Tobacco Retailer Training Program – Details on FDA’s Proposed Guidance

February 29, 2016

FDA to Require Tobacco Retailers to Implement Effective Training Programs for Employees

On Friday, February 26th, the FDA announced plans to issue a guidance requiring tobacco retailers to establish an employee training program. Under this proposed regulation, all current and new employees would be required to pass a written test prior to selling tobacco products.

Topics to be Covered in Training Programs

In the Federal Register notice, FDA stated that the proposed guidance will discuss the elements to be covered in a training program. These include:

  1. “Federal laws restricting the access to, and the advertising and promotion of, cigarettes and smokeless tobacco product.
  2. The health and economic effects of tobacco use, especially when the tobacco use begins at a young age.
  3. Written company policies against sales to minors.
  4. Identification of the tobacco products sold in the retail establishment that are subject to the Federal laws prohibiting their sale to persons under the age of 18.
  5. Age verification methods.
  6. Practical guidelines for refusing sales.
  7. Testing to ensure that employees have the required knowledge.”

Record Keeping

In order to “provide evidence of a training program during the 48-month time period covered by the civil money penalty schedules in section 103(q)(2)(A) of the Tobacco Control Act,” the FDA recommends that retailers maintain records documenting that all employees have completed training. Retailers should keep these records for a minimum of four years.

Hiring Recommendations

As part of an effective training program, FDA recommends that tobacco retailers implement various hiring and management practices as well. As part of these recommended practices, FDA says that all applicants and current employees should be provided with verbal and written notification that details the importance of the laws governing the sale of tobacco products. It is critical for employees to understand that anyone under the age of 18 is prohibited from purchasing tobacco products. To accentuate the important nature of this law, retailers should require employees to sign a document acknowledging that they have read and understand the laws and information surrounding the sale of tobacco products.

In addition, the Agency recommends that an internal program be implemented to ensure compliance with the laws mentioned above. Tobacco retailers should have procedures and corrective actions that accompany the program, which should be documented and posted for all employees to see.

The FDA is seeking feedback and has asked all interested persons to submit comments by April 26, 2016.  For additional information or to submit your comments, view the public docket.

Are you in the process of developing a tobacco product or do you already manufacture a tobacco product that is subject to FDA’s regulations? We are leaders in the developing category of tobacco related submissions.  To learn more about our services and how we can help your product successfully move through FDA, contact us today.


November 27, 2018

FDA Takes Steps to Promote Digital Tools for Prescription Drugs

On Tuesday, November 20th, FDA announced the establishment of a public docket to solicit comments and feedback on a proposed framework regarding the regulation of prescription drug-use-related...

December 14, 2018

FDA Proposes Changes to the De Novo Pathway

On Tuesday, December 4th, FDA published the De Novo Classification Proposed Rule. If finalized, the rule would establish procedures for the De Novo classification process by facilitating appropriate...

October 22, 2018

Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules

On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...