Legislative & regulatory Priorities
RAI and its subsidiaries believe reducing disease and death associated with cigarette smoking is in the best interest of not only smokers, but society as well. We believe a science-based tobacco harm reduction strategy serves as a complementary approach to smoking cessation that may lead to a greater reduction in cigarette usage and an improvement to overall public health, and we support legislation and regulation that builds on the science-based approach and incorporates relative risk.
ENGAGING IN CONVERSATIONS
RAI Services Company‘s public affairs department advocates for legislation that enables adult smokers to make informed decisions about switching to smoke-free alternatives.
Our current legislative priorities include:
- Differential treatment of excise taxes, marketing restrictions, flavor availability, public place use, etc., that help adult smokers switch to alternative options that may present less risk;
- Clearly defined regulatory pathways that encourage manufacturers to innovate and create products which pose or may pose less risk for smokers compared to cigarettes; and
- Complete and accurate information available through trusted sources to adult smokers, regulators and health care practitioners, that outline the relative risk of different tobacco and nicotine products.
RAI and its subsidiaries believe the U.S. can learn from the experience in the U.K. and Sweden, where vapor products and smokeless products, respectively, are being used to move adult smokers toward smoke-free.
In the U.K., Public Health England (PHE) launched several public awareness campaigns over the last several years, encouraging smokers to quit or — if unwilling to quit — to switch to e-cigarettes. In 2016, the U.K. enacted the Tobacco and Related Products Regulations, which treats cigarettes differently from other tobacco products. The Medicine and Healthcare Products Regulatory Agency goes so far as to license specific e-cigarettes as tobacco cessation medication. PHE announced that in 2016, the smoking rate in England fell below 17 percent for the first time.
In Sweden, the availability of Snus as a socially acceptable alternative to smoking has drastically lowered smoking rates. At 13 percent, Sweden has the lowest smoking rate in the European Union (28 percent, on average), as well as the lowest rate of smoking-related diseases of the E.U., U.S., Canada and Australia.
We believe a similar approach to tobacco harm reduction can improve the lives of millions of Americans. RAI and its subsidiaries will continue to work with legislators and regulators to make accurate, credible information available to smokers, so they can make informed decisions about switching to smoke-free alternatives.
The Family Smoking Prevention and Tobacco Control Act ushered in a new era for the U.S. tobacco industry. Passed by Congress in 2009, the Act gives the FDA the authority to regulate “any [non-pharmaceutical] product made from or derived from tobacco that is intended for human consumption.”
Although the FDA is prohibited from banning or eliminating nicotine from tobacco products, the agency does have broad authority over virtually every aspect of U.S. tobacco companies’ operations. Among these are:
- Manufacturing, marketing and sale of tobacco products;
- Changes in products;
- The development and introduction of, and communication concerning, modified-risk products; and
- Regulation and communication of tar, nicotine and “other harmful or potentially harmful constituents.”
In 2016, the FDA finalized and published its deeming regulations for vapor products. In its final rule, the Agency outlined its plans to require the following:
- Manufacturer and product registration;
- Ingredient disclosures and initial reporting of harmful and potentially harmful constituents (HPHCs);
- Product approvals processes;
- Ban on the sale of these products to anyone below the age of 18;
- Ban on the distribution of free samples;
- Ban on vending machine sales, unless located in a facility that ensures individuals under 18 are prohibited from entering at any time; and
- Health warnings for product packaging and advertisements.
It is important to note that the deeming regulations do not directly impact internet sales, television or radio advertising, exposed or “open” tank systems, or characterizing flavors. The FDA may determine that future regulation is required to address these topics.
Since passage of the Family Smoking Prevention and Tobacco Control Act and subsequent regulation by the FDA, RAI’s tobacco operating companies have diligently complied with the timelines set by the Act and the agency, including:
- Paying user fees through 2016 in the amount of $842,338,828;
- Registering domestic tobacco product manufacturing establishments;
- Submitting thousands of pages of product lists and reporting any changes for domestic establishments;
- Submitting documents relating to health effects of tobacco products;
- Submitting a list of all ingredients by brand/sub-brand/quantity;
- Submitting substantial equivalence documentation;
- Complying with advertising and marketing restrictions in the Final Rule; and
- Placing required warning statements and additional mandated information on advertisements and labels of smokeless tobacco products.
Our companies continue to engage the FDA and its Center for Tobacco Products on matters of interest because we believe open communication is the best approach to establishing an effective, science-based regulatory framework for the tobacco industry.