Ever since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) the authority to regulate tobacco products, CDA has worked to represent members’ interests before the agency.
This has included meetings with FDA officials, regular contact and communications with FDA staff members and testimony on Capitol Hill and before the agency itself. In addition, CDA and Merchants Grocer Co., Culpeper, VA, hosted a visit of FDA regulators to help them understand the complexities of distributor tobacco stamping operations.
FDA Finalized Deeming Regulations
The Food and Drug Administration (FDA) has created webinars to explain the new deeming regulations and how they will be implemented. These webinars (links provided below) are designed for distributors, retailers, vape shop owners, manufacturers, importers and others associated with the tobacco supply chain. There are different webinars for the specific segments of the tobacco industry.
The webinars are designed to provide general information about the new tobacco deeming regulations and provide specific information for those involved in the tobacco supply chain. CDA has also prepared a white paper on the FDA’s new deeming regulations which may be found here.
1. The Final Deeming Rule: All Tobacco Products Subject to the Federal Food, Drug, and Cosmetic Act.
2. New Regulatory Requirements for Vape Shops.
3. New Regulatory Requirements for Tobacco Retailers.
4. Retail Compliance Check Inspections: An Overview for Tobacco Retailers.
5. New Regulatory Requirements for Tobacco Manufacturers and Importers.
FDA Deeming Authority Clarification Act
CDA supports legislation in Congress – HR 1136 – introduced by Representatives Cole (R-OK) and Bishop (D-GA) to clarify the FDA deeming authority specifically urging a change in the “predicate date” by which new tobacco and tobacco-derived products such as premium cigars and electronic cigarettes must undergo expensive and unnecessary regulatory hurdles imposed by the Food and Drug Administration (FDA).
Without such Congressional action, the FDA will require all products that have hit the market since February 2007 to undergo a Pre-Market Tobacco Applications (PMTA) process that could cost upwards of several million dollars per product simply to undergo review.
Because of the speed at which innovation has occurred with vapor products since 2007, essentially all products currently being sold to consumers fall into this regulatory trap. Congress must act to permit innovation to continue for these smoking cessation products that stand to save millions of lives and billions of tax dollars resulting from harm reduction associated with smokers switching to tobacco-free alternatives like e-cigarettes.
HR 1136 would not impede upon FDA’s general efforts to regulate this product category and the bill would go further than FDA’s final rule to fill in gaps around consumer safety and marketing by mandating “Keep out of Reach of Children” and “Underage Sale Prohibited” language on labels of vapor products. HR 1136 would also restrict advertising of these products to only publications that meet FDA’s current regulatory criteria of an adult only publication and would prohibit self-service displays of vapor. To write to your legislators on this important issue please visit CDA’s Advocacy Center.
FDA Tobacco Compliance
In response to requests by CDA wholesale distributor members, a basic editable template regarding compliance with the new FDA regulations concerning tobacco may be found here. CDA recognizes that many of its manufacturer members already have guidelines in place ensuring FDA compliance and strictly adhere to the FDA’s regulations.
Federal Excise Tax
President Obama has proposed a 94-cents per pack increase in the federal tax on cigarettes. Take a moment to let your legislators know about your concern with this proposal.