Q: Which agency/agencies promulgated the regulation?
A: The FDA, particularly the CTP (Center for Tobacco Products)
Q: Which title, parts, and/or sections of the Code of Federal Regulations (C.F.R.) should be rescinded?
A: PMTA/Pre-Market Tobacco Application (21 CFR Parts 1100, 1107 and 1114)
Q: What is your name? (Only answer if you would like the rescission to be named after you or your organization. Providing your name does not guarantee that it will appear on any final agency action, and we reserve the right to refrain from using names that are inappropriate or offensive.)
A: I didn't answer, I don't want the rescission named after me.
Q: Is your proposed rescission a notice of proposed rulemaking, final rule, direct final rule, interim final rule, or interpretive rule?
A: Final Rule
Q: What is the name of the regulation being rescinded, if applicable? *
A: PMTA/Pre-Market Tobacco Application
Q: Please provide a short summary of the justifications for the rescission.
A: NOTE, the answer I give below is my response to this. It includes my story in it. I would advise you typing up your story in this response as to why you think the FDA should end tobacco and nicotine over-regulation.
My Answer: Before reading my responses to this, please note that I am not a lawyer. I am not an expert in regulations. However, I am a consumer, and an advocate. And I am writing because the FDA's over-regulation on tobacco and nicotine products is getting out of hand. People are dying because of it. At that point, it becomes an issue that needs to be solved. It is time for the FDA to follow the science and end their war on nicotine.
Greetings, to the FDA, and to whoever reads this. And, thank you for taking the time to hear from the public about certain over-regulation issues that need to be corrected. In 2009, I discovered Swedish Snus and was able to quit smoking. Nothing else worked for me. In short, Swedish Snus saved my life. Over the past 15-16 years, many of us (adult age consumers) have been able to import it to the US for personal use, without issue. The joy of the US Constitution is that it allows us to do what we want with our own bodies, such as enjoying nicotine. However, since the year began, the FDA has been putting multiple products on "import alert" and banning them from consumer access. Products are being "red-listed", and kept from consumer access. This needs to end.
Also, the PMTA process is deeply flawed. It favors big tobacco, and keeps consumers from having access to safer nicotine alternatives. For example, vape and nicotine pouches. I don't use them, but they're safer than smoking. Consumers should be able to access safer alternatives such as snus, vape, and nicotine pouches. The FDA should not be blocking the import of products such as Swedish Snus and nicotine pouches to consumers who choose to use them. The labeling, such as "sale only allowed in the United States" is keeping products from being imported. This is silly, and should be done away with.
In short, the FDA is over-regulating nicotine. The FDA should back off tobacco and nicotine proudcts and let consumers use what they want. We should be able to import what we want. Import Alerts need to end. Red-Listing needs to end. Products like snus save lives, and it's time for the FDA to follow the science and embrace tobacco harm reduction.
Q: Please insert the address of the agency. [NPRM, DFR, and IFR only]
A: Food and Drug Administration, 10903 New Hampshire Avenue, Building 71, Room G335, Silver Spring, MD 20993-0002
Q: Please insert the contact information for the agency
A: AskCTP@fda.hhs.gov
Q: What is the background for the regulation being rescinded? *
A: The FDA has pursued tobacco control for two general stated reasons: "public health" and "to keep kids from using these products". However, they are not working in the interest of either one. Kids aren't using these products in any large numbers. And, the FDA isn't working in the interest of public health. In fact, they're doing quite the opposite. By ignoring the science, fighting against tobacco harm reduction, and banning/blocking as many of these products as they possibly can, they are keeping consumers from having access to safer nicotine alternatives, such as snus. The background is faulty, because it doesn't approach this issue in a public health light. If this issue was approached with public health in mind, the FDA would de-regulate as much as humanly possible in regard to safer nicotine alternatives such as snus.
Q: Explain the reasons for the rescission
A: Millions of Americans are dying from smoking. This should be reason enough. But surprisingly, it hasn't been. The FDA has continued to fight against safer nicotine alternatives while more and more people are dying because access to these products is being blocked, at every turn, by the FDA. The FDA needs to rescind any regulations that keep safer nicotine alternatives from consumers (outside of warning labeling and age requirements), and let people have access to these products.
Q: Describe the text of the relevant C.F.R. provisions as it will exist after the rescission.
A: After the rescission, there shouldn't be any text. All of this needs to be done away with. This issue is being over-regulated to the point of exhaustion.
Q: Please insert the name of the current agency head.
A: Martin A. Makary, M.D.
Q: Please insert the title of the agency head.
A: FDA Commissioner
Final Thoughts
I don't know if I filled it out adequately. I don't know if I listed all the relevant law codes and whatnot that they want to know. But I did my best. In the end, I wanted to at least share my story, and get something across to them about my thoughts on FDA over-regulation of tobacco and nicotine products. In the end, it is my hope that the FDA sees the public interest, and realizes they are working against public health, and they do something about this!
Fill it out, today: https://www.regulations.gov/deregulation
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