Part 1: FDA Restructuring and FTC Activity
Part 2: Supplement Access, Safety, and CBD
Part 3: Communication, Education, and Trust
Part 4: Advanced/Advancing Technologies and Research
Part 5: Advocating Best Practices
Part 6: Business Trends and Innovation

---

NW: Several advanced technologies are emerging (AI, precision fermentation, synbio, etc.), and the language used to discuss them is inconsistent. What’s your viewpoint on where we are and where we’re going with the application of these tools in the dietary supplement industry? What responsibility does industry have to develop and present a clear representation of these technologies and communicate with consumers transparently?

Loren Israelsen, President, United Natural Products Alliance (UNPA): Advanced technologies are emerging at an astonishing pace in virtually every industry. Certainly, the natural product industry is no exception. We do have the responsibility to understand and set boundaries. But what qualifies as a natural product, which itself requires definition?

In order to have informed discussion/debate on these topics, a lexicon is needed. And, most of all, we must insist on accurate and prominent disclosure of ingredients and processes. This can be done on labels, websites, and literature. Trade show standards will play an important role in all of this, as will policies from industry organizations. The pace of change is so swift. We must devote focused attention to advanced technologies right now.

Karen Howard, CEO, Executive Director, Organic & Natural Health Association: Herein lies a battle between science and language. Companies (that) create ingredients and products using terminology like AI, precision fermentation, or synbio are desperate to ensure they cannot be tagged with the term “bioengineered.” As we all know, the law requires that any product containing GMO DNA must be labeled as bioengineered. We lost that battle, but there is still a war to fight.

Consumers are fairly adamant they do not want to consume GMO DNA. Poor sales of these non-foods, along with a dearth of public companies taking the risk to invest in this technology, are evidence of the challenges faced by this nascent industry. O&N Health is working diligently to define exactly what these non-foods are and are not. In this case, science is the solution to ensuring legal transparency in the supply chain.   

---

“As new technologies emerge, we must be diligent with our responsibility to inform as much, and as timely, as possible. Information, including sales tools and websites, should be continuously updated to provide current information as it is curated.”

— Scott Steinford, Trust Transparency Center

---

Scott Steinford, Founder, Trust Transparency Center: When it comes to ingestible products, clear and consistent information must occur. Failure to be transparent with all levels of the supply chain and the consumer will result in lower trust and can ultimately challenge the trust factor of the entire industry. As new technologies emerge, we must be diligent with our responsibility to inform as much, and as timely, as possible. Information, including sales tools and websites, should be continuously updated to provide current information as it is curated.

NW: Radicle Science is an AI-driven healthtech B Corp that offers a “proof-as-a-service” concept based on a virtual, direct-to-consumer clinical trial approach designed to increase speed and scale while lowering cost.

Now, outside the dietary supplement industry there’s a lot of skepticism about the efficacy of products. In the field of nutritional science, there’s an evolution of understanding as new research is conducted, often there are conflicting conclusions from meta-analyses, and people are generally confused about what to believe and who to trust. What’s your assessment of this complicated landscape?

Jeff Chen, MD, Co-Founder and CEO, Radicle Science: A vast majority of supplement products on shelves don’t have proof of their effectiveness because access to traditional clinical trials has been prohibitive; they have been too expensive and slow. Traditional clinical trials were created to serve a patented pharmaceutical pathway, not natural botanical ingredients.

Even if supplement companies accessed a clinical trial, the results may not be accurate or relevant for most consumers. Historically, most participants in U.S. clinical trials have been Caucasian males living in major cities. Demographic and behavioral differences such as gender, ethnicity, socioeconomic status, and environmental exposures can all impact health outcomes and thus the results of a trial are only relevant to the types of people who participated in the trial. Moreover, supplement trials often have small sample sizes, reducing confidence in the accuracy of the conclusions and making it difficult to reach statistical significance.

That lack of diversity is why researchers often lament “further investigation utilizing larger sample sizes, diverse clinical and cultural populations, and varying treatment dosages are needed to substantiate clinical trial findings.”

