In the previous parts of this series we explained the FDA’s proposed Tobacco Product Manufacturing Practice (TPMP) rule and the Premarket Tobacco Product Application (PMTA). This final part gives practical advice for small and medium-sized manufacturers.
Use the grace period wisely
If TPMP is finalised as proposed, small manufacturers would have an additional four years after the rule takes effect to comply. Use this time for a phased upgrade plan rather than waiting until the last year. Starting early spreads the investment and reduces risk.
For example: year one – complete the document system; year two – upgrade equipment and facilities; year three – internal audits and trial runs; year four – external pre-inspection. This builds team competence step by step so that compliance is in place when enforcement begins.
Check the definition of “small manufacturer”
The proposed rule allows small manufacturers a delayed compliance date, but companies must confirm whether they meet the definition, which is typically based on employee numbers or annual turnover. Companies above the threshold cannot count on the extra four years and must comply within the general deadline (two years after the final rule is published). Watch closely how the final rule defines “small”.
Use the exemption and variance mechanism with care
The proposed TPMP rule provides for exemptions and variances. Under Section 906(e)(2) of the Federal Food, Drug, and Cosmetic Act, anyone subject to a TPMP requirement may petition the FDA for a permanent or temporary exemption or variance.
A company that cannot fully meet a specific requirement (for example because certain equipment is disproportionately expensive) can submit a well-founded petition. Until the FDA grants it, the original requirement still applies. Petitions must demonstrate in detail that the alternative ensures equivalent quality, and they are not granted easily. Use this mechanism as a last resort and with expert guidance.
Follow policy and industry developments
Keep up to date through FDA announcements, Federal Register publications and industry events. Subscribe to e-mail updates from the FDA Center for Tobacco Products (CTP) and watch its regulatory agenda. Further measures – such as nicotine limits or flavour restrictions – may directly affect market access. Industry associations and chambers of commerce can help companies make their voice heard in consultations and often provide training and guidance.
Control compliance costs
Compliance requires investment, but costs can be managed. Several companies can share laboratory capacity instead of each financing expensive testing alone, or jointly engage consultants and share expert reports. Budget for training, equipment upgrades, certification and consultancy, and treat these costs as the entry ticket to the US market by building them into product costing and pricing.
Assess the strategy realistically
Finally, management should carry out a full risk assessment. If the effort to meet US requirements turns out to be disproportionate, alternative strategies should be considered – for example partnering with a US company that already holds authorisations, or focusing on other markets. Before committing major resources, conduct market research and a cost-benefit analysis. Companies that decide to enter the US market need the determination and patience for a long and complex regulatory process.
How EVERBIZ can help
EVERBIZ offers TPMP training for management and staff, covering the regulation, practical implementation and documentation requirements, delivered by trainers with hands-on FDA review and inspection experience. We also support PMTA preparation. Contact us for details.
This article is for general information only and does not constitute legal advice. As of publication, TPMP was still a proposed rule; the final FDA rule is authoritative.