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Tag: Tobacco Products

Congress Increases Minimum Tobacco Sales Age to 21

18to21, minimumage, Tobacco Control Act, Tobacco Products, Tobacco Retailer InspectionsFDA

On December 20, 2019, changes to the minimum tobacco-sale age were signed into law, increasing the federal minimum age for tobacco sales from 18 to 21. The U.S. Food & Drug Administration (“FDA”), the Agency responsible for enforcing age-related sale …

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FDA Warns JUUL, Alleging Marketing Violations

e-cigarettes, fda warning letters, tobacco, Tobacco Control Act, Tobacco Products, Tobacco Warning LetterUncategorized

On September 9, 2019, the U.S. Food & Drug Administration (FDA) issued a Warning Letter to JUUL Labs, Inc. (JUUL), in connection with the marketing of its exceedingly popular e-cigarette products. According to the FDA, JUUL is alleged to have …

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FDA to Regulate New Tobacco Products, E-Cigarettes

e-cigarettes, FDA, imports, Labeling, Rulemaking, Tobacco ProductsFDA

On April 24, 2014, the U.S Food and Drug Administration (FDA) announced its publication of newly proposed regulations pertaining to new tobacco products, as permitted by the Family Smoking Prevention and Tobacco Control Act of 2009. The products covered under …

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FDA Considering Rulemaking for Menthol Cigarettes

Cigarettes, FDA, Menthol Cigarettes, Rulemaking, Tobacco ProductsFDA

On July 23, 2013, the U.S. Food and Drug Administration (FDA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) to request information regarding the agency’s regulation of menthol cigarettes. Menthol is a common flavoring additive used in tobacco products and …

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FDA Issues Substantially Equivalent Marketing Orders for New Tobacco Products

FDA, Tobacco ProductsFDA

On June 25, 2013, the U.S. Food and Drug Administration (FDA) issued substantially equivalent (SE) marketing orders for two new tobacco products marketed by Lorillard Tobacco Company, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. This is the …

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FDA Issues Warning Letters to Online Cigarette Companies

Cigarettes, FDA, Labeling, Tobacco Products, Warning LettersFDA

In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many of their products adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the …

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FDA Warns Online Cigarette Retailers for Marketing Violations

FDA, Guidance, Tobacco Products, Warning LettersFDA

In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes, detailing certain marketing or product statements made that are in violation of federal laws that govern the practice. Several companies …

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    Katherine L. Giannamore
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    FDA Legal Topics

    510(k) Adverse Events Allergens Beverages CDRH CGMP Cosmetics Dietary Supplements Disease Claims Drug Drugs Enforcement FDA Food Food Facility Registration Food Safety Modernization Act FSMA FTC Gluten-Free GRAS Guidance imports Injunction Labeling Listeria mad cow Medical Devices NDA Nutrition Facts off-label promotion off-label use Orphan Designation Orphan Drug PMA post-marketing studies Recalls Rulemaking Salmonella Structure-Function Claims Substantiation Tobacco Control Act Tobacco Products Tobacco Warning Letter USDA Warning Letters

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    Recent Posts

    • FDA Halts Voluntary Cosmetic Registrations Amidst Overhauls      
    • Congress Increases Minimum Tobacco Sales Age to 21
    • FDA Warns JUUL, Alleging Marketing Violations
    • FDA Warning Letters for Alzheimer’s Supplement Claims
    • FDA Considers Changing Major Food Allergen Labeling Requirements
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