The Tobacco Control Act of 2009 provided the FDA authoritative oversight of the manufacture, distribution, and marketing of all tobacco products, including cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. As well, newly “deemed” products include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.
Tobacco firms are required to submit applications to the FDA for any new tobacco product (unless it meets certain criteria) as well as products with modified risk claims.
In addition to marketing requirements, manufacturers and distributors of tobacco products must maintain strict compliance with registrations, Good Manufacturing Practices as well as “Premarket Reviews and “Modified Risk” products.
Among other things, The FDA requires:
- Annual registration and biannual inspections of their facilities, per Section 905
- Maintain compliance for standards for things such as tar and nicotine, per Section 907
- A “Premarket Review” of new tobacco products from the FDA prior to any marketing of a new product, Sections 910 and 905
- “Modified risk” products or claims of reduced harm must obtain an FDA marketing order, Section 911
- Disclosure of information on ingredients and constituents in tobacco products; Section 904
- The FDA has provided an Enforcement Action Plan for advertising and promotion restrictions which details current thinking on enforcement of Tobacco Control Act Requirements
EAS Consulting Group, LLC offers a range of consulting, submission and auditing services for tobacco products and services industry including:
- Assisting with regulatory compliance, registration, listing and submission requirements
- Preparing the industry for FDA tobacco GMPs and audits
- Implementing FDA recognized quality systems
- The Family Smoking Prevention and Tobacco Control Act, supplemental FDA guidance and the May 2016 Deeming Rule
- Monitoring of FDA tobacco activities, dockets and regulation and developments