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Decoding Claims for Your Brand: Clinically Tested vs. Clinically Proven


Clinically Tested vs. Clinically Proven with Dr. Swathi Varanasi, Prinicpal Investigator and Susanne Mitschke, CEO and Co-founder of Citruslabs


Have you ever wondered about the difference between "clinically tested" and "clinically proven" on your competitor's product labels? Both terms hold weight with consumers, but for supplement and cosmetic brands, it is important to understand the nuances of responsible marketing and ethical claims. This is the first in a series of posts exploring the topic with insights from Dr. Swathi Varanasi, Principal Investigator at Citruslabs, and Susanne Mitschke, CEO at Citruslabs.


Clinically Tested: Undergoing Scientific Evaluation

“Clinically tested" means that a product was tested in a clinical setting. It indicates the product has undergone some form of clinical evaluation, but “clinically tested” doesn’t specify the outcome. So “clinically tested” is about the process in which some form of clinical test happened but it doesn't necessarily mean that the results were conclusive or that the product demonstrated significant efficacy or safety benefits. "Clinically tested" could encompass a wide range of studies, from preliminary trials to larger-scale investigations. But can brands use the term “clinically tested?” When looking at that question, it’s important to understand the FTC guidelines from December 2022. The FTC doesn’t want to make life harder for brands, but they created these guidelines to help consumers in a maze of overpromising product claims and under delivering products. The term “clinically tested” gets scrutinized by the FTC. They define it as a randomized controlled trial and, ideally, a double-blind placebo-controlled study.


Technically, even brands that conducted a pilot single-group study could use the term, but keep in mind that it’s likely getting scrutinized by the FTC. At Citruslabs, we don’t agree with the FTC's interpretation of this. We believe that a well-designed single-group study that includes objective data measurements, for example, from blood markers, should also count as “clinically tested.” However, we agree that “clinically tested” doesn't imply the same level of rigorous evidence as "clinically proven.”


Clinically Proven: Building Strong Evidence

The term "Clinically proven" carries heavier weight and implies your product has successfully demonstrated efficacy or safety through a number of rigorous clinical trials. So, your product was not just tested once and received good results (e.g., statistically significant compared to placebo), but the results could be replicated in subsequent studies. These trials are tightly controlled studies employing specific protocols and methodologies to assess performance. Products labeled "clinically proven" imply there is strong scientific evidence to support their claims. It suggests that your results are replicable. To put it in the words of our Director of Clinical Research, Dr. Scott Conger, one good study result is luck, two good study results are a coincidence, and three good study results are the beginning of a trend. To make a “clinically proven” claim, the Citruslabs team believes that you should conduct more than one randomized control trial (RCT) with at least two arms along the way. However, if you start off with a robust single-group study and then graduate to an RCT with a placebo and/or control group, we believe that this is also sufficient evidence for “clinically proven.” At Citruslabs, we also believe that “clinically proven” claims should involve objective biomarkers, such as blood, stool, and/or device markers. 


Comparing the Two:

Here’s an analogy: think of “Clinically Tested” as a university student acing ONE exam, while “Clinically Proven” is a university student acing ALL of their exams and graduating with top honors.


Both terms involve some level of scientific engagement and build consumer trust and brand credibility, but "clinically proven" speaks volumes about the product's efficacy.


Regulatory Compliance

This is particularly important when considering regulatory compliance. The FDA has stricter requirements for medications, often demanding multiple robust clinical studies before allowing "clinically proven" claims about benefits and side effects. Beauty and wellness products, on the other hand, may undergo some clinical testing, but establishing definitive proof often requires a more extensive research path.


The Federal Trade Commission (FTC) has strict guidelines regarding advertising claims.  Vague claims can be misleading to consumers, especially when the tests conducted were minimal, inconclusive, or misrepresented. It's important to ensure your claims are truthful and supported by sound scientific evidence, especially when making claims about a product's efficacy or safety. 


The Citruslabs Tested Seal: 

Unfortunately, the FTC often cracks down on both terms. So, we created the Citruslabs Tested Seal. This is an official seal safeguarded by the stringent criteria of Citruslabs' clinical trials. This seal represents a formidable, distinguished asset for brands seeking to stand out in the market and establish consumer trust and confidence. By incorporating the Citruslabs Tested Seal, brands showcase to consumers and other stakeholders that their goods have undergone rigorous scientific studies and have been confirmed to be effective.


Empowering Your Brand’s Narrative: 

Understanding the difference between "clinically tested," "clinically proven," and “Citruslabs Tested” empowers you to craft a clear and responsible brand narrative. In the coming posts, we'll further discuss specific claims, explore the intricacies of clinical trials, and equip you to confidently manage the world of product claims to maximize the impact of your brand message. Stay tuned!


If you have any questions on this topic, please contact our team

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