26 May Pipe Tobacco: Are You a Retailer or a Manufacturer?
On May 10, 2016, the Food and Drug Administration (FDA) released its final rule deeming additional tobacco products, including pipe tobacco, subject to its regulatory authority under the Federal Food, Drug and Cosmetic Act and the Family Smoking Prevention & Tobacco Control Act. In its comments to the FDA, IPCPR argued for a “safe harbor” for retailers blending up to 5,000 pounds of pipe tobacco per year and suggested how the FDA should define pipe tobacco. On both accounts, FDA declined to do so, hence any blending of pipe tobacco would result in retailers needing to comply with the statutory and regulatory requirements which apply to tobacco product manufacturers. These requirements include:
- Register with the FDA and list every product (domestic only) as of August 8, 2016,
- Obtain premarket authorization through one of three approval pathways for any product introduced after August 8, 2016. Depending on which approval pathway, enforcement dates are August 8, 2017 (substantial equivalence exemption), February 8, 2018 (substantial equivalence), or August 8, 2018 (premarket tobacco product application)
- Submit information to the FDA by August 20, 2016 which FDA will utilize to calculate user fees the manufacturer must pay,
- Prohibition of free samples to consumers as of August 8, 2016
- Requirements for manufacturers to list ingredients in all tobacco products take effect in 2017,
- Reporting of harmful or potentially harmful constituents takes effect August 8, 2019 – FDA has indicated it will release additional guidance at a later date,
- Placing warning labels on packaging and advertising by August 8, 2018,
- FDA has indicated a future notice which will ban “characterizing flavors” in all tobacco products.
IPCPR remains committed to protecting pipe tobacco retailers and will pursue all options available through legislation and/or litigation where appropriate. As mentioned in the IPCPR comments to FDA, retailers who are simply blending two or more regulated pipe tobacco varietals should not be considered manufacturers.