Shots were fired in Washington in the form of a lawsuit filed by the e-liquid company "Nicopure" against the Food and Drug Administration (FDA), FDA Commissioner Robert Califf, M.D., and Sylvia Mathews Burwell, Secretary of #Health and Human Services. This lawsuit has ignited battleground maneuvers with organizations to fight the newly released regulations. The lawsuit contends, according to the company's press release that regulations "violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the United States Constitution". Nicopure is a Tampa based company with operations in Europe and the Netherlands.
Where there are sparks
According to the Alliance for Human Research Protection (AHRP) website, Former FDA Commissioner Margaret Hamburg is under fire along with the pharmaceutical company Johnson & Johnson facing federal charges in a different lawsuit filed April 11, 2016. Charges include the federal Racketeer Influenced and Corrupt Organizations Act (RICO) for concealing deadly risks of the drug, Levaquin - among others, and those risks were concealed to protect financial interests.
Hamburg was appointed by President Obama in 2009. The lawsuit also claims during her confirmation, Hamburg "failed to disclose to Congress and other relevant authorities, her and her husband’s clear-cut conflict of interest". Her husband, Peter L. Brown is also a defendant in the case and was "Co-CEO of a hedge fund named Renaissance Technologies" that held "hundreds of millions of dollars of Johnson & Johnson stock".
Hamburg's departure from the FDA in 2015 is noted as she was also in charge of forming e-cigarette regulations during her tenure. Johnson & Johnson are the makers of smoking cessation products like Nicorette gum, patch, inhaler and more. There are no known conflicts of interest by either party specifically during the "deeming regulations" process at this time.
Regulations under fire
On May 10th, The FDA released regulations of e-cigarettes, calling them "tobacco products", and forcibly regulating them as such despite research showing they are far less dangerous. In April, the Royal College of Physicians released their statement encouraging the use of the products. U.S. consumer and industry groups have formed a coalition to pursue legal and legislative strategies against the FDA regulations themselves. In the mean time, vaping products are "deemed tobacco products" according to the FDA.
Lost in the smoke
Regulations are under heavy scrutiny. The FDA has sparked a fire by classifying non-combustible vaping products as "tobacco products", and the battle to fight those fires has just begun. The National Center for Public #Policy Research has submitted a request under the Freedom Of Information Act (FOIA) to obtain information from all communications related to discussions with the FDA.
In the attempt to misrepresent or exclude crucial science and research proving these products are much less harmful than smoking, the US #Government and health organizations are failing current smokers. The public may be lost in the ashes and deeming regulations may cost a billion lives.