Recent FDA Updates
FDA Announces New Compliance Deadlines Following 90-Day Delay
Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule
The FDA has issued a revised guidance with new compliance deadlines for retailers and manufacturers. This guidance document is intended to assist any person who manufactures, packages, sells, offers to sell, distributes, or imports for sale and distribution within the United States newly regulated tobacco products, roll-your-own tobacco, and cigarette tobacco. This guidance document discusses the FDA’s three-month extension of future compliance deadlines for certain provisions under the May 2016 final Deeming Rule. The revised guidance with a full list of new deadlines can be found here.
Below are highlights of the newly promulgated schedule.
New Deadline Highlights
Submission of cigar warning plans (August 10th, 2017)
Manufacturer registration & product listing (September 30th, 2017)
SE exemption requests (November 8th, 2017)
Submission of health documents & ingredient listings (November 8th, 2017)
Submission of SE Reports for non-grandfathered products (May 8th, 2018)
Implementation of required health warnings and labeling statements including point of sale signs (August 10th, 2018)
Premarket Tobacco Product Applications (PMTA) deadline – (November 8th, 2018)
Harmful and Potentially Harmful Constituent (HPHC) reporting requirements – (November 8th, 2019)
The recent 90-day delay is an encouraging development; however, the International Premium Cigar and Pipe Retailers Association (IPCPR) has vowed to continue to engage with the FDA on behalf of the industry and provide additional information when available to members.
Senate Confirms Scott Gottlieb, MD as FDA Commissioner
Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017. Dr. Gottlieb is a physician, medical policy expert, and public health advocate who previously served as the FDA's Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner.
He also worked on implementation of the Medicare drug benefit as a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services, where he supported policy work on quality improvement and the agency’s coverage process, particularly as it related to new medical technologies. In 2013, Dr. Gottlieb was appointed by the Senate to serve on the Federal Health Information Technology Policy Committee, which advises the Department of Health and Human Services on healthcare information technology.
The IPCPR commends the Senate’s decision to put "thoughtful and experienced leadership at the head of an organization as critical as the FDA." Dr. Gottlieb’s confirmation puts a reform minded physician with experience in both the public and private sectors as head of a regulatory body that has too often failed in its mission to protect the public health without needlessly hampering commerce in this country. The small business retailers and professional tobacconists that make up IPCPR are counting on the leadership of Dr. Gottlieb and the actions of his FDA to address and correct the onerous and catastrophic elements of last year’s Deeming Rule.
According to IPCPR CEO Mark Pursell, Dr. Gottlieb’s confirmation gives hope to premium tobacco retailers. “During his confirmation process, Dr. Gottlieb repeatedly stressed that he will rely on science and good sense, not ideology, to help define his time as commissioner. His past statements on then-proposed regulations for our industry further highlight the new viewpoint he will bring to the FDA. As an industry that knows there is no sound scientific argument to support the new requirements placed on traditional and premium cigars, Dr. Gottlieb’s sober attitude toward regulation combined with his vast public health experience is refreshing.” Previously as a Resident Fellow at the American Enterprise Institute, Dr. Gottlieb authored an op-ed that appeared in the New York Post on August 16, 2012, in which he expressed his sentiments on the bureaucratic overreach in the regulation of premium handmade cigars (click here to read).
Dr. Gottlieb was a Clinical Assistant Professor at the New York University School of Medicine in Manhattan, where he also practiced medicine as a hospitalist physician. He completed a residency in internal medicine at the Mount Sinai Medical Center in New York, New York and is a graduate of the Mount Sinai School of Medicine and of Wesleyan University, in Middletown, Connecticut, where he studied Economics.