FDA GRAS NDI or Other Food Or Supplement Regulatory Ingredient Review and Analysis
Well first: what’s NOT new: Pharmaceutical ingredients masquerading as nootropic supplements. A February 2019 Warning Letter from FDA to Pure Nootropics LLC regarding disease claims for legitimate supplements, along with drugs sold as supplements (like piracetam and its analogs) was followed by a polite closeout letter in June of that year, failing to mention whether said ingredients are actually dietary ingredients. The takeaway? Unapproved drugs are regulated just like all the legal dietary ingredients, as long as you don’t claim it prevents or cures disease.
What a missed opportunity to draw the line between dietary ingredient — and totally not one! Now, the deluge of -racetams and analogs of unapproved drugs continues. Because after aniracetam comes johnnyracetam and billyracetam, according to our historically accurate crystal ball. So much for the well-regulated vitamin militia.
Luckily, there’s a lot of safe and natural ingredients in food that boost brain power. Choline, the building block of neurotransmitters now no longer “conditionally” essential, but fully essential at a recommended amount of 550mg per day. Choline is the place where nootropics and nutrition meet. Recent work has shown that phospholipid-bound choline from food sources like egg absorb around 4 times better than choline bitartrate salt. Maybe no surprise, since the egg came first — but the chicken is crossing the road too. Recently, hydrolyzed chicken essence peptides improved memory in people with stress.
Evolving science is starting to consider effective combinations of antioxidants to improve brain function. As we know, the brain burns hot with energy, at the expense of a lot of waste byproducts – a lot of oxidative stress. So we could look at ingredients like astaxanthin, the super-powered antioxidant from the deep sea, as a kind of base ingredient from which to expand. Conventional wisdom, enabled by improved clinical methods, suggests that combinations of ingredients can be helpful to exert an effect on the brain beyond simply “antioxidant activity”. Cerebral blood flow, brain waves and validated clinical instruments for cognitive function lead the way, so we can drill down more precisely on nootropics’ effects on the brain.
Recently, we have studies on astaxanthin and tocotrienols or sesamin shown to improve cognitive function and perform complex tasks quickly and efficiently. And in 2020, a polyphenol-rich beverage with apple polyphenols, ginseng and coffee berry extract improved cognition, mood and cerebral blood flow in a randomized controlled human trial. I’m looking for new product launches inspired by the science on studied combinations to provide synergistic mental gains, compared to any one ingredient alone. That means more finished product marketers need to invest in studies on their products.
Dietary flavanols, like those from cocoa, are being increasingly studied for the brain. Like with many supplements, clinical results from cocoa flavanols on the brain have been mixed. But we know one of the reasons why – because results are confounded by scientific and practical limitations of clinical measurements and study design. For example, if all your study has is a ruler marked to the nearest inch, then you can’t use the ruler to measure millimeters — or time, for that matter. In a new study, researchers found that the cognitive benefits of cocoa flavanols — likely due to increased blood flow to the brain — occurs mainly in people who have inadequate blood oxygenation to start with. Clinical trialists are starting to understand that every human is different, and that to avoid another null or confusing result, they need to more carefully select the trial subjects who are most likely to benefit from a nutritional intervention.
Science is also investigating alternatives to caffeine. While we love our morning joe, chock full o’ xanthine alkaloids, we also can’t escape the jitters, cortisol spike and crash that comes with the daily mainline. The emergence of low- and no-caffeine products to boost brain power are likely to deliver on benefits where caffeine cannot – more sustained energy, less stress, better sleep and recovery, no habituation, and a refreshing start to the next day. So that in the future, maybe we’ll prefer to wake up to a triple shot of green oat espresso.
Speaking of refreshing starts, it’s well established that sleep quality is directly correlated with next-day mental and physical performance. So it makes sense that supplements that truly improve sleep and stress levels are likely to improve brain power as well. A low-sugar drink with tart cherry, protein, valerian and L-theanine improved some markers of sleep without detrimental effects the next day. I’m looking for more products that you consume today, to be more productive and healthy, and less stressed tomorrow.
Many traditional remedies used for relaxation have been studied for improved cognitive function. Essential oils, once the black sheep of evidence-based health, are getting a new look. Lamiaceae, the marvelous mint family of botanicals that includes lavender, rosemary, lemon balm and sage, is being tapped to induce relaxation and improve mental function. Recently, a small, 100 microliter oral dose of peppermint oil rich in menthol and menthone improved information processing and lowered mental fatigue in demanding cognitive tasks. Combinations of other botanicals from this family are also being studied for improved cognitive function.
