Are you familiar with the phrase “soapbox issue?” If not, it refers to a topic that someone cares about deeply and brings up frequently to express a strong opinion or complaint. The phrase comes from the 19th and early 20th centuries when public speakers stood on empty wooden crates to elevate themselves in parks or street corners.
In any case, my soapbox issue is the importance of formulating evidence-based dietary supplements in favor of products that are largely fairy dust. Besides the ethical implications, formulating evidence-based products is a smart business decision. As the title of this article promises, I’m going to be discussing strategies for formulating evidence-based supplements with compelling and substantiated claims.
The Importance of Evidence to Consumers
Let’s start with the fact that recent consumer surveys show that dietary supplement consumers are becoming more information-driven and discriminating in their purchasing decisions. Recent consumer research from Ipsos,1 NIQ,2 FMI3 and CRN4 shows increasing demand for information about ingredients, health benefits, efficacy, safety and product attributes, along with growing use of digital tools to investigate products. This does not necessarily mean consumers are always independently evaluating clinical trials, although a 2024 peer-reviewed paper in PharmaNutrition5 described the use of the internet for researching dietary supplements. In any case, the trends indicate a meaningful shift from passive brand-driven purchasing toward more active pre-purchase research and scrutiny.
I would add that in March of 2026 I spoke at a Natural Products Expo panel titled, “Precision Evidence: How AI & Clinical Trials are Redefining Efficacy & Consumer Trust in Health Products.” Consistent with the aforementioned data, the take-home message of this panel session was that consumers are using AI to see if there are clinical trials to support product claims before they purchase supplements.
So now that we know how important evidence is to consumers, when formulating a product, what should you avoid doing, and what should you make sure to do?
Clinically Relevant Doses Instead of Fairy Dusting
A persistent formulation error in the dietary supplement industry is the assumption that a greater number of ingredients necessarily translates into a more comprehensive or more effective product. In practice, some formulations incorporate an extensive array of nutraceutical ingredients at concentrations substantially below those evaluated in human clinical research. This practice, commonly referred to as “fairy dusting,” prioritizes label appeal over evidence-based formulation.
The fundamental concern is not simply that an ingredient is present at a low dose, but that the amount included may fall below the level for which a physiological or clinical effect has been demonstrated. The presence of an ingredient on a Supplement Facts panel does not, by itself, establish that the finished product can reasonably be expected to deliver the benefit associated with that ingredient. When an ingredient is included at a fraction of the dose used in relevant human studies, the scientific rationale supporting an efficacy-related claim may be weak or absent. This can create challenges from both a product substantiation and regulatory perspective, particularly when the intended benefit of the formulation depends on the activity of one or more underdosed ingredients.
The growing sophistication of supplement consumers further increases the potential downside of this strategy. As noted, consumers increasingly have access to information regarding clinically studied ingredients and their effective dose ranges. As a result, discrepancies between the amount of an ingredient included in a product and the amount evaluated in human research may be readily identified. A formula containing a long list of recognizable ingredients at marginal doses may therefore be perceived as a marketing-driven formulation rather than one designed around evidence and efficacy.
A more rigorous formulation strategy begins with the intended physiological outcome and works backward from the available scientific evidence. Ingredient selection should be based on relevant human research, with particular attention given to the study population, intervention, dose, duration, formulation and measured outcomes. The amount incorporated into the finished product should correspond to a dose or dose range supported by research for the intended use. In other words, use a clinically relevant dose.
For example, if well-designed human studies demonstrate a benefit at approximately 100 mg per day, including 10 mg to enhance the Supplement Facts panel (or to be able to make the claim “Contains 50 ingredients”) provides little scientific justification for expecting the same outcome. Conversely, exceeding the clinically studied dose is not inherently advantageous. Higher doses should be supported by evidence demonstrating either an incremental benefit, a dose-response relationship, or another scientifically valid rationale, while also taking safety, tolerability, formulation constraints and cost into consideration.
Ultimately, evidence-based formulation should emphasize a clinically relevant dose rather than ingredient count. A focused formula containing a smaller number of appropriately dosed, clinically substantiated ingredients has a stronger scientific rationale and greater marketplace credibility than a product containing an extensive list of ingredients included at levels insufficient to reasonably support the intended benefit.