NW: What impact do you hope to make through your service offerings?

Jeff Chen: As a public benefit organization (B Corp), we are on a mission to close the proof gap for the supplement industry. We believe that by providing easy, affordable access to gold-standard clinical trials, we can usher in a new chapter for our industry where: 

• Companies create innovative products backed by clinical evidence on that specific formulation;
• Consumers confidently buy clinically proven products;
• Healthcare providers finally have the clinical data to trust and recommend supplements; and  
• Clinical trials are diverse, which improves personalized medicine and health equity.

NW: You’ve talked previously about the “democratization” of clinical evidence in the context of an historic lack of diversity in clinical trials. How does the Radicle Science model address inequity and underrepresentation?

Jeff Chen: Our large-scale virtual clinical trials were especially designed to address the need for diversity in research. Our smallest trials are often a magnitude larger in size than average supplement trials. Combine that with our 100% virtual approach, and we can ensure Americans of all walks of life can be meaningfully represented in Radicle Science’s clinical trials. Thus far, we have screened more than 83,000 Americans and studied over 30,000 Americans since launching the company in 2021. Another 11,000 are currently enrolled in ongoing trials.

Pelin Thorogood, Co-Founder and Executive Chairwoman, Radicle Science: We have addressed the traditional inequity and underrepresentation in clinical trials by meeting Americans 100% where they live, 100% of the time, even if they work two jobs as a single parent or live in rural, hard-to-reach areas. Since our studies are 100% virtual, we have removed geographic and socioeconomic barriers and can reach Americans who have typically been excluded from clinical trials. 

This includes rural populations (who usually cannot access clinical trials mostly conducted in major metropolitan areas where academic medical centers are located). Of all our participants, 20% are located outside of metropolitan areas, reflecting the most recent census population distribution. This figure is not based solely on population density calculations, but also incorporates traffic flows and commuting patterns to and from each ZIP code; this gives us a more accurate picture of these 20% of participants who would otherwise have very limited access to in-person trials.

Importantly, we have achieved gender parity, with about 54% of our study participants identifying as female.

Across all our studies, approximately 20% are people of color as well, with representation continuing to increase with each study. In our most recent gut health study, 28% of participants are people of color. (Usually people of color represent from 2% to 16% of patients in trials, according to Harvard Business Review.)

Of note, American Indians/Alaskan Natives are especially well represented in our studies, making up 3.1% of our study population, even though they are only 1.3% of census estimates.

---

“Precision medicine depends on gathering and analyzing massive amounts of information from a widely representative and diverse range of individuals. This isn’t without challenges, but we’re in a unique historical moment where we have the technological means to achieve this ambitious goal.”

— Pelin Thorogood, Radicle Science

---

NW: AI is talked about everywhere today and the field is advancing quickly. What’s your assessment or expectation of how analytics and AI can or should impact the field of health and healthcare?

Pelin Thorogood: Precision medicine depends on gathering and analyzing massive amounts of information from a widely representative and diverse range of individuals. This isn’t without challenges, but we’re in a unique historical moment where we have the technological means to achieve this ambitious goal. 

With AI, we can analyze large data sets for our original hypotheses—as well as explore hidden correlations in the data to see how demographic, behavioral, prescription medications, and pre-existing conditions may play a role in the efficacy or side effects of the therapeutic studies.

These signals can be the perfect hypothesis to drive further targeted research that can:

• Anticipate patient health outcomes;
• Explore hidden correlations for further potential signals;
• Accelerate and iterate protocol design;
• Enable precision targeting; and
• Optimize trial recruitment, engagement, and retention efforts.

This is precisely why Radicle Science is adamant about only conducting large-scale standardized trials. It requires a large standardized data set to apply AI models to correlate interactions between a product and an individual’s genetic, geographic, socioeconomic, environmental, behavioral, or cultural differences. Leveraging AI on large and diverse health data sets, we will be able to offer predictive insights that are broadly applicable, driving toward precision health for all.