Nutrasource Blog

How to Develop Cutting-Edge (and Compliant) Dietary Supplements

Posted by Nutrasource on Thu, Aug 20, 2020

Developing dietary supplements with strong claims not only allows brands to stand out from the pack but also provides a competitive advantage.

That said, there's a big difference between claims you've seen time and time again and those that are unique and attention-grabbing.

In a quest to develop effective products with compelling claims, many brands are wondering: Is there a foolproof way to turn science into sales?

In this post, adapted from the original presentation by Douglas Kalman, PhD, RD and Susan Hewlings, PhD, RD for the Nutra to Pharma Digital Summit, we provide a blueprint on how to remain legally compliant, yet cutting-edge, during product development - and how to drive sales in the process.

Understand the Research Process

Once you have your product idea, the next step to product success is understanding how clinical research is used to support claims. Not all clinical studies are created equal. In fact, there is a hierarchy based on the type of research and applicability to substantiating claims.

Intervention studies such as randomized, double-blind, placebo-controlled clinical trials are considered the "gold standard" for supporting claims. For multiple-ingredient products, it is recommended to test your finished product in the EXACT medium you wish to sell it.

FTC Study Hierarchy

That's not to say that the lower levels are not applicable. Research in animals or in vitro studies, for example, are done early in product development and their findings can help direct further stages of research. They can be included as part of substantiation but should not be relied on by itself.

Choose the Right Study Design, Population, and Biomarkers

Once you recognize the need for original research to adequately support your product, you'll want to pay careful attention when choosing the study population. Ensure the population characteristics represent the desired target market in terms of demographics and health factors.

Selecting appropriate biomarkers is also critical to the success of a study and ultimately substantiating your product claim. An independent research group with experience in your specific research area can save time, money, and resources because of the expertise they bring in aiding trial design.

Craft Your Claim and ensure it is adequately substantiated

Claims can be implicit or explicit, including testimonials, and compliance is a must not just on product labels but also on marketing materials and websites.

Though the FTC has previously recommended two randomized, double-blind, placebo-controlled clinical trials to substantiate claims, recent court cases have argued that there is no fixed number of studies required.

However, for strong claim substantiation, we strongly suggest always using clinical trials (ideally randomized, double-blind, placebo-controlled studies) on your exact product in your target population of interest.

Ready to turn science into sales?

Want more guidance on turning science into sales? Download our new guide, How to Develop Cutting-Edge (and Compliant) Dietary Supplements - Regulatory and Research Considerations for Compelling Marketing and Claims.

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This post is an excerpt from the Nutra to Pharma Digital Summit. View the entire event FREE, available now on-demand.

Want more help from our team of over 100 clinical and regulatory experts? Contact us today.

Topics: Claims, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products