Using the formulation of a sleep support supplement as an example, let’s take this information and translate it into pathway to creating an evidence-based supplement with compelling and substantiated claims.
Use More Than One Nutraceutical at the Right Dose
Although we don’t want to fairy dust, we do want to have more one nutraceutical to address different aspects of promoting quality sleep. To be clear, between two to five nutraceuticals is a good target, and it’s best to avoid redundancy and focus on nutraceuticals with different mechanisms of action that approach sleep from different angles. Naturally you’ll want to provide clinically relevant doses of each nutraceutical. However, if you can’t put in a clinically relevant dose of a given nutraceutical, then don’t use that nutraceutical at all to avoid fairy dusting, thereby misleading your consumers and leaving your product open to criticism. In addition, you want to make sure to include at least one nutraceutical with a “wow” factor—a “sexy” nutraceutical if you will.
Approaching Issue From Different Angles: Sleep Supplement Example
When formulating a supplement, in this case a sleep support supplement, you might want to focus on nutraceuticals that can help with different aspects of the issue, such as:
• Falling asleep
• Staying asleep
• Quality sleep
• Calming the mind
Consider that people often have different problems associated with sleep. Some have difficulty falling asleep, while some people have difficulty staying asleep. Others are able to fall asleep and stay asleep, but they just don’t feel well rested because they had poor quality sleep. In other cases, people are tired and want to sleep, but their mind is just too active and needs calming. Consequently, you can approach the formulation by addressing all four of these sleep-related issues, or you can choose to address as little as two. In addition, you should consider using nutraceuticals that have different mechanisms of action to avoid redundancy and to increase the likelihood of efficacy. The following are some select evidence-based nutraceuticals that address one or more of these issues.
• Melatonin/Phytomelatonin – Melatonin is the most well-researched and widely used sleep support nutraceutical,6-11 but it lacks a wow factor is not particularly sexy. Phytomelatonin (i.e., plant sources of melatonin), does have the wow factor and is sexy. In an RCT,12 1 or 3 mg of phytomelatonin derived from St. John’s wort (Somnatural, Nutraland USA) performed as well as, or better than, 10 mg of conventional synthetic melatonin or certain sleep problems in specific cohorts.
A sexier phytomelatonin option is Somato tomato extract (Nutraland USA). In a pilot study,13 participants given 2 mg of phytomelatonin from Somato fell asleep 33 percent faster (p=0.005), spent less awake (p=0.002), had better sleep efficiency (p=0.011), and experienced an overall improved global sleep score (p=0.025). In an RCT,14 Somato users (2 mg phytomelatonin) were substantially more likely to become “good sleepers” compared to 10 mg synthetic melatonin users (p=0.044).
• GABA—Human clinical studies15-17 have demonstrated that supplementation with 100 mg of GABA significantly increases calming alpha brain waves and decreases excitatory beta waves while inducing relaxation and diminishing anxiety.
• Apocynum venetum leaf extract—In human research18-19 25 mg/day of Apocynum venetum leaf extract was shown to improve symptoms of depression and decrease anxiety and insomnia in the middle of the night and later in the sleep cycle.
• GABA with Apocynum venetum leaf extract—A human study20 showed that a combination of 100 mg/day GABA and 25 mg/day Apocynum venetum leaf extract shortened the time it took to fall asleep and increased non-REM sleep time.
• Valerian root extract—In 29 clinical studies with more than 5,000 patients, valerian demonstrated positive effects for all indications, including anxiety, sleep disorders and mood.21 Doses of 40-600 mg of the extract have commonly been used.22,23 The downside of valerian is that it smells like dirty old sweat socks. However, there are a couple of “deodorized” valerian materials on the market.
• Magnesium—Research from multiple human studies24 found that magnesium helped with sleep quality (daytime falling asleep, sleepiness, snoring and sleep duration). A dose of 500 mg/day elemental magnesium has been used.25
Other Considerations: Dosage Form and Serving Size
According to Nutrition Business Journal (NBJ) data for 2025 and reported in 2026, sales of the most popular dosage/delivery form in the U.S. Dietary Supplement market are as follows:
When deciding which dosage form to use, it is useful to understand that the traditional distinction between “pill” and “non-pill” supplements is becoming increasingly important. Based on NBJ data reported for 2024, non-pill formats accounted for approximately 65 percent of the U.S. supplement market, reflecting the continued growth of gummies, powders, liquids and other more food-like formats. Nevertheless, the trend should not be interpreted as the disappearance of conventional formats. Soft gels, capsules and tablets collectively still represent approximately 29.8 percent of sales in the 2025 breakdown, while newer formats are capturing increasing share.
