American Association of Poison Control Centers Applauds the United States Food and Drug Administration’s Extension to Regulate E-Cigarette and Additional Nicotine Products
May 5, 2016 | Download PDF
ALEXANDRIA, VA – On May 5, 2016, the United States Food and Drug Administration (FDA) issued a final rule deeming tobacco products such as gels, water pipe tobacco, cigars, pipe tobacco, and e-products including e-cigarettes, e-hookahs, e-cigars, vape pens, e-pipes, and refillable personal vaporizers to be subject to inclusion under the Family Smoking Prevention and Tobacco Control Act of 2009. Given the dangers of unintentional pediatric exposure to these products, the American Association of Poison Control Centers (AAPCC) applauds the FDA’s efforts.
“The FDA’s decision to expand its reach represents a significant breakthrough in addressing an increasingly significant public health threat in our country,” said Stephen T. Kaminski, JD, AAPCC CEO and Executive Director. “This action not only protects a consumer’s right to a healthy and safe environment, but more importantly, addresses hazards posed by e-cigarette products and liquid nicotine to our children.”
Key provisions of the FDA’s ruling, which will go into effect on August 8, 2016, include: a restriction on the sale of all such products to minors under 18, requiring health warnings on product packaging, evaluation of the ingredients in these products, and requiring pre-market review and authorization by the FDA.
Additionally, vape shops that mix or prepare e-liquids or create or modify devices for direct sale to consumers will be considered to be tobacco product manufacturers and are subject to the FDA’s regulatory requirements.
Data from America’s 55 poison centers—which was cited by the FDA in issuing today’s rule—show that e-cigarettes and liquid nicotine refills have been implicated in the growing number of calls to poison centers, especially those involving accidental exposures in children. In 2014, about 59 percent of all e-cigarette and liquid nicotine exposures reported to poison centers were for children ages 5 and under. In 2015, preliminary analysis shows that approximately 70 percent of these exposures were in kids, roughly 2,600 reported cases. Concurrent with the new rule, the FDA also issued draft industry guidance for pre-market e-cigarette applications, which requires manufacturers to submit information about child-resistant packaging.
Ingestion of liquid nicotine is dangerous because it can cause acute nicotine toxicity. One teaspoon of liquid nicotine can be lethal to a child, and smaller amounts can cause severe illness, often requiring visits to the emergency room, with nausea and vomiting being the most significant symptoms. Toxic exposures to e-liquid can occur through not only ingestion and inhalation, but also absorption through the skin or eyes.
“The FDA’s ruling is a considerable step forward in protecting our children’s safety,” said Jay L. Schauben, PharmD, DABAT, FAACT, Director of the Florida/USVI Poison Information Center - Jacksonville, and current AAPCC President. “E-cigarette poisoning cases have been very challenging for poison centers due to the irregularity in the amounts and components of liquid nicotine from product to product. Poison Specialists handling these emergency calls often find themselves at the mercy of the product’s packaging to determine how dangerous each exposure is. Allowing the government to regulate the contents of these products not only helps to protect children from possible future exposures to liquid nicotine, but also helps poison centers to more quickly and accurately assess and manage these types of calls.”
Even with the new rule in place, adults should take care to keep all tobacco and e-cigarette products up, away, and out of sight of kids. In addition, programming the Poison Help line, 1-800-222-1222, into your mobile telephone, and posting it in a visible place in your home is the best way to be prepared for poisoning emergencies.
To access AAPCC’s e-cigarette and liquid nicotine exposure data, please visit http://www.aapcc.org/alerts/e-cigarettes/.
For more information, the media may contact Angela Gonzales, AAPCC Associate Manager, Communications and Outreach, at 703-894-1865 or firstname.lastname@example.org.
AAPCC supports the nation’s 55 poison center members in their efforts to treat and prevent drug, consumer product, animal, environmental and food poisoning. Members staff the Poison Help hotline at 1-800-222-1222 that provides free, confidential, expert medical advice 24 hours a day, seven days a week, 365 days a year from toxicology specialists, including nurses, pharmacists, physicians and poison information providers. In addition, AAPCC maintains the only poison information and surveillance database in the United States, providing real-time monitoring of unusual poisoning patterns, chemical exposures and other emerging public health hazards. AAPCC partners with federal agencies such as HRSA, CDC, FDA and EPA, as well as private industry.