Writing claims conforming to The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), can be both challenging and frustrating. It’s a classic clash of needs versus wants.
What’s needed to write an acceptable claim, may not always match the evidence you want to use. For nutraceuticals producers, what you can claim—and just importantly, what competitors don’t—impacts demand for your products.
Writing strong claims depends on facts. If those facts get questioned, the data used to categorize your fact as a ‘fact’, will come under rigorous scrutiny. Success will depend on the strength of your data. What can be proved, determines what can be written on a product label.
As a full-service contract research organization (CRO), ObvioHealth assists organizations with substantiation of product claims. ObvioHealth’s integration of a proprietary smartphone app and digital platform with traditional clinical trial design, brings new reliability to data collected via human clinical trials.
In this executive summary, we’ve defined a best practices process to reduce risks while delivering substantiation of high enough quality and flexibility to meet demands for manufacturers in the nutraceuticals industry.
- Know what you want
- Do your research
- Finding claims with value
- Collect the right data
- Executing a clinical trial
- Data analysis
Know What You Want: Establish desired business outcomes and acceptable levels of risk from the onset.
What business outcome do you desire?
- More sales
- Greater market share
- Increase in profit margin
The need for stronger claims, almost always finds it most basic motive to be a specific business outcome. What must you achieve in order to generate a measurable business benefit?
Nutraceutical producers most often find themselves competing for sales and market share. The highly competitive nature of the supplements industry, creates a constant need to provide new product innovations to meet consumer market demands.
What Opportunities Exist
Product Innovation to Meet Consumer Demand
As a nutraceutical producer, your sales depend immensely on what retailers believe consumers desire most. In fact, retailers will tell you what they need if it doesn’t exist.
With such a high and cyclical demand for ‘better’, finding new benefits may be more reasonable than discovering entirely new ingredients. Improvements to quality of life can often be a low barrier entry point for innovation.
Expanding to New Markets
If you’re looking to focus on a new group of consumers, what claims will be most important?
In these instances, you’ll often want to isolate the needs of a well-defined market segment. Knowing what’s most important to consumers will provide a good start towards developing goals for claims
Do consumers desire improvements to quality of life? Or are they looking for something that causes a physiological benefit which reduces risk of a particular disease?
The drivers of consumer demand provide a solid business basis for developing unique end points.
Do Your Research: Existing quality research will be your greatest asset, from study design to actual claim writing.
Honing in on an area of focus in step 1 makes the next step towards building stronger claims easier and more efficient.
We discussed what can be proven, can be claimed. If someone else has already proven facts supporting your case, use that to your advantage. Document and cite exactly how this existing research demonstrates the truth in your data and claims.
If your ingredient or formula causes an increase in a chemical known to prevent a particular disease, with the right evidence and original research of your own, you’ve got the foundations for a very powerful claim. Expanding on documented science can greatly reduce your level of risk and effort.
Start the Race for Innovation with a Head Start
With substantiated findings already in hand, uncovering areas of potential opportunity such as unique endpoints worth exploring—without the need to start from the very beginning.
If your product claims get challenged, FDA will rely on all available and reliable research. Don’t go it alone, use research that has been tested as a foundation for your own new innovation.
This task can take quite a bit of time and resources, but will pay for itself in savings in the long run. Need help with research? One solution we recommend would be EvidScience.
One other very important point about this research, it will begin to lay the foundation for your upcoming trial design.
Claim Type: Finding the Best Value for your investment will be important in order to reduce risk
Smart organizations always hope to attain the most value from a particular strategy or tool.
As a nutraceutical manufacturer, the smart move means developing claims leading to the most perceived value for your buyers.
A Claim By Any Other Name
Multiple types of claims exist. Structure/Function claims have become by far the staple for the nutraceutical industry. These claims require the minimal amount of substantiation, and can generate significant returns for the investment of resources.
Structure/Function, It’s Not All Good News
Yes structure/function claims require the least amount substantiation. Yet, the FDA guidelines for such claims come with very restrictive limitations.
And while structure/function claims require the least amount of substantiation, they still require scientific data for support.
Arriving at a marketable structure/function claim begins with facts. Existing research, your own research amd a combination thereof will actually ‘write’ your claim at the end of the process.
