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Senators Express Frustration with FDA for Slow Response to Vaping Hazards

November 15, 2019 by Tom Ramstack

WASHINGTON — A Food and Drug Administration official told a U.S. Senate committee this week that new regulations to control vaping are likely coming soon, but couldn’t say when.

His testimony drew rebukes and words of frustration from members of the Senate Health, Education, Labor and Pensions Committee.

“There is no final answer as of now,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

Trump administration officials said in September that it would clamp down soon on the flavored e-cigarettes that are blamed for killing at least 40 people and sickening thousands with a respiratory illness.

Electronic cigarettes, also known as e-cigarettes, are handheld battery-powered vaporizers that simulate smoking but without burning tobacco. Using an e-cigarette is known as “vaping.” 

The White House announcement said “the FDA intends to finalize a compliance policy in the coming weeks … clearing the market of non-authorized e-cigarette products …”

Some senators during a hearing Wednesday questioned whether the FDA was wavering under pressure from the e-cigarette industry.

“I think any questions about the current state of policy really needs to be directed to the White House,” Zeller said in response. “We are in a deliberative process. The White House made an announcement in September and we are working to advance a policy consistent with taking steps to do everything that we can to protect kids from these products.”

Sen. Tim Kaine, D-Va., accused Zeller of either hiding or not knowing how the Trump administration plans to eliminate hazards of e-cigarettes.

Zeller replied, “There is no final answer on the policy question, that’s why we continue to have these discussions internally.”

Kaine suggested that further delays are dangerous.

“We should get an answer to this question about whether the administration is going to honor the policy that they announced or not,” Kaine said.

Sen. Maggie Hassan, D-N.H., told the FDA official, “You’ve had plenty of time already, and kids, people, Americans all over this country are being hurt.”

Anne Schuchat, a deputy director for the Atlanta-based Centers for Disease Control and Prevention (CDC), described how health officials are responding to health problems from e-cigarettes.

“As of November 5, 2019, there are 2051 confirmed and probable cases of [e-cigarette lung injuries] reported” in the United States,” Schuchat said.

“Most patients reported a gradual onset of difficulty breathing, shortness of breath or chest pain before hospitalization,” she said. “Some patients reported mild to moderate gastrointestinal illness. This lung condition is serious.”

The CDC activated its Emergency Operations Center in September. About 300 of its staff members are either investigating the lung illnesses or disseminating information about them to state health officials.

The CDC reported last week that vitamin E acetate is the most likely culprit in causing vaping-related illnesses and deaths. Most of the victims were teenage boys and young men.

The report was based on samples of lung fluid from 29 patients affected by the mysterious e-cigarette lung illness. Two of them died.

Vitamin E acetate was found in all samples. The substance is most commonly found in skin creams, where it is harmless.

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