FDA Committee Meets on Proposed Tobacco Product Manufacturing Practices

On May 18th, the Tobacco Product Manufacturing Practices (TPMP) committee of the US Food and Drug Administration (FDA) held a 3-hour meeting to discuss proposed rules aimed at ensuring tobacco product manufacturing meets established standards.

During the conference, experts from various fields presented their views, including Brian King, the Director of the FDA Tobacco Product Center, Dr. Bailey, from the University of Kentucky, representing tobacco growers' interests , David Johnson representing small to medium-sized tobacco manufacturers, and Maria Gogova, the Chief Scientific Officer of Altria to represent large tobacco.

TPMP's Objectives and Responsibilities

During the meeting, the members focused on discussing the goals and responsibilities of TPMP. One of TPMP's goals is to minimize or prevent health issues unrelated to tobacco product use, and to ensure that the production of these products meets established specifications.

Participants emphasized the responsibility and obligation of manufacturers. Manufacturers must maintain master manufacturing records (MMR), and take appropriate action in response to complaints, including recalls and investigations. The MMR requires tracking of all components, parts, ingredients, additives, and materials used to manufacture the product, as well as every batch of distributed finished or bulk tobacco products, in accordance with their PMTA specifications.

Different compliance dates.

Large tobacco product manufacturers will meet compliance requirements within two years of the issuance of TPMP regulations, while small tobacco product manufacturers (with less than 350 employees) will have an additional four years to comply.

This action may help small tobacco manufacturers maintain their profits after the TPMP takes effect, avoiding the threat of being swallowed up by larger tobacco companies.

The attending experts also made suggestions regarding issues such as material tracing tags and shelf life. They emphasized the importance of accurate nicotine concentration information on the labels and the shelf life of ingredients such as nicotine.

In addition, according to the regulations of TPMP, design, development, and validation activities only apply to future products. For products that came to market before February 15, 2007, these activities are not mandatory, but if the product is modified, these design and development activities are required.

Intended collection of production processes and records.

The importance of record keeping was emphasized at the meeting.

The FDA will be collecting records of tobacco product manufacturing processes and documentation, but specific regulations regarding expiration dates have not yet been determined as it is a general rule applicable to all tobacco products, but will be considered if related to the product. The TPMP requires manufacturers to identify the specifications of tobacco products in the MMR and verify them against PMTA data standards.

In addition, experts in attendance put forth some recommendations:

• Extend the rule for expiration date labeling required for manufacturers to the retailers as well;
• Developing policies applicable to existing tobacco products that were on market before February 15, 2007;
• Proposing a shorter compliance date for tobacco products, from 2 years to 1 year;
• and requiring e-cigarette manufacturers to develop programs to recycle discarded batteries.

At the end of the meeting, participants generally expressed support for the TPMP rules. They felt that these rules would help ensure the safety and compliance of tobacco products and protect the health of consumers. However, further discussion and research is needed to develop more specific labeling requirements and specifications, and to allow room to accommodate new scientific research to continually improve regulatory standards for tobacco products.