Collins Sefa Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are crippling small- and medium-sized enterprises (SMEs), discouraging them from obtaining sanitary permits and product approvals—raising both public health concerns and questions about the future of this vital sector.
Industry experts warn that the current regulatory framework acts as a major barrier for small producers, especially in the food and beverage industry, where many businesses operate informally or from home. Without a simplified pathway to compliance, these producers risk being left out of formal retail channels, while consumers face the growing danger of unregulated and potentially unsafe products.
SMEs: Backbone of the Economy Under Pressure
SMEs make up 92% of all registered businesses in Ghana and contribute nearly 70% to national GDP. Despite being celebrated as the backbone of the economy, the sector faces persistent challenges—from limited access to finance and high operational costs to poor infrastructure. Regulatory hurdles from the FDA have now emerged as a serious threat to growth and sustainability.
Research shows that up to 75% of SMEs fail within their first three years of operation, a trend worsened by complex regulatory requirements.
The Story of a Small-Scale Honey Producer
Kwaku Agyeman (not his real name), a home-based honey seller operating for eight years, illustrates the struggles many entrepreneurs face. Despite his efforts to formalize his business with FDA certification, he describes the process as unrealistic and unfriendly to small producers.
“I wanted to have the standard badge, the FDA number. But we are producing domestically and they are looking at larger quantities,” he told B&FT. “Even the sample quantity they required was more than I was producing.”
As of 2025, Mr. Agyeman’s operations remain small-scale, serving only a loyal but shrinking customer base.
“I had a 20-bottle order for the whole of June. In July, I’ve had no orders at all,” he said.
The lack of certification has made it impossible for him to expand into supermarkets or formal retail chains.
Fruit Drink Entrepreneur Battles High Costs
Similarly, Akosua Frema (not her real name), a local fruit drink producer, secured FDA approval in 2021 with financial support from the Ghana Enterprises Agency (GEA). However, when her certificate expired in 2024, renewal became a financial nightmare.
“I paid about GH₵350 per flavour for testing – totalling over GH₵3,500 for my ten products. That’s just for testing. I still don’t know how much the certificate itself will cost,” she explained.
Since February 2025, Ms. Frema has been stuck between the FDA and the Council for Scientific and Industrial Research (CSIR) over compliance issues, including water quality and production environment standards.
“They said something was wrong. I haven’t corrected it yet, but I’m still producing and selling,” she admitted.
A Broken System?
The disconnect between FDA and CSIR raises critical questions. If CSIR test results show a product is unsafe, how quickly does this information reach the FDA? And if problems are flagged, what systems exist to halt unsafe production?
The inefficiencies—combined with weak enforcement measures—risk exposing consumers to contaminated food and beverages, aggravating Ghana’s existing struggles with sanitation-related diseases like cholera and diarrhoea.
The Need for Reform
By law, the FDA is tasked with ensuring the safety, quality, and efficacy of food and drugs under the Public Health Act, 2012 (Act 851). While its mandate is critical, the approval process appears skewed against low-volume producers.
It is still unclear whether this reluctance to approve small-scale businesses stems from policy or institutional practice. Moreover, there’s confusion over whether CSIR test results are automatically communicated to FDA or left for applicants to handle—adding yet another costly step in an already complex process.
Balancing Safety and Business Growth
With SMEs serving as a cornerstone of employment, food security, and economic stability, Ghana urgently needs a regulatory framework that balances public health protection with business accessibility.
Without reforms—such as clearer guidelines, lower fees for micro-producers, and faster processing times—small entrepreneurs like Agyeman and Frema may continue to shrink or shut down, threatening both economic growth and consumer safety.