And finally, the 2021 award for most-overlooked-but-recently-studied nootropic ingredient is…. Plain old water. It makes up 73% of your brain. It’s cheap. Safe. And it is unquestionably not a drug in disguise. In recent studies, water improved memory in kids. In another study in young adults, a small amount of water (200 mL) was enough to improve mood and fatigue, but only the higher dose of water (500 mL) improved working memory.
So when it comes to nootropics, maybe it’s time to throw away the billyracetam, and enjoy a cool drink of H2O instead.
August 29, 2026: On Logan Talks Health, Blake Ebersole, co-founding member of the Ashwagandha Standards Alliance, discusses ashwagandha quality, plant-part controversies, testing methods, analytical transparency and why a
FDA GRAS NDI or Other Food Or Supplement Regulatory Ingredient Review and Analysis
What Ingredients Are You Showing Off? How we’re fearlessly curating ingredients like baseball cards… ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏
From Me-Too to Defensible: Product development, sourcing and quality strategy for supplement brands who want to survive past the first order. By NaturPro Scientific LLC
July 16, 2026 NaturPro Scientific Founder and President Blake Ebersole presented on behalf of the Ashwagandha Standards Alliance for policymakers at the European Parliament in Brussels.
NaturPro Scientific founder Blake Ebersole recently joined Stephen Lukawski, “Captain Cran Man,” and Peter Mingils on the KISC My Health Radio Show for a wide-ranging
The supply chain for hemp ingredients like CBD is crowded, with the whole spectrum of quality available. At the top are legitimate, transparent sources exerting extreme care, control and expertise. At the bottom, a glut of traders and speculators who are blind to product provenance and production.
While learning from success is seemingly more enjoyable, there are lessons to be learned in failure as well. Learn the top tips for success and avoiding failure in the RTD beverage aisle.
Blake Ebersole | Sep 17, 2020
First published in Natural Products Insider
Insider Takes
Everyone likes to emulate and learn from the success stories in product development—the ones that made it big and struck it rich. But learning from failure is important, too. Because for every success story in ready-to-drink (RTD) beverages, a dozen struggled to turn a profit. In the internet age, products developed with great fanfare all too often disappear into oblivion within a couple years. And whatever happened to (insert the name of that drink)? Fortunately, there’s a place to see what’s ready to fall off the edge of the world.
In almost every decent-sized town and city, a closeout grocery market offers expired and overstock goods that couldn’t be sold in the primary markets. The RTD beverage aisle in closeout stores is prominent, due to its large size and great selection of drinks that no one else wanted when they were fresh. I call it the aisle of failure. This place is fascinating, because each bottle tells its own story—with its dusty caps and sedimented bottoms, its past-expiration dates, and prices marked down to a dollar or less. Their stories are about the superfruit that never really was, about the outdated formulas that ignored consumer trends and basic concepts of functional drinks. Their stories tell a lot about consumers, who are both less intelligent and smarter than is often realized.
On these shelves is a university of education for a product developer in how to keep products away from their final oblivion…
Today’s peri-COVID world is tiring and stressful, and that’s before turning on the TV or scrolling through one’s social media feed. Fewer people than ever have the disposable income to take a vacation or buy their next house. So, $3 for a temporary indulgence has become the Calgon bubble bath of the 2020s. The current demand has never been greater for more energy and less stress, filling in nutritional gaps, or just something satisfying that seems healthy. Today more than ever, for better or worse, enjoyment often comes in a bottle or can.
Sure, sugar tastes good. (Really good). And it secretly wants to kill us softly with its song. And consumers, now accustomed to the taste of noncaloric sweeteners, are increasingly willing to sacrifice a little bit of that authentic sugary flavor for what they perceive as a real benefit. (And did I mention, health is top of mind now?)
Then there’s “junk,” which like beauty, is in the eye of the beholder. It’s always interesting to see each brand’s unique take on what junk means to them. But looking at a population of products in a category, repeated definitions of junk emerge, which must mean something—at least in terms of anticipated demand. The junk ingredients have funny or chemical-sounding names, and don’t state the ingredient’s natural source or purpose. At the same time, the “not junk” ingredients are typically from plants, and are often called “organic,” whatever that means in reality. Whether one agrees with the meaning of junk ingredients, it’s fair to say that in general, natural, plant-based is better. (Although isn’t sugar from a plant too? But I digress.)
The drink market is crowded and challenging. Sure, a brand could launch another me-too flavored water with antioxidants, but turning a profit on knockoffs requires brute strength, patient investors and a lot of luck. Meeting high-demand and up-trending needs in a new and meaningful way is the holy grail, and hitting on this combination requires a mix of familiar yet different. And still, what’s different needs to be meaningful to the consumer, and provide a clear benefit that competitors have difficulty offering.
