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From Australia, writing a book. Unsure of legal position for the US reader.

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#1
Hello there,

I am a Psychologist that specialises in tobacco cessation in Australia and currently writing a smoking cessation book that I plan to publish online, andtherefore available to anyone across the globe.
To cut a long story short, in Australia and Great Britain, it is common practice to reduce smoking first with the help of Nicotine Replacement Therapy (NRT) while you continue to smoke, and this is outlined in the consumer medicine leaflet as an approved option by our regulators. These NRT products are available to anyone over the age of 12 here, over the counter at the pharmacist (with or without prescription)
However, in the USA, it's a different story. When buying NRT over the counter, 'reducing smoking while using NRT to aid in reduction' is not yet approved and is not an option written on the instruction insert. Although it is common practice to use NRT products to reduce smoking first, a consumer would officially need approval by their doctor as it would be considered 'off-label' use otherwise.
My question is, is it sufficient enough to provide an explanation about this and to request that they visit their doctor first before trying to use NRT while continuing to smoke? If not, what would need to occur to ensure this met legal responsibilities?
Below is the general guidance I plan to provide in the book. (note: NRT are known to be very safe products and I've never come across a case yet where there has been legal issues on behalf of a consumer).
Your assistance would be most appreciated.

From the book:

Information you need to know about first
You could be reading this guide anywhere in the world. Your own country has Government Departments that develop and administer rules, regulations and guidelines around quit smoking strategies and medications. These can vary quite a lot between countries even though we all have access to the same scientific evidence. They also change and update regulations and guidelines frequently.
One suggestion in this section is to reduce smoking first by using Nicotine Replacement Therapy (NRT) to help with the reduction before trying to quit. In some countries like Australia and Great Britain this is an approved and standard practice. The procedure to follow and who it is suitable for is outlined clearly on the NRT pack insert. In some countries this may not a typical practice and yet in others it’s not an approved practice. You will need to find out through your local Pharmacist, Doctor or Quitline (smoker’s helpline) if this is currently an approved approach in your country. In some countries reducing smoking to quit with NRT may not be usual practice, but is still frequently provided by a Doctor or Pharmacist’s guidance.
Access to and cost of Nicotine Replacement Therapy (NRT) varies from country to country too. Some countries provide NRT ‘over the counter’ (that is, no prescription is needed) at pharmacists and sometimes supermarkets while others provide access through a Doctor’s prescription and is subsidised by government. In others the cost is subsidised through a voucher system. Please see your own local pharmacist or Health care provider or call your local Quitline to find out more about current access and cost.
Before you commence any plan
You should visit your Medical Doctor first before starting this or any other quit smoking plan. Discuss this plan or any other method with your doctor. Your doctor can decide with you if it is appropriate after taking into account all of your circumstances. Please do not go against your doctor’s advice.
The nicotine replacement therapy part of the plan in this book is not intended for and is not suitable for children, pregnant women, breastfeeding women or those with any unstable mental or physical illness or people with cardiovascular disease, unless under medical doctor approval and supervision. The strategies provided in this plan are a general guide only but still one that you can easily discuss with your doctor and/or pharmacist. It could save your life. It is suited to the large majority of adult smokers.
In countries where reducing with nicotine replacement therapy first before completely quitting sometimes called pre-quit and ‘cut down and stop’ is approved and where you can buy the nicotine replacement therapy without a medical prescription, you may simply start the plan after discussing this with your pharmacist and then purchasing NRT at the pharmacist. Your pharmacist will guide you. However do not go against your pharmacist’s advice. It is a good idea to see your Medical Doctor first though to discuss this or any other smoking cessation plan.


