Ghana's Food and Drugs Authority (FDA) and COA Research and Manufacturing Limited Company (COARMLC) have issued strong denials regarding false media reports claiming that COA-72, a plant-based pharmaceutical product, is undergoing FDA-approved clinical trials as an anti-HIV drug.
The controversy erupted following a Daily Graphic publication on July 16, 2025, which incorrectly reported that COA-72 had entered clinical trial stages for HIV treatment. The FDA responded swiftly, stating that no clinical trial for COA-72 related to HIV has been approved and that claims about FDA-authorized trials are "false and dangerous."
Company Clarifies Product Status
COARMLC, led by founder and CEO Samuel Ato Duncan, emphasized that the media coverage misrepresented their position during a Parliamentary Select Committee on Health visit to their facility on July 14, 2025. "Nowhere did we state that COA-72 is in active clinical trials for HIV treatment," the company stated in an official release on July 28, 2025.
The company explained that COA-72 is a new formulation that has shown promising results in pre-clinical and internal studies, with early findings suggesting potential antiviral and anticancer properties. However, these preliminary studies, which have demonstrated reduced HIV viral loads and in some cases viral clearance, "must not be misconstrued as clinical evidence" and "do not replace the need for formal, FDA-approved clinical research."
Regulatory Application History
COARMLC revealed that it formally applied to the FDA in 2019 to initiate clinical trials on COA-72. The FDA acknowledged this application through a letter dated October 29, 2019, referenced as FDA/SMC/CTD/CTA/19/0059, which outlined specific requirements for beginning clinical testing including partnerships with accredited research institutions and adherence to international protocols.
As of the current date, the company has not fulfilled all conditions necessary for FDA approval to begin clinical trials.
Economic Projections and Research Background
The company's research stems from Duncan's public commitment on November 30, 2005, to pursue a natural cure for HIV. This vision has guided nearly two decades of plant-based pharmaceutical work, leading to the development of several products including COA Mixture, COA Plus, COA-MT, and COA Capsules, though none are currently approved for HIV treatment.
COARMLC estimates that if COA-72 proves successful through official trials, it could contribute as much as $76.8 billion annually to Ghana's economy and create thousands of jobs.
Public Health Concerns
The FDA emphasized that spreading misinformation about unapproved treatments poses serious public health risks and undermines the integrity of regulatory oversight. Prof. Kwabena Frimpong-Manso Opuni, acting Chief Executive Officer of the FDA, demanded an immediate retraction of the false publication within one week, threatening legal action if the request was not met.
COARMLC expressed regret over the confusion caused by the misreporting and called for greater responsibility in health-related journalism. The company reaffirmed its commitment to working within regulatory frameworks with the FDA, WHO, and accredited research institutions, stating that "public trust and regulatory compliance are not optional—they are non-negotiable."
