Judicial Watch Sues HHS For FDA Deeming Rule Records

Another Freedom of Information Act, or FOIA, lawsuit has been filed regarding the FDA deeming rule and it looks to be coming from a watchdog group independent from the industry.

Judicial Watch has sued the Department of Health and Human Services for supporting the Food and Drug Administration’s justification for categorizing vaping as tradition tobacco products. The lawsuit, which can be viewed here, is seeking records from the FDA, the Centers for Disease Control and Prevention, and the Office of the Surgeon General that claim that vaping can possibly cause cancer.

The lawsuit was filed on May 5 in the United States District Court in Washington DC. It comes after the watchdog group saw repeated requests for records from the agencies ignored.

Tom Fitton, who is President of Judicial Watch, released a statement on the lawsuit. He stated that: “The emails sought by Judicial Watch could shed light on how the Obama FDA arrived at the decision to strictly regulate e-cigarettes, despite its own admission that it had done inadequate research – and, in fact, that the devices helped smokers quit tobacco.”

He went on to summarize the intent of the filing, stating: “the lawsuit was filed after the agencies failed to respond to FOIA requests sent in March 2017 seeking…all internal [FDA, CDC, or OSG] emails discussing the relative carcinogenicity of inhalation from Electronic Nicotine Delivery Systems compared to inhalation from traditional combustible cigarettes.”

The lawsuit is significant because it points to the government’s resistance to assessing vaping as an alternative to tobacco. In fact, many public health experts have spoken out against the FDA deeming rule and presented findings that directly contradicted the FDA’s position. This is perhaps best underscored by the April 2016 study that was conducted by the London’s Royal College of Physicians; the study showed that vaping products are 95 percent less dangerous than traditional cigarettes.

In spite of all of the evidence the FDA has at its disposal, the agency decided last year to enforce it’s so-called “deeming” rule, which categorizes vape products, including the devices, accessories, and batteries, as traditional tobacco products. The rule subjects the products to the same strict regulations and rules, as well as taxes, as traditional cigarettes; this also includes the onerous Pre-Market Tobacco Applications, a costly process that is expected to cost vape manufacturers between $200,000 to $500,000 dollars per product per nicotine level.

The FDA has stated a position that seems confusing to most in the vape community, especially as restrictions are tightening against the industry.

In one statement regarding the deeming rule, the agency stated that it had chosen to take “this action to reduce the death and disease from tobacco products.” This is not strange, as the FDA has a mission to assess and approve products that benefit, not detract from, public health. To this end, the agency has introduced many regulations, such as setting a minimum age for the sale of vape products, child-proof caps on bottles and more, that the industry welcomes.

However, the FDA has overstepped their bounds with over-regulating the industry with rules that make sense for traditional cigarettes but make no sense for vape products. This includes requiring the vape industry to undergo PMTAs, which are applications that focus exclusively on tobacco products and the issues that come along with them.

On the other hand, the FDA has admitted in the past that vaping hasn’t had a fair shot in terms of accepting medical and scientific data that perhaps shows the industry in a different light.

The FDA has stated in a memo that: “We do not have sufficient data to determine what effects e-cigarettes have on public health at the population level. We also noted that some individuals report using e-cigarettes to successfully quit smoking…”

This is in reference to the various endorsements, most notably by Public Health England, a governmental body in the United Kingdom, that vaping could be used as a smoking cessation method. In fact, the rate of smoking by Americans has been drastically reduced in recent years, a sign that vaping could be helping smokers quit the habit.

The FDA’s assertion that it does not have sufficient data to determine effects is also inaccurate. While it is true that there are not a lot of long-term vape studies that have been completed and presented in academic journals, there are dozens of short-term and mid-term studies that have proven that as a short-term smoking cessation method, vaping is safer than smoking.

It’s also important to note that smoking is a behavioral as much as a chemical addiction. By utilizing similar behaviors as smoking, vaping allows smokers to gradually reduce the nicotine level while still continuing the behaviors that have become second nature to them. And because the nicotine levels and flavors in vape liquids are customizable, former smokers can start at high doses in different flavors and then move to nicotine-free flavors, effectively ending their addiction to nicotine with few, if any, side effects.

Also worth noting is that nicotine, which has been reported by the FDA to be detrimental to adolescents and young adults with regard to cognitive development, is a nootropic that can enhance cognitive abilities and may delay the onset of Alzheimer’s in older people. So while young adults should not ingest nicotine in any form, it is safe in regulated amounts for adult smokers.

The lawsuit has yet to move past the filing phase but is expected to have a response by the agency in the coming weeks.

Until then, Judicial Watch has the last word, with Fitton stating that:

“The emails sought by Judicial Watch could shed light on how the Obama FDA arrived at the decision to strictly regulate e-cigarettes, despite its own admission that it had done inadequate research – and, in fact, that the devices helped smokers quit tobacco. The American people deserve to know if a corrupt government power grab put the public health at risk.”

Judicial Watch is a conservative watchdog organization that is essentially non-partisan in its work. It files Freedom of Information Act request lawsuits in order to investigate alleged misconduct or criminal behavior by government officials. Since it was founded in 1994, the group has sued three White House administrations and is currently in court proceedings in more than 20 lawsuits against former Democratic presidential candidate Hillary Clinton.

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