FDA Product registration extended to June 30, 2017.
Revised Guidance: New Compliance Period for Registration and Product Listing
Today, the FDA issued the revised guidance, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” In the initial revised guidance issued in July of this year, U.S. manufacturers of newly regulated products faced a deadline of December 31, 2016 for compliance with the registration and product listing requirements of section 905 of the Tobacco Control Act. The guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8 effective date of the deeming rule must register and list immediately with the FDA.
The FDA is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date.
Miller: “The harm of the combustible cigarette is dramatically greater than the harm of the e-cigarette”
“The harm of the combustible cigarette is dramatically greater than the harm of the e-cigarette. The combustible cigarette is by far the most harmful consumer product known to mankind, killing 480,000 people each year in the United States alone. This is largely due to the many deadly toxins created and released by the combustion. A panel of experts estimates that the e-cigarette is 95 percent less harmful. Some push back on this study, in part questioning the ability to put an exact number on it. Another estimate is 90-98 percent less harmful. But whatever number is correct, e-cigarettes are dramatically less harmful than combustible cigarettes.
“There has been an effort to say that combustible cigarettes and e-cigarettes are equally harmful, that their companies are equally evil, and that they should be strongly regulated the same way. This view is incorrect, but it has gotten significant traction. Polling indicates that 32 percent of Americans believe that combustible cigarettes and e-cigarettes are equally harmful. This means that as many as 13 million adult smokers believe them to be equally harmful, and are very unlikely to switch when switching may save their lives. People making misstatements about e-cigarettes have the best of intentions—to keep kids from being addicted to nicotine through e-cigarettes. But adults misleading kids to get them to do what we want has always been a failed strategy.
“There also is a misconception about the prevalence of teen e-cigarette smoking. According to the National Youth Tobacco Survey, 13 percent of American high school students smoked an e-cigarette once or more in the last 30 days. This includes regular use and experimental use. As the figure is repeated, the number 13 percent is used without that qualification. After a few repetitions, people then tend to assume that 13 percent are regular users. However, regular use—if defined by usage in 20 or more days in the last 30 days—is actually 2 percent. The numbers should be seen together—13 percent used e-cigarettes once or more in the last 30 days; two percent have used an e-cigarette 20 or more days in the last 30 days.”
New Jersey Governor Chris Christie wisely vetoes misguided Tobacco 21 legislation.