Modified Risk Tobacco Modified Risk Tobacco Product Regulation
Modified Risk Tobacco Modified Risk Tobacco Product Regulation: Product Regulation: The Top Two Myths Michael Siegel, MD, MPH Professor, Department of Community Health Sciences Boston University School of Public Health Boston University School of Public Health
Myth 1: The MRTP provisions, as implemented by the FDA guidance, will serve primarily to prevent false will serve primarily to prevent false claims by tobacco companies about the hazards of their products. h h d f h d
Myth 1: The MRTP provisions, as implemented by the FDA guidance, will serve primarily to prevent false claims by guidance, will serve primarily to prevent false claims by tobacco companies about the hazards of their products.
The MRTP provisions serve primarily to prevent MRTPs from reaching the market. prevent MRTPs from reaching the market. •
•
MRTP provisions are not necessary to prevent false claims by tobacco companies about the hazards of their products. MRTP provisions put a nearly insurmountable MRTP provisions put a nearly insurmountable barrier in front of the introduction and successful marketing of truly modified risk products.
MRTP provisions are not necessary to prevent f l false claims by tobacco companies about the l i b b i b h hazards of their products.
1. New products must be approved by the FDA and db h d must be “appropriate” for pp p the public’s health. 2 FDA now has authority to 2. FDA h h i regulate tobacco g advertising.
MRTP provisions put a nearly insurmountable barrier in front of the introduction and successful marketing of truly modified risk products.
IIn order to introduce and market a d t i t d d k t reduced risk product, the manufacturer must know: f t tk • the “likelihood that existing tobacco product users who would otherwise stop using such products will switch to using the modified risk tobacco product” tobacco product • the “likelihood that persons who do not use tobacco products will start using the modified risk tobacco product.” k b d ”
In order to know the proportion of users who would h have quit in the absence of marketing the MRTP, it i th b f k ti th MRTP one needs to conduct a trial or natural experiment.
This means that the product This means that the product must first be introduced into the market and advertised to the k t d d ti d t th public as a reduced risk product.
In order to know the proportion of non‐users who will start using the MRTP, one needs to conduct a ill t t i th MRTP d t d t trial or natural experiment.
This means that the product This means that the product must first be introduced into the market and advertised to the k t d d ti d t th public as a reduced risk product.
In order to know the proportion of users who would h have quit in the absence of marketing the MRTP, it i th b f k ti th MRTP one needs to conduct a trial or natural experiment.
This means that the product This means that the product must first be introduced into the market and advertised to the k t d d ti d t th public as a reduced risk product.
The Catch 22 The Catch‐22 In order for a truly reduced y risk product to be introduced and marketed it must first and marketed, it must first have already been introduced and marketed.
What about reduced exposure p products? The manufacturer must demonstrate that: “as the applicant proposed to label and market the product, consumers will not be misled into believing that the product is or has been demonstrated to be less harmful.”
Catch 22 Number Two Catch‐22 Number Two If consumers do not believe the product is safer, then there is no incentive or value there is no incentive or value for the manufacturer to develop or market the product. product
Myth 1: The MRTP provisions, as implemented by the FDA guidance, will serve primarily to prevent false claims by guidance, will serve primarily to prevent false claims by tobacco companies about the hazards of their products.
The MRTP provisions serve primarily to prevent MRTPs from reaching the market. prevent MRTPs from reaching the market. •
•
MRTP provisions are not necessary to prevent false claims by tobacco companies about the hazards of their products. MRTP provisions put a nearly insurmountable MRTP provisions put a nearly insurmountable barrier in front of the introduction and successful marketing of truly modified risk products.
The Irony The Irony It’s business as usual for the g most harmful of the range of tobacco products on the market. There are stringent regulatory obstacles in front of what might g be much safer products.
The Example of Electronic Cigarettes The Example of Electronic Cigarettes No tobacco No combustion No combustion Only minor identified safety concerns: • long‐term propylene glycol inhalation • lipoid pneumonia (rare) • quality control: nicotine levels, battery safety, PG grade Documented TSNA levels 1000 times lower than Marlboros; no other carcinogens identified in GC/MS testing More than 2 5 million users; quadrupled from 2009 to 2010 More than 2.5 million users; quadrupled from 2009 to 2010 Qualitative research shows major advantage over NRT/drugs First clinical trial suggests more effective than NRT/drugs (no spoiler)
Despite all of this, if subject to MRTP provisions, distributors could not: • •
Market the product as safer than regular cigarettes M k h Market the product as not containing tobacco d i i b
Myth 2: The MRTP provisions will Myth 2: The MRTP provisions will protect consumers by ensuring honesty from product manufacturers.
Myth 2: The MRTP provisions will protect consumers by ensuring honesty from product manufacturers. i h f d f
In some cases, the MRTP provisions preclude consumers from receiving preclude consumers from receiving truthful information from manufacturers. If subject to MRTP provisions, electronic cigarette distributors could not: • Market the product as safer than regular cigarettes M k t th d t f th l i tt • Market the product as not containing tobacco
Recommendations 1. In regulating electronic cigarettes, FDA should avoid applying section 911 to these products. products 2. Congress needs to consider amending 2 Con ress needs to onsider amendin the statute to facilitate, rather than block, the emergence of truly reduced risk the emergence of truly reduced risk products, some form of which is undeniably the wave of the future.
