Pure powdered caffeine is dangerous and presents a significant or unreasonable risk of illness or injury to consumers, the U.S. Food and Drug Administration said Tuesday in letters to five companies that sell the products.
Under federal law, the FDA can take action to remove products from the market. However, the agency first needs to establish that the products are adulterated, for example, that the product is unsafe, or misbranded, for example, that the labeling is false or misleading.
The five companies have 15 business days to tell the agency the specific they’ll take to bring their products into compliance with the law.
The Center for Science in the Public Interest said the letters show progress on the issue, but the agency’s action falls short of a comprehensive ban and recall of the product.
“We know that powdered caffeine caused the tragic deaths of Logan Stiner, an 18-year-old, and Wade Sweatt, a 23-year-old, who both died in the summer of 2014,” said Laura MacCleery, director of regulatory affairs for the center. “We hope that these letters are a first step toward a ban, as our petition last year urged, and not a substitute for one.”
Pure caffeine never should have been sold to consumers, MacCleery said.
A teaspoon is a fatal dose for a child, and two teaspoons would kill most adults.
“FDA has clear authority to ban such a hazardous product and should do so,” she said.
Read the FDA's letters here:
- Bridge City
- Hard Eight Nutrition
- Kreativ Health Inc.
- PureBulk
- Smartpowders
