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Juul sues FDA for documents said to justify e-cigarette ban

By Jonathan Stempel (Reuters) - Juul Labs has sued the U.S. Food and Drug Administration over the agency's refusal to disclose documents supporting its order banning the company,...
Juul sues FDA for documents said to justify e-cigarette ban © Reuters. FILE PHOTO: A man uses a Juul vaporizer in Atlanta, Georgia, U.S., September 26, 2019. REUTERS/Elijah Nouvelage
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By Jonathan Stempel

(Reuters) - Juul Labs has sued the U.S. Food and Drug Administration over the agency's refusal to disclose documents supporting its order banning the company, which has been blamed for fueling a teenage vaping crisis, from selling e-cigarettes on the U.S. market.

In a complaint filed on Tuesday with a federal court in Washington, D.C., Juul accused the FDA of invoking the "widely abused" deliberative process privilege to improperly withhold scientific materials that are "central" to understanding the basis for the June 23 sales ban.

Juul said the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims they help smokers quit cigarettes, and whether the agency's reasoning was scientifically sound.

"The public deserves a complete picture of the scientific facts behind one of the agency's most controversial and closely scrutinized decisions in recent years," Juul said.

An FDA spokeswoman declined to comment, saying the agency does not discuss pending litigation.

Juul accused the FDA of violating the federal Freedom of Information Act by withholding a majority of the "scientific disciplinary reviews" underlying the sales ban.

It said it filed an administrative appeal through the agency, but the FDA missed a Sept. 13 deadline to resolve it.

A federal appeals court temporarily stayed the sales ban on June 24.

The FDA then decided on July 5 to let Juul keep selling its products for the time being, saying "scientific issues" unique to the company warranted further review.

On Sept. 6, Juul agreed to pay $438.5 million to settle claims by 34 U.S. states and territories over its marketing and sales practices, including that it improperly courted teenage buyers.

Marlboro cigarette maker Altria Group (NYSE:MO) Inc paid $12.8 billion in 2018 for a 35% stake in Juul. Altria valued that stake at $450 million as of June 30.

The case is Juul Labs Inc v Food & Drug Administration, U.S. District Court, District of Columbia, No. 22-02853.

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    EUR/USD 0.9726 ↑ Sell  
    GBP/USD 1.0866 ↑ Sell  
    USD/JPY 144.18 ↑ Buy  
    AUD/USD 0.6515 ↑ Sell  
    USD/CAD 1.3615 ↑ Buy  
    EUR/JPY 140.23 ↑ Sell  
    EUR/CHF 0.9497 Neutral  
    Gold 1,667.20 ↑ Sell  
    Silver 18.887 Sell  
    Copper 3.3825 ↑ Sell  
    Crude Oil WTI 81.74 ↑ Sell  
    Brent Oil 87.98 ↑ Buy  
    Natural Gas 7.016 ↑ Sell  
    US Coffee C 227.80 ↑ Sell  
    Euro Stoxx 50 3,335.30 Neutral  
    S&P 500 3,719.04 ↑ Sell  
    DAX 12,183.28 Neutral  
    FTSE 100 7,005.39 Neutral  
    Hang Seng 17,250.88 Buy  
    Small Cap 2000 1,725.13 ↑ Buy  
    IBEX 35 7,442.20 Neutral  
    BASF 39.415 ↑ Buy  
    Bayer 48.19 Neutral  
    Allianz 160.72 ↑ Buy  
    Adidas 130.24 ↑ Buy  
    Lufthansa 5.772 ↑ Buy  
    Siemens AG 99.46 ↑ Buy  
    Deutsche Bank AG 7.854 ↑ Sell  
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