Are dangerous chemicals lurking in YOUR medicine cabinet? Generic drugs imported from China and India increasingly contaminated with carcinogens… and FDA is failing to detect them
- An independent lab found common products contain cancer-causing chemicals
- Oversight of drug manufacturing is difficult because it is outsourced to China
- READ MORE: Acid reflux drugs taken by millions raise the risk of dementia
The US Department of Defense will partner with a small lab to test some of America’s most common drugs in a bid to clamp down on dangerous chemicals finding their way into the US supply.
A recent increase in reliance on Chinese and Indian manufacturers to produce common medications has coincided with a rise in medications containing cancer-causing substances.
And the Food and Drug Association (FDA) – the federal agency whose job it is to protect Americans from harmful chemicals – has been slow to react.
Now, the DoD and small Connecticut-based lab Valisure will enter into a multi-year cooperative research and development agreement, under which Valisure will independently test dozens of drugs for harmful chemicals and substances.
The lab, which has been far ahead of the FDA in identifying carcinogens in common products like hand sanitizers, dry shampoos, sunscreens, and medications, will test and quality score samples of drugs to provide a risk assessment for medications.
Valisure, a Connecticut-based lab, has identified toxic chemicals and carcinogens in common products like hand sanitizers, dry shampoos, sunscreens, and medications. The toxins were only detected in certain batches of the above products. Some companies recalled their products and have since reformulated them to remove the harmful substances from the ingredients list
It will also rate manufacturers’ quality to help the DoD identify and weed out potentially harmful products.
The partnership, announced by the lab and DoD on Tuesday, hopes to complement FDA efforts to regulate and test medications, generating meaningful and actionable transparency when it comes to drug quality.
The government will not pay Valisure as part of the collaboration.
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Throughout its research, the lab has revealed contaminants in goods produced by major manufacturers, including Procter & Gamble Co., Johnson & Johnson, and CVS Health Corp., leading to massive recalls of pharmaceutical and personal hygiene products.
Valisure said it has grown increasingly difficult to regulate America’s drugs and their ingredients because most production has been moved to India and China, where there is limited oversight.
Politicians have recently expressed their dissatisfaction over 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 are from these two countries, we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations’, a letter to the FDA from the House Energy and Commerce Committee said.
Some of the chemicals Valisure has found in products it’s tested since 2018 include nitrosamine, benzene and N-Nitrosodimethylamine, or NDMA — all of which can cause cancer.
Nitrosamine is considered to be a strong carcinogen that may produce cancer in various organs and tissues, including lung, brain, liver, kidney, bladder, stomach, and esophagus.
Benzene is a carcinogen that may be harmful to reproductive organs and can lead to altered gene expression.
NDMA is an organic chemical shown to cause tumors of the liver, respiratory tract, kidneys, and blood vessels in animal studies.
Certain batches of common medications and products Valisure tested that contained these cancer-causing substances included:
Zantac, the popular heartburn and acid reflux drug, contained high levels of N-Nitrosodimethylamine, or NDMA.
Ranitidine, the generic drug 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 of the liver, respiratory tract, kidneys, and blood vessels
One type of Neutrogena’s sunscreen was found to contain benzene, a chemical that can be harmful to reproductive organs
Accuretic, a blood pressure drug manufactured by Pfizer, contained nitrosamine.
Chantax, a popular anti-smoking drug manufactured by Pfizer, was also found to contain high levels of nitrosamine.
Certain brands of the popular beauty product dry shampoo, which is used by millions, were found to contain benzene.
Additionally, certain brands of popular sunscreens were also found to contain benzene.
Lastly, certain brands of hand sanitizer, which saw use skyrocket 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 pharmaceutical products that are used by tens of millions of Americans. Following the recalls, some companies have reformulated their products to remove the carcinogens from the ingredients list.
While the new partnership is progress, it only applies to medications, leaving consumers at risk when it comes to cosmetics and certain personal hygiene products, which the FDA has no legal authority at all to regulate or approve before they go to 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, combined with limited oversight and authority, means harmful products could still be making their way onto store shelves and into people’s homes.
During the Covid-19 pandemic, the agency scaled back personnel and operations, which postponed hundreds of drug company inspections. The backlog also delayed new drug approvals and led to shortages of existing medications.
Chantax, a popular anti-smoking drug manufactured by Pfizer, was found to contain high levels of nitrosamine, a chemical considered to be a strong carcinogen that may cause cancer in various organs and tissues
Several brands of dry shampoo were also found to contain the carcinogen benzene
For drugs and medical products produced domestically, the FDA inspects the operations process at a manufacturing facility and ensures the manufacturer is following agency rules. The FDA also conducts inspections when a company receives a complaint or is believed to not be following standard practice.
In about 20 percent of cases, the agency will review applications before a drug goes to market to determine whether it is in compliance with standards and the data submitted is accurate and complete.
However, medications and products from outside the US drug supply chain are not subject to the same assurances of safety and efficacy.
The FDA reviews shipments of imported drugs to determine if they are admissible and will deny entry if a drug appears to be adulterated or low quality, misbranded, containing false or misleading information, lacks FDA-required information, does not follow FDA label rules and has not been registered or listed with the agency.
Additionally, the FDA will block entry to drugs that have not been proven to be safe and effective. Before admittance to the US, the regulatory agency will examine and analyze samples of imported drugs to ensure they comply with America’s standards.
For cosmetics and some personal hygiene products, the FDA has no legal authority to approve products before going to market. However, there are some laws that partially govern these products, including prohibiting marketing of misbranded products and allowing the FDA to pursue enforcement against products that are not in compliance.
Additionally, the laws require a manufacturer or distributor to certify the products are safe, but the FDA does not have a list of required tests that would demonstrate safety.
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