Juul defends product benefits in FDA court battle

Jun.29.2022
Juul defends product benefits in FDA court battle
Juul argues that FDA ignored data showing benefits to public health, and bans have "serious flaws.

Electronic cigarette giant Juul has defended itself in court filings submitted on Tuesday, stating that the US Food and Drug Administration (FDA) ignored extensive data included in its application that showed the product is beneficial for public health. Juul also claimed that the ban on its product has "serious flaws.

 

In court documents, Juul stated that it included over 110 scientific studies and more than 125,000 pages of data and analysis, which showed that its products provide "significant public health benefits.

 

The company claims that its electronic cigarette helps people transition from traditional cigarettes to e-cigarettes, reducing their exposure to "deadly toxins." It also claims that e-cigarettes are "less attractive to non-smokers.

 

Last week, the FDA announced a ban on Juul's marketing and sale of their products. According to the agency's decision, products already on the market must be removed. According to the US Food and Drug Administration, Juul failed to prove that keeping its products on the market "serves the public interest in protecting public health.

 

One day after the FDA announced a ban, a federal appeals court has temporarily blocked the decision, pending further arguments.

 

In their statement, Juul argued that the FDA's refusal of their application and demand for all Juul products to be removed from shelves was based on arbitrary reasons instead of acknowledging significant public health successes. They claimed that the FDA's decision failed to address scientific facts.

 

Juul has refuted the FDA's claim that it did not provide data on the impact of four chemicals in its aerosol. Juul has stated that it has actually provided over 6,000 pages of valuable data.

 

Juul appears to suggest that the FDA has succumbed to political pressure from lawmakers, claiming that Congress has unprecedentedly intervened in the approval process.

 

Juul has expressed concern that if the ban is enforced, the company will suffer "significant and irreversible harm," and is advocating for its products to continue being available in the interest of public health.

 


Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
China Tobacco Supply-Chain Leader Huabao’s Three-Way Transformation Takes Hold as Overseas Revenue Jumps 216%, Non-Flavor Businesses Reach 42.2% and the Company Expands Into Global Next-Generation Tobacco Supply Chains
Huabao’s H1 2026 results show the company advancing across three connected fronts: international expansion, entry into next-generation tobacco supply chains and diversification beyond its traditional tobacco-related base. Overseas revenue rose 216.08% to CNY 96.02 million, while non-flavor businesses reached 42.2% of total revenue. Huabao also said it had entered the supply chains of leading global tobacco customers, as its nutrition, food ingredient, fragrance and personal-care businesses gained ground in Europe, Southeast Asia, Australia and New Zealand. However, adjusted net profit increased only 2.78%, and next-generation tobacco revenue was not separately disclosed, showing that the transformation is reshaping revenue and customer exposure but has yet to translate fully into underlying earnings.
Aug.28
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Couche-Tard Posts Double-Digit U.S. Same-Store Growth in Other Nicotine Products, Led by Pouches
Alimentation Couche-Tard said U.S. same-store sales in its “other nicotine products” category grew at a double-digit rate in the first quarter of fiscal 2027, led by nicotine pouches, while overall U.S. same-store merchandise revenues increased 1.7%. The company also said its Canadian nicotine business continued to face regulatory pressure and illicit-market headwinds. The U.S. performance coincides with Couche-Tard's participation in efforts to reopen Canadian convenience-store access to authorized nicotine pouches, though the company has not established a direct causal link between the two.
Sep.14
Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping
Philippines BIR Steps Up Illicit Vape Enforcement Ahead of Christmas Shopping
The Philippines’ Bureau of Internal Revenue is intensifying enforcement against illicit vape and tobacco products ahead of the Christmas shopping season, directing regional and enforcement offices to strengthen monitoring of production sites, warehouses, distribution channels and retail outlets. The BIR destroyed 240,550 illicit vape products in August with an estimated tax liability of about PHP1.53 billion. A nationwide tax-compliance operation in July also inspected 3,590 businesses involved in tobacco and vapor products.
Regulations
Sep.17 by 2Firsts Perspectives
Smoore Seeks to Toss CCELL Price-Fixing Claim as Court Weighs Vertical Distribution Versus Horizontal Conspiracy
Smoore Seeks to Toss CCELL Price-Fixing Claim as Court Weighs Vertical Distribution Versus Horizontal Conspiracy
Smoore and four authorized U.S. CCELL distributors are asking a California federal court to permanently dismiss a core antitrust claim brought by direct purchasers. Plaintiffs allege that Smoore coordinated minimum wholesale prices, customer allocation and limits on price competition among distributors, amounting to a per se unlawful horizontal conspiracy. The defendants say the alleged conduct reflects ordinary vertical relationships between a manufacturer and its distributors. The court previously dismissed a similar claim, and the latest dispute centers on whether the second amended complaint adds sufficient facts to establish a horizontal agreement.
Sep.14
Trump Picks White House Health Policy Aide Heidi Overton to Lead FDA, Pending Senate Confirmation
Trump Picks White House Health Policy Aide Heidi Overton to Lead FDA, Pending Senate Confirmation
U.S. President Donald Trump has chosen White House health policy aide Heidi Overton to lead the Food and Drug Administration, Bloomberg reported, citing a person familiar with the matter. Overton currently works on health policy at the White House and previously held a senior role at the America First Policy Institute. If confirmed by the Senate, she would take over an FDA that has experienced months of senior-level turnover. The agency regulates products representing roughly one-fifth of U.S. consumer spending, including e-cigarettes, drugs, vaccines and much of the food supply.
News
Aug.19
Special Report|AIR H1 Revenue Rises 3.7% as Shisha Volumes Fall 9%, Testing Its Shift Beyond Traditional Hookah
Special Report|AIR H1 Revenue Rises 3.7% as Shisha Volumes Fall 9%, Testing Its Shift Beyond Traditional Hookah
AIR’s first half-year results as a listed company offer a new test of how far a traditional hookah business can transform. H1 2026 revenue rose 3.7%, even as Flavored Shisha Molasses shipments fell 9%, with pricing and mix supporting growth. Traditional shisha still generates almost all revenue, while OOKA, Crown Switch, Greentank and U.S. regulatory spending point to accelerating diversification. The next test is whether those investments can become a second business of meaningful scale and profitability.
Capital Markets
Aug.21