Why We Make No Health Claims

Why we make no health claims

We sell water. We will tell you exactly what is in it, exactly how it was made, exactly where it was made, and exactly what an independent laboratory measured in the batch you are about to buy.

We will not tell you what it will do for you.

That is a deliberate decision, not a gap in our marketing. This page explains the decision, because we would rather you understood it than assumed we were being coy.

What the law actually says

Bottled water is a food. In the United States it is regulated by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, and it has its own standard of identity at 21 CFR 165.110, which sets out the permitted names, the quality standards and the labeling rules for bottled water. It is not a dietary supplement and it is not a drug.

A health claim is a claim that links a substance to a disease or health-related condition, and under 21 CFR 101.14 no such claim may appear on a food label unless the FDA has already authorized it by regulation. The FDA authorizes a claim only where there is significant scientific agreement among qualified experts, based on well designed studies. There is a second route, the qualified health claim, for evidence that falls short of that bar, and it also requires a petition and an FDA response. Neither an authorized nor a qualified health claim exists for deuterium-depleted water, and we have not petitioned for one.

Here is the part that surprises people, because American law is looser than most other countries' on this point and it still does not help us. A conventional food may make a structure or function claim, which describes an effect on the normal structure or function of the body rather than on a disease. Those claims need no FDA authorization. But for a conventional food, the FDA's position is that a structure or function claim must derive from the food's nutritive value. Nothing proposed about deuterium depletion is nutritive. Removing an isotope of hydrogen adds no nutrient and changes no nutrient. So the one door that is genuinely open to American food companies is closed to this product, on the merits, before anyone gets to the evidence.

Beyond that sits a harder line. Under 21 U.S.C. 321(g)(1)(B), an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease is a drug. Intent is read from what the seller says. A bottle of water advertised as helping with an illness becomes, in law, an unapproved new drug, which is a considerably worse problem than a labeling violation.

And underneath all of it sits the Federal Trade Commission, which governs advertising while the FDA governs labeling. The FTC requires competent and reliable scientific evidence for health benefit claims, and its Health Products Compliance Guidance states that randomized, controlled human clinical trials "are the most reliable form of evidence and are generally the type of substantiation that experts would require for health benefit claims." The same guidance says that disclaimers and qualifying language will not cure an otherwise deceptive advertisement. You cannot make a claim and then take it back in smaller type.

So the short version: we could not lawfully tell you that this water will do anything for your health. Neither can anyone else selling bottled water in the United States.

The part nobody explains: why the evidence does not exist

The obvious question is why nobody has simply run the studies and settled it.

The answer is not scientific. It is economic, and it is worth understanding because it applies to a great deal more than water.

Substantiating a health claim requires a body of human evidence, and producing one costs an enormous amount of money. The FTC's standard is not a matter of opinion, and neither is significant scientific agreement. Both require human trials. Those trials are expensive. One analysis of the pivotal trials supporting new drug approvals put the median cost of a single trial at about $19 million, with half of them falling between $12 million and $33 million and the most expensive above $300 million (Moore, Zhang, Anderson and Alexander, JAMA Internal Medicine 2018, doi:10.1001/jamainternmed.2018.3931). Across a full development program, including the cost of everything that fails along the way, the median capitalized investment behind a new medicine has been estimated at roughly $985 million, with a mean of about $1.3 billion (Wouters, McKee and Luyten, JAMA 2020, doi:10.1001/jama.2020.1166). Those are not numbers a beverage company can reach.

Someone will spend that money only if they can own the result. The commercial logic of clinical research depends on exclusivity. A company funds a trial because a patent means that, if the trial succeeds, it has a protected period in which to recover the investment. Take away the patent and the arithmetic collapses: you would be spending a fortune to prove something that any competitor could then sell on the day your results were published.

Water is not patentable. Neither is the underlying chemistry. Deuterium is a naturally occurring isotope of hydrogen, present in all water on earth. Isotope separation is nearly a century old. There is nothing here to own.

So the funding never arrives. What exists instead is what the research world produces when there is no commercial sponsor: laboratory work, animal studies, mechanistic hypotheses, and a small number of human trials that are small, short, and mostly conducted in specific patient populations under supervision. Alongside that there is a genuine skeptical literature arguing the effects are overstated or absent.

This is not a scandal and it is not a conspiracy. It is the ordinary consequence of how medical research is funded, and it affects everything that cannot be owned: repurposed generic medicines, dietary patterns, exercise, sunlight, sleep. The absence of a large trial is not evidence that something works. It is also not evidence that it does not. It is evidence that nobody had a commercial reason to find out.

What follows from that is simple. The evidence required to support a health claim does not exist for deuterium-depleted water. Therefore no such claim can lawfully be made. If a seller in this category tells you their water helps with a named condition, they are not in possession of evidence you have not seen. There is no such evidence.

What making a claim would cost us

There is a version of this business that makes claims quietly, is never noticed, and sells more water. We understand the temptation. Here is why we are not doing it.

We intend to still be here in ten years, and we intend for you to still be able to buy this water.

