ADDITIONAL FDA V.S. E-CIGARETTE ARTICLES
NEW FDA REGULATIONS
The FDA's new deeming rule has labeled all e-liquid and vaping hardware as tobacco products and extends their authority over these products. The new FDA regulations require us to confirm customer's age via a state ID and the process for doing this over the internet is costly. While we love being able to offer our customer's the convenience of ordering online, it is no longer cost effective for us to offer an online ordering system. If the FDA regulations change in the future, we will reconsider offering the online store once again. We appreciate your continued support and patronage and apologize for this disappointing inconvenince. For more information on the new FDA regulations, please see below.
Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah
Tobacco use is the single largest preventable cause of disease and death in the United States. As part of its goal to improve public health and protect future generations from the risks of tobacco use, the FDA has extended its authority to cover all products that meet the definition of a tobacco product.
Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule – Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act – which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.
This action is a milestone in consumer protection – going forward, the FDA will be able to:
Review new tobacco products not yet on the market;
Help prevent misleading claims by tobacco product manufacturers;
Evaluate the ingredients of tobacco products and how they are made; and
Communicate the potential risks of tobacco products.
Provisions and Requirements
The final rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions related to tobacco products in the Federal Food, Drug, and Cosmetic Act and FDA regulations, including:
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.
In addition, there are several provisions aimed at restricting youth access to tobacco products, including:
Not allowing products to be sold to persons under the age of 18 years (both in-person and online);
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.
Today’s historic rule serves as the foundation for future FDA regulations.
A New Standard of Effective Regulation
FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole, including users and nonusers. Similarly, when developing certain regulations, the law requires FDA to apply a public health approach that considers the effect of the regulatory action on the population as a whole, not just on individual users, with respect to initiation and cessation of tobacco use.
Final Rule 05/05/16
Final Rule 05/05/16
Final Rule 09/24/15
Proposed Rule 09/24/15
Advance Notice of Proposed Rulemaking (ANPRM) 07/01/15
Final Rule 07/10/14
Advance Notice of Proposed Rulemaking (ANPRM) 07/24/13
Established List 04/03/12
Regulatory Update 02/24/12
Advance Notice of Proposed Rulemaking (ANPRM) 12/06/11
Proposed Rule 11/10/11
Enforcement Action Plan 10/31/11
Advance Notice of Proposed Rulemaking (ANPRM) 09/09/11
Final Rule 07/05/11
Final Rule 06/22/11
Final Rule 11/30/10
Advance Notice of Proposed Rulemaking (ANPRM) 03/19/10
Final Rule 03/18/10