In today’s competitive dietary supplements marketplace, the role of contract manufacturers is more complex and nuanced than ever. Evolving and increasingly values-driven consumer preferences are driving change in the industry, opening new opportunities for supplement producers to diversify their portfolios to meet these needs. At the same time, increased competition is driving innovation, creating new challenges for brand owners along the entire product journey.
One issue is clear, however: successful development of dietary supplement products requires collaboration. A brand may have an outstanding idea, but it may not have the knowledge and experience to turn it into a reality. Here, contract manufacturers can step in, bringing their resources, facilities and technology along with their wealth of expertise. Contract manufacturers can help producers propel innovation in the supplement space and can bridge gaps they could not traverse alone. Their capabilities are vital during the setting of product specifications.
The term “product specification” covers a broad spectrum. At the core, however, product specifications must be established for any point, step or stage in the manufacturing process where controls ensure the quality and safety of the dietary supplement. This includes, for instance, technical aspects such as a product’s dimensions and raw materials, which are increasingly important to consumers as they become more concerned with the source of ingredients in the products they purchase. Component specifications must also be set to ensure specifications are met for the purity, strength and composition of dietary supplement components. Supplement product specifications also encompass consumer experience. They can cover quality controls and lead time expectations, as well as desired product claims, consumer targets and markets—even the desired supplement delivery profile. Specifications must also be established during in-process production, and to ensure correct labeling and packaging of the resulting supplement product, which is particularly important when products contain potential allergens.
Contract manufacturers and brand owners collaborating on product specifications offers a valuable opportunity to build trust and efficiency for mutual benefit. Together, both parties define a clear process, with expectations and opportunities to reassess along the way. This enables a contract manufacturer to meet a brand owner’s needs with responsiveness and agility.
The role of product specifications
Setting specifications helps ensure that the brand owner and contract manufacturer share a defined goal and a mutual understanding of which actions and achievements map the route to that goal. This not only takes the risk out of the process, but also helps to ensure that the desired result can be feasibly achieved. Not setting product specifications can lead to assumptions and unanswered questions. Misconstruing what a product could or should become can lead to significant inefficiencies that cost valuable time and money, which is why it is vital that all processes and operations are agreed upon and remain fully transparent from start to finish.
The process of setting specifications for supplement products also allows brands and contract manufacturers to put timelines in place, with clear stages of progression. Defining points of assessment in advance allows time management questions to be raised early. It also creates moments to discuss and adjust before moving on with the partnership. Ground rules are established as both parties agree on mutual standards and how they will be met. A contract manufacturer can then tailor their competencies to ensure they meet these requirements. Later, at the point of product testing, both parties will have agreed standards in mind, helping to further streamline the development process.
Specifications that must be set for dietary supplement products:
- Technical specifications, including the source and type of raw materials used. In some cases, technical specifications can be an integral part of a brand’s identity; defining and verifying those specifications is crucial for ensuring that a product delivers on its claims. If, for example, a brand is marketing a natural or plant-based product, the raw materials in that product should only be derived from plant-based sources. This is one reason why technical specifications should also include packaging requirements with clean label expectations or lack thereof.
- Sensory characteristics, such as taste, texture and smell. Setting these in advance manages expectations of the end product’s look and feel. It also ensures that sensory appeal does not become an afterthought. Even a product with the most promising claims must appeal to consumers’ sensory preferences to be successful.
- Regulatory specifications. Brands must put measures in place to ensure they meet FDA regulations regarding product claims and labeling, as well as adherence to current good manufacturing practices (cGMPs). Manufacturers should ensure they have a solid idea of the responsibilities around regulatory changes, and how the brand and its products will remain compliant throughout its lifetime. Stringent regulatory evaluation can also be advantageous for a brand looking to expand globally, and pursue distribution and importation into other countries, which creates the need for further regulatory assessment of the product.
- Product testing specifications. Testing is a vital way of assessing a supplement product’s safety, purity and efficacy. Many aspects need to be verified, including the compatibility of ingredients, choice of dosage form and more. Both parties must agree on what will be tested, how often and using which methods, which must also be validated to guarantee a sound analysis of the material. Another question to ask is: will the contract manufacturer or a third party will be doing the testing, and why? The brand owner should have ample opportunity to assess samples before full commercialization, as part of the quality assurance (QA) and control (QC) process.
- Worst-case scenario specifications. Both sides must agree on how to manage risk, and what happens when the worst cannot be avoided. In cases of product recall, once a standard of transparency has been established, a contract manufacturer would be able to provide all necessary documentation to support the brand during this process, offering traceability to see where the error originated.
