FDA issues strong warning to maker of illegal nicotine gummies
The Food and Drug Administration has issued a stark warning about nicotine gummies, which are illegal, saying they can cause severe nicotine toxicity or even death among young children.
Why it matters: "Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year," FDA Commissioner Robert Califf said in a statement.
Driving the news: The FDA on Thursday in a first-of-its-kind letter issued to the maker of nicotine gummies, VPR Brands, said that the firm does not have a marketing authorization to manufacture, sell or distribute the products.
- VPR Brands markets its square-shaped gummies as containing "tobacco-free nicotine."
- The FDA's letter gives the company 15 days to remove or address the violations.
- VPR Brands could not be reached for comment.
Between the lines: FDA warnings are not legally binding, but the agency can take companies to court if they are ignored, AP notes.
The big picture: Congress in March passed a law giving the FDA authority to regulate all forms of nicotine — a departure from previous legislation that gave the agency oversight of cigarettes and related products pertained solely to tobacco-based nicotine.
What they're saying: "We want parents to be aware of these products and the potential for health consequences for children of all ages – including toxicity to young children and appeal of these addictive products to our youth," Califf said.
- "The FDA will not stand by as illegal products infiltrate the marketplace."
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