The future isn't just something that happens. It's a brutal force with a great sense of humor that will steamroll you if you're not watching. -- Aloha
As America goes, so goes the rest of the world.
The greatest superpower is necessarily also the global trailblazer, trendsetter, and pacesetter.
Quite simply, follow the leader the rest of the world must, to borrow from wise, old Yoda.
US regulatory authorities and enforcement agencies are sticklers for compliance.
And only rightly so because their findings, investigations, and recommendations are meticulously done, closely cross-referenced, and thoroughly vetted.
Americans can thus bank on their decisions.
When America sets minimum standards for the health, safety, and welfare of its people, it must be good enough for the rest of the world.
The US Food and Drug Administration has authorized the marketing of Philip Morris Products S.A.’s “IQOS Tobacco Heating System” as modified risk tobacco products, marking the second set of products ever to be authorized as MRTPs and the first innovative electronic tobacco products to receive “exposure modification” orders.
The US FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, efficacy, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of the nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
An EMO permits the marketing of a product as containing a lower level of or presenting a reduced exposure to a substance or as being free of a substance. The issuance of the order is “expected to benefit the health of the population”.
For those uninitiated in tobacco harm reduction, PMI’s IQOS is a variant of electronic nicotine delivery systems or heated tobacco products. Like ENDS/HTPs, IQOS does not burn tobacco.
The IQOS Tobacco Heating System includes the electronic IQOS device that generates a nicotine-containing aerosol by heating tobacco-filled sticks wrapped in paper.
Since combustion is taken out of the picture, IQOS significantly “reduces the production of harmful and potentially harmful chemicals”.
Scientific studies have shown that switching completely from conventional cigarettes to the IQOS and similar systems “significantly reduces your body’s exposure to harmful or potentially harmful chemicals”.
With this landmark decision, foreign food and drug regulators can be expected to anchor their policy decisions on the US FDA action.
Can we expect the World Health Organization to follow suit in crafting its global policy mandate on THR? Is it going on board and easing up its total rejection of THR now that the US has shown the way?
Slamming the door on the subject, the WHO said: "There is currently no evidence to suggest that reduced exposure to these chemicals translates to reduced risk in humans. Therefore, additional independent studies will be required to substantiate claims of reduced risk/harm. "
It insists: “All forms of tobacco use are harmful, including HTPs. Tobacco is inherently toxic and contains carcinogens even in its natural form. Therefore, HTPs should be subject to policy and regulatory measures applied to all other tobacco products, in line with the WHO Framework Convention on Tobacco Control.”
For a supposedly science-based global body whose decisions impact on public health policies of members of the United Nations community of nations, the WHO would rather lean on the unknown rather than what has been firmly established.
“There is a large knowledge gap, as this generation of HTPs has not been on the market long enough for potential effects to be studied. Conclusions cannot yet be drawn about their ability to assist with quitting smoking (cessation), their potential to attract new youth tobacco users (gateway effect), or the interaction in dual-use with other conventional tobacco products and e-cigarettes. Future independent studies should address these effects, as well as the safety and risk of HTPs,” it said in a primer.
But the industry going through a self-imposed tectonic shift in its core business to less harmful consumer products celebrated the US FDA decision as an affirmation of the propriety of its massive, industry-altering move.
A thoroughly elated Philip Morris International heralded the FDA decision and announcement thus:
Today’s decision by the US FDA is a public health milestone illustrating that the iQOS system is fundamentally different compared to cigarettes and a better choice for adults who would otherwise continue smoking. What is urgently needed is a fundamentally different societal conversation and policy direction to rapidly shift men and women who would otherwise continue smoking to scientifically substantiated smoke-free alternatives.
André Calantzopoulos, PMI’s chief executive officer, said:
The FDA’s decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.
IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized. Now—more than ever—there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future.
We are excited that this important decision will help guide the choices of adult smokers in the U.S. The best choice for health is to never start smoking or to quit altogether. For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product. As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to IQOS. We believe that this decision can help to further accelerate the transition of U.S. adults away from cigarettes. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.”
Today’s decision is a result of our ongoing commitment to put science at the forefront as we continue on our quest to replace cigarettes with smoke-free alternatives as quickly as possible.
We look forward to working with the FDA to provide any additional information they may require in order to market IQOS with reduced risk claims.
Harnessing innovations like IQOS to dramatically speed up the decline in cigarette smoking is the opportunity of this century. Comprehensive, science-based regulation can help to rapidly shift adult smokers who would otherwise continue smoking to better options, while simultaneously guarding against unintended consequences.”
The US FDA authorization requires Philip Morris Products S.A. to conduct post-market surveillance and studies to determine the impact of these orders on consumer perception, behavior and health, and to enable the agency to review the accuracy of the determinations upon which the orders were based.
These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use.
The company must also keep the FDA apprised of efforts to prevent youth access and exposure.
These requirements are in addition to the post-market requirements and restrictions previously placed on these products in their April 2019 PMTA authorizations, such as reporting information to the FDA about consumer research studies, sales and advertising information and adverse experiences, among others.
Behold God’s glory and seek His mercy.
Pause and pray people.