Federal Regulation of Tobacco - Altria

 

The Food and Drug Administration (FDA) has authority to regulate cigarettes, cigarette tobacco, “roll-your-own” tobacco and smokeless tobacco products, and may extend its authority to regulate other tobacco products such as cigars and pipe tobacco. The FDA has indicated that regulation of cigars is on its agenda of items to consider possible rulemaking during the summer of 2010.

Altria Group actively supported legislation for more than eight years that provided FDA with this authority and seeks to work constructively with the FDA as it begins to establish a comprehensive national regulatory framework. We believe that this regulation can provide significant benefits to adult consumers by, among other things:

  • Establishing a common set of high standards for all tobacco manufacturers and importers doing business in the U.S.;
  • Providing a framework for the evaluation of tobacco products that are potentially less harmful than conventional cigarettes;
  • Creating clear principles for accurate and scientifically grounded communications about tobacco products to adult consumers.

 

Altria believes that regulation is best achieved through an approach that draws upon the experience and expertise of all stakeholders, including regulated industry. The experience, expertise and viewpoints of the industry can be a valuable resource to the FDA in achieving a science-and evidence-based program that results in reasonable regulation.

The implementation of the Family Smoking Prevention and Tobacco Control Act will take place over time. While some provisions took effect when the President signed the bill into law, many of the changes required by the statute will not take effect for some time. Several areas require the Food and Drug Administration (FDA) to take action through rulemaking, which generally involves public comment and, for some issues, scientific review.

This general timeline shows some significant implementation activities provided by the statute:


Effective Immediately Upon Enactment

Inspection Authority

FDA’s authority to inspect tobacco product factories, warehouses and establishments.

General Misbranding Authority

General requirement that tobacco product labeling and advertising cannot be “false or misleading in any particular” (the violation of which is referred to as the “misbranding” of the product).

Advance Review and Authorization of Potentially Reduced Exposure Product Claims:

Requirement for advance FDA review and authorization of any reduced exposure/risk claim, including any communication that would reasonably be expected to result in consumers believing that a tobacco product may present a lower risk of disease or be less harmful than another tobacco product.

Prohibition on Certain Communications about FDA Regulation:

Prohibition on any communication directed to consumers conveying that:

  • tobacco products are approved by the Food and Drug Administration;
  • the FDA deems tobacco products to be safe for use by consumers;
  • tobacco products have been endorsed by the Food and Drug Administration for use by consumers; or
  • tobacco products are safe or less harmful by virtue of FDA regulation or inspection or by virtue of compliance with FDA’s regulatory requirements.

Illegal Trade Reporting Requirement

Requirement that all manufacturers and distributors report certain information regarding illegal trade activities to the U.S. Attorney General and Secretary of the Treasury.

Effective within the First Year

User Fee Payments

The first quarterly user fee was paid on September 30, 2009 (moving forward quarterly user fees will be payable by the end of each quarter).

Cigarette Characterizing Flavor Prohibition (other than menthol of tobacco)

Effective September 22, 2009, cigarettes and cigarette tobacco were prohibited from having a characterizing flavor other than tobacco or menthol.

Marketing and Sales Regulations

The FDA has published regulations regarding the sale, promotion and advertising of tobacco products. Under the statute these rules take effect one year from the date of enactment.

Removal of Cigarette Descriptors

Effective one year after the date of enactment, manufacturers will be required to remove the descriptors, “light,” “low tar,” and “mild” from their cigarette packages, advertising and labeling.

Smokeless Tobacco Product Package Requirements

Effective one year after the date of enactment, manufacturers must make warning label changes (black and white text warnings covering 30% of the two principal display panels).

Reporting Requirements

One year after the date of enactment, manufacturers will begin providing certain specified information to FDA, including tobacco product ingredient information.

Effective after the First Year

Cigarette Package Requirements

FDA is required to prescribe graphic warning requirements for cigarettes not later than two years after the date of enactment; in turn, manufacturers will be required to comply with these package label requirements, as well as other label requirements imposed under the law for cigarettes, within 15 months after the date of the final FDA regulations that specify these graphic warning requirements.

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The FDA has opened a series of dockets through the Federal Register to solicit information from all stakeholders on a number of specific issues related to implementation of the Family Smoking Prevention and Tobacco Control Act. Both Philip Morris USA and U.S. Smokeless Tobacco Company have actively engaged in this process.

For convenience, we have posted publicly available docket submissions made on behalf of our operating companies. It is our intention to update this site periodically with current and relevant submissions.

