U.S. Sen. Richard Blumenthal (D-CT) called on U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D. to take “appropriate actions to investigate and recall products with unacceptable levels of benzene.”
In a letter to Califf on October 31, 2023, Blumenthal alleged an “independent quality assurance company,” a fancy phrase for a lab, found “unacceptable” levels of benzene in popular over-the-counter acne treatment products in a “study” conducted in March 2023. Benzene, Blumenthal wrote, is a “known hormone disruptor and carcinogen.”
Blumenthal left out three key facts. First, the FDA had already found “methodological deficiencies” in at least four areas of Valisure’s laboratory work. Second, a federal judge chastised Valisure for subjecting the heartburn drug Zantac to unrealistic temperatures to show the product contained a carcinogen. Third, and finally, Valisure is in Blumenthal’s home state. More on that in a moment.
If Blumenthal gets his way, a recall of acne treatment products will do more than just anger some teenagers. Product recalls can lead to drug shortages, higher prices on everything and for everybody, and a hard stop on research and development. Who would want to put a new product on a shelf, a product that meets FDA safety standards, when recall threats and lawsuits are so easy?
Fear Factor
Many consumers have no idea what benzene is let alone its health risks. If given the choice, consumers would probably opt not to have any dangerous-sounding chemical in a health and beauty product.
Without chemicals, however, these products would be ineffective. People have been using acne products for decades, and while cancer rates persist, it is impossible to pinpoint a specific cause. The human body is a complicated machine, and humans are constantly exposed to countless risk factors. Carcinogens abound, but not everyone gets cancer.
Consider the specific case of acne medications. Valisure is what many might call a “hired gun.” These are the “experts” we see in lawsuits hired by plaintiff attorneys to implicate deep-pocketed defendants.
The acne medication industry is a $5 billion cash cow. As with Zantac, evidence suggests Valisure heated acne products to 158 degrees to produce the carcinogen. Naturally, the pigs are lining up at the trough. Google “acne lawsuits” and you will find no shortage of law firms willing to help consumers with a “claim,” which will require the person to fill out all kinds of paperwork, and if the attack lawyers prevail, could garner the consumer with something like a $12.50 check.
The lawyers, by contrast, will collect typically one-third of each award, sometimes hundreds of millions of dollars, depending on where the jury pool lives.
Holy Grail of Lawsuits
As if the shakedown lawsuits weren’t enough, consider the latest development. With the political help of Blumenthal and another Connecticut politician, Rep. Rosa DeLauro (D-CT), Valisure has secured a contract with the Department of Defense (DoD) to “generate objective drug quality data through independent chemical testing of certain drugs, ” states a Valisure news release.
Laughably, the release goes on to say, “Drug quality issues are the reason for the majority of drug shortages currently plaguing the nation.”
Thank you, Valisure, for contributing to that plague! The DoD will be a bonanza of potential lawsuits, given that the department maintains the massive Defense Medical Epidemiology Database (DMED). That will be a huge “get” for lawyers to mine for potential lawsuits.
Consumers Losers
Under the “Cooperative Research and Development Agreement,” DoD will establish a “working group” to “assess risks to the Department’s pharmaceutical supply chain,” to “complement FDA efforts by conducting independent testing of medicines and generating meaningful and actionable
transparency to drug quality” (emphasis added).
As at least one lawsuit has shown and as the FDA’s own report against Valisure suggests, “independence” comes with strings attached. In fact, Valisure doesn’t have to indict any one company specifically. The lab could use the opportunity to sell “certification” programs to keep companies out of the clutches of plaintiff attorneys.
The contract will keep Valisure in business for years to come. DeLauro and Blumenthal gain bragging points in the next tight election in their home state, not to mention a deep stream of campaign contributions.
Unfortunately, the losers will be the rest of us. Consumers will find fewer products on store shelves because of unnecessary recalls, higher prices due to shortages, and no exciting new products on the horizon.
AnneMarie Schieber ([email protected]) is the managing editor of Health Care News. A version of this article appeared in Red State on January 7, 2025. Reprinted with permission.
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