If you are looking at products rather than sales, an analysis of approximately 50,000 products in the FDA (U.S. Food and Drug Administration) Dietary Supplement Label Database found:
• Capsules: 34 percent
• Tablets: 20 percent
• Powders: 19 percent
• Soft gels: 10 percent
• Liquids: 9 percent
Thus, capsules may be the most common format when measuring the number of products on the market, even though gummies currently lead when measuring dollar sales or market share. In any case, if you plan to use nutraceuticals with bitter notes or other undesirable flavor/taste qualities, you would do well to avoid gummies, liquids, powders, etc.
Essentially, avoid dosage forms where consumers will be able to taste the nutraceuticals and choose capsules or tablets instead. If you are using capsules or tablets, a serving size of one or two pills is generally acceptable to consumers. Consumer compliance decreases when the serving size exceeds two pills.
Substantiated Claims
Besides the likelihood of improved efficacy, one great advantage to the use of clinically relevant doses of the right nutraceuticals shown in human research to be effective for the purpose intended, is that it is so much substantiate claims for your dietary supplement. You can’t do this when you fairy dust. Of course, you still need to craft your structure/function claims so that they are compliant with the regulations, but when you have studies you can cite on the right nutraceuticals at the right doses, that makes all the difference in the world for claim substantiation.
Conclusion
There are many nutraceuticals with supportive human research demonstrating efficacy in promoting various aspects of healthy sleep. Combining two or more together is likely to yield better results in your sleep support formulation. The nutraceuticals presented in this article are just a few options—although good ones. Whenever possible, I recommend using phytomelatonin in your formulation since most people tend to have a positive response to it, and a relatively small amount (1-3 mg) is required for good results.
When formulating evidence-based dietary supplements, it is vital that you avoid fairy dusting. With just a little extra effort, you can create products with a much greater likelihood of being effective rather than being a waste of space.
Furthermore, when your product works, that bodes well for reorders and future business. Likewise, this strategy lends itself to providing your brand with a reputation as being a company that produces real products that consumers can depend upon. Don’t be one of the industry bad players, formulate with integrity and enjoy the respect and success that goes along with this winning approach to formulating evidence-based supplements.
References:
1 Ipsos. Why vitamin and nutrition brands need to supplement Americans’ knowledge. March 14, 2024.
2 NielsenIQ. Dive into ingredients to find growth. August 16, 2024.
3 NielsenIQ/FMI. 5 Ways Transparency Will Evolve. September 16, 2024.
4 Council for Responsible Nutrition. 2024 CRN Consumer Survey on Dietary Supplements.
5 Kovačević et al. Internet marketing of dietary supplements for improving memory and cognitive abilities. PharmaNutrition. 2024;27:100379.
6 Buscemi N, Vandermeer B, Hooton N, et al. The efficacy and safety of exogenous melatonin for primary sleep disorders. A meta-analysis. J Gen Intern Med 2005;20:1151-8.
7 Buscemi N, Vandermeer B, Hooton N, et al. The efficacy and safety of exogenous melatonin for primary sleep disorders. A meta-analysis. J Gen Intern Med 2005;20:1151-8.
8 Ellis CM, Lemmens G, Parkes JD. Melatonin and insomnia. J Sleep Res 1996;5:61-5.
9 James SP, Sack DA, Rosenthal NE, Mendelson WB. Melatonin administration in insomnia. Neuropsychopharmacol 1990;3:19-23.
10 Buscemi N, Vandermeer B, Pandya R, et al. Melatonin for treatment of sleep disorders. Summary, Evidence Report/Technology Assessment #108. (Prepared by the Univ of Alberta Evidence-based Practice Center, under Contract#290-02-0023.) AHRQ Publ #05-E002-2. Rockville, MD: Agency for Healthcare Research & Quality. November 2004.
