Earlier this year, the U.S. Food and Drug Administration (FDA) published draft guidance on the Substantial Equivalence process. As a part of issuing such guidance, there must be a public comment period. The comment period came to a close on July 17th (following a 30-day extension granted by the FDA). This saw many cigar companies […]
The U.S. Food and Drug Administration (FDA) has extended the period to comment on the agency’s draft guidance around Substantial Equivalence (SE) by 30 days. The deadline to submit comments around the Substantial Equivalence Rules is now July 17, 2019. Substantial Equivalence marks a pathway where many cigar companies can keep products introduced after February […]
Dominican Republic President Danilo Medina met with leaders of the premium cigar industry in his country. The agenda of the meeting was to make him aware of the concerns and challenges resulting from regulations being implemented in the United States by the U.S. Food and Drug Administration (FDA). The meeting was held in the Private […]
Late in March HR 1854, the bill to exempt premium cigars from U.S. Food and Drug Administration (FDA) regulation was introduced to the House of Representatives for the 116th Congress. While in previous years it has been consistent, this time around there is one notable change of the bill’s text – flavored cigars are not […]
The movement to raise the tobacco purchase to 21 has now reached a national stage. Today, Congressman Robert Aderholt (R-Alabama) has introduced the “Stopping Consumption of Tobacco by Teens” (SCOTT Act). This bill not only proposes raising the tobacco purchase to 21, but it also will mandate age verification for online sales of vaping products. […]
U.S. Senator Marco Rubio, who also is the Chairman of the Senate Committee on Small Business and Entrepreneurship, will hold a field hearing called “Keeping Small, Premium Cigar Businesses Rolling” on Friday, April 5, 2019, at 1:00 PM Hillsborough Community College, Ybor City Campus in Florida. The topic will take a closer look at the impact of regulations […]
If there is one thing that has been keeping the premium cigar industry up at night, it is substantial equivalence. This past week the U.S. Food and Drug Administration (FDA) issued a draft guidance on proposed rule-making around the SE process. As part of the rulemaking process, the draft guidance will be open to public […]
It took a while but the House of Representatives now has a companion bill to the Senate Bill released earlier this year to exempt premium cigars from regulation from the U.S. Food and Drug Administration (FDA). The bill was introduced by Representatives Bill Posey and Kathy Castor. H.R. 1854 joins Senate Bill S.9 introduced by Senator […]
The U.S. Food and Drug Administration has announced it will issue draft guidance that makes major policy change in terms of enforcement of regulations on flavored tobacco products, including flavored cigars. This will involve modifying its compliance policy from August 2017 where it will begin enforcing the deeming regulations for non-grandfathered flavored cigars that were […]
Secretary of Health and Human Services Alex Azar has announced that National Cancer Institute Director Dr. Norman “Ned” E. Sharpless will become the U.S. Food and Drug Administration (FDA) Commissioner. Dr. Sharpless will succeed Dr. Scott Gottlieb who has announced he is stepping down from the position at the end of the month. “Change is […]
