30-07-2025
Sunscreen Boss Slams FDA Recall for Putting Him 'Out of Business'
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources.
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The owner of a sunscreen company has criticized the Food and Drug Administration (FDA) for putting him "out of business," after his company had to initiate a recall of multiple products that did not meet what he calls "impossible" regulatory requirements.
Several Kabana Skin Care products did not meet the specific requirements that come as part of the Current Good Manufacturing Practice (cGMP) regulations, following an FDA inspection, prompting the company to initiate the recall in March.
The recall affected consumers in New Jersey, Florida, and Michigan, and the FDA's Class II classification of the recall, released on July 10, indicated that "use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences."
In an interview with Newsweek, Erik Kreider said: "I am out of the business of sunscreen, there's no way for me to produce a sunscreen under law that's compliant with the standards that they want to see."
When approached for comment, the FDA pointed Newsweek to the page on its website that details how the FDA regulates sunscreens.
The Context
Sunscreens are regulated by the FDA and checked to ensure they are safe and effective in protecting against UV exposure.
As they are classified as over-the-counter (OTC) drug products, they are subject to much stricter regulations and requirements than other cosmetic products, like makeup and skincare products.
The ingredients in sunscreens that provide UV protection are considered "active ingredients," meaning that they have to follow a longer string of rules, and typically, it is a lot more expensive to get approval for sunscreen products.
File photos of the Food and Drug Administration headquarters and a spilled bottle of sunscreen.
File photos of the Food and Drug Administration headquarters and a spilled bottle of sunscreen.
hapabapa left) and Halyna Romaniv (right/Getty Images
What To Know
The product was recalled because a federal inspector noted one cGMP regulation was not met, Kreider told Newsweek. When asked for the specific regulation, neither the FDA nor Kreider provided the information.
Kreider said he found that when reviewing the criteria expected by the FDA for sunscreen products, there was "no conceivable way" he would be able to meet the "rigorous application" of the regulations required, given that his products are organic.
"This is because process validation requires chemical consistency batch to batch, which for an edible grade oil like extra virgin olive oil, is simply impossible because such oils are chemically variable batch to batch and season to season, being agricultural produce," he said.
Extra virgin olive oil is the main ingredient in his sunscreen product, alongside a few other organic ingredients and zinc oxide, one of the chemicals the FDA deems generally recognized as safe and effective (GRASE) for use in sunscreens.
Kreider said that, in comparison, chemical consistency is easier to manage for the non-organic, "petrochemical ingredients" that many pharmaceutical companies use in their sunscreen products.
The millions of dollars required to implement methodologies to attempt to meet the regulatory standards for an organic product are not "feasible" for his company, he said, given that its total revenue last year was less than $300,000.
In light of that, Kreider has had to pull his sunscreen from manufacture, and has taken his sunscreen off Kabana Skin Care's website entirely.
This method of regulation "puts the entire mineral sunscreen made with botanical ingredients industry in jeopardy," he said.
Kreider said that, simultaneously, the chemicals permitted in non-organic sunscreen products, which more easily pass the FDA's regulations, are not safe and have "never been tested under the drug regimen." He said these sunscreen products were "public enemy number one in terms of chemical exposure."
In 2019, the FDA altered the GRASE ranking for several chemicals, leaving two, zinc oxide and titanium dioxide, as still considered safe, while aminobenzoic acid (PABA) and trolamine salicylate were placed in Category II, meaning they posed risks of "serious detrimental health effects" and could not be used.
A long list of other chemicals used in sunscreens was placed in Category III, subject to continued review due to insufficient data, but this did not mean they could no longer be used in sunscreen products during the review process.
Studies have since shown that some of the Category III chemicals can be traced in human breast milk, blood and urine, in some cases at levels significantly exceeding the FDA's safety threshold of 0.5 ng/ml. However, the FDA's review is still ongoing.
While the FDA regulates sunscreens as drugs, "they are not drugs, because they have never been tested under the testing regimen that the FDA requires of every single other chemical out there to be marketed as a drug, namely, clinical trials and clinical safety data," Kreider said.
He added it was "criminal and wrong" that these chemicals, commonly still used in sunscreens, were not being clinically tested, and that he thought it was a "classic example of government regulatory corruption and it's at the expense of every single consumer who uses sunscreens."
"Why I was being singled out is beyond me, there are much bigger fish to fry out there," he said.
What People Are Saying
Erik Kreider, CEO of Kabana Skin Care, told Newsweek: "There's no guarantee that I could even comply with [the regulations] given what the product is made of. I mean, there's fundamental chemical variability and botanical raw materials, and given that situation, they cannot comply with GMP standards. It's just not possible given they're fundamentally variable so I was like well if I'd known that they were going to come after me with this high a level of rigor I wouldn't have probably even started this business."
He added: "I use the product daily. I literally use my sunscreens every day. I know they're safe, I know their effective. I have nearly 100 percent customer satisfaction."
What Happens Next
In the wake of the recall, Kreider has been trying to figure out what to do next, and told Newsweek that while he's trying to keep his business going and his customers have been "clamoring for me to continue offering the formulas," he is no longer making sunscreen.
"I'm really trying to determine what I should do here and if I should just roll it up and do something else with my life," he said.
