Rep. Kim applauds FDA for issuing public warning about dangerous hand sanitizer, introduces legislation to protect U.S. consumers

Rep. Kim applauds FDA for issuing public warning about dangerous hand sanitizer, introduces legislation to protect U.S. consumers

WASHINGTON, DC – Today, Andy Kim, Congressman (NJ-03) issued the following statement in response to the Food and Drug Administration’s (FDA) public warning urging the maker of Premium Nature hand sanitizer to recall its hazardous product as it introduced its Protecting Americans from Dangerous Drugs Act. .

“I am pleased to see the FDA taking action to protect the public from an unsafe product brought to my attention by a concerned small business owner in my district,” said Congressman Kim. “David Kahan, owner of Omni Distributors, was reselling hand sanitizer during the worst of the COVID-19 pandemic. Unfortunately, he was dealing with a warehouse full of a dangerous product and couldn’t get his money back because the manufacturer didn’t cooperate. David chose not to resell it because he knew it was a danger to public health. I urge the FDA to take immediate action against the other manufacturers involved in this matter. David deserves to get his money back which will allow Omni to stay in business, continue to employ 20 workers and continue to be part of New Jersey’s vibrant small business community. For David and other small businesses across the country, I’m introducing legislation to ensure the FDA has the tools it needs to protect the public when manufacturers don’t do the right thing.

Omni Distributors, a small business in Lakewood, NJ, contacted Congressman Kim’s office in June 2021, two weeks after alerting the FDA to the dangerous product. The company’s co-founder, Mr. Kahan, is a constituent of Congressman Kim’s district. Since becoming aware of the issue, Congressman Kim has repeatedly urged the FDA to act on Mr. Kahan’s behalf.

Omni distributors purchased 2.2 million bottles of hand sanitizer at a cost of around $5.5 million to resell. Omni had samples of the product tested by a third-party lab and found that they contained levels of carcinogens (acetylaldehyde and acetal) that exceeded safety levels established by the FDA. Part of the product was also found to be under-potent, meaning it did not contain enough of the active ingredient, ethyl alcohol, to effectively kill bacteria or SARS-CoV-2, the virus that causes COVID-19.

On January 24, 2022, the FDA added Premium Nature hand sanitizer, manufactured by Shuzy Rock, Inc., to List of FDA hand sanitizers consumers should not use. According to the FDA website, they tested the product and the ethyl alcohol level was found to be underpowered. The FDA recommended a recall on January 20, 2022. To date, Shuzy Rock has not issued any recalls.

The FDA said at least three different manufacturers may be involved. Omni believes that FDA enforcement action against the remaining manufacturers would help them get their money back, save them ongoing storage costs and prevent staff layoffs, while protecting the public from unsafe products that are still on the shelf. the market.

Many consumers don’t realize that the FDA doesn’t have mandatory recall authority for all products — including hand sanitizer — and most prescription and over-the-counter medications. In 2018, as part of the SUPPORT for Patients and Communities Act to address the opioid crisis, Congress expanded the FDA’s mandatory recall authority to include controlled substances. For other drugs, the FDA relies on the good faith of manufacturers to recall their products.

Congressman Kim’s new legislation would give the FDA mandatory recall authority for all drugs — including hand sanitizer — when it finds a product has the potential to cause serious adverse health or dead.

“We thank Congressman Andy Kim and his office, who have worked tirelessly over the past 8 months to push and get the FDA to act,” said David Kahan, co-founder of Omni Distributors. “This bill is so important because in my experience and what I know now, the FDA, even after learning about a harmful product, cannot force the company to do anything. that is. After going through this experience, it is imperative that the FDA has the authority and ability to not only recommend a recall, but to impose a recall and remove the products from the market. Without this authority, there is nothing to stop unreputable companies from cutting corners and using substandard products to line their pockets, especially during a pandemic or in times of chaos, knowing that even if they take, the FDA does not have the ability to penalize them.”

“Public Citizen strongly supports the Protecting Americans from Unsafe Drugs Act. Granting the FDA the power to order the recall of contaminated drugs is long overdue and will provide the agency with an essential tool to protect American consumers from unscrupulous drugmakers,” said Michael Carome, MD, director of Public Citizen’s Health Research Group.

The full text of the bill is available here.

The Protecting Americans from Unsafe Drugs Act is included in the America COMPETES Act which will be considered in the House the first week of February 2022. This is a key part of improving the supply chain for medical products in the United States. A similar arrangement has been adopted unanimously by the House of Representatives on a bipartisan basis in 2018 and again by the House Appropriations Committee in 2020.

Congressman Kim is the only member of New Jersey’s delegation to the House Small Business Committee.

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