 


LdiJ

Senior Member
#2
It sounds to me like you have fully covered your bases. However, it would probably be in your best interest to run that by an attorney that is working for you, in at least the countries where English is the primary language. I realize that it would be absurdly expensive to run it by an attorney in every country in the world, but it would make sense to do so in the countries where English is the primary language.
 

quincy

Senior Member
#3
Hello there,

I am a Psychologist that specialises in tobacco cessation in Australia and currently writing a smoking cessation book that I plan to publish online, andtherefore available to anyone across the globe.
To cut a long story short, in Australia and Great Britain, it is common practice to reduce smoking first with the help of Nicotine Replacement Therapy (NRT) while you continue to smoke, and this is outlined in the consumer medicine leaflet as an approved option by our regulators. These NRT products are available to anyone over the age of 12 here, over the counter at the pharmacist (with or without prescription)
However, in the USA, it's a different story. When buying NRT over the counter, 'reducing smoking while using NRT to aid in reduction' is not yet approved and is not an option written on the instruction insert. Although it is common practice to use NRT products to reduce smoking first, a consumer would officially need approval by their doctor as it would be considered 'off-label' use otherwise.
My question is, is it sufficient enough to provide an explanation about this and to request that they visit their doctor first before trying to use NRT while continuing to smoke? If not, what would need to occur to ensure this met legal responsibilities?
Below is the general guidance I plan to provide in the book. (note: NRT are known to be very safe products and I've never come across a case yet where there has been legal issues on behalf of a consumer).
Your assistance would be most appreciated.

From the book:

Information you need to know about first
You could be reading this guide anywhere in the world. Your own country has Government Departments that develop and administer rules, regulations and guidelines around quit smoking strategies and medications. These can vary quite a lot between countries even though we all have access to the same scientific evidence. They also change and update regulations and guidelines frequently.
One suggestion in this section is to reduce smoking first by using Nicotine Replacement Therapy (NRT) to help with the reduction before trying to quit. In some countries like Australia and Great Britain this is an approved and standard practice. The procedure to follow and who it is suitable for is outlined clearly on the NRT pack insert. In some countries this may not a typical practice and yet in others it’s not an approved practice. You will need to find out through your local Pharmacist, Doctor or Quitline (smoker’s helpline) if this is currently an approved approach in your country. In some countries reducing smoking to quit with NRT may not be usual practice, but is still frequently provided by a Doctor or Pharmacist’s guidance.
Access to and cost of Nicotine Replacement Therapy (NRT) varies from country to country too. Some countries provide NRT ‘over the counter’ (that is, no prescription is needed) at pharmacists and sometimes supermarkets while others provide access through a Doctor’s prescription and is subsidised by government. In others the cost is subsidised through a voucher system. Please see your own local pharmacist or Health care provider or call your local Quitline to find out more about current access and cost.
Before you commence any plan
You should visit your Medical Doctor first before starting this or any other quit smoking plan. Discuss this plan or any other method with your doctor. Your doctor can decide with you if it is appropriate after taking into account all of your circumstances. Please do not go against your doctor’s advice.
The nicotine replacement therapy part of the plan in this book is not intended for and is not suitable for children, pregnant women, breastfeeding women or those with any unstable mental or physical illness or people with cardiovascular disease, unless under medical doctor approval and supervision. The strategies provided in this plan are a general guide only but still one that you can easily discuss with your doctor and/or pharmacist. It could save your life. It is suited to the large majority of adult smokers.
In countries where reducing with nicotine replacement therapy first before completely quitting sometimes called pre-quit and ‘cut down and stop’ is approved and where you can buy the nicotine replacement therapy without a medical prescription, you may simply start the plan after discussing this with your pharmacist and then purchasing NRT at the pharmacist. Your pharmacist will guide you. However do not go against your pharmacist’s advice. It is a good idea to see your Medical Doctor first though to discuss this or any other smoking cessation plan.
If you have not consulted with a publishing law attorney already, you should. Your disclaimers and your manuscript should be personally reviewed in their entirety and edited and revised as deemed necessary prior to publication.

Any publication that is aimed at a specific audience should make that clear.

We cannot analyze the text for you to tell you if it adequately protects you. The analysis gets into the practice of law and for that you will need an attorney licensed to practice in your jurisdiction.

Good luck.
 

quincy

Senior Member
#5
You're welcome, from afar. We both appreciate the thanks.

As an off-topic note: Your Australian bush ticks (also known as long-horned ticks) recently arrived in the US. I much prefer the alcohol you export. ;)
 

Just Blue

Senior Member
#6
You're welcome, from afar. We both appreciate the thanks.

As an off-topic note: Your Australian bush ticks (also known as long-horned ticks) recently arrived in the US. I much prefer the alcohol you export. ;)
Gross....Where are the little buggers? (Please not NV...please not NV...please not NV...)
 
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