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It’s not uncommon in today’s regulatory landscape to hear that the U.S. Food and Drug Administration (FDA) has sent a warning letter to a retailer or manufacturer over concerns about certain covered tobacco products being sold, distributed or promoted. Now, however, the federal government appears to be going beyond manufacturers and retailers as it begins […]
The post FDA and FTC Issue Warning Letters Over Social Media Influencer Concerns appeared first on Tobacco Business Magazine.
Some of the largest premium cigar manufacturers have come together to file a comment with the U.S. Food and Drug Administration on the subject of Substantial Equivalence (SE) applications. These manufacturers are challenging this piece of the FDA Deeming Rule which would require manufacturers to submit an extensive application and subject their products to costly […]
The post Premium Cigar Manufacturers File Joint FDA Comment on Regulations appeared first on Tobacco Business Magazine.
A federal judge has given cigar and e-cigarette manufacturers 10-months to apply for approval from the U.S. Food and Drug Administration (FDA) to keep their products on the market. This decision stems from a lawsuit filed on March 27, 2018 by the American Heart Association and five other groups and individual pediatricians. It’s a decision […]
The post May 2020 Deadline Set for Substantial Equivalence Applications appeared first on Tobacco Business Magazine.
On July 2, 2019, the ongoing legal battle between the cigar industry and the U.S. Food and Drug Administration (FDA) reached a new level when the cigar industry trade organizations that originally filed the lawsuit against the FDA filed a new motion urging a Washington, D.C.-based federal court to maintain the compliance deadlines previously set […]
The post Cigar Trade Groups Fight to Keep Substantial Equivalence Extension appeared first on Tobacco Business Magazine.
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.