Tag: Dick Durbin

  • FDA Whistleblower Dishes on Agency’s Shortfalls

    FDA Whistleblower Dishes on Agency’s Shortfalls

    David Oliveira, who recently left the FDA after six years as a senior staffer, is speaking out about problems at the agency under the Biden administration, including tobacco control, diversity, equity and inclusion, and failures to combat China flooding the U.S. market with illicit vapes after the FDA’s top tobacco official was removed from his position. 

    “Many of us had been anticipating it for quite some time. We knew that change was drastically needed at FDA when it came to Tobacco Control,” Oliveira said in an interview with Fox News Digital. “Because Tobacco Control had really gotten out of control, there were many, many failures in core missions for the center that needed dramatic change and new leadership.

    “Many of us, whether it be from public health, consumers, small business owners, industry, and including even Senator Dick Durbin, who last year at a hearing said to Brian King, ‘It looks to me that you have fallen down on the job.’ So really, it runs the spectrum of people who are unhappy with what’s gone on recently with FDA in terms of tobacco regulation.

    “I frequently would attend shows and visit vape shops, and I was somewhat a canary in a coalmine, and would report back as to what I was seeing, and I would warn them that what I was seeing on the ground was out of control. We had a lot of people in the building who would go online and try to do some surveillance, but when you get out into the real world and you see the number of vape shops that are flooded with these illicit products, and I started to warn them about the amount of nicotine that was in these devices. We went from a Juul device, which had around 200 puffs, which was the equivalent of one pack of cigarettes, then I started seeing 5,000 puffs. I brought that warning back to the center, and then the following year would see 10,000 puffs. Now on the market, you can see 40,000 and 50,000 puffs. This is what the Chinese have done. They have not sought to get products authorized. They will introduce the latest and greatest technology. I saw a Santa one that was red and white. They’ll introduce flavors like Gummy Bear, Blow Pop, and Fruit Rollups, and these things that are absolutely youth-appealing because they do not care.” 

    View the 15-minute interview here.

  • Durbin Blasts FDA Failures in Vape Rules

    Durbin Blasts FDA Failures in Vape Rules

    Senator Dick Durbin

    U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.

    In a press release, Durbin stated that he has repeatedly criticized the FDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.

    FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.

    During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.

    “I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”

    The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.

  • AVM Urges Investigation of Dick Durbin

    AVM Urges Investigation of Dick Durbin

    Dick Durbin and Center for Tobacco Products Director Brian King (Photo: The office of Senator Dick Durbin)

    The American Vapor Manufacturers Association (AVM) has requested that the Senate Ethics Committee investigate Illinois Senator Dick Durbin for allegedly violating Senate rules by attempting to improperly influence U.S. Food and Drug Administration scientific decisions about vaping products, according to Vaping360.

    On Oct. 14, the AVM delivered a letter to the chair and vice chair of the Senate Select Committee on Ethics that alleged Durbin pressured the FDA to ban all vaping products despite the agency’s premarket tobacco product application (PMTA) review process.

    Citing Durbin’s track record (urging the FDA to ban vapor products via letters, Senate floor speeches, press releases and private meetings) the AVM says it believes Durbin attempted “to interfere with and influence the outcome of an ongoing executive branch agency review process in violation of Senate Ethics rules.”

    “Senator Durbin’s arrogant bullying has now become a grave threat to public health.”

    “Senator Durbin’s arrogant bullying has now become a grave threat to public health,” AVM President Amanda Wheeler said in a press release. “At a time when trust in public health authorities is already shaky, Durbin’s shameful campaign to hijack federal policy on this crucial health issue should come to an immediate end.”

    The letter to the Senate committee marks the second time this year that the AVM has asked a government body to investigate corruption of the FDA PMTA review process.

    According to Vaping360, the ethics committee is unlikely to seriously investigate Durbin or cite him for misconduct; Durbin is Senate Majority Whip, making him the second-highest ranking Democrat in the Democratic-led body.