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The deadline for e-cigarette manufacturers to submit their premarket tobacco applications (PMTA) to the U.S. Food and Drug Administration (FDA) will be coming sooner rather than later. The FDA announced that the deadline for PMTA applications would move up to 2020, up two years from the previous deadline of 2022. The earlier deadline comes as […]
The post FDA Proposed 10-Month Deadline for E-Cigarette PMTA Applications appeared first on Tobacco Business Magazine.
The U.S. Food and Drug Administration (FDA) has announced that it has extended the commenting period for the agency’s draft guidance on Substantial Equivalence (SE) by 30 days, to July 17, 2019. Substantial Equivalence is a means in which tobacco manufacturers can utilize to keep products introduced after Feb. 15, 2017 on the market, bypassing […]
The post FDA Extends Commenting Period for Substantial Equivalence Draft Guidance appeared first on Tobacco Business Magazine.
On May 31, 2019, the U.S. Food and Drug Administration (FDA) held its first public hearing on cannabidiol (CBD). The popular extract is derived from hemp or marijuana plants and has become a popular product in recent years, now found in food, beauty, oils, tinctures and other products sold in many different retail outlets including […]
A federal budget has ordered the U.S. Food and Drug Administration (FDA) speed up the review of e-cigarettes currently being sold on the U.S. market. This ruling coincides with claims made by several public health groups that accused the FDA of neglecting its public duty of reviewing all U.S. vaping products by several years. Last […]
The post Judge Orders FDA to Speed Up Review of E-cigarettes appeared first on Tobacco Business Magazine.
A variety of retailers have been caught up in the latest round of warning letters issued by the U.S. Food and Drug Administration (FDA) after being accused of selling tobacco products to minors. Among the retailers that received warning letters on April 5, 2-19, from the FDA include Kroger, Walmart, 7-Eleven, Family Dollar, Exxon, BP, […]
The post Convenience Stores and Big Retailers Caught Up in FDA Warning Letters appeared first on Tobacco Business Magazine.
The U.S. Food and Drug Administration (FDA) has announced several new actions as part of its efforts to improve the application review process for tobacco products. These new proposals and updated guidances were created in response to a public meeting held in October 2018 and input from tobacco manufacturers gathered in the past year [read […]
The post FDA Aims to Improve Substantial Equivalence Report Process for Tobacco Manufacturers appeared first on Tobacco Business Magazine.
If you’re a retailer that carries vapor and e-cigarette products, the U.S. Food and Drug Administration (FDA) has finalized its compliance policy surrounding retailer actions regarding e-cigarette products. The updated guidance comes as the FDA prepares to lose its current leader, commissioner Dr. Scott Gottlieb, who announced his resignation in early March 2019 [read more […]
The post FDA Finalizes Compliance Policy for Vape Shops that Modify E-Cigarettes appeared first on Tobacco Business Magazine.
The U.S. Food and Drug Administration (FDA) has announced new policies impacting e-cigarettes and the use of flavors in tobacco products, including e-cigarettes and cigars. This policy shift comes as the FDA continues to look at ways to limit youth access to e-cigarettes and tobacco products and addiction to nicotine. The FDA has released a […]
The post FDA Announces New Policies Aimed at E-Cigarettes and Flavored Tobacco Products appeared first on Tobacco Business Magazine.
In mid-November 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement regarding proposed regulatory policy changes on certain flavored electronic cigarettes, flavors in cigars and menthol in combustible tobacco products (including cigarettes and cigars). Since that time, questions have arisen as to exactly what the FDA can do and what it […]
The U.S. Food and Drug Administration (FDA) has extended the Harmful and Potentially Harmful Constituents (HPHCs) reporting compliance date. The deadline for this testing was set for Nov. 8, 2019. The new deadline is now six months for large manufacturers, and nine months for smaller manufacturers, after the FDA releases guidance for how the testing […]
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