11 Buscemi N, Vandermeer B, Hooton N, et al. Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis. BMJ 2006;332:385-93.
12 Pauli EK, et al. A Randomized, Blinded, Placebo-Controlled Direct to-Consumer Study of Health and Wellness Products on Sleep and Other Health Outcomes. Radicle Science. 2024; unpublished.
13 De Jesus M, Bergquist K, Bruno G. Effects of Somato TOMATO Fruit Extract on Key Physiological and Psychological Domains Associated with Sleep Quality, Autonomic Function, and Health-Related Quality of Life: A Pilot Study. Altern Ther Health Med. 2026 Jan;32(1):20-24. PMID: 40985949.
14 De Jesus M, Bruno G. Effects of Somato TOMATO Fruit Extract on Sleep Quality and Achievement of Healthy Sleep Compared with Synthetic Melatonin in a 28-Day Randomized, Double-Blind, Placebo-Controlled Trial. 2026; submitted for publication.
15 Abdou AM, Higashiguchi S, Horie K, Kim M, Hatta H, Yokogoshi H. Relaxation and immunity enhancement effects of gamma-aminobutyric acid (GABA) administration in humans. Biofactors. 2006;26(3):201-8.
16 Yoto A, Murao S, Motoki M, Yokoyama Y, Horie N, Takeshima K, Masuda K, Kim M, Yokogoshi H. Oral
intake of γ-aminobutyric acid affects mood and activities of central nervous system during stressed condition induced by mental tasks. Amino Acids. 2012 Sep;43(3):1331-7.
17 Nakamura H, Takishima T, Kometani T, Yokogoshi H. Psychological stress-reducing effect of chocolate enriched with gamma-aminobutyric acid (GABA) in humans: assessment of stress using heart rate variability and salivary chromogranin A. Int J Food Sci Nutr. 2009;60 Suppl 5:106-13.
18 Venetron brochure, Tokiwa. Summarized in Maypro document “Venetron Clinical Evidence.” Topic: What was the effect of a daily dose of 50 mg of Venetron in individuals with mild depression over 8 weeks?
19 Venetron brochure, Tokiwa. Summarized in Maypro document “Venetron Clinical Evidence.” Topic: What effect does Venetron have on patients with various degrees of depression?
20 Yamatsu A, Yamashita Y, Maru I, Yang J, Tatsuzaki J, Kim M. The Improvement of Sleep by Oral Intake of GABA and Apocynum venetum Leaf Extract. J Nutr Sci Vitaminol (Tokyo). 2015;61(2):182-7.
21 Blumenthal M (ed.). The ABC Clinical Guide To Herbs. Austin, Texas: American Botanical Council; 2003:351-364.
22 Leathwood PD, Chauffard F, Heck E, Munoz-Box R. Aqueous extract of valerian root (Valeriana officinalis L.) improves sleep quality in man. Pharmacol Biochem Behav. 1982 Jul;17(1):65-71. doi: 10.1016/0091-3057(82)90264-7.
23 Shinjyo N, Waddell G, Green J. Valerian Root in Treating Sleep Problems and Associated Disorders-A Systematic Review and Meta-Analysis. J Evid Based Integr Med. 2020 Jan-Dec;25:2515690X20967323. doi: 10.1177/2515690X20967323.
24 Arab A, Rafie N, Amani R, Shirani F. The Role of Magnesium in Sleep Health: a Systematic Review of Available Literature. Biol Trace Elem Res. 2023 Jan;201(1):121-128.
25 Abbasi B, Kimiagar M, Sadeghniiat K, Shirazi MM, Hedayati M, Rashidkhani B. The effect of magnesium supplementation on primary insomnia in elderly: A double-blind placebo-controlled clinical trial. J Res Med Sci. 2012 Dec;17(12):1161-9.
Gene Bruno, DBM, MHS, Professor Emeritus of Nutraceutical Science, is a writer, educator and a nutraceutical scientist with more than 45 years of experience educating natural product retailers and health care professionals and formulating natural products for dozens of dietary supplement companies. He has written articles on nutrition, herbal medicine, nutraceuticals and integrative health issues for trade, consumer magazines and peer-reviewed publications. Dr. Bruno also hosts “The Vitamin Professor Podcast” brought to you by VRM Media. He can be reached at [email protected].
