FDA Rules Extended to Cover Electronic Nicotine Delivery Systems

Published By:
Jessie Paluch
Jessie Paluch

Attorney Jessie Paluch, founder of TruLaw, has over 25 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.

TruLaw does everything possible to make sure the information in this article is up to date and accurate. If you need specific legal advice about your case, contact us by using the chat on the bottom of this page. This article should not be taken as advice from an attorney.

FDA Rules Extended to Cover Electronic Nicotine Delivery Systems

On April 25, 2016, long-awaited federal rules putting regulation of all tobacco products, including e-cigarettes, vaporizers, and other electronic nicotine delivery systems (ENDS), under the authority of the U.S. Food and Drug Administration (FDA) became final.

Until now, ENDS, or products that use liquid nicotine, as well as varying compositions of flavorings, propylene glycol, glycerin, and other ingredients, have been largely unsupervised by the government.

fda electronic nicotine delivery systems
Table of Contents

What The New Rules Require

The FDA rules for electronic nicotine delivery systems (ENDS) prohibit selling “covered tobacco products” to people younger than 18, and buyers must show photo ID.

Under the rules, the FDA would have to approve all tobacco products not currently regulated that hit stores after February 2007, and e-cigarette manufacturers will be required to allow government review of how the devices are made before they can be sold to adults in the U.S. The federal rules include other controls on tobacco products, including banning free samples, prohibiting vending machine sales, and requiring warning labels on packaging.

Manufacturers will also be required to disclose the ingredients in the liquid nicotine used in vaping.

Currently, the disclosure of what is contained in that liquid is not required, and dangerous chemicals such as Diacetyl and Acetyl Propionyl, flavorings associated with lung disease, have been found in e-cigarette juice.

E-cigarettes commonly contain flavorings that make them more popular with youth, including cotton candy, bubble gum, and chocolate, but these flavorings may cause respiratory disease and are known to be dangerous when inhaled.

E-Cigarettes Popular with America’s Youth

Use of these electronic nicotine delivery systems has been growing rapidly in the last few years, particularly among young people.

According to the Center for Disease Control and Prevention (CDC), three million middle and high school students are current users of e-cigarettes, up from 2.5 million in 2014.

Previous research has shown that teenagers who try e-cigarettes may be more than twice as likely to try conventional cigarettes as opposed to adolescents who have never tried the devices.

Diacetyl, a flavoring chemical linked to cases of severe respiratory disease referred to as “popcorn lung disease” and the subject of a number of diacetyl lawsuits was found in more than 75% of flavored electronic cigarettes, according to a Harvard Chan School of Public Health study.

More research is needed to determine how the heating mechanism in E-cigarettes would effect e-juice containing Diacetyl.

Until such research is complete, consumers need to be warned that a dangerous substance that causes an irreversible disease is in their e-cigarettes.

Published By:
Jessie Paluch
Jessie Paluch

Experienced Attorney & Legal SaaS CEO

With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!

AFFF Lawsuit

AFFF Lawsuit claims are being filed against manufacturers of aqueous film-forming foam (AFFF), commonly used in firefighting.

Claims allege that companies such as 3M, DuPont, and Tyco Fire Products failed to adequately warn users about the potential dangers of AFFF exposure — including increased risks of various cancers and diseases.

Suboxone Lawsuit

Suboxone Tooth Decay Lawsuit claims are being filed against Indivior, the manufacturer of Suboxone, a medication used to treat opioid addiction.

Claims allege that Indivior failed to adequately warn users about the potential dangers of severe tooth decay and dental injuries associated with Suboxone’s sublingual film version.

Social Media Lawsuits

Social Media Harm Lawsuits are being filed against social media companies for allegedly causing mental health issues in children and teens.

Claims allege that companies like Meta, Google, ByteDance, and Snap designed addictive platforms that led to anxiety, depression, and other mental health issues without adequately warning users or parents.

Vaginal Mesh Lawsuits

Transvaginal Mesh Lawsuits are being filed against manufacturers of transvaginal mesh products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Claims allege that companies like Ethicon, C.R. Bard, and Boston Scientific failed to adequately warn about potential dangers — including erosion, pain, and infection.

Bair Hugger Lawsuit

Bair Hugger Warming Blanket Lawsuits involve claims against 3M — alleging their surgical warming blankets caused severe infections and complications (particularly in hip and knee replacement surgeries).

Plaintiffs claim 3M failed to warn about potential risks — despite knowing about increased risk of deep joint infections since 2011.

Baby Formula NEC Lawsuit

Baby Formula NEC Lawsuit claims are being filed against manufacturers of cow’s milk-based baby formula products.

Claims allege that companies like Abbott Laboratories (Similac) and Mead Johnson & Company (Enfamil) failed to warn about the increased risk of necrotizing enterocolitis (NEC) in premature infants.

Do You
Have A Case?

Here, at TruLaw, we’re committed to helping victims get the justice they deserve.

Alongside our partner law firms, we have successfully collected over $3 Billion in verdicts and settlements on behalf of injured individuals.

Would you like our help?

Helpful Sites & Resources