Tobacco product Manufacturing Practice (TPMP) counseling services

At present, the FDA (US Food and Drug Administration) has not implemented the enforcement regulation of PMTA (tobacco premarket application), one of the reasons is that the corresponding product standards and manufacturing standards are not clear. Recently, the FDA issued Tobacco Product Manufacturing Practices (TPMP), which specifies new requirements for the manufacture, design, packaging, storage, distribution and recall of tobacco products. The proposed regulation is expected to provide the FDA with the legal basis to enforce PMtas, indicating a clear trend toward stricter enforcement of PMtas. Therefore, tobacco product manufacturers should make timely preparations to ensure that their products meet FDA requirements.

FDA's TPMP in this release includes the following:

(1) Establish tobacco product design and development controls;

(2) Ensure that finished products and bulk tobacco products are manufactured to established specifications;

(3) Minimizing the manufacturing and distribution of tobacco products that do not meet specifications;

(4) Require manufacturers to take appropriate measures to prevent contamination of tobacco products;

(5) Require investigation and identification of products that do not conform to specifications, so as to take appropriate corrective action, such as recall;

(6) Establish the ability to track all ingredients or components, ingredients, additives and materials, as well as each lot of finished or bulk tobacco product, to help investigate products that do not meet specifications.

Skyte Testing has conducted a comprehensive interpretation of the proposed regulations, and now launches the Tobacco Product Manufacturing Practice (TPMP) counseling service. Please contact us.