Senate bill aims to give FDA more recall authority

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Senate bills aims to give FDA more recall authority

UNITED STATES – A recently introduced Senate bill looks to grant the U.S. Food and Drug Administration (FDA) the authority to recall “all unsafe drug products and help protect consumers”, a move that comes as the agency has reported multiple deaths from toxic hand-sanitizer around the country.

According to a press release issued by the U.S. Senate Committee on Homeland Security and Governmental Affairs, the Safe Drugs Act would help protect people across the country by giving the FDA “full authority” to require companies to recall any unsafe drug product.

A recently introduced U.S. Senate Bill called he Safe Drugs Act seeks to give the U.S. Food and Drug Administration full authority to require companies to recall any unsafe drug product, like tainted hand sanitizers.

The bill was introduced by U.S. Senator Gary Peters, Ranking Member of the Homeland Security and Governmental Affairs Committee.

“Americans deserve to know that the medications and health products they are using are safe – whether it’s prescriptions from their local pharmacy, over-the-counter medications, or hand sanitizer,” Peters said in the press release.

Currently the FDA can not actually recall dangerous items from American shelves, they can only recommend it. That means companies have to choose to follow those recall recommendations, and despite the numerous FDA warnings, toxic hand sanitizer is still ending on shelves.

The Safe Drugs Act would ensure the FDA’s public safety recalls protect consumers by requiring companies to pull unsafe drug products from stores and pharmacies.

In a recent bombshell report by FairWarning, the non-profit investigative news organization showed the FDA had counted 17 deaths caused by toxic hand sanitizer since the start of the COVID-19 pandemic in March. Some poison control centers in parts of the country reporting their sanitizer-related cases had more than doubled since the pandemic began.

“It’s a vivid example of the Food and Drug Administration’s lack of authority to crack down on dangerous over-the-counter drugs, a category that includes hand sanitizers,” the FairWarning report said. “The FDA has responded by issuing numerous alerts about the dangers of ingesting methanol-containing sanitizers and asking manufacturers to issue recalls. But the agency lacks authority to force recalls, and some manufacturers have delayed taking action, according to warnings issued by the FDA and a FairWarning review of the agency’s database of hand sanitizers to avoid.”  

The agency does not currently have a breakdown of how many problem hand sanitizers are still for sale in the U.S. compared to how many have been recalled.

As of Oct. 16, the FDA had recalled 202 toxic hand sanitizers, most of which contain potential methanol or propanol contamination. According to their report on July 20, the “agency has seen a sharp increase” in products labeled to contain ethanol, but have tested positive for methanol contamination.

“Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested,” the FDA statement said. “The agency is aware of adults and children ingesting hand sanitizer products contaminated with methanol that has led to recent adverse events including blindness, hospitalizations and death.”  

Peter Pitts, a former associate commissioner at the FDA who is now the president of the Center for Medicine in the Public Interest, recently told NBC News that the toxic hand sanitizers ended up on store shelves in the U.S. after companies started breaking usual procedures ensuring product safety, particularly to meet current market demands.  

“When you’re in a large company or a small company and you’re buying products in bulk, as sanitizer is purchased, you want to understand the provenance of that product—where it was manufactured, whether or not it’s been approved under good manufacturing standards brought by the FDA—and clearly that was simply ignored,” he said. 

But while some companies are looking to cut corners, some are looking to the FDA and World Health Organization when formulating their sanitizers. One veteran-owned small business, which produces a 75% isopropyl alcohol-based sanitizer in Indianapolis, IN., recently encouraged consumers to remain vigilant during the COVID-19 crisis.  

“While we know our USA made sanitizer is safe, that’s not the case with all products on the market currently,” SaniGo Business Development Manager Jordan Mendenhall said. “If you can’t find SaniGo, we would hope that any consumer would do their research before trying a new hand-rub. In this case, an ounce of prevention is truly worth a pound of cure.”

Want more news? Check out these other LemonWire headlines:

FDA counts 17 Americans dead this year from tainted sanitizer

Veteran-owned business helps fight COVID-19 with USA made sanitizer

FDA recalled sanitizer list tops 200

Officials recall sanitizer labeled as edible alcohol

Indiana woman sues recalled hand sanitizer distributor

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