Myth 1: The MRTP provisions, as implemented by the FDA guidance, will serve primarily to prevent false will serve primarily to prevent false claims by tobacco companies about the hazards of their products. h h d f h d
Myth 1: The MRTP provisions, as implemented by the FDA guidance, will serve primarily to prevent false claims by guidance, will serve primarily to prevent false claims by tobacco companies about the hazards of their products.
The MRTP provisions serve primarily to prevent MRTPs from reaching the market. prevent MRTPs from reaching the market. •
•
MRTP provisions are not necessary to prevent false claims by tobacco companies about the hazards of their products. MRTP provisions put a nearly insurmountable MRTP provisions put a nearly insurmountable barrier in front of the introduction and successful marketing of truly modified risk products.
MRTP provisions are not necessary to prevent f l false claims by tobacco companies about the l i b b i b h hazards of their products.
1. New products must be approved by the FDA and db h d must be “appropriate” for pp p the public’s health. 2 FDA now has authority to 2. FDA h h i regulate tobacco g advertising.
MRTP provisions put a nearly insurmountable barrier in front of the introduction and successful marketing of truly modified risk products.
IIn order to introduce and market a d t i t d d k t reduced risk product, the manufacturer must know: f t tk • the “likelihood that existing tobacco product users who would otherwise stop using such products will switch to using the modified risk tobacco product” tobacco product • the “likelihood that persons who do not use tobacco products will start using the modified risk tobacco product.” k b d ”
In order to know the proportion of users who would h have quit in the absence of marketing the MRTP, it i th b f k ti th MRTP one needs to conduct a trial or natural experiment.
This means that the product This means that the product must first be introduced into the market and advertised to the k t d d ti d t th public as a reduced risk product.
In order to know the proportion of non‐users who will start using the MRTP, one needs to conduct a ill t t i th MRTP d t d t trial or natural experiment.
This means that the product This means that the product must first be introduced into the market and advertised to the k t d d ti d t th public as a reduced risk product.
In order to know the proportion of users who would h have quit in the absence of marketing the MRTP, it i th b f k ti th MRTP one needs to conduct a trial or natural experiment.
This means that the product This means that the product must first be introduced into the market and advertised to the k t d d ti d t th public as a reduced risk product.
The Catch 22 The Catch‐22 In order for a truly reduced y risk product to be introduced and marketed it must first and marketed, it must first have already been introduced and marketed.
What about reduced exposure p products? The manufacturer must demonstrate that: “as the applicant proposed to label and market the product, consumers will not be misled into believing that the product is or has been demonstrated to be less harmful.”
Catch 22 Number Two Catch‐22 Number Two If consumers do not believe the product is safer, then there is no incentive or value there is no incentive or value for the manufacturer to develop or market the product. product
Myth 1: The MRTP provisions, as implemented by the FDA guidance, will serve primarily to prevent false claims by guidance, will serve primarily to prevent false claims by tobacco companies about the hazards of their products.
The MRTP provisions serve primarily to prevent MRTPs from reaching the market. prevent MRTPs from reaching the market. •
•
MRTP provisions are not necessary to prevent false claims by tobacco companies about the hazards of their products. MRTP provisions put a nearly insurmountable MRTP provisions put a nearly insurmountable barrier in front of the introduction and successful marketing of truly modified risk products.
The Irony The Irony It’s business as usual for the g most harmful of the range of tobacco products on the market. There are stringent regulatory obstacles in front of what might g be much safer products.
The Example of Electronic Cigarettes The Example of Electronic Cigarettes No tobacco No combustion No combustion Only minor identified safety concerns: • long‐term propylene glycol inhalation • lipoid pneumonia (rare) • quality control: nicotine levels, battery safety, PG grade Documented TSNA levels 1000 times lower than Marlboros; no other carcinogens identified in GC/MS testing More than 2 5 million users; quadrupled from 2009 to 2010 More than 2.5 million users; quadrupled from 2009 to 2010 Qualitative research shows major advantage over NRT/drugs First clinical trial suggests more effective than NRT/drugs (no spoiler)
Despite all of this, if subject to MRTP provisions, distributors could not: • •
Market the product as safer than regular cigarettes M k h Market the product as not containing tobacco d i i b
Myth 2: The MRTP provisions will Myth 2: The MRTP provisions will protect consumers by ensuring honesty from product manufacturers.
Myth 2: The MRTP provisions will protect consumers by ensuring honesty from product manufacturers. i h f d f
In some cases, the MRTP provisions preclude consumers from receiving preclude consumers from receiving truthful information from manufacturers. If subject to MRTP provisions, electronic cigarette distributors could not: • Market the product as safer than regular cigarettes M k t th d t f th l i tt • Market the product as not containing tobacco
Recommendations 1. In regulating electronic cigarettes, FDA should avoid applying section 911 to these products. products 2. Congress needs to consider amending 2 Con ress needs to onsider amendin the statute to facilitate, rather than block, the emergence of truly reduced risk the emergence of truly reduced risk products, some form of which is undeniably the wave of the future.
