HM regulation and the Food and Drug Board (FDB)

Earlier blog has highlighted the contemporary HM’s cultural break with the past and has discussed some of the ways its current form fits in a continuum of increasing urban use prevalence. But, there are longstanding systemic weaknesses related to regulation and control of HM that have existed within the Food and Drug Board (FDB) and such laxity go well beyond the tenure of contemporary alterations.

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Regulatory control over the manufacture, distribution and marketing of HM products is vested in the hands of the Ghana Food and Drug Board (FDB). The FDB is an independent body that is required by law to take reasonable and necessary steps to protect the public from the adverse health effect of injurious herbs and deleterious HM formulations.

Measures adopted by the FDB in compliance with the mandates of law include the requirement for practicing herbalist to procure a license before practice and the requirement of FDB permission before commencement of marketing of herbal products. To ensure compliance with regulatory mandate, FDB has the power to authorize law enforcements agents to seize and destroy unregistered formulation and marketed formulations reported by users to be unsafe. The FDB has the power to make law enforcement agents responsible for compliance with regulatory issues involving HM in a literal move to keep the plurality of formulation from devolving into chaos and to use the multiplicity of safe and efficacious formulations to address therapeutic challenges.

But the FDB is beset with multiple challenges that hinder its smooth operation. Most obvious institutional weaknesses comprise a lack of a science base, insufficient manpower and lack of scientific infrastructure has drawn little public and stakeholder attention. The assumption that the FDB is uncooperative and unresponsive to challenges faced by HM providers is so widespread among provider communities that it has almost become a caricature. A common theme among provider complaints is that AM cultural orientation is built into FDB policy and that triggers regulatory restrictions that are impossible for them as herbalists to meet. Coupled with the complaints are that the lack of assumption of good faith on the part of the FDB alienates providers from the activities of the regulatory body. Health policy advocates contend that the FDB has not grappled deeply enough with contemporary issues including pressing questions of safety and efficacy of emergent formulations. While these complaints may probably be distortions of the FDB’s position, no study has explored this dichotomy and this mention in this report relies only on anecdotal evidence.

As regulatory body the FDB need to earn the trust and confidence of HM providers to enable them achieve regulatory success. The consequences of the FDB’s “seize and destroy” policy as well as its embedded punitive provisions have set the stage for much recrimination between providers and regulators. The lack of clarity in FDB requirements for providers’ licensure, for formulations’ safety limits and for formulation efficacy assessment has conferred a perception that FDB exercises are intrusive, chaotic, ineffectual and retrogressive. But the regulatory process raises even bigger question, not just for HM-based prophylaxis but for alternative healthcare as a whole: does regulation have an underlying science base? Supporting the implementation of the new regulatory programs such as enhancement of regulatory science will introduce scientifically-based rationale to guide formulation approval and disapproval for marketing.

The sophistication, resources and scale of HM use in urban communities across Ghana underscores to regulatory authorities that HM culture has reached a new level and that the calculus of regulatory effort against injurious formulations has to fundamentally change. The FDB must establish national labs in all regional capitals to enable a quick regional response to localized new and emerging threats to public health stemming from changing trends in HM presentation and marketing. But the pace of new formulation additions to the market has far outstripped the FDB’s capacity of its sole national lab to mount an effective market monitoring for injurious formulations. Regulatory stringency has not kept pace with market evolution.

Pre-marketing scientific testing of products’ safety using certified biochemical indicators will establish a rational basis for FDB’s seizure and destruction regulatory action on potentially injurious products and may burnish HM provider unhealthy perception of a regulatory control that is governed by arbitrary decision and by anecdotes of dissatisfied users.

Regulatory authorities attempt at licensure of providers has been difficult to enforce for varied reasons including the vastness of the unregistered pool of herbalists, the enormity of the field of coverage and the institutional bottlenecks that hamper approval-seeking efforts by well-intentioned herbalist. Provider objections to the regulatory process have been publicly voiced in strongly-worded language with purported strategic pitfalls at its undertow: draconian regulatory restrictions will take HM underground where it is liable to create unforeseen problematic health outcomes. Consequently future debates over the scope of regulatory breaches and control must also acknowledge that the continuing threat to public health of unregulated HM is very real.  Underneath this dichotomy are broader issues regarding regulatory oversight and the contextual policy-related factors associated with such regulation. Taken together, this perspective suggests that new reforms are needed to help regulatory authorities manage and sustain gains in the health related quality of life offered by the transformative changes in HM without sacrificing public health safety. And a pragmatic constructive vision that uses regulatory power prudently to eliminate fraudsters and empower genuine providers will be a welcome boon.

