Warnings about cesium demonstrate difficulty of getting questionable ingredients off market

By Hank Schultz contact

- Last updated on GMT

©Getty Images - serggn
©Getty Images - serggn

Related tags: cesium, Cancer, New dietary ingredient, New dietary ingredients, Regulation

The US Food and Drug Administration has sent warning letters to five supplement companies about the sale of cesium chloride products, which the Agency said present significant health risks. The products have been a concern for several years.

Most cesium products are sold as cesium chloride, though other salts of the element have also been on the market.  FDA has said that most consumers who use cesium products are apparently seeking alternative modes for treating cancer. But no cesium chloride products have been approved for this use, the Agency said.

Products have been subject of at least two warnings

At least twice in recent years FDA has warned consumers and healthcare professionals not to use or dispense cesium products.  In 2018 the Agency warned health care professionals about the products​, saying that they present a significant risk of causing dangerous heart arrhythmias.  Cesium chloride has the side effect of disrupting the blood’s potassium homeostasis.  Adequate potassium levels are crucial to normal heart function.  On Feb. 5, 2020 the Agency repeated the warning​, adding consumers to the target audience.

“Multiple clinical case reports and non-clinical studies show significant safety concerns related to the use of such products, including potentially fatal cardiac arrhythmias, hypokalemia (low potassium), seizures, syncope (fainting, unresponsiveness), and death,”​ the Agency warned.

“Cesium salts, such as cesium chloride, are sometimes promoted as alternative treatments for cancer.  Cesium salts have never been proven to be safe and effective to treat cancer or for any other use.

“While it appears that few dietary supplements containing cesium salts are currently on the market, consumers should be aware of the risks associated with them and should avoid purchasing and using such products,” ​the FDA warning letter concluded.

The five warning letters are structured similarly in that they all hinge on cesium chloride’s status as a New Dietary Ingredient for which no notification is on file.  The Agency went on to say that it is unlikely a notification would be successful in that there is no evidence of the safety of the ingredient;  quite the contrary.

FDA seen as barrier to best products

Frank Lampe, principal in the consulting firm Frank Lampe and Associates who has had long experience in the communications end of the natural products industry, said ingredients like this tend to have long market half lives, even when FDA actively seeks to remove them from commerce.  He said there is still a portion of the industry that seems to believe that only by working in contravention to FDA can the most efficacious ingredients and products be created.

“There is a cadre of people out there who believe that the only way to create health is to work around FDA and to try to stay under the radar so that they can make the products they strongly believe have health benefits,”​ he said.

UNPA: Freedom demands vigilance

Loren Israelsen, president of the Natural Products Alliance, said while some critics of the industry might point to this cesium chloride episode as an example of toothless enforcement, he believes it actually demonstrates the system working as it should.

“This is an example of the system working as envisioned.  If it’s not an ODI or an NDI with a notification or a clear GRAS recognition of some sort, FDA says, take it off the market.  It’s a simple mechanism, not complicated,” ​Israelsen said.

“The conundrum under DSHEA has always been that the goal was to create an open market so that consumers would indeed have a broad range of choices while at the same time knowing that at the outer spectrum there would be products that perhaps shouldn’t be on the market.  The price of this freedom is constant vigilance,” ​Israelsen said.

Israelsen also cautioned against assuming that a more restrictive regulatory regime would necessarily be a cure all for keeping questionable ingredients off the market.

“Even in countries with a ‘tighter’ regulatory structure, these kind of products show up.  The market gets it to market without regard to the regulatory system,” ​he added.

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