The FDA’s New Rule: Expanded Regulatory Authority Over the Tobacco Industry

Within the United States, cigarette smoking is the leading cause of preventable death; accounting for over 480,000 deaths each year¹. Given the health risks of tobacco use, the FDA has established regulations that aim to reduce its associated morbidity and mortality; with the overall goal being to improve public health and reduce the risk to future generations.

In 2009, the FDA was granted the ability to regulate tobacco products when the Tobacco Control Act (Family Smoking Prevention and Tobacco Control Act) was signed into law. As an amendment to the Federal Food, Drug, and Cosmetic Act (FD&C), it provided the FDA with authority to regulate the tobacco industry; specifically, the tobacco used in cigarettes, smokeless tobacco, roll-your-own “loose” tobacco, and cigarettes themselves².

On May 10^th 2016, the FDA issued notice of a new rule which expanded their authority over the tobacco market, allowing them to regulate all other tobacco products as well.  This final rule deemed all products falling under the statutory definition of “tobacco product” (excluding accessories related to the new tobacco products), as under the jurisdiction of the FD&C Act. The FDA defines the term “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)³.”

As a result of this rule, the FDA is now able to regulate pipes and hookahs (waterpipes), nicotine gels, cigars, dissolvables, electronic nicotine delivery systems (i.e. e-cigarettes, electronic pipes, vaporizer pens), and many other tobacco or nicotine products.

The FDA’s final rule is divided into two major sections: 1) Deeming Provisions and 2) Additional Provisions to Protect Public Health

Deeming Provisions- (Manufacturing Standards & Labeling)

All manufacturers, importers, distributors, and retailers of these newly-regulated tobacco and nicotine products are subject to this new rule. Upon the effective date of this final rule (i.e., 90 days from the date of publication: 8/8/2016), the newly deemed tobacco products will be held to the same FD&C Act regulatory requirements as the original regulated products. This includes:

• FDA enforcement action is able to be taken against products that are misbranded or adulterated.
  • This includes any manufacturer who sells or distributes products with false or misleading advertising/labeling claims, or products with unsubstantiated modified risk tobacco product (MRTP) claims.
• Submission of an ingredient list and reporting of harmful and potentially harmful constituents (HPHC’s) to the FDA is required.
• Tobacco product manufacturing establishments must be registered.
  • Persons who own or operate “manufacturing establishments” (domestic establishments engaged in manufacturing, preparing, compounding, or processing tobacco products), must register and provide product listings according to FDA registration requirements.
    • This includes establishments that blend pipe tobacco or mix e-liquids, etc.
• The distribution and sale of products with modified risk descriptors is prohibited.
  • E.g. “Light”, “Low”, and “Mild”, or similar descriptors.
  • Any modified risk product being produced and marketed without a Modified Risk Tobacco Product order from the FDA is considered health fraud⁴.

• The distribution of free samples is prohibited.
• These products are also subject to premarket review requirements.
  • Tobacco products manufactured before February 15, 2007 are exempt. They are known as “grandfathered tobacco products,” and are not considered new⁵.
  • Manufacturers of the newly deemed tobacco products that were produced after February 15, 2007 are required to obtain premarket authorization of their products.
  • However, it should be noted that products already on the market could continue to be sold for up to three additional years. This is because the FDA has a year to evaluate the product applications that manufacturers will have two years to submit.

Note: The final rule also applies to future tobacco products that have yet to be developed. This means that any future product that meets the statutory definition of “tobacco product” will be subject to the FDA’s authority per chapter IX of the FD&C Act. In addition, all of the newly deemed tobacco products are subject to any future FDA regulations that may be established.

Additional Provisions that Aim to Protect Public Health and Restrict Youth Access to Tobacco Products:

• The FDA has modified the definition of the term “covered tobacco products”.  Now, the term applies not only to products containing tobacco and nicotine, but also to any product that contains a tobacco derivative. This is relevant because the FDA has also established three restrictions for covered tobacco products:

1. Minimum age of purchase requirement

a.The sale of tobacco products to people under 18 is prohibited (online and in-person)

1. The sale of such tobacco products from vending machines is prohibited.

a.This is the case unless it is located in a qualified adults-only facility, where proper age is verified using photo ID and individuals under the age of 18 are restricted from entering.

1. Health warning for product packages and advertisements requirement

Effective Dates:

• The deeming provisions and two of the restrictions under the additional provisions to protect public health (age/identification, and vending machine restrictions), are effective 90 days from the date of publication of the final rule: August 8^th, 2016.
• The health warning for product packages and advertisements requirements are effective 24 months from the date of publication of the final rule: May 2018.
  • However, there is an additional 30-day grace period where a manufacture is able to continue selling their existing inventory (manufactured before the effective date) that does not contain the required warning statements.

The entirety of FDA’s final rule can be found here: https://federalregister.gov/a/2016-10685

Visit this page on the FDA’s website to review the Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Newly Deemed Tobacco Products:

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm500778.htm

References:

1. Centers for Disease Control and Prevention. (2016). Health Effects of Cigarette Smoking. Available from: http://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/.

1. Office of the Federal Registrar/Unified Agenda 0910-AG38. (2014). “Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act. Available from: https://www.federalregister.gov/regulations/0910-AG38/-tobacco-products-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the-family-smoking.

1. U.S. Food and Drug Administration. (2015). What Products Are Considered to be Tobacco Products as Defined by the Tobacco Control Act?. Available from: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194443.htm.

1. U.S. Food and Drug Administration. (2015). Light, Low, Mild or Similar Descriptors. Available from: http://www.fda.gov/TobaccoProducts/Labeling/Labeling/ucm2023661.htm

1. U.S. Food and Drug Administration. (2014). Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007. Available from: http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm416495.htm.

1. U.S. Food and Drug Administration. (2016). Tobacco Products Now Regulated by the FDA. Available from: http://www.fda.gov/TobaccoProducts/NewsEvents/ucm500458.htm