As HM formulations become more diverse and plentiful, a clear need exists for the FDB to connect policies to changing trends. Nevertheless, the challenge to adapt policy to a HM healthcare world that has changed radically from that of the two earlier decades when transformation of HM into the modern era began has been met with indecision by all stakeholders. Provocative and unanswered questions about regulation and policy abound. Are regulatory policies flexible and dictating current market trends or are they reflexively used in response to new and current developments in the market? How often are new FDB policies enacted? Does the policy offer herbalists and provider’s freedom to formulate new recipes? Does the policy saddle providers with vexatious regulatory restrictions and hamper their creativity in developing new formulations? Is the current level of FDB protection sufficient to keep unsafe formulations out of the market? Does the policy ultimately advance or stymie the growth of the HM industry?

HM advertisements are a potential draw for new users as providers often embellish the medicinal value by branding their formulations as “wonder cures.”  Does the FDB policy enforce truth in relation to HM advertisement?

The high frequency of new formulation additions to the large assortment of ready-to-use formulations suggests that new regulatory policies are needed to prevent the marketing of unsafe formulation and thereby protect the public from the adverse health effect of unproven recipes. 

Regulators have to leverage the expertise of all stakeholder representatives groups and experts from relevant integrative health domains to identify approaches and policy priorities that can help eliminate the marketing of fake and injurious formulations. Changes in regulatory policy could be made with collaboration from herbalist, physicians, scientists and users and health advocacy groups, and policy makers and regulators. Health advocacy groups should: discuss underlying cultural issues relevant to effective HM regulation; address shortfalls in current policy and press for policy change or make policy recommendations where appropriate. Efforts should be directed to the development of the next generation of basic, clinical, and translational academic investigators in HM-related science and to cross-train such investigators in HM regulatory policy. Such knowledge will improve the science base and may critically inform future policy decisions.

Changes in approval procedures and in regulatory policies in response to changes in the regulatory environment must be communicated in timely manner so that HM providers can address emergent issues in good time and avoid regulatory penalties.

Contemporary laissez-faire provider cultural norms ensure a continually open door to the marketing of untested formulations. Widespread provider perception of being targeted by the FDB with unyielding regulations musty be burnished with openness and public education in the science of HM. Additionally, the tendency to treat injurious formulations as a policing matter means that the “flawed” provider recipe and unscrupulous provider motives behind their presence seem to go unquestioned and unchecked. Consequently, efforts should be redirected toward strengthening the informal association of providers in a way that will help them moderate each other’s professional activities and will instinctively instill in them the maintenance of a professional code of conduct that eschews fraud and that rejects formulations with ill-advised recipes.

The dearth of published literature on HM regulation has created a vacuum of information on operational FDB policy on sale and marketing of HM and on the influence of such policy on the availability and marketing of HM. There is appetite for reform among a majority of HM stakeholders who are asking for a modern well-regulated institution with transparent operations and for policy changes that can curb current gaps in regulation. The FDB system should promote regular and consistent ongoing review of policy to permit timely changes in regulatory procedures as the regulatory environment changes in response to the fluidity of the HM market. The FDB should initiate cooperative agreement with all the diverse stakeholder groups on technical, policy, advances in regulatory science and procedural issues that supports FDB’s oversight activities.

Lack of dissemination of policy details breeds rumors and suspicions. By equipping scientists and educating the public, regulators can bring to public policy all available information that increasingly pervades the healthcare sector while reviving provider communities to combat fraud and adulteration.

But on the whole, regulatory policy has done more to advance, than impede, the ongoing revival of Ghana’s HM. It blended priorities of FDB with top needs of users. But given the momentum around HM use and the continued influx of ready to use formulations in the market, it remains to be seen how much of an impact FDB policy changes will have on the direction of future HM formulation, marketing and use. Interest in a new model is driven by political and social factors but such political shift must be followed by cultural shifts if enacted policies have a chance at successful execution.

Understanding how the legislators and the FDB undergo policy changes under such a natural selective pressures represents a major gap in knowledge in emerging HM research and is specifically relevant to public health as the burgeoning HM industry undergoes shifts in healthcare, including new formulations to treat prevalent diseases.

The FDB may assemble a multidisciplinary group of investigators ranging from bench biologists to clinicians and herbalists, epidemiologists, and health regulatory authorities to provide a thorough state-of-the-science update on all aspects of HM use and HM therapy and to propose new scientific initiatives going forward that critically : (a) assesses the conceptual and methodological issues related to clinical trials on efficacy and safety; b) offers solutions to the inherent challenges that stymies the safety-related toxicological assessment; c) raises regulatory issues including the culturally sensitive way of handling false and misleading advertisements, incipient HM use abuse, and curbing of fakes and adulterated formulations; d) strategizes on the inclusion of the scientific community and the general public in HM-related policy enactment; d) permits translational research possibilities leading to the eventual development of drugs from scientifically proven efficacious and safe formulations.