BOTTOM PART IS MY EMAIL TO FDA, TOP IS THEIR RESPONSE
Dear Mr. Songer,
Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, “Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act” (Deeming rule). Thank you for sharing your article with us. We cannot provide any comment on your opinion of the new law. However, I have provided some information that may assist with any dissemination of information that you choose as a part of your advocacy.
You may be interested to know that the FDA Center for Tobacco Products is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law—commonly called the Tobacco Control Act—gives us broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. The FDA’s mandate is to protect Americans from tobacco-related disease and death. Ultimately, we hope that regulating all tobacco products will have a positive impact on public health. That is the motivation for finalizing the rule.
We understand that consumers, manufacturers, retailers and related businesses will be impacted by this rule in some way. Given your interest in the rule, I want to share some additional information about it in case you would like to read more.
Final Rule Addresses Public Health Concerns Focusing on Youth
The Family Smoking Prevention and Tobacco Control Act (TCA), passed by Congress on a bipartisan basis and signed by the President in 2009, gave the FDA tools to protect the public from the harms of tobacco use. Since June 2009, the FDA has regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products under its tobacco control authority. The law also gave the FDA the ability, through rulemaking, to regulate additional products that meet the legal definition of a tobacco product.
This new rule brings all tobacco products under FDA oversight, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic step will help improve public health and protect future generations from the risks of tobacco use by putting additional restrictions in place that make it illegal to sell tobacco products to minors.
Before this rule, there was no federal law prohibiting stores and websites from selling e-cigarettes, hookah tobacco, and cigars to minors. The new rule aims to deter youth initiation through restricting youth access to these products by:
• Not allowing products to be sold to persons under the age of 18 years;
• Requiring age verification by photo ID;
• Not allowing the selling of tobacco products in vending machines (unless in an adult-only facility); and
• Not allowing the distribution of free samples.
The rule also serves as the foundation for future FDA actions related to tobacco, including where scientific data supports regulatory action, addressing flavors in combustible products.
Extending the FDA’s Authority is a Milestone in Public Health and Consumer Protection
Going forward, the FDA will be able to review all new tobacco products not yet on the market. The actions being taken also will help the FDA prevent misleading claims and provide consumers with better information about the risks of tobacco use. The rule also will allow the FDA to evaluate the ingredients of tobacco products, how those products are made, and their potential dangers.
The rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.
These requirements include:
• Registering manufacturing establishments and providing product listings to the FDA;
• Reporting ingredients, and harmful and potentially harmful constituents;
• Requiring premarket review and authorization of new tobacco products by the FDA;
• Placing health warnings on product packages and advertisements; and
• Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.
Under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to three years while manufacturers submit – and the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise the product will be subject to enforcement.
For More Information
To assist the newly-regulated tobacco industry in complying with the requirements, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.
For more information:
• Final Rule: https://federalregister.gov/a/2016-10685
• Deeming – Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah:http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm388395.htm
• FDA takes significant steps to protect Americans from dangers of tobacco through new regulation:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM499234.htm
We respect your opinion and value all of the comments that we receive. We appreciate you taking the time to share your thoughts with us.
Center for Tobacco Products
Food and Drug Administration
CTP Call Center: 1-877-CTP-1373
From: John T Songer Jr [mailto:email@example.com]
Sent: Tuesday, May 10, 2016 8:17 PM
After me and a few other reviewers and advocates came together we wrote this article, wanted to know if we left anything out?
The FDA has declared war on vaping. This so called deeming regulations aren’t rules any vaping business can work with. They’re an attack on what we do and who we are, and vapers are right to feel mad and betrayed. The regs are as bad as the most pessimistic advocates expected — or maybe even worse.
Don’t let anyone kid you. If you’re a manufacturer or seller of vapor products in the US, this is a death sentence for your business. And if you’re a consumer of anything other than cigalikes, it’s going to reduce your choices of legal products to almost zero. As it stands, on August 8 the vaping market will be frozen. You will not be able to make or sell any new products without approval from the FDA. And common consensus is, no one besides makers or cigalikes (Tobacco companies) will ever receive any sort of approval. No doubt after quite large financial fee (officially or under the table) Beyond that, vendors will have two years to file their pre-market tobacco applications. Each application for approval to sell “tobacco products” will probably cost over a million dollars, and there is no guarantee it will be accepted by the FDA.
