FDA and Health Canada – are we asking these trains to come off their tracks?

Yes, that is a bit of an unwieldly title.

I was reading the FDA response to a citizen petition from Nirav Shah (NY State Commissioner of Health), Kathleen Hoke (Director of the Legal Resource Center for Tobacco Regulation etc.) and Matthew Myers (Tobacco-Free Kids) – see full letter below – on their request that the labels for pharmaceutical nicotine replacement therapies change to allow for comparison to smoking, longer use, higher doses, use while smoking, being available wherever cigarettes are sold, collaborate with the manufacturers on further development, etc., and noted that

1. these anti-nicotine campaigners (Myers certainly) were advocating reasonable changes to products that would improve their efficacy in weaning smokers and

2. these same changes would improve the possibility of these products as long time alternatives to smoking and

3. these labels would state unequivocally that using these smokeless products were safer than smoking (the FDA responds that this is too broad a statement and may not be true in all cases).

All well and good but it is quite obvious that while these are good suggestions, and that these suggestions should be applied to all smokeless tobacco products, that

1. the petitioners would never support these suggestions for non-pharmaceutical products and

2. this might easily have been intended to undermine the market and advocacy for other effective smoking alternatives (smokeless tobacco and e-cigarettes) and to get to the main point of this posting

3. the FDA response was we can’t consider doing anything unless the sponsors (the pharmaceutical industry) ask us to

And hence the title in that we have government (supposedly public) agencies that cannot act in response to the public but only to industry or other government queries. And yet these same agencies hold public consultations.

The FDA tagline is Protecting and Promoting Your Health. What should be added is the phrase – As long as the corporation making the product asks us to do so. Though the general impression of the agency is one looking to improve public health within this letter is a sentence which states that the FDA “evaluation of new products is based on the intended use proposed by the sponsor”.

In other words, no matter how beneficial a product might be, no matter how perfect an alternative to smoking, if the producer does not promote it as such, the FDA cannot or will not label it as such. I would have thought that (and I am quite naive it seems in the matters of those looking to the public interest) such an agency would be a little more proactive when it came to these matters.

But what we are left with is the depressing thought that no amount of public response can directly influence these agencies. Not only do they seem recalcitrant but they are bound by rules that sometimes prevent them from acting in the public interest. They are trains and we are asking them to divert to our towns not realizing they cannot leave the tracks.

The point is that the only effective action is to influence those who can influence the FDA or Health Canada. Letters to these agencies may be less effective than growing the market for the products or uses of products they do not approve of. There is a point where most governments cannot neglect the public interest (smoking still being legal is a case in point). E-cigarettes are being challenged like clockwork but each day more people are switching over from smoking and banning becomes less likely.

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