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Tobacco Harm Reduction

Product Integrity

Product stewardship at each of RAI’s operating companies begins with the principle that nothing is to be done or added to products that increases their inherent risks. Whenever any of RAI’s operating companies considers a change in the ingredients, materials or design of an existing product, the company evaluates the potential effect of that change by using an analytical framework based on the best scientific information available.

This evaluation uses a multi-tiered testing process that has guided our product-stewardship efforts for many years. The process includes scientific literature reviews, analytical chemistry, in vitro and in vivo toxicological tests, and human studies, as appropriate.

Our companies have devoted substantial resources to developing product technologies and designs with the potential to reduce tobacco risks, while continuing to meet the changing expectations of adult tobacco consumers. Consumer acceptability is crucial, as products with the potential to lower risk will not reduce harm if they are not acceptable to, and thus never adopted by, adult tobacco consumers.

Regulatory Compliance

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.” However, FDA jurisdiction is currently limited to cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco products.

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.”

Since passage of the law 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 in the amount of $792,820,286.78;
  • Registering domestic tobacco product 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.