Starting with the end in mind
Budget, timelines, and pressure to be innovative are just a few of the barriers that many companies face when looking to gain market access. The trick is knowing what you want to say about your product, what you can say, and having a clear understanding of the marketplace you’re looking to penetrate. From there, a strategic solution can be developed to assist in achieving your goals.
Looking to the pharmaceutical industry and adopting critical aspects is one way to support prolonged market entry, additional claims, further regulatory classifications, and future development opportunities. At Nutrasource, we call this the “pharma-lite” approach, and it has proven to be effective time and time again.
Forming the concept
A strong, well-developed, scientifically sound concept (or lack of one) will determine your marketplace success. Whether you’re starting from scratch and in the early developmental stages or optimizing your current concept, here are a few questions worth considering:
- What is the product? Which category does it fall under and what are the active compounds?
- What is the correct dosing?
- What is known about the product? What is revealed in the literature review?
- Who is the product intended for?
- What does your product do, and how does it do it? Know the targeted space and mechanism of action that will dictate the regulatory pathway and help to narrow your marketing messages.
- Where is the product made and where do you want to sell it?
- How is the product made? Is GMP and Quality Assurance ensured?
- Is there safety data established?
Clarifying these research questions helps define the concept and ensures every aspect is examined. Additionally, an analysis of warning letters and case law in the targeted space is critical and provides context for product marketing.
Filling the gaps with science
Conducting a comprehensive review of the peer-reviewed scientific literature will be a pivotal indicator of strength and weaknesses of your concept. What you obtain from the literature review will help you understand the safety, efficacy, and claims potential of your ingredient or product. Furthermore, this links the science to marketing opportunities down the road including published, peer reviewed literature, whitepapers, substantiation, direct research, and more.
Setting yourself up for success
How can you form a strategy that will allow you to research efficiently and with purpose? Knowing what you want to say about the product, understanding the mechanism of action, thoroughly scanning the scientific literature, and leveraging safety data will lead you to a concise study design to support your marketing and regulatory goals. Ultimately, time and money will be best used once the goal and direction is clearly outlined.
Achieving the Claim
Once you’ve established a structured plan to follow, achieving the claim is realistic. A confident approach to claim substantiation includes strategic assessment of current regulations, a review of scientific literature for existing supporting evidence, submission of regulatory documents in countries requiring pre-market approval/notification, and/or clinical trials to further support the claim.
Fundamentally, we know you want to educate your customers about your product’s benefits. When properly substantiated, health claims can give brands a competitive edge in today’s ambitious marketplace. Most importantly, having strong science to support health claims can help reduce regulatory risk.
Here’s what to avoid
While the process is straightforward, there are a couple of ways you could find yourself in trouble and we want to make sure you’re aware of the caveats. First and foremost, stay away from disease claims, mentioning or implying disease or disease state can cause issues almost immediately. Refrain from using language that is associated with drug claims such as “therapeutic,” “defense,” and “boost.” Alternatively, use words such as “support,” “promotes,” and “maintains function.” As always, be wary of hashtags and know that hashtags or endorsing certain third-party reviews can be indirect claims. Eventually you’ll need to explore this in detail and the FDA provides guidance on how to navigate structure function and health claims related to dietary supplements and food.
Additionally, be careful in what material you are linking content to—always link to credible sources that are scientifically sound and be cautious not to reference disease studies.
In summary, there are three critical components to successful marketplace access. As mentioned, addressing the key research questions will help in connecting the science and realizing marketing objectives. Performing a comprehensive literature review informs product development teams of strengths and weaknesses of the product and highlights product potential. Lastly, knowing your options when it comes to claim substantiation as well as what to avoid will streamline the workflow and keep you on the right track.
When in doubt, seek out third–party expert consultation. Partnering with an experienced team will catalyze the concept to claim process. Contact Nutrasource today and we’d be happy to work with you in research & development, regulatory strategy, clinical research, products testing, general consulting, and of course, health and marketing claims.