By Mark Land, M.S., RAC, AAHP President
What will homeopathic medicines look like in the future in the United States? AAHP examines the possibilities and problems ahead with the products’ dosage forms, active ingredients, packaging, and labeling.
Since the founding of homeopathy, dosage forms have been defined by their simplicity. The Homeopathic Pharmacopoeia of the United States (HPUS) asserts, “Homeopathic drugs shall be based on their simplicity.”1 Diluents for homeopathic drug products have historically been limited, most commonly to alcohol, water, glycerin, and simple sugars such as sucrose and lactose.2 These diluents have many inherent properties that aid formulators in maintaining simplicity, such as: compatibility with homeopathic active ingredients; stability including microbiological stability; and having well-known human pharmacokinetics and metabolism.
Simplicity served the homeopathic industry well and favors many important facets of drug quality and performance. It kept production costs low; minimized the use of potentially bioactive compounds like preservatives; and maintained a formulation legacy with original homeopathic dosage forms.
In contrast, simplicity constrained the range of homeopathic dosage forms to primarily tablets, pellets, and liquids by oral route and to ointments and salves by topical route of administration.3 Nevertheless, certain drivers have, and will continue to, prompt a wider range of homeopathic dosage forms.
One of the leading drivers of dosage form change is manufacturers’ goal to present more consumer benefits such as convenience, taste, and ease of swallowing.4,5
Keeping pace with competition is another strong driver. While oral dosage forms in the homeopathic category are most popular among consumers,6 shoppers may be familiar with or prefer innovative presentations from competing allopathic OTCs. Consumers have access to more products than ever. E-commerce marketers display a range of products previously inaccessible to most consumers. This phenomenon is driving development of both innovative and “follow-on” healthcare products. The Homeopathic category will most likely follow suit.
New science and technologies are a third driver of dosage form change as manufacturers explore formulations to enhance stability and improve performance of existing products.7 Homeopathic manufacturers have access to a wide range of emergent technology, including offerings through contract manufactures and laboratories, to facilitate the development of products.
This emergence of a wider range of homeopathic dosage forms is evident in the FDA’s drug listing database. As of 2021, more than 40 dosage forms of homeopathic drug products are registered with the agency.8
The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2020 (“OTC Monograph Reform”)9 provides a lightweight but defined pathway for manufacturers to propose innovative formulations for existing active ingredients that may already be on the market in other jurisdictions.
OTC Monograph Reform also enables changes in dosage strength, which will incite changes to existing products.10 In turn, changes in dosage strength will cause changes in indications, directions, and warnings. These developments in allopathic OTCs will likely be followed by homeopathic drugs.
FDA’s June 27, 2022 proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) will also stimulate changes in active ingredients.11 Rx-to-OTC switch is the transfer of proven prescription drugs to nonprescription, OTC status. Like OTC Monograph Reform, Rx-to-OTC switches will create and open new therapeutic categories to other products, including homeopathics.
A third driver is new HPUS monographs. HPCUS approves several new monographs per year. History has shown that new monographs are generally implemented by the sponsoring manufacturer. However, ingredients with wide appeal may spark development by a broader range of competitors.
The last driver of active ingredient change is the evolution of selfcare. Consumers have demonstrated wanting greater control over their individual health and the health of their families; Consumers have also shown an increased interest in proactive healthcare management through diet, exercise, sleep, hygiene, personal engagement in health, and medication safety.12,13 Due to inherent safety, homeopathic medicines are often a consumer’s first choice. For these reasons, consumer demand for more and new homeopathic drug products is likely to increase.
Packaging has come a long way from its basic function to protect the product. Homeopathic products must keep pace with consumers’ expectation for packaging, including being attractive and distinct enough to promote itself, as well as now be environmentally sustainable.14
Environmentally-friendly packaging is increasingly important to consumers. For example in food service, according to a 2020 McKinsey global survey of 10,000 people, 68 percent of U.S. consumers say they are willing to pay “a lot” or “a bit more” for sustainable packaging.15 Sustainability is a key topic; many consumers say they are willing to pay more for sustainable packaging.
The pharmaceutical industry must balance satisfying the health and safety demands of industry regulators with the desires of modern convenience-minded, eco-conscious consumers. This may be even more so for homeopathic manufacturers whose products have been purchased traditionally by the natural channel shopper.
Global markets for packaging materials and technology, however, offer a variety of solutions to both the regulatory constraints and commercial demands for innovative packaging.16 Homeopathic products are well-positioned to take advantage of new technologies given the international footprint of many U.S. marketers of homeopathic products.
Manufactures also need to anticipate change in labeling. One factor is consumer interest in more product information. Product packages, however, have limited space to communicate important information to consumers. Over informing on the package can affect comprehension and interfere with the consumer self-selection17 Focusing too narrowly on clinical value often leads companies to neglect a powerful driver of a product’s success: the customer experience. By addressing pain points along the consumer’s journey, companies can increase customer satisfaction and improve adherence. As complexity increases in the OTC market and competition intensifies, optimizing the customer experience becomes even more important.18
To better ensure a positive consumer experience or to protect the company from poor product performance due to lack of instructional clarity, manufacturers may choose to provide supporting product information on their websites. This is especially helpful for homeopathic products that may be unconventional in application, or traditionally have small labels, or have packaging unable to carry an insert.
Retailers’ websites, especially those for online-only retailers, are another source for labeling information. Manufacturers should establish a database of informative text and informative graphics for retailers’ websites. Retailers are eager to differentiate themselves by providing consumers with more information on the health products they sell. While this is not practical at store shelves, product information over product image is favored on retailers’ websites. Online retailing is also a virtual laboratory to understand the need for greater prioritization and presentation of product information.
Consumer demand — and therefore retailer demand — for more product information cannot be fulfilled on-pack. However, momentum is gathering to electronically enable access to supplemental information via technologies like QR codes leading to manufacturers’ websites.19
Indeed, the future is beyond the basic drug fact label requirements instituted since FDA’s 1999 Drug Facts Rule, which was designed to standardize formatting and therefore improve consumer comprehension.20 Currently nonprescription drug products are limited to drugs that can be labeled with sufficient information for consumers to appropriately self-select and use the drug product. This is challenging sometime due to labeling limitations.21 However, under FDA proposed rule (Nonprescription Drug with an Additional Condition for Nonprescription Use), when labeling alone is not sufficient to ensure that the consumer can appropriately self-select, appropriately use, or both, a drug product correctly in a nonprescription setting, an applicant may submit an application proposing an ACNU that a consumer must successfully fulfill to obtain the nonprescription drug product with an ACNU. Homeopathic labelers will likely take advantage of developments in labeling of OTC drug products.