Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and medium-sized enterprises (SMEs) from obtaining the necessary sanitary permits and product approvals – raising concerns about public safety and the long-term survival of this critical sector.

According to industry experts, the current regulatory regime creates a significant barrier for smaller producers, particularly in the food and beverage industry where a large proportion of businesses operate from informal or home-based settings. Failure to address these challenges increases the risk of unregulated and potentially contaminated products entering the market.

The SME sector, which constitutes 92 percent of all registered businesses and contributes approximately 70 percent to national GDP, is often heralded as the economy’s backbone. However, the sector continues to face persistent challenges such as limited access to finance, poor infrastructure and high operational costs. Regulatory hurdles, now more than ever, appear to be another pressing concern.

Research indicates that up to 75 percent of SMEs fail within their first three years of operation. Among those struggling is Kwaku Agyeman (not his real name), a honey seller operating from his home for the past eight years.

Despite his desire to formalise and scale up his business by obtaining FDA certification, his efforts have been thwarted by what he describes as unrealistic production requirements and a lack of clear guidance.

“I wanted to have the standard badge, the FDA number. But we are producing domestically and they are looking at larger quantities,” Mr. Agyeman told B&FT, recounting his first attempt to engage the FDA in 2017. “Even the sample quantity they required was more than I was producing.”

Now, in 2025, Mr. Agyeman still produces on demand for a small, loyal customer base. “I had a 20-bottle order for the whole of June. In July, I’ve had no orders at all,” he said.

With mounting production costs and no prospect of expanding to formal retail channels, his business teeters on the brink.

“The process is tedious. If you’re not producing large quantities, you’ll be discouraged. I closed my mind on it after the first rejection,” he admitted.

Despite the lack of certification, he continues to supply his honey to consumers who trust the product blindly.

This issue is not unique to Mr. Agyeman. Across the country many SMEs, especially those operating in informal settings, do not possess sanitary permits – posing a potential risk to public health. Because of their size and operational style, these businesses are hard to inspect and often overlooked by regulators.

Larger companies, with reputations to protect, are more likely to comply with safety standards. But it is the informal producers – without certifications, oversight or structured facilities – who pose the greater public health risk.

Another affected entrepreneur, Akosua Frema (not her real name) – a local fruit drink maker – initially received a three-year FDA certificate in 2021 through support from the Ghana Enterprises Agency (GEA).

“GEA paid for registration the first time. I don’t remember paying anything,” she said.

However, after the certificate expired in 2024 she has struggled to renew it – citing both financial and procedural burdens. “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.

Ms. Frema has been shuttling between the FDA and Council for Scientific and Industrial Research (CSIR) since February 2025 to renew her certification. After samples of her products were collected and tested, CSIR flagged problems related to 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.

The apparent disconnect between the FDA and CSIR raises additional questions about communication and enforcement. If test results from CSIR show a product is unsafe, how quickly and directly does that information reach the FDA? And if issues are identified, are there mechanisms in place to prevent continued production and sale?

These inefficiencies, compounded by a lax enforcement regime, could expose consumers to unsafe food and beverages – with broader public health consequences. Ghana already battles sanitation-related diseases such as cholera and diarrhoea. Without prompt intervention to streamline certification processes and bring more SMEs into the regulatory fold, the country risks a wider health crisis.

By law, the FDA is mandated to ensure the safety, quality and efficacy of regulated products – including food, drugs, and tobacco – under the Public Health Act, 2012 (Act 851). The Authority issues food hygiene permits and conducts routine inspections of facilities before issuing approvals. However, the process appears skewed against small producers.

It remains unclear whether FDA’s reluctance to approve low-volume producers is grounded in policy or practice. Also unclear is whether CSIR’s test results are relayed directly to FDA or whether the burden falls entirely on applicants – adding yet another step in an already complex and costly process.

At the time of publication, the FDA declined to comment when contacted by B&FT.

With SMEs playing a vital role in employment, food security and national economic growth, there is an urgent need for the regulatory architecture to evolve – balancing rigorous safety standards with accessibility and support for small-scale producers. Otherwise, both public health and the very survival of the country’s SMEs remain at risk.