The Modified Risk Products Provisions of the FDA Tobacco Act:

Science Based PolicyScience‐Based Policy or Protectionism?

Michael Siegel, MD, MPHProfessor

Boston UniversityBoston University School of Public Health

Who Am I?

•Testified in more than 100 cities for smoke‐free bar and restaurant lawssmoke‐free bar and restaurant laws

•Testified in 7 tobacco lawsuits against the tobacco companies, including Engle

•No conflicts of interest

Two Pathways for Modified Risk Productsfor Modified Risk Products

Modified Risk Tobacco Product

Reduced Risk Product Reduced Exposure Product

Requirements forRequirements for Reduced Risk Products

•Demonstrate that product will “significantly reduce harm and the risk ofsignificantly reduce harm and the risk of tobacco‐related disease to individual tobacco users”

•Demonstrate that product will “benefit the health of the population taking into account both users of tobacco products d h d land persons who do not currently use 

tobacco products.”

Scientific Standard: DemonstrateScientific Standard: Demonstrate Reduction in Individual Disease Risk

•Long‐term epidemiologic studies with thousands of human subjectswith thousands of human subjects•15‐20 year time period required to d t t d ti i i kdemonstrate reduction in cancer risk•Clinical trials not possible•There are no established biomarkers or other non‐epidemiologic (e.g., clinical or laboratory) markers for disease risk

A C t h 22A Catch‐22

You can’t market the product until you demonstrate reduced disease risk

You can’t demonstrate reduced disease risk 

until you market the productuntil you market the product

S i ifi S d d f R d d Ri kScientific Standards for Reduced Risk: Far More Stringent than Pharmaceutical 

Product Requirements

Pharmaceutical Products:1‐2 year follow‐up

Reduced Risk Tobacco Products:15‐20 year follow‐up

Scientific Standard: DemonstrateScientific Standard: Demonstrate Benefit to Population as a Whole

•Long‐term epidemiologic studies with human subjectswith human subjects

•No way to tell if nonsmokers will take up product or smokers will use product instead of quitting unless the product is marketed

A C t h 22A Catch‐22

You can’t market the product until you demonstrate population benefit

You can’t demonstrate population benefit 

until you market the productuntil you market the product

Prospect forProspect for Reduced Risk Products

•Virtually, if not literally impossible to meet scientific standards for approvalmeet scientific standards for approval

•Even if technically possible, would require extreme financial investment with no guarantee of success

•Will simply not happen under the current standardcurrent standard

Requirements forRequirements for Reduced Exposure Products•Demonstrate actual reduction in exposure

h h “ bl•Demonstrate that there is a “reasonably likely” chance that product reduces diseasedisease

•Demonstrate that as actually marketed, d ill k hi kproduct will not make consumers think 

that it is safer (by virtue of the reduced exposure)exposure)

Scientific Standard: DemonstrateScientific Standard: Demonstrate Actual Reduction in Exposure

•Easy: Can be done with simple laboratory testing of small number of subjects

Scientific Standard: Demonstrate “Reasonably Likely” Chance that 

Product Reduces DiseaseProduct Reduces Disease

E C b d ith l b t•Easy: Can be done with laboratory studies alone

Scientific Standard: Demonstrate That As Marketed, Consumers Will 

Not Think Product is SaferNot Think Product is Safer

C b t di d ith•Can be studied with consumer perception studies in laboratory ttisetting

•HOWEVER, most consumers ARE ,GOING TO THINK PRODUCT IS SAFER

A C t h 22A Catch‐22You can’t market the product asYou can t market the product as reduced exposure unless you show that consumers will not perceive ANY health benefit

If consumers do not perceive pANY health benefit, then you can’t successfully market the 

product

Example: Electronic Cigarettes

•There is compelling scientific evidence that these products are much safer than regular cigarettes

•There is compelling evidence that•There is compelling evidence that thousands of ex‐smokers are using these products to quit smoking orthese products to quit smoking or substantially cut down

Implications of FDA Tobacco Act’sImplications of FDA Tobacco Act s “Science‐Based” Policies

•If regulated under the FDA Tobacco Act electronic cigarettes will not beAct, electronic cigarettes will not be able to make ANY claims of reduced risk improved health or evenrisk, improved health, or even reduced exposure. •The ill ha e to be marketed•They will have to be marketed simply as “alternatives to smoking.”

Implications of FDA Tobacco Act’sImplications of FDA Tobacco Act s “Science‐Based” Policies

•The Act destroys any meaningful possibility of using harm reduction aspossibility of using harm reduction as a strategy in tobacco controlTh A t t t i ti hi h i k•The Act protects existing, high‐risk products – the highest risk products on the market from competitionon the market – from competition from potentially lower risk products •This strategy will result in increased disease and death

Relationship Between Product Risk d land FDA Regulatory Action

Product Evidence‐Base Action

El t i i tt M h f th l Eff ti l b dElectronic cigarettes Much safer than regular cigarettesNo evidence youth are using these products

Effectively banned (imports have been seized)

g p

Dissolvable tobacco products

Probably safer than cigarettesNo evidence youth are 

Considering ban

using these products

Regular cigarettes Killing more than 400,000 people per yearCl d t ti th t

Approved for sale and marketingN ti t k t th tClear documentation that 

more than 3 million kids are regularly using these products

No action taken yet that will substantially reduce the number of youth smokers or make cigarettes substantially safer to use

Relationship Between Product Risk d land FDA Regulatory Action

Product Evidence‐Base Action

Flavored cigarettes, non‐menthol

No youths using any products made by major 

Banned

tobacco companies

Menthol cigarettes Tens of thousands of youth using these products

Approved for sale and marketing by FDA

Conclusions

1. The Act makes it virtually, if not absolutely impossible to market aabsolutely, impossible to market a reduced risk tobacco product

2 Th A t k it ibl t ll2. The Act makes it possible to sell a reduced exposure product, but irt all impossible to market it asvirtually impossible to market it as such

Conclusions

3. The Act therefore sacrifices public health protection at the expense of protection of the dominant segments of the existing market

Conclusions

4. The Act, and the FDA’s implementation efforts to date, are not science‐based.

Instead, they have both served a , yprotectionist purpose: to protect the current market share of the leading cigarette brands and insulate them from competition pfrom potentially safer products

Final Conclusions

The purpose of the legislation, and of the entire regulatory scheme, is to institutionalize and protect the existing tobacco market.

The result is to ensure that current, high‐risk products are favored g pover products that could potentially save millions of lives.p y