Rep. Kim Applauds FDA for Issuing Public Warning About Dangerous Hand Sanitizer, Introduces Legislation to Protect American Consumers
WASHINGTON, DC – Today, Congressman Andy Kim (NJ-03) released the following statement in response to the Food and Drug Administration (FDA) public warning that urges the manufacturer of Premium Nature hand sanitizer to conduct a recall of its unsafe product, as he introduced his Protecting Americans from Unsafe Drugs Act.
"I'm glad to see FDA taking action to protect the public from a dangerous 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 saddled with a warehouse full of a dangerous product and couldn't get his money back because the manufacturer wouldn't cooperate. David chose not to resell it because he knew it was a danger to public health. I urge FDA to take immediate action against the other manufacturers involved in this case. David deserves to recoup his money that will keep Omni in business, continuing to employ 20 workers and remain a part of New Jersey's vibrant small business community. For David and other small businesses around the country, I am introducing legislation to ensure 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, N.J., contacted Congressman Kim's office in June 2021, two weeks after alerting FDA about the unsafe product. The company's co-founder, Mr. Kahan, is a constituent in Congressman Kim's district. Since learning of the issue, Congressman Kim has repeatedly urged FDA to take action on Mr. Kahan's behalf.
Omni Distributors purchased 2.2 million bottles of hand sanitizer at a cost of around $5.5 million for resale. Omni had samples of the product tested by a third-party lab and found them to contain levels of carcinogens (acetylaldehyde and acetal) that exceeded safety levels established by FDA. Some of the product was also found to be subpotent, 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, FDA added Premium Nature hand sanitizer, manufactured by Shuzy Rock, Inc., to FDA's List of Hand Sanitizers Consumers Should Not Use. According to FDA's website, they tested the product and the ethyl alcohol level was found to be subpotent. FDA recommended a recall on January 20, 2022. To date, Shuzy Rock has not issued a recall.*
FDA has indicated that at least three different manufacturers may be involved. Omni believes that enforcement action by FDA against the remaining manufacturers would help them recoup their money, save them ongoing storage costs, and prevent staff layoffs, while protecting the public from the unsafe products that are still out in the market.
Many consumers do not realize that FDA does not have mandatory recall authority for all products – including hand sanitizer – and most prescription and over-the-counter drugs. In 2018, as part of the SUPPORT for Patients and Communities Act to address the opioid crisis, Congress expanded FDA's mandatory recall authority to include controlled substances. For other drugs, FDA relies on the good faith of manufacturers to recall their products.
Congressman Kim's new legislation would give FDA mandatory recall authority for all drugs – including hand sanitizer – when they discover that a product is at risk of causing serious adverse health consequences or death.
"We thank Congressman Andy Kim and his office, who worked tirelessly the last 8 months to push and get FDA to take action," said David Kahan, co-founder of Omni Distributors. "This bill is so important because, learning from my experience and what I know now, the FDA—even after learning about a harmful product—cannot force the company to do anything. After going through this experience, it's imperative that FDA has the authority and the ability not just to recommend a recall, but to compel a recall and remove the products from the market. Without this authority, there's nothing stopping non-reputable companies from cutting corners and using sub-par products to line their pockets, especially during a pandemic or times of chaos, knowing that even if they do get caught, FDA lacks the ability to penalize them."
"Public Citizen strongly endorses the Protecting Americans from Unsafe Drugs Act. Granting FDA the authority to order recalls of tainted drug products is long overdue and will provide the agency with a critical tool for protecting U.S. consumers from unscrupulous drugmakers," said Michael Carome, M.D., director of Public Citizen's Health Research Group.
The full text of the bill can be found here.
The Protecting Americans from Unsafe Drugs Act is included in the America COMPETES Act that will be considered on the House floor the first week of February 2022. It is a key component of improving America's medical product supply chain. A similar provision was unanimously adopted 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 the New Jersey delegation on the House Small Business Committee.
*On February 3rd, FDA publicly announced that the manufacturer had initiated a voluntary recall on January 28th.