” the marketplace. “JUUL has a sleek design like a flash drive, is easy to hide, and comes in cool colors and fruity flavors. This has caused its popularity in school-age children to skyrocket, prompting some schools to ban flash drives and doctors and educators to condemn JUUL as a major teen health threat,” he said.
Other elements of the FDA’s initiative include collaborating with online retailers such as eBay to remove listings that target children, requesting information from and increasing enforcement against additional manufacturers, and running an online e-cigarette prevention advertising campaign. Sanginiti noted that although these efforts are a step in the right direction, the agency should treat e-cigarettes more aggressively, as it does traditional cigarettes—from banning flavors that appeal to children to lowering and eventually removing nicotine from e-cigarettes.
Sanginiti also pointed out that regulatory rollbacks of the FDA’s “deeming rule” to include ENDS products in its tobacco-regulating authority have exacerbated the situation. “The original deeming rule would have already required e-cigarette companies to file FDA applications for existing and new tobacco products. . . . However, after a comment period, the FDA pushed that requirement out to 2022. Had it not done so, it’s possible that the JUUL product and others would not have been approved without modifications.”
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