A DANGEROUS chemical that has been banned in several countries can still be found in dozens of products used by millions of Americans every day.
The health warning comes after several brands of generic Mucinex pain reliever medicine were tested for unsafe levels of a potential carcinogen called benzene.
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Benzene is known to lead to the development of blood cancers like leukemia and lymphoma but is still used in the production of plastics, synthetic fibers, rubber, and various other chemicals.
It has also been used to make medicinal elements — an ingredient called a carbomer in this case — that help medicines become extended-release agents.
Several countries have phased out the use of benzene in products consumed by people due to its connection to cancer.
Benzene is highly regulated by the European Chemicals Agency, but the US Food and Drug Administration has yet to enact strict limitations on safe levels of the carcinogen in American products.
Read more about carcinogen
Mucinex-brand versions of the medicine, sold by British pharmaceutical giant Reckitt Benckiser Group, are made with carbomer that does not include benzene, according to a report.
Because substituting a benzene-free carbomer costs more, several companies have yet to make the switch — including the biggest retailers in the US, according to a report.
But the generic versions of Mucinex with the benzene carcinogen are still sold at Walmart, Target, CVS, Walgreens, and dozens of other national chains across the country, according to the analysis by Bloomberg News.
A KNOWN CARCINOGEN
The FDA began investigating the dangers of benzene and announced last year that it would begin phasing the chemical out of pharmaceutical use by 2025.
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After pushback from the drug industry, the phase-out deadline was extended to 2026.
“The FDA is continuously working to ensure that all drugs meet the highest quality standards with the health and well-being of Americans top of mind,” Amanda Hils, a spokesperson for the agency, said.
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These retailers all source the contaminated carbomer from a single manufacturer in New Jersey: Amneal Pharmaceuticals Inc., according to Bloomberg.
Benzene can be found in several popular medicines and household products beyond Mucinex, including Walgreens’ version of the oral pain reliever Anbesol, Walmart’s Equate brand face moisturizer with sunscreen, and Rite Aid’s generic Bengay muscle rub.
American regulators have allowed drugmakers to continue using benzene for decades even though international officials have been against it.
CVS has revealed that it would work with its supplier to replace the ingredient.
"Our store brand products are developed to be safe and high-quality, work as intended, comply with regulations, and satisfy customers," a spokesperson for CVS told The U.S. Sun.
"We require suppliers to comply with all laws and regulations and are committed to following the FDA’s guidance.
"When setting up any drug or cosmetic product, CVS store brand suppliers are required to certify that neither their raw material nor finished product contains benzene.
"While CVS Health Mucus Relief (NDCs: 69842-732-14, 69842-732-28, & 69842-732-42) currently contains the inactive ingredient Carbomer 934P, we are working with the supplier to replace the ingredient."
Learn more about Benzene
BENZENE is a colorless or light yellow liquid chemical that can be highly toxic and has been revealed to lead to the development of blood cancers like leukemia and lymphoma.
It is used in a variety of products that Americans use every day including Paints, varnishes, glues, and other solvents.
Benzene is also used in some cleaning products, such as degreasers and oven cleaners.
The chemical is a component of tobacco smoke, which can put smokers and those exposed to secondhand smoke at risk of exposure.
Benzene is also in some of the tasty treats Americans eat daily including Lucky Charms, Froot Loops, Skittles, Nerds, M&M’s, and Doritos.
Walgreens said that it works with its suppliers to follow FDA regulations.
Retailers are responsible for store-brand medicines while store-brand generics liability lies with the manufacturer.
To swap ingredients out is “dramatically costly and dramatically time-consuming," said Vivek Dave, an associate professor of pharmaceutical sciences at St. John Fisher University in New York.
The product would have to be tested again and be approved by the FDA, he added.
"There’s no scientific or therapeutic reason to use a carbomer made with benzene," said Jeff Keyser, inventor of Mucinex and now chief executive officerofa pharmaceutical startup Renibus Therapeutics.
“There are other things out there they can use.”
Benzene has also been found inartificial colorings and sweetenersin snacks eaten every day including Lucky Charms, Froot Loops, Skittles, Nerds, M&M’s, and Doritos, according to The New York Post.
Amneal Pharmaceuticals stood by its products in a statement provided to The U.S. Sun.
“Our guaifenesin products are manufactured in accordance with all FDA-prescribed limits as well as more stringent company limits," the statement read.
"We use carbomers from the world’s largest and most trusted manufacturer that also supplies for most branded products, and incoming materials undergo regular quality testing.
"Additionally, we immediately began reformulating these products upon publication of FDA’s reformulation guidance.
"We are conducting the FDA-required testing and will submit our reformulation to FDA by the end of 2024.
"We expect to bring these products to market in advance of the FDA’s August 2025 deadline.”
The U.S. Sun has also reached out to Walgreens, Walmart, and Target for comment.
TAKE IT OFF THE SHELVES
Meanwhile, CVS removed a nasal decongestantfrom its shelves this year after an advisory committee to the FDA revealed it was ineffective.
The decongestants contained the oral formulation of phenylephrine which can be found in many over-the-counter medicines.
The FDA Nonprescription Drugs Advisory Committee unanimously voted in September2023 that phenylephrine did not improve nasal congestion any more than a placebo dosage.
CVS removed products containing the ingredient off its shelves despite the FDA never determining if it was unsafe and an ineffective medication.
"We are aware of the FDA Advisory Committee's position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations," CVS Health said in a statement.
"We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores.
"Other oral cough and cold products will continue to be offered to meet consumer needs."
Concerns were first raised about phenylephrine in 2007 as experts believe the body processes the drugbefore it reaches the nasal passage which is where it is supposed to help.
Read More on The US Sun
Walgreens revealed its plan of action to combat products containing phenylephrine.
"Walgreens follows FDA regulations, we are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps," a Walgreens spokesperson told ABC News.