The requirements are stupidly extreme. Aside from exacting scientific studies, you will have to prove that your product has a net benefit to the overall public health. Really? It’s an impossible standard to meet. If you don’t have several million dollars to gamble with, you can’t and won't survive if these regulations go into effect. That’s intentional on the FDA’s part. They know we can’t live in the world of extreme and exacting tobacco regulations and compliance. Our only hope is to stop the regulations from choking the thing that we love and depend on.
The Vapor Technology Association has a pretty good summary of what we know so far. And Mark Dickinson of Clarityse sums it up neatly: “The sheer scale of the regulatory burden is very likely to be the death knell for the huge majority of independent manufacturers and vape stores in the US, with almost all products currently available being taken off the market in 2-3 years time. It will also bring to an immediate halt all the US based innovation that has been so prevalent in the last few years.”
While claiming to protect children from nicotine addiction, Mitch Zeller and his agency have delivered a carefully crafted ban of all vapor products, except perhaps cigalikes made by Big Tobacco. They justify this by quoting the National Youth Tobacco Survey(NYTS) that shows vaping among teenagers growing. But they ignore the National Institute on Drug Abuse survey that showed only 20 percent of teens use nicotine in their e-cigs. The NYTS surveys don’t even ask whether kids use nicotine — or if they’re regular users or have just taken a single puff in the last 30 days. How convenient! They also ignore that all surveys show teen smoking at its lowest level ever. It’s not about smoking anymore; the objection is now to nicotine itself.
The FDA specifically says that nicotine in pharma products like patches and gum, lollipops, and flavored lozenges is not addictive or dangerous. But they ignore all evidence that the same may be true of nicotine in vapor products and couch their regulation in the lie that they’re protecting kids from “a lifetime of addiction.” Hello, nicotine candy and lollipops. If your company’s name is Pfizer or Johnson & Johnson, your tobacco-derived nicotine is a safe, non-addictive medicine. If your name is Joe’s Vape Juice, you’re a producer of deadly addictive poison that is a menace to society.
The age limit on buying vapor products that goes into effect on August 8 is window dressing. 48 states already ban sales to minors (and the others don’t because “health groups” fought against the minor bans because they wanted other restrictions included). But the FDA is playing this as an example of “protecting children.” And most of the mainstream media is swallowing it whole.
Meanwhile, the most dangerous consumer product in the history of the world will remain available and protected from competition. Adult smokers desperate for a way out will have the option of buying ineffective junk from the same companies that make the cigarettes that are killing them — or, if they want to jump through hoops and skirt the law, they can seek out black market vapeproducts. Many will just keep smoking.
The FDA wants to hand the vapor market to the supposed enemies of tobacco control on a silver platter. Call it a gift, a token offering to the tobacco industry that has learned to play so well within the restrictive regulatory framework they built together. The FDA loves Big Tobacco, but not because of bribes or collusion. It’s because they speak the same language and inhabit the same world — the world of legalistic government business regulations. The tobacco industry knows how to play this game, and has the resources available to play it.
In the UK, voices of logic have won the day. Public Health Englandand the Royal College of Physicians have advocated a harm reduction approach that includes encouraging smokers switching to vaping to avoid cigarettes. The FDA, afraid of criticism from their friends in the pharma-funded anti-nicotine “health” groups, went in the polar opposite direction: prohibition.
So, Is It All Over? Should We Pack up Our Mods and Buy a Pack of Camels?
No! We still have avenues open to fight this thing. But everyone needs to stop pretending that this pathway of pre-market applications and substantial equivalence is one we can walk. The deemings regs are a ban, plain and simple. But we need to get busy and act now. We have to get embrace the fact that we are the only ones who have a chance to stop the deeming ban from killing vaping as we know it. No white knight is riding in to protect us. What should we do now?