 

Presentations made at July 15-16, 2010, TPSAC Meeting on Menthol in Cigarettes

Below please find a list of frequently asked questions about the Family Smoking Prevention and Tobacco Control Act


 Q. What does the new law do?

A. The FDA legislation establishes a new federal regulatory system over tobacco products. Currently, the FDA regulates cigarettes, cigarette tobacco, “roll-your-own” tobacco and smokeless tobacco products; however, the law allows the FDA to extend its regulatory authority over other tobacco products, including cigars and pipe tobacco. The FDA has indicated that regulation of cigars is on its agenda of items to consider possible rulemaking during the summer of 2010.

The law includes:

  • rules governing the introduction of new and certain modified tobacco products;
  • new warnings and other packaging and labeling requirements;
  • restrictions on advertising and marketing;
  • restrictions on external communications about tobacco products;
  • authority to issue new reporting and disclosure requirements;
  • rules banning the use of product descriptors such as “light,” "mild" and “low” or similar descriptors;
  • rules governing statements that may imply a health claim – such as a claim that a product is less harmful than another product; and
  • authority to issue good manufacturing practices regulations.


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Q. When does it take effect?

A. Based on the statute, some provisions took effect when the President signed the bill into law. Other provisions become effective over time.

For more information on timing of the law, please click here.


Q. Why did Altria Group support this law?

A. Altria supported federal regulation of tobacco products for more than eight years. Fundamentally, we acknowledge the health issues associated with tobacco use and their implications for consumers and society as a whole. At the same time, as Congress confirmed by passing this legislation, society has decided to continue to permit the sale of tobacco products to adults and to leave decisions about the use of tobacco products to those adults.

We believe that a comprehensive regulatory framework, implemented thoughtfully, can provide significant benefits to tobacco consumers. These benefits include establishing a common set of high standards for all tobacco manufacturers and importers doing business in the U.S., providing a framework for the evaluation of tobacco products that are potentially less harmful than conventional cigarettes, and creating clear principles for accurate and scientifically grounded communication about tobacco products to consumers.

Moreover, tobacco products and tobacco companies have been a source of considerable conflict and controversy over the years. We firmly believe that federal regulation of tobacco products is a significant step in the right direction by resolving those issues. By supporting FDA regulation, we hoped to provide leadership in helping resolve many of the issues that concern the public, our consumers, the public health community and our tobacco companies, including a framework for guidance on harm reduction efforts. In the end, having clear rules established by a federal agency should provide more predictability for how our tobacco businesses are expected to operate.

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Q. Do you agree with every aspect of the law?

A. No. We consistently expressed our views throughout the legislative process on all aspects of the legislation. But the legislative process often involves compromise, and that is why we believe the law as enacted is not perfect. Among other things, we have consistently expressed our belief that certain provisions of the law cross constitutional limits. We are hopeful that these issues will be addressed as part of an ongoing collaborative process with the FDA and other stakeholders.


Q. Who will pay for Food and Drug Administration regulation?

A. The legislation provides for a user fee paid by manufacturers on a quarterly basis, based on market share. Total industry fees are $85 million in the first year after enactment; $235 million in the second year; and $450 million in the third year. Fees increase up to year 10 according to a statutory schedule.

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Q. How does the statute change how tobacco products can be made and marketed?

A. It establishes a regulatory structure and standards for the manufacturing and marketing of tobacco products. The provisions include among other things:

  • a ban on the sale of cigarettes with characterizing flavors other than tobacco and menthol;
  • a ban on product descriptors such as “light,” “mild,” and “low” or similar descriptors;
  • changes to the current cigarette and smokeless tobacco product health warnings, including enlarging their size;
  • mandatory graphic warnings for cigarette packages to be developed by the FDA;
  • authority for the FDA to require new warnings in the future;
  • authority for the FDA to mandate changes in the design of tobacco products to protect the public health;
  • authority for the FDA to establish standards for products that could potentially reduce the harm caused by tobacco products and to define the appropriate ways to communicate about these products;
  • requirement that the FDA establish good manufacturing practices for tobacco manufacturing; and
  • recognition that implementation of any advertising and promotion restrictions, including those in the statute and those required or authorized to be promulgated as regulations, must pass muster under the First Amendment.


Q. Does FDA regulation impact manufacturing practices?

A. Yes. For example, the legislation requires the FDA to issue good manufacturing practice regulations. These regulations may take effect no earlier than three years after the date of enactment.

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