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Category

FDA/Deeming Regulations

FDA Asks Court to Delay Substantial Equivalence Deadline by At Least 10 Months

The U.S. Food & Drug Administration (FDA) has asked a federal court in Maryland to order that FDA’s substantial equivalence deadline should begin no sooner...
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FDA Extends Comment Period for Revised Substantial Equivalence Process to July 17

The U.S. Food & Drug Administration (FDA) has announced a 30-day extension to its current request for comments on how it should revise its substantial...
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Plaintiffs Respond to FDA in Texas Lawsuit Summary Judgement

Earlier this week, attorneys for the plaintiffs in the Texas FDA lawsuit responded to the FDA’s arguments against summary judgment. The case, En Fuego et al....
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FDA Loses Maryland Court Battle, Substantial Equivalence Delay in Jeopardy

There are some court battles the cigar industry would like FDA to win—and it just lost one of them. Earlier today, the U.S. District Court...
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Rubio Hosting Field Hearing on Premium Cigars Next Week

Next Friday, Sen. Marco Rubio, R-Fla., will chair a field hearing on premium cigar regulation. The hearing is entitled Keeping Small, Premium Cigar Businesses Rolling and will...
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FDA Plans Updated Substantial Equivalence Process for Tobacco Products

One of the many complaints cigar companies have with the FDA and the agency’s regulations on tobacco products is a lack of clarity. Nowhere is...
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New House Bill Introduced to Exempt Premium Cigars from FDA Regulation

Over three months after a bill was first reintroduced in the Senate, a bill has been introduced in the U.S. House of Representatives that would...
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Plaintiffs Request Summary Judgment in Texas FDA Cigar Case

Recently, most of the attention surrounding the lawsuits against the U.S. Food & Drug Administration (FDA) has centered around the original case filed in Washington...
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FDA Announces New Flavored E-Cigarette Rules, Changes Some Flavored Cigar Rules

The U.S. Food & Drug Administration (FDA) has announced its much new anticipated rules for e-cigarettes and in it is a change that could affect...
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Ned Sharpless, National Cancer Institute Head, Named Acting FDA Commissioner

Dr. Norman “Ned” Sharpless, the current director of the National Cancer Insitute, has been named the acting commissioner of the U.S. Food & Drug Administration...
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