How you setup and conduct your clinical trial, what endpoints you identify and the accuracy of your data will intrinsically generate the value derived from your claims.
Quality of Life Matters in Nutraceuticals
Quality of life (QoL) claims can be a pathway-of-least resistance to building evidence for marketable claims.
QoL claims driven research can be the least time-consuming and least expensive strategy for developing new product claims.
QoL claims also mesh well with consumer motivations for using supplements. Consumers, even those considered most health-aware, cite using supplements to improve overall health and wellbeing, rather than as a way to fill nutritional deficiencies.
Qualified Health Claims: Bigger Potential. Greater Accountability
Armed with the knowledge that health benefits and overall well-being influences purchases more than nutritional makeup, FDA’s qualified health claims offer an attractive option for those willing to perform the necessary work and administrative follow-up.
Qualified health claims introduce powerful new capabilities in terms of connecting your claims to benefits associated with a particular disease or condition.
These types of claims will require more extensive substantiation, including well-established and vetted third-party research. The FDA’s Evidence-Based Review System for Scientific Evaluation sets forth stringent standards for acceptable scientific proof.
The substantiation needed to prove qualified health claims needs to be reliable and based upon good clinical practice. Your data, study methods and supporting published scientific evidence will be highly scrutinized for anomalies and weaknesses that threaten the validity of findings.
A serious attempt at developing data to build a qualified health claim, does not have to be an all or none objective. The data gathered in substantiating your qualified health claim, will almost certainly provide enough scientific substantiation to develop marketable structure/function claims.
Your initial assessment of existing products and desired business outcomes, along with your research, can identify these “diamonds in the rough” prior to designing or implementing your actual clinical study.
This approach leads to exposing unrecognized opportunities that can be leveraged to achieve positive business outcomes with greater efficiency and less risk.
Collect the Right Data: Understand what you want to prove, in order to ensure your trial design generates the right data.
Which facts should you prove? Not all facts have been created equal in the eyes of dietary supplement consumers.
As noted earlier, benefits to overall health supercede supercede nutritional claims. Efforts to substantiate claims showing benefits to well-being should be a consideration when planning research projects.
This doesn’t necessarily mean you should be seeking to solely build qualified health claims. Though restrictive, DSHEA structure/function claim guidelines do allow for the building of claims relating to health and well-being.
Each type of claim requisites varying levels of data substantiation to pass muster with the FDA’s Evidence-Based Review System. Maintain focus on your business outcomes, and what approach makes the most business sense.
Attempting to Make Chicken Salad Out of Chicken Feathers?
What you want to prove will predispose your clinical trial design to gathering certain evidence. Future claims will can only go as far as the evidence can carry them.
Measure the incorrect markers, and even a flawlessly executed clinical trial can produce data useless for your goals.
Claim Types and the Burden of Proof
QoL based studies will require less resources and planning. Integrated with the correct digital technology, these observational studies can be executed 100% remotely. Imagine the savings in effort and resources with this capability.
If recording of biomarkers or other reasons make clinical visits necessary, designing a decentralized clinical trial with the help of mobile technology still provides substantial savings in time and resources.
More importantly, whether clinical visits will be needed or not, your data will be more reliable when time comes to build and support your claims.
Finally, determination of what measurements to record will become vitally important. Here your desired outcomes will face the reality of scientific substantiation. Planning will require creativity and working within the limits of your budget and technology.
The experience and expertise of clinical operations professionals will play heavily in this phase of the process. They’ll put the foundation in place that ensures your clinical trial induces the type of data needed to test your hypothesis.
Evidence Gathering: Executing a clinical trial that delivers reliable data.
Due diligence performed, the time to execute your trial has arrived.
A great deal depends on the ability to execute the study in a manner that will ultimately produce quality data. Clinical trial execution carries many risk factors threatening an organization’s successful achievement of business outcomes.
- Recruitment of qualified participants
- Participant retention
- Protocol compliance
- Navigating regulatory requirements
These present just a few of the inherent obstacles faced by every clinical trial. How your clinical operations team addresses and meets the demands, directly impacts the ultimate strength of your data and subsequent facts you can prove.
