The US Department of Defense will work with a small lab to test some of America’s most common drugs to prevent dangerous chemicals from entering US stockpiles.
Recent increased reliance on Chinese and Indian manufacturers to produce common drugs has been accompanied by a rise in drugs containing carcinogenic substances.
And the Food and Drug Administration (FDA) — the federal agency charged with protecting Americans from harmful chemicals — has been slow to respond.
Now, the Department of Defense and a small Connecticut-based laboratory, Valisure, will enter into a multi-year collaborative research and development agreement under which Valisure will independently test dozens of drugs for harmful chemicals and substances.
The lab, which is far ahead of the FDA in identifying carcinogens in common products like hand sanitizer, dry shampoo, sunscreen and medications, will test drug samples and assess their quality to create a drug risk assessment.
Valisure, a Connecticut-based laboratory, has identified toxic chemicals and carcinogens in common products like hand sanitizer, dry shampoo, sunscreen, and medication. The toxins have only been detected in certain batches of the above products. Some companies have recalled their products and have since reformulated them to remove the harmful substances from the ingredients list
It also assesses the quality of manufacturers to help the Department of Defense identify and weed out potentially harmful products.
The partnership, announced by the laboratory and the Department of Defense on Tuesday, is intended to complement FDA’s drug regulation and testing efforts and provide meaningful and actionable transparency into drug quality.
The government will not pay Valisure as part of the collaboration.
The lab’s investigations have uncovered contamination in merchandise from major manufacturers, including Procter & Gamble Co., Johnson & Johnson and CVS Health Corp., leading to massive drug and personal care product recalls.
Valisure said it has become increasingly difficult to regulate American drugs and their ingredients as most production has shifted to India and China, where there is limited oversight.
Politicians have recently expressed dissatisfaction with the FDA’s inadequate inspection of drug manufacturing in India and China.
“Given that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients come from these two countries, we are concerned that the United States is over-reliant on sourcing from foreign manufacturers with documented evidence of repeated FDA safety violations A letter from the House Energy and Commerce Committee to the FDA reads.
Chemicals Valisure has found in products it has tested since 2018 include nitrosamine, benzene, and N-nitrosodimethylamine, or NDMA — all of which are carcinogenic.
Nitrosamine is considered a powerful carcinogen that can cause cancer in various organs and tissues, including the lungs, brain, liver, kidney, bladder, stomach, and esophagus.
Benzene is a carcinogen that can damage the reproductive system and lead to altered gene expression.
NDMA is an organic chemical that has been shown in animal studies to cause tumors of the liver, airways, kidneys, and blood vessels.
Lots of common drugs and products that Valisure tested that contained these cancer-causing substances included:
Zantac, the popular heartburn and acid reflux medication, contained high levels of N-nitrosodimethylamine, or NDMA.
Ranitidine, the generic version of Zantac found in dozens of medications, also contained NDMA.
Zantac, the popular heartburn and acid reflux drug, contained high levels of the carcinogen N-nitrosodimethylamine, or NDMA, which can cause tumors in the liver, airways, kidneys, and blood vessels
A Neutrogena sunscreen has been found to contain benzene, a chemical that can be harmful to the reproductive system
Accuretic, a blood pressure medication made by Pfizer, contained nitrosamine.
High levels of nitrosamines have also been found in Chantax, a popular anti-smoking drug from Pfizer.
Certain brands of the popular beauty product used by millions, dry shampoo, have been found to contain benzene.
In addition, certain brands of popular sunscreen have also been found to contain benzene.
Eventually, certain brands of hand sanitizer, whose use skyrocketed during the Covid-19 pandemic, were found to contain benzene.
The lab’s findings have led to companies and the FDA issuing voluntary recalls of consumer and drug products used by tens of millions of Americans. After the recalls, some companies reformulated their products to remove the carcinogens from the ingredients list.
While the new partnership is a step forward, it only applies to drugs, leaving consumers at risk when it comes to cosmetics and certain personal care products that the FDA has absolutely no legal authority to regulate or approve before issuing them come on the market.
The FDA has quality standards for safety and effectiveness when it comes to drugs and certain products available to Americans. However, a backlog caused by the Covid-19 pandemic, coupled with reduced oversight and authority, means harmful products could still make their way onto store shelves and into people’s homes.
During the Covid-19 pandemic, the agency reduced staff and operations, delaying hundreds of inspections at pharmaceutical companies. The backlog also delayed the approval of new drugs and created shortages of existing drugs.
Chantax, a popular Pfizer anti-smoking drug, has been found to contain high levels of nitrosamine, a chemical known to be a potent carcinogen that can cause cancer in various organs and tissues
Several brands of dry shampoo have also been found to contain the cancer-causing benzene
For domestically manufactured drugs and medical devices, the FDA audits operations at a manufacturing facility and ensures that the manufacturer is complying with government regulations. The FDA also conducts inspections when a company receives a complaint or suspects that it is not following standard practice.
In about 20 percent of cases, before a drug goes on the market, the agency reviews applications to determine if they meet standards and the data submitted is accurate and complete.
However, drugs and products from outside the US drug supply chain are not subject to the same guarantees of safety and efficacy.
The FDA screens shipments of imported drugs to determine if they are legitimate and will refuse import if a drug appears to be adulterated or of inferior quality, is misbranded, contains incorrect or misleading information, lacks information required by the FDA, did not follow FDA labeling rules and has not registered or listed with the agency.
In addition, the FDA will block access to drugs that have not been proven to be safe and effective. Before entering the United States, the regulator examines and analyzes samples of imported drugs to ensure they meet American standards.
For cosmetics and some personal care products, the FDA does not have legal authority to approve products before they are placed on the market. However, there are some laws that partially regulate these products, including prohibiting the marketing of mislabeled products and allowing the FDA to take action against products that do not comply with the regulations.
In addition, the laws require a manufacturer or retailer to certify the safety of the products, but the FDA does not have a list of required tests that would demonstrate safety.