The people who buy Yavelle are not casual customers. Many have built a daily routine around it and want to know that the same water, at the same specification, will be there next month and next year. That continuity is the single most valuable thing we can offer, and it is the thing a regulatory problem destroys fastest.

A brand that makes disease claims is a brand living on borrowed time. When the regulator arrives, the outcome is not a stern letter. It is a warning letter published on a government website, mandated withdrawal of advertising and potentially of product, retail partners exiting the category, and a class action filed by the plaintiffs' bar that reads warning letters for a living. The customers who lose most are the ones who depended on the supply.

We are not willing to put your supply at risk in exchange for better conversion on a landing page. That is the whole reasoning. It is not noble, it is just arithmetic over a longer horizon than a quarter.

So what do we actually stand behind?

Everything we say about this product is a fact about the product, measurable and checked.

A specification. Yavelle is produced to 25 parts per million deuterium, against roughly 150 parts per million in ordinary drinking water.

Independent verification, every batch. Every batch is tested by an independent isotope laboratory before it goes on sale, and we publish the certificate. We label the specification we guarantee, not the best number we have ever seen, so the certificate is usually better than the label.

Full disclosure of what is in it. Distilled water, potassium bicarbonate, calcium chloride, magnesium chloride. No sugar, sweeteners, flavors, preservatives or caffeine.

Where it was made. The United States. Stated plainly, on the label and on every product page.

A guarantee. If you are not glad you bought it, you get your money back.

That is the entire offer. It is a smaller offer than some of our competitors make. It is also all of it true.

Where our water is made

We are asked this often, so here is the plain answer.

Ours is made in the USA. That is not a marketing line, it is a regulated statement. An unqualified "Made in USA" claim is governed by the FTC's all or virtually all standard, codified in the Made in USA Labeling Rule at 16 CFR Part 323, and using it on a product that does not meet the standard carries civil penalties. We say it because it is true and because we can support it.

It is worth knowing why that is unusual in this category.

Depleting deuterium is not filtration and it is not purification. Deuterium is chemically identical to ordinary hydrogen and differs only in mass, so no filter removes it. Carbon filters, ceramic filters, reverse osmosis and ordinary distillation all leave it exactly where it was. The only method is repeated industrial isotope separation, typically low temperature vacuum rectification in fractionating columns that can stand many meters tall and run thousands of sequential stages. It is heavy industrial infrastructure and it is enormously energy intensive.

There are only a handful of such facilities in the world. The ones we are aware of are in the United States, Hungary, Romania, Russia and China. Most deuterium-depleted water on the market anywhere was manufactured in one of a very small number of places, and many sellers will not tell you which. The only real questions are which country, and whether the seller will say.

We would rather tell you plainly than let you assume something else.

How to read anyone's claims, including ours

You do not have to take our word for any of this. Apply the same test to us that you apply to everyone.

  1. Does the seller name a specific disease or condition? If a food or beverage brand tells you their product helps with a named illness, they are describing a drug, and they do not have evidence you have not seen.
  2. Is there a number attached to a benefit, and is it cited? A figure like "up to 50% more of something" is either supported by a specific study you can go and read, or it is invented.
  3. If there is a citation, does it exist and does it say what they claim? Look up the DOI. It takes thirty seconds. You will be surprised how often this fails.
  4. Do the studies involve humans, and how many? Findings in cells, worms and mice are interesting and are not evidence of an effect in people.
  5. Which single country was the water manufactured in? Not bottled in, not packed in, not distributed from. Manufactured in. And if the label says "Made in USA," it is claiming the FTC's all or virtually all standard, so it should be able to explain how it meets it.
  6. Can you see the full laboratory certificate as a document? Not a cropped screenshot. A certificate should carry the laboratory, the method, the batch identifier, the date and the measurement uncertainty.
  7. Does the batch number on the bottle match the certificate?
  8. Is there a disclaimer doing work the claim should have done? The FTC's position is that a disclaimer does not rescue a claim the advertisement should not have made. A page that promises a lot in large type and takes it back in small type has told you what it knows.

In one paragraph

Deuterium-depleted water has a real research literature and a real skeptical literature. The human trials are small. The evidence required to make a health claim under United States law does not exist, largely because water cannot be patented and so nobody has a commercial reason to fund the research that would produce it. We therefore make no health claims, and we would not make them even if we thought we could. What we do instead is publish the specification, publish the independent certificate for every batch before we sell it, tell you that the water is made in the USA, and give you your money back if you are not glad you bought it. Read the literature yourself and make your own decision. We would rather have a customer who decided than one who was persuaded.

Sources

Yavelle 25ppm Deuterium-Depleted Water is a conventional food. It is not a dietary supplement and it is not a drug, and it is not intended to diagnose, treat, cure or prevent any disease. Information on this page is general and is not medical advice. If you have a health condition or are undergoing treatment, speak with a qualified health practitioner.

The information on this page is general information about United States food and advertising regulation and is not legal advice. Last reviewed August 2026.