Build Quality Data, and the Stronger Claims Will Come
Any experienced clinical operations professional can attest to the difficulty of acquiring usable data. Recent surveys of clinical trial operation professionals show that acquiring quality data represents the industry’s greatest challenge.
Moreover, those same studies tell us that degradation of data quality begins as early as recruitment and initial enrollment of clinical trial participants.
Management of clinical trials may be best handled by a clinical research organization (CRO) such as ObvioHealth. A CRO focuses solely on the design and execution of clinical trials. With in-house expertise and established infrastructure, CROs can help prevent many of the pitfalls potentially jeopardizing ability to use collected data to support claims.
Our company, ObvioHealth, offers complete CRO services with the added advantage of integration of our own proprietary mobile application. With the use of digital technology, we’ve been able to increase the overall quality of clinical trials for both participants and organizations collecting the data.
Our ClaimIt technology enables features such as real-time data collection, compliance verification and ability to collect data points from a myriad of bluetooth enabled medical devices.
Quality data and analysis, understanding the facts your data can prove.
Any clinical trial runs the risk of disproving your hypothesis. But getting an undesired definite answer, creates more value than data that produces no conclusions. Data incapable of supporting any significant scientific conclusion, means time and resources utilized to execute a clinical trial were a waste.
By clearly defining business goals, identifying potential opportunities and weighing important business considerations, clinical trial sponsors can mitigate bigger risks associated with scientific substantiation.
In the end, the data will define the entire success or failure of your project.
Let’s repeat the unstated montra of this process, claims can only state what supporting data can prove. Therefore, protecting the quality of data must always be first priority.
Quality of Clinical Trial Data: The Threat to Nutraceutical Success
A survey of global leaders in Clinical Operations cited data quality as the biggest influence in executing clinical trials within projected schedules and within budget.
Ensuring data quality from start to finish will be a daunting task. Real world evidence seems to indicate many organizations fail at protecting data quality.
In the end, the data will define the entire success or failure of your project.
Fortune Magazine succinctly summarized the data quality problem,
“...as much medical data as there might be, little of it arrives ‘clean’ enough for use.”
The earlier survey of clinical operations professionals also listed the main areas of focus to avoid time and budget overruns:
- Study quality metrics
- Continuous quality
- Risk-based monitoring
- Centralized monitoring
- CRO oversight
These challenges have co-existed as an accepted part of the discipline of clinical operations. In the past, these factors needed to be worked around instead of overcome.
New technology, the advent of advanced artificial intelligence and the digitally connected cloud, presents new solutions to old problems.
Not integrating digitally enabled technology with your clinical trial almost guarantees data integrity issues. One only has to look at the history of failed clinical trials to realize the hazards of doing things the way they’ve always been done.
Digital Clinical Trials—Built to Do the Job
The features of digital clinical trials directly address many of the threats to data quality.
The ability to record official measurements at time of consultation prevents data transfer errors. Bluetooth connectivity of mobile phones and medical devices, means getting data directly from the source—as it happens.
Because you get data instantly, you’ll know when appointments or dosage times are missed. Direct communication such as texting and video calls make assisting participants easy and convenient.
ObvioHealth offers complete CRO services. Clients leverage our extensive expertise and experience to design and execute professional clinical trials. We in turn utilize our proprietary technological tool-set to optimize results and data reporting.
The Devil is In the Process Details
Clinical operations leaders identified 3 key processes that can greatly improve data quality, but where most clinical trials usually fail:
- Subject recruitment
- Site productivity
- Participant compliance
53%, 78% and 75% of respondents said they fail at these processes respectively. Again, these are old challenges with new and innovative solutions.
ObvioHealth specializes in implementing digital technology to overcome these common threats.
Digital recruitment and its ability to target specific population segments, has allowed us to find participants who complete trials for less extremely low costs per recruit.
Decentralizing clinical trials with digital technology can circumvent trial sites, thus eradicating threats caused by poor site productivity.
As we explained earlier, the direct access provided by smartphones, makes compliance monitoring more centralized and real-time.
Digitization of clinical trial process creates opportunities that were once too costly or inconvenient to realize.