Earlier this month the FDA posted a news release about a big step it’s taken to protect consumers from dangerously high amounts of caffeine. The US Food and Drug Administration has said that products containing high doses of concentrated or pure caffeine “have been linked to at least two deaths in the United States in the last few years”.
The FDA now considers powder or liquid supplements with concentrated or pure caffeine, unlawful when sold in bulk amounts. It has also made a new guidance document available to clarify its stance on caffeine products that came into effect immediately with its news release.
In the FDA’s guidance, it talks about how powder and liquid caffeine supplements sold in bulk packages, require users to measure their servings very accurately. It also features links to warning letters it’s issued to manufacturers of bulk caffeine products in the past including Smart Powders, Pure Bulk, and Bulk Supplements.
You can find the FDA’s guidance document on its website which provides a lot of good information for supplement manufacturers and brands. Right at the end, there is also an outline for producing safer caffeine supplements with three types of products the FDA does not consider to be adulterated when they comply with all other applicable legal requirements.