Dueling Agencies - Part 2? | Citizens Against Government Waste

Dueling Agencies - Part 2?

The WasteWatcher

In November 2014, Citizens Against Government Waste’s WasteWatcher, "Dueling Agencies,” discussed how it was bad enough that the federal government spent precious tax dollars on frivolous projects but when one federal agency used tax dollars to attack another agency’s research, it was downright preposterous.

At that time, we discussed how the Food and Drug Administration (FDA) had long declared that the indirect food additive, bisphenol A (BPA), was safe at the current levels used in foods.  FDA’s National Center for Toxicological Research (NCTR) had studied BPA for years and found it had shown no harm.  Yet, the National Institute of Environmental Health Studies (NIEHS), a division of the National Institutes of Health, had been providing millions of dollars in grants, approximately $173 million between 2000 to 2014 to study BPA, with most of it going to scientists that were determined to eliminate its use entirely.

To finally solve the BPA safety question, the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA) program was developed.  On September 28, 2018, NTP announced that the CLARITY-BPA studies were available.  CLARITY determined what has been known for years:  BPA is safe.

Now it appears there may be another wasteful duel between agencies underway.  On January 26, the Centers for Disease Control tweeted, “Heated tobacco products contain nicotine, regardless of whether they are heated by flame or electronically.  More research is needed to understand the health effects of these products” and “Heated tobacco products are NOT an FDA-approved method for quitting smoking.”

It is the burning of tobacco, where the lit end of a cigarette can reach 1100° to 1600°F, that creates the toxic chemicals that cause the serious and adverse harm to smokers like heart disease, lung disease, and many types of cancer.  Heat-not-burn or non-combustible cigarettes are a different kind of electronic cigarette.  Instead of heating a liquid, these products heat tobacco at much lower temperatures, around 600°F.  This process significantly reduces the production of harmful and potentially harmful chemicals.  The FDA, which regulates tobacco products, has stated that non-combustible cigarettes could help nicotine addicted adult smokers move away from deadly combustible cigarettes, provided they switch completely.

On July 19, 2018, the FDA completed a substantially equivalent review of R.J. Reynolds Eclipse and the Eclipse Menthol non-combustible cigarettes, allowing the company to market their product because they were substantially equivalent to a product the company had on the market before February 2007, making it not subject to FDA premarket requirements.  This was the first time the FDA issued a substantial equivalence order to any non-combustible cigarette.  However, this product does not have a modified risk tobacco product (MRTP) order, which means the company cannot market it as a harm reduction product.

In April 2019, the FDA authorized the marketing of a new, heated tobacco product, the Phillip Morris IQOS.  The FDA decided that, “Following a rigorous science based review through the premarket tobacco product application (PMTA) pathway, the agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes.”  In July 2020, the FDA went one step further and authorized the marketing of the IQOS as a MRTP for certain claims, such as allowing the label to include use of the product “significantly reduces the production of harmful and potentially harmful chemicals.”

Encouraging the development and use of tobacco harm reduction products is contained in the 2009 Tobacco Control Act.  Section 918 of the law requires the secretary of the Department of Health and Human Services, after consulting with other health and scientific experts, to submit to Congress within three years, “a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine based products and treatments) to better achieve, in a manner that best protects and promotes the public health: total abstinence from tobacco use; reductions in consumption of tobacco; and reductions in the harm associated with continued tobacco use.” 

The CDC itself has said that, “E-cigarettes have the potential to benefit adults who smoke and who are not pregnant if used as a complete substitute for regular cigarettes and other smoked tobacco products.”  Both the CDC and FDA have stated electronic nicotine delivery systems (ENDS) are not safe for use by youth, women that are pregnant, and people who do not currently use tobacco products should not use non-combustible tobacco products, or any tobacco product.  Few would disagree with these assessments, including the manufacturers of these types of innovative products and other types of tobacco harm reduction products.

CDC is being disingenuous in the January 26 tweet.  It is true that these products are not approved by the FDA, but they have received FDA marketing orders, which is significant.  Declaring these products contain nicotine is an unnecessary criticism of the product because the purpose of these tobacco harm reduction products is to help adults that are addicted to the nicotine contained in combustible cigarettes to move to a much less harmful product.

As for the CDC declaring more research is needed to understand the health effects of these products and are effective in helping moving people away from smoking, that is occurring.  Obtaining a MRTP authorization requires the company “to conduct postmarket surveillance and studies to determine whether the MRTP orders continues to be appropriate, including assessing the potential for increased use among youth.”

CAGW is concerned that the CDC’s January tweet is a signal that it may be entering a phase of attacking non-combustible cigarettes, or any other tobacco harm reduction product that has received FDA marketing orders, creating yet another dueling agency scenario that taxpayers will fund.  The FDA is charged with the oversight of these products and conducts lengthy scientific PMTA reviews of any new innovative tobacco product and those that require a MRTP authorization.

Smoking continues to be one the most preventable causes of illness and premature death.  China, which produces the most tobacco in the world, would no doubt be willing to fill any demand for this commodity based on its behavior for trafficking fentanyl.  It would be better for taxpayers and smokers if the CDC would not cause confusion over what the FDA has determined and instead adopt Public Health England’s policy of encouraging smokers to switch to less harmful tobacco products, like heat-not-burn cigarettes, and move completely away from deadly combustible cigarettes.

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