Letter to the Hon. Norman Sharpless, Acting Commissioner of the Food and Drug Administration - Schumer Urges Fed Crackdown to Inspect, Detect & Remove Dangerous, Counterfeit E-Cig Products Made in China & Aimed at Kids from Market; Fake Pods, with Alluring Flavors, Like Fruits & Candy Fda Has Acted on Are Now Flooding Market Illegally

Letter

Date: June 23, 2019

Dear Acting Commissioner Sharpless:

I write to express my grave concerns regarding reports of an influx of counterfeit e-cigarette devices into the United States and the New York-area from China and other countries. As the federal agency responsible for protecting public health, I ask that you take immediate action to more aggressively intercept this contraband and help address the epidemic of e-cigarette use by children.

For the past several years, I have successfully pushed for action to address the skyrocketing use of e-cigarettes by children, including prohibiting manufacturers of e-cigarettes from targeting children and teens by banning attractive flavors and regulating marketing tactics aimed at kids. However, this advancing success to combat the scourge --and use-- of e-cigs among children has created a demand void that countries like China are anxious to supply.

While some of the FDA's most recent actions towards e-cigarettes have been a step in the right direction, I am troubled by recent reports of counterfeit e-cigarette products -- largely from China -- flooding the market in ways that undermine efforts to make it harder for underage users to access these products. In response to complaints about these counterfeits, the U.S. International Trade Commission opened an investigation into the unlawful importation of these products, many of which appear to be sold online or in convenience stores with little or no age-verification.

These counterfeits "pods" come in flavors having obvious, if not deliberate, youth appeal, such as "Apple Juice," "Pineapple Crush," "Sour Gummy," and "Strawberry Milk" to name a few. In addition, these counterfeiters, reportedly operating with little oversight in places like China, may have flawed or sloppy manufacturing that could result in heavy metals or carcinogens that have been detected in some e-cigarettes that also raise serious safety concerns. I ask that the FDA test these products and release information on their chemical content as soon as possible. It is vital that the public know of any increased health threats that these illegal products present.

To ensure these illicit products are stopped before they reach the U.S., the FDA, U.S. Customs and Border Protection (CBP), and the U.S. Postal Service must all work together to inspect, detect, and prevent these products from entering the country. I understand that the FDA has recently taken steps to address threats like these, including recently signing an agreement with CBP. According to this agreement, FDA and CBP will maximize inspection and detection capabilities at ports of entry and increase scientific presence at international mail facility locations, including in New York, to support real-time decision-making.

To better support FDA's efforts to prevent the influx of counterfeit e-cigarettes from getting into the hands of children, I ask that your agency respond to the following questions:

How does the FDA work with CBP and the Postal Service to inspect, detect, and prevent counterfeit e-cigarettes?
How will the FDA's recent agreement with CBP address the influx of counterfeit e-cigarettes from countries like China? How will this agreement effect operations at the International Mail Facility at John F. Kennedy International Airport and the Port of New York and New Jersey?
How does the FDA use its database, the Operational and Administrative System for Import Support (OASIS) to inspect, detect, and prevent counterfeit e-cigarettes from entering the country?
Has the FDA conducted specialized training or used advanced screening technology to improve the detection of counterfeit e-cigarettes?
What more, if anything, might you require from the legislative branch to address the spike in "fake' pods arriving to the U.S and to curtail these shipments?
Thank you for your prompt attention to this matter.

Sincerely,


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