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Source: United States House of Representatives – Representative Nita Lowey (17th District of New York)

Lowey: Administration should advise public to stop using e-cigarettes, not “consider not using” them

WASHINGTON, DC Congresswoman Nita Lowey (D-NY17/Rockland-Westchester), Chairwoman of the House Appropriations Committee, today sent a letter to the U.S. Food and Drug Administration (FDA) Acting Commissioner Dr. Ned Sharpless urging the FDA to quickly finalize the compliance policy on flavored e-cigarette products and to prioritize enforcement with much greater urgency than it has previously demonstrated.

Two weeks ago, the Administration announced its intent to pull flavored e-cigarettes off the market to stem a growing youth e-cigarette epidemic following recent data that shows one in four kids currently use e-cigarettes. A new generation of Americans is now hooked on nicotine because these products have been available, unregulated, and even marketed to kids. Yet the FDA has still not provided Congress with additional details on the implementation of this new policy, and the epidemic remains pervasive in communities across the country. Additionally, the Centers for Disease Control and Prevention has reported an outbreak of vaping-related illnesses among 530 individuals in 38 states, and that it has claimed at least seven lives. News reports today indicate this total is now up to nine.

“It is heartbreaking and outrageous that we are at the nexus of two public health crises that were avoidable,” Lowey wrote. “The role of the FDA is to protect public health, and the outbreak – as well as the epidemic among youth — emphasizes the failure of the federal government to protect the public against the harms of these products. Despite calls to action from the health community and my questioning the FDA numerous times in recent years, it was slow to take regulatory and enforcement action to mitigate these crises. This cost is far too high, and the FDA has taken far too long to act.”

Lowey highlights the FDA’s history of inaction and failure to enforce existing e-cigarette marketing and product regulations. Despite increasing evidence of risks associated with e-cigarette use, the Administration has said the public should “consider not using” vaping and e-cigarette products. As a result, Lowey called on Dr. Sharpless to encourage the Administration to definitively advise the public to stop using these harmful products.

Lowey has been a strong advocate for tough regulations of e-cigarettes and is a member of the Congressional Caucus to End the Youth Vaping Epidemic. As Chairwoman of the House Appropriations Committee, she has consistently opposed tobacco industry efforts to weaken FDA’s enforcement of the Family Smoking Prevention and Tobacco Control Act and recently included an increase of $40 million for the Office on Smoking and Health in the House-passed health spending bill for Fiscal Year 2020.

The full text of the letter is below. A PDF copy is available here.

Dear Acting Commissioner Sharpless:                                                                                               

As we discussed during our call on September 12, 2019, I am extremely troubled by recent news related to the use of e-cigarettes and vaping. It is heartbreaking and outrageous that we are at the nexus of two public health crises that were avoidable. The Centers for Disease Control and Prevention has reported an outbreak of vaping-related illnesses among 530 individuals in 38 states, and that it has claimed at least seven lives. News reports today indicate this total is now up to nine. Additionally, recent data show that one in four kids currently use e-cigarettes; now, a new generation of Americans is hooked on nicotine because these products have been available, unregulated, and even marketed to kids.

The role of the U.S. Food and Drug Administration (FDA) is to protect public health, and the outbreak — as well as the epidemic among youth — emphasizes the failure of the federal government to protect the public against the harms of these products. While I welcomed the Administration’s recent announcement of a plan to pull flavored e-cigarettes off the market in an apparent attempt to stem the youth epidemic, this action is much too late. Despite calls to action from the health community and my questioning the FDA numerous times in recent years, it was slow to take regulatory and enforcement action to mitigate these crises. This cost is far too high, and the FDA has taken far too long to act.

The FDA must act quickly to finalize a compliance policy on flavored e-cigarette products that prioritizes enforcement with much greater urgency than it has previously demonstrated. Several issues still require clarification:

  • On September 11, 2019, the FDA said it plans to “share more on the specific details of the plan and its implementation soon.” Given the very serious nature of the crises associated with vaping products, formal guidance should be completed within a matter of days, not weeks or months. When will the new policy be finalized?
     
  • It was announced that retailers and manufacturers will have 30 days from the policy announcement to remove flavored e-cigarette products from both online and brick-and-mortar stores, at which point enforcement will be essential to ensure maximum effectiveness of any ban. Will FDA aggressively enforce its new policy, and how? What can FDA do, and what support does it need from Congress, to ensure that producers and sellers don’t turn to alternative marketing and retail options, including online, in the absence of the ability to sell these products in stores?
     
  • What actions can the FDA take, and what support does it need from Congress, to ensure that this policy does not lead to a spike in the use of tobacco-flavored e-cigarette products, especially among youth, and that consumers do not turn toward combustible cigarettes as an alternative?
     
  • It appears as though there is still no standard definition for what it meant to be on the market as of August 2016, and therefore I am unsure how FDA is enforcing its new product review requirement as of that date. I am gravely concerned that many products, such as an unauthorized product that looks like an Apple watch about which I wrote you recently, are on the market illegally. Will a definition for these types of products be clearly included in the new compliance policy?   

The FDA must do much more to address the public health emergency of e-cigarettes, and in doing so, must take care to ensure that new challenges do not emerge as a result. I urge you to bring aggressive regulatory and enforcement actions to help ensure that consumers are protected and encourage the Administration to definitively advise the public to stop using e-cigarettes, rather than to loosely suggest the public “consider not using” them. I would support a ban that would prohibit these products from being returned to shelves unless or until a specific e-cigarette has been found to be safe and effective by the FDA in helping smokers quit.

                                                                        Sincerely,

                                                                        Nita M. Lowey

                                                                        Member of Congress

CC: Secretary of Health and Human Services Alex Azar

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