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NECA, SON, Health Ministry oppose proposed NAFDAC bill over regulatory overlaps

National Agency for Food and Drug Administration and Control (NAFDAC)

…Employers’ body urges National Assembly to exclude tobacco products from legislation

The Nigeria Employers’ Consultative Association (NECA), the Standards Organisation of Nigeria (SON) and the Federal Ministry of Health and Social Welfare have raised concerns over a proposed bill seeking to expand the regulatory framework for food, medical products and related items, warning that it could create overlapping mandates, increase compliance costs and disrupt businesses.

The stakeholders expressed their reservations about the proposed Food, Medical Products and Related Products (Registration, Etc.) Bill, 2026, which seeks to repeal the Food, Drugs and Related Products Act, 2004, and establish a new regulatory framework.

NECA, in its submission to the Senate Committee on Health, urged the National Assembly to exclude tobacco products from the proposed legislation, arguing that the sector is already governed by dedicated laws and regulations.

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The bill, sponsored by Senator Umar Sadiq Suleiman, passed second reading in the Senate on July 21, 2026.

According to NECA, extending the proposed legislation to tobacco products could conflict with the National Tobacco Control Act, 2015, the National Tobacco Control Regulations, 2019, and the SON Act, 2015.

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The association warned that the proposed framework could create overlapping responsibilities among the National Agency for Food and Drug Administration and Control (NAFDAC), the Federal Ministry of Health and Social Welfare, SON and the Nigeria Customs Service.

It said such overlaps could result in multiple registration requirements, duplicated approvals, conflicting enforcement decisions, higher compliance costs and uncertainty for businesses operating within the existing regulatory framework.

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NECA argued that tobacco products constitute a distinct regulatory category and should not be treated as food or medicines under the proposed legislation.

It also questioned the extension of NAFDAC’s authority to tobacco products, maintaining that their regulation should remain within the framework established by existing tobacco control legislation.

The employers’ body expressed further concern about provisions that would grant additional powers over product registration, suspension, seizure, factory operations and enforcement, warning that these could interfere with the statutory responsibilities of other government institutions.

It particularly criticised the proposed ceiling-list mechanism, which it said could give NAFDAC excessive administrative discretion to restrict products without adequate statutory safeguards and oversight.

NECA called on lawmakers to amend the bill to prevent unilateral regulatory decisions, clarify the responsibilities of relevant agencies and strengthen coordination among existing institutions.

The association maintained that effective regulation requires clearly defined institutional mandates, predictable compliance requirements, proportionate enforcement and collaboration among government agencies.

It added that a coherent regulatory environment was important for investment, economic growth, public health protection and compliance with applicable laws.

At the public hearing on the proposed legislation, the Federal Ministry of Health and Social Welfare also expressed reservations about provisions that could lead to regulatory conflicts and duplication.

Represented by Dr Adebisi Adegoke, Director of Hospital Services, the ministry reportedly highlighted the risk of overlapping mandates and said the proposed changes could create institutional conflicts.

It recommended deferring consideration of the bill to allow broader consultations among affected stakeholders and ensure alignment with the ministry’s existing regulatory responsibilities.

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SON similarly raised concerns that some provisions of the proposed legislation could conflict with its establishing law and interfere with its statutory responsibilities.

The organisation supported calls for the bill to be deferred for further review, noting that more comprehensive engagement was needed to address potential overlaps and avoid unnecessary regulatory complications.

Tobacco industry operators have also opposed the proposed framework, arguing that manufacturing, importation, distribution, packaging, health warnings and product standards are already subject to extensive statutory controls.

They warned that introducing parallel approval and enforcement structures could expose manufacturers and importers to conflicting directives, additional administrative costs, operational disruptions and uncertainty over regulatory authority.

The industry stakeholders maintained that their concerns were not about resisting public-health regulation but about avoiding additional layers of oversight without clearly established benefits.

They argued that unpredictable compliance requirements could weaken investor confidence, discourage business expansion and complicate efforts to improve Nigeria’s competitiveness and ease of doing business.

The operators also warned that additional administrative burdens on compliant businesses could divert regulatory resources from other enforcement priorities, including illicit trade and operators that fail to comply with existing laws.

NECA said it remained willing to engage with the National Assembly and other stakeholders to achieve a legislative outcome that protects public health while preserving regulatory certainty and business confidence.

The association urged lawmakers to ensure that the proposed legislation complements, rather than contradicts, Nigeria’s existing tobacco control framework.

It maintained that stronger coordination among regulatory agencies, rather than duplicating their mandates, would provide a more effective and predictable approach to regulation.

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