- Customer expectation specifications. Brands and contract manufacturers must always consider their end customer. Certain retail channels have their own requirements for verification and regulation, so it needs to be determined how will these needs be met.
Considerations when setting product specifications
Setting specifications for supplements requires a balancing act. Consumer expectations must be weighed alongside manufacturing and regulatory requirements and market need; for instance, the end product should fulfil the needs of consumers and enhance consumer loyalty and, therefore, support the brand’s success. It should also adhere to current industry regulations. At the same time, brand owners need scope to explore and discover their product’s potential during the process of setting specifications, which a solutions provider should support. The process should give both parties the opportunity to discuss exactly what kinds of support may be required and how they will be delivered. The transparency that drives such discussion becomes a foundation for mutual trust and benefit. It is vital to ensure specifications are set from the beginning of the process to establish that foundation, and to prevent the product development journey from becoming reactionary and disjointed.
While many elements are at play, balance can only be achieved through collaboration. A brand owner may approach a contract manufacturer with a list of specifications in mind, or perhaps just an idea. In either case, a contract manufacturer can craft a tailored offering of assistance, depending on the level of support required. Integrated solutions providers work closely with brands to fine-tune the details along every step of the journey. Their expertise, knowledge and trusted network qualifies them to offer support to brand owners with diverse aims and resources and help them to deliver the products customers are looking for. Of course, brand owners must ensure that their contract manufacturing partner brings all these qualities at the start of the process, which is why they must have the opportunity to audit and qualify all vendors. They should also ensure that they engage with a contract manufacturer that has its own rigorous process for testing and qualifying the vendors they work with to ensure that the end product meets quality standards.
Ensuring that brands and contract manufacturers stay connected throughout the process, with opportunities to align on every major decision, is also essential to ensuring product specifications and quality requirements are met. Brands and contract manufacturers must agree when qualifying raw materials, building, testing the formulation and moving to full commercialization. Brand owners and solutions providers can work together to establish quality from the outset, beginning with pre-defined objectives and achieving high levels of product and process understanding, as per FDA’s quality by design (QbD) principles. A a pre-determined process must allow for continuous, responsive knowledge sharing throughout, and it is also crucial to commit to a review, with mutual agreement on when and how often reviews should take place, as well as what the expected results are. This optimizes operational efficiencies, helping to avoid costly setbacks and minimizing the need for change later on. A tweak to packaging design may not be too disruptive, but a raw material replacement might reset the whole process. Setting the right specifications works to prevent this and helps both parties remain aligned.
Setting specifications also creates opportunities for growth. As a brand owner’s ideas grow and evolve, a contract manufacturer can support them by evolving their own offering. For example, if a project requires certification a contract manufacturer does not possess, investing in that certification not only supports the brand, but also enables the contract manufacturer to be better positioned to support them as part of an ongoing partnership.
An integrated solutions provider can also provide a brand with expert consultation when it comes to regulatory compliance. That means offering guidance to ensure it can adhere not only to FDA regulations, but also to FTC regulations, which is integral to support a brand’s efforts when marketing their final supplement product. While FDA regulates both finished dietary supplement products and dietary ingredients, FTC regulates product advertising. A contract manufacturer can help a brand understand how it can align their product and process with FDA and FTC requirements while also meeting its own requirements, which might include clean labels, for example. Some solutions providers have in-house regulatory departments, which monitor changes in the regulatory landscape so they can best advise brand owners on remaining compliant.
Actions of the right contract manufacturer
While the contract manufacturer’s role as solutions provider is more complex than ever, a successful partnership comes down to a few essential qualities: transparency, accessibility and a willingness to collaborate. These qualities shine a guiding light along the product development journey, maximizing the chance of delivering an optimal result that is mutually beneficial and supports growth in the wider industry to meet the needs of today’s demanding consumers.
To make the most of their relationship with the right contract manufacturers, a brand owner can cultivate those same qualities. When a brand meets a contract manufacturer with the same willingness to plan, share and evolve, the chance of mutual success increases exponentially.
Barri Sigvertsen is global innovation marketing manager at Lonza Consumer Health & Nutrition. Lonza offers fully integrated contract manufacturing capabilities, including high-quality technical services, and a network of resources and expertise in manufacturing and regulation. Its team of experts work closely with brands from the outset, setting comprehensive product specifications that consider every aspect of the supplement project journey in a clear, transparent manner.