Long Time Coming? Drinkable Sunscreen Maker Sued For Fraud

Osmosis Pür Medical Skincare has been marketing a drinkable UV Neutralizer for around five years as part of its Harmonized H2O line. Skeptics abound, including the American Academy of Dermatology, but the company appears to have eluded litigation prior to the Iowa attorney general’s suit filed March 14.

Drinkable UV Neutralizer maker Osmosis, LLC has had a good run, but it could be that the jig is up, with the Iowa attorney general’s office suing the company for swindling consumers and putting their health at risk.

In a suit filed March 14 in Iowa District Court for Polk County, Attorney General Thomas J. Miller alleges that Benjamin Johnson – owner of Evergreen, Colo.-based Osmosis (Osmosis Pür Medical Skincare) and Harmonized Water, LLC – “is in the business of selling ordinary water at premium prices” based on claims of “near-miraculous” benefits.

According to Osmosis’s website, the Harmonized H2O line, available online as well as through spas and other professional skin-care sellers, “works by communicating therapeutic frequency messages imprinted on water” via radio waves.

Sipping on the products – or ingesting spray pumps of the water, more precisely – “resets [users’] cell frequencies, restoring the body to an optimal state. As organ systems improve, so does the skin,” the company says.

The Iowa AG, which views the Harmonized H2O claims as “almost certainly pure bunk,” seeks restitution to victims, injunctive relief and civil penalties of at least $40,000 per violation per defendant.

The Harmonized H2O range includes variants for promoting digestive health, treating joint soreness, “activating” men’s hair, alleviating menstrual cramps and minimizing hangover symptoms.

While Miller asserts that many of the company’s products likely violate Iowa’s Consumer Fraud Act, his suit targets two in particular – UV Neutralizer, available in Tan Enhancing and No Tan options, and Mosquito, designed to help “fend off those pesky bugs using frequencies that mosquitos find annoying.”

While Osmosis’ electromagnetic frequency claims are “almost certainly pure bunk” and “pseudo-science at its worst,” according to the Iowa AG, the state is merely required to demonstrate that the company lacks adequate substantiating evidence for its claims, Miller notes.

The UV Neutralizer, said to afford protection comparable to an SPF 30 sunscreen, and Mosquito, recently promoted as a potential guard against Zika infection, are particularly concerning because “in each instance, defendants recklessly gave consumers hollow assurances that they were protected from known health hazards.”

Osmosis does have clinical trial evidence at its disposal, but the studies were conducted well after the company began marketing products with the disputed claims, and Miller identifies numerous issues that undermine their reliability.

Concerns regarding a 2014 study on the UV Neutralizer include lack of control groups and blinding, questionable ties between subjects and lead investigator Paul Ver Hoeve (including enrollment of family members, clients and their friends), and Ver Hoeve’s “disciplinary history.”

Miller notes that the physician was briefly suspended and then placed on five-year probation by the Medical Board of California in 2003 “for having been convicted in 2000 of mail fraud (a felony) in connection with charges that he had defrauded Medicare.”

Johnson has a checkered past of his own. He was forced to surrender his Colorado medical license in 2001, reportedly after patients complained to the Colorado Medical Board about injuries they received as a result of his laser hair-removal services.

A report for the study in question identified Ver Hoeve as a Fellow of the American College of Surgeons, a title he admittedly never held, and Osmosis has touted the study as peer-reviewed, which it never was.

Further, Osmosis did not retain critical clinical trial documents, stating that it “did not see a need to keep the notes after the final results were calculated,” according to the suit.

Even setting such issues aside, a third of the study’s 24 subjects suffered burns after using the UV Neutralizer, including three who incurred “significant sunburns.”

Nevertheless, Osmosis characterizes the results as “definitive” proof of the product’s efficacy, the Iowa AG says.

The complaint lists slews of allegedly bogus claims made by Osmosis for its UV Neutralizer and Mosquito offerings in various promotional contexts, including many purported consumer testimonials.

The state, which says the Harmonized H2O products have been available to Iowans since 2013 or earlier, cites violations of the Iowa CFA and Older Iowans Law, which seeks to protect seniors from fraud.

It asks the court to impose the full range of remedies available under the statutes, including restitution to victims, injunctive relief and civil penalties of $40,000 per violation per defendant (Osmosis, Harmonized Water and majority owner Johnson), raised to $45,000 for each violation committed against older Iowans.

UV Neutralizer (3.4 oz.) sells online for $30. According to the Iowa AG’s office, labeling for the product identifies water as the sole ingredient, with an additional statement that the contents are “enhanced with proprietary frequencies in the form of scalar waves.”

AAD Among Product Skeptics

According to BuzzFeed, Johnson sees the lawsuit as motivated by a “personal agenda” and questions the use of taxpayers’ money, given that the company has sold just roughly 35 bottles of UV Neutralizer into Iowa in the five years that the product has been available.

He says the Iowa AG’s suit is “full of falsities and misleading statements.”

Johnson continues to stand by Harmonized H2O products’ efficacy, noting that the company has had thousands of reorders, which shows that consumers are getting results.

Scientific bloggers have been skeptical for years of the UV Neutralizer, to say the least.

Media attention in 2014 prompted the American Academy of Dermatology to issue a statement warning consumers not to use the allegedly electromagnetic wave-infused drink as a replacement for sunscreen or sun-protective clothing, citing the absence of scientific evidence supporting the product.

To date, Osmosis and its Harmonized H2O line appear to have flown under FDA’s radar.

The agency has been on the lookout for sunscreens marketed in formats ineligible for OTC review, which makes them unapproved drugs. In October 2016, FDA issued a handful of warning letters to companies that sell SPF-laden wipes and shower products designed to stick UV filters to skin while cleansing. (Also see "FDA Scorches Sunscreen Wipe Marketers With October Warning Letters" - HBW Insight, 25 Oct, 2016.)

The Harmonized H2O maker also seems to have eluded consumer litigation at a time of rampant class actions against personal-care companies for alleged false advertising. (Also see "FDA Warnings Slow, But Anti-Aging Claims Remain Class Action Targets" - HBW Insight, 28 Dec, 2016.)

However, such suits are known to follow highly publicized action from government authorities, so Osmosis/Harmonized Water’s day may be coming.