Imagine for a moment a new superfruit called the bubbleberry—claimed to have magical antioxidant powers. Plenty of superfruits have come and gone whose long-term value didn’t live up to their hype. Some critical questions on “hero” ingredients like the bubbleberry should be answered before their promise is burst. Namely, why should consumers care about the bubbleberry? What are its benefits, and will it make the consumer feel good about their purchase? Does the science support its claims, much less its safety for all types of people? And especially, where on Earth is this magical berry grown and processed, how is it grown and processed, and by whom?
The past few decades have brought a number of safe, clinically proven ingredients to choose from, and suppliers who have dedicated their entire business to developing them. There’s no need to find the next bubbleberry when options already exist with validated science, benefits and safety.
Avoiding the shelf of product oblivion means learning from the textbook of product failures, and understanding the rapidly changing needs of the current consumer. Let’s not forget the lessons history had to teach us—especially at the end of a product’s lifespan.
August 29, 2026: On Logan Talks Health, Blake Ebersole, co-founding member of the Ashwagandha Standards Alliance, discusses ashwagandha quality, plant-part controversies, testing methods, analytical transparency and why a
FDA GRAS NDI or Other Food Or Supplement Regulatory Ingredient Review and Analysis
What Ingredients Are You Showing Off? How we’re fearlessly curating ingredients like baseball cards… ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏
From Me-Too to Defensible: Product development, sourcing and quality strategy for supplement brands who want to survive past the first order. By NaturPro Scientific LLC
July 16, 2026 NaturPro Scientific Founder and President Blake Ebersole presented on behalf of the Ashwagandha Standards Alliance for policymakers at the European Parliament in Brussels.
NaturPro Scientific founder Blake Ebersole recently joined Stephen Lukawski, “Captain Cran Man,” and Peter Mingils on the KISC My Health Radio Show for a wide-ranging
Creating a successful healthy food or beverage is a lot more than selecting a list of ingredients that mix well together.
NaturPro has a broad base of knowledge in product development and production of dietary supplements, healthy foods and healthy beverages, spanning from raw material to finished functional food or beverage.
We guide our clients in the right direction, by helping to manage all or parts of the process for healthy food and beverage formulation and development — from seed to shelf — for dietary supplement and health food products.
Our client list includes folks of all shapes and sizes, from startup to large corporation.
No two clients or products are the same, but there are some common approaches found in our Product Development Toolbox:
Product development requires a ‘toolbox’ of analysis including the following
Creating a successful pilot and bench top prototype capsule is a lot more than creating a list of ingredients that mix well together.
NaturPro has a broad base of knowledge in capsule development and prototype formulation as well as healthy foods and natural products, spanning from raw material to finished consumer product.
We guide our clients in the right direction, by helping to manage all or parts of the process for natural product formulation and development — from seed to shelf — for dietary supplement and health food products.
Our client list includes folks of all shapes and sizes, from startup to large corporation. Many of them need small runs of new or custom products for stability and human survey trials.
No two clients or projects are the same, but there are some common approaches found in our Development Toolbox:
Product development for dietary supplement capsules requires a ‘toolbox’ of analysis including the following
“These are mostly no-name brands,” said Blake Ebersole, founder and president of NaturPro Scientific, a consultancy helping companies with product development, quality compliance and manufacturing of supplements. “The products were actually purchased from convenience stores and ‘CBD shops’ as opposed to health-food stores.”
Behind every successful product is a great contract supplement manufacturer.
We’ve audited and worked together with a lot of contract manufacturers.
That means we know how to get the best value, at the best quality, from supplement contract manufacturer partners.
We often get asked what we think of a product concept. The thought process to develop an answer is generally similar, regardless of the type of product, and whether its a consumer packaged good (CPG) or finished product, or an ingredient or raw material.
A number of considerations go into developing and producing successful, effective, safe and compliant dietary supplements, foods, and food and dietary ingredients. These include:
There are seven basic elements to developing a groundbreaking product:
Working backwards from the product claim may sound simple, but it is an analytical process that benefits greatly from industry experience and forethought. A solid plan is what separates a rocket from a dud.
Product development plans often coordinate the knowledge of supplement consultants and experts, review regulatory status of the product and evaluate the available scientific evidence. A good development plan will identify not only opportunities, but also gaps and risks that may prevent success.
Contact us for more information on Natural Product Development
Additional Reading:
Food and Supplement Claims with Confidence
Dietary Supplement Formula Development
Creating Natural Product Intellectual Property
Adulteration of food and agricultural materials has a long history. NaturPro has generated a list of references citing adulteration of food and dietary ingredients in recent times (publications in the past ~30 years).
The intent of this list to promote awareness for historical adulterants in natural products. This list is for comprehensive and historical reference only.
[wpforms id=”1985″ title=”false” description=”false”]