Strategies to prepare for and meet the requirements of the Tobacco Control Act
The FDA regulates the traditional and deemed tobacco industries according to the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed into law on June 22, 2009. The Act includes requirements for facility registrations, product and ingredient listings, HPHC submissions and pre-market approval of new tobacco products (i.e. SEs. PMTAs, MRTPs). In addition, the Act requires the FDA to issue good manufacturing practices (GMPs) for the tobacco industry, which will be called tobacco product manufacturing practices (TPMPs). Once tobacco facilities are registered the FDA has the authority to inspect them to ensure compliance with all requirements of the Tobacco Act. EAS Consulting Group’s staff and a team of consultants are recognized as the leading experts in Tobacco compliance and can provide training on specific compliance issues to assist companies in meeting the requirements and preparing for the regulations that are issued under the Tobacco Control Act. Subjects for which EAS can be provided training include:
- Preparing for Tobacco GMPs – what may be required
- How to host and manage an FDA inspection
- How to write and implement FDA acceptable Standard Operating Procedures (SOPs)
- How to prepare and utilize Quality Agreements
- How to select and qualify Contract Manufacturers and Laboratories
In addition, EAS can provide any specific and customized training that our clients may require.