The marketing approval applies to eight Swedish Match snus, according to FDA. (Swedish Match photo)

FDA Approves Marketing of Smokeless Tobacco Products Through Premarket Process

"Today's action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed, as long as the public health can be protected," said Mitch Zeller, J.D., director of FDA's Center for Tobacco Products.

The U.S. Food and Drug Administration announced Nov. 10 that, for the first time, it has authorized the marketing of new tobacco products through the premarket tobacco application pathway. This allows the tobacco products to be sold in the United States but does not mean that they are safe or "FDA approved," the agency cautioned, adding that all tobacco products are potentially harmful and addictive. The marketing orders in this case are for Swedish Match North America Inc. snus smokeless tobacco products under the General brand name. Snus is term describing a moist powder tobacco product.

The Family Smoking Prevention and Tobacco Control Act of 2009 granted FDA the authority to regulate the manufacturing, marketing, and distribution of tobacco products and also to permit new tobacco products to be introduced to the U.S. market under specific circumstances. "The law is clear: Companies must apply to the FDA first and then the FDA uses a rigorous scientific review to determine if new tobacco products should come to market under this pathway. Today's action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed, as long as the public health can be protected," said Mitch Zeller, J.D., director of FDA's Center for Tobacco Products. "As other manufacturers seek to market new tobacco products, the FDA will remain committed to upholding the important public health standards under the law."

Manufacturers using the PMTA pathway must demonstrate that marketing of the new tobacco product would be appropriate for the protection of the public health, and FDA must consider the risks and benefits to the population as a whole. FDA announced that the PMTA decisions for the Swedish Match products "reflect evidence showing that these products, marketed as described in the manufacturer's application, would result in a low likelihood of new initiation, delayed cessation or relapse" and that FDA's review "also determined that these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively." The marketing orders are product-specific and do not apply to other tobacco products.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • The Top 5 Safety and Technology Trends to Watch in 2019

    Get the latest on trends you can expect to hear more about in 2019, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; pending OSHA recordkeeping rulemaking; and increased adoption of international safety standard, ISO 45001.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe

OH&S Digital Edition

  • OHS Magazine Digital Edition - January 2019

    January 2019

    Featuring:

    • PREVENTING ERRORS
      Production vs. Safety 
    • EMERGENCY SHOWERS & EYEWASH
      Meeting the Requirements for Emergency Equipment
    • CONSTRUCTION SAFETY
      The State of Contractor Safety
    • FOOT PROTECTION
      The Three Keys to Effective Chemical Management
    View This Issue