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 This past week the U.S. Food and Drug Administration (FDA) issued a draft guidance on proposed rule-making around the SE process. As part of the rulemaking process, the draft guidance will be open to public […]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The U.S. Food and Drug Administration has announced it will issue draft guidance that makes major policy change in terms of enforcement of regulations on flavored tobacco products, including flavored cigars.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 […]
The U.S. Food and Drug Administration has announced it is delaying the November 8, 2019 deadline for cigar and and pipe tobacco manufacturers to report Harmful and Potentially Harmful Constituents (HPHC) in their products. The deadline has been extended six months for large manufacturers and nine months for small manufacturers after the FDA releases the […]
Dr. Scott Gottlieb appeared on a videocast with The Hill where he addressed his resignation as FDA Commissioner. Dr. Gottlieb confirmed the reasons he was leaving were due to the toll the job was taking on his family. Each week, he was commuting to Washington, DC from his home in Westport, Connecticut, leaving only weekends […]
Dr. Scott Gottlieb, the Commissioner of the U.S. Food and Drug Administration is resigning. The resignation was originally reported by the Washington Post and confirmed by Secretary of Health and Human Services Alex Azar. “I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public […]
The cigar industry trade associations (Cigar Association of America (CAA), Cigar Rights of America (CRA), and the International Premium Cigar and Pipe Retailers (IPCPR) have officially filed an appeal in the lawsuit against the U.S. Food and Drug Administration (FDA)’s Deeming Regulations. Most specifically, the crux of the lawsuit focuses around the implementation of warning […]
As the 116th Congress came into session on January 8, 2019, a new bill was introduced by Rep. Rose DeLauro (D-CT) to House of Representatives that could have devastating consequences for the cigar industry. While H.R. 293 is called the “Youth Vaping Prevention Act of 2019”, it is a bill designed to take extreme actions […]
With the 116th Congress now in session, the time has come to re-introduce proposed legislation. This past week, Senate Bill S.9 was re-introduced by Senator Marco Rubio of Florida. The purpose of the bill is to introduce legislation to exempt premium cigars from regulations being proposed by the United States Food and Drug Administration (FDA). […]
