16 April 2018 - Deborah Wilkes
The US Food and Drug Administration (FDA) is stepping up its efforts to protect consumers from products containing highly concentrated or pure caffeine.
New guidance from the FDA makes it clear that dietary supplements containing highly concentrated or pure caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. The regulatory agency said the guidance had taken effect immediately.
Commenting on the guidance, the US Council for Responsible Nutrition (CRN) said "extremely concentrated or pure caffeine has no place in the consumer marketplace".
The trade association for the dietary supplement and functional food industry added that the FDA's announcement "puts all dietary supplement stakeholders, including online retailers, on notice that highly concentrated caffeine sold in bulk to consumers is dangerous and illegal".
The FDA said the products presented a "significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses". "Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals," the agency pointed out.
Thousands of recommended servings per container
"Despite multiple actions against these products in the past," commented FDA commissioner Scott Gottlieb, "we have seen a continued trend of products containing highly concentrated or pure caffeine being marketed directly to consumers as dietary supplements and sold in bulk quantities, with up to thousands of recommended servings per container."
Gottlieb said the guidance made it clear to industry that highly concentrated forms of caffeine sold in bulk packages were generally illegal under current law. "We will act to remove these dangerous bulk products from the market," he promised.
The guidance – titled 'Highly concentrated caffeine in dietary supplements' – points out that dietary supplements containing caffeine in certain forms are less likely to present safety risks. The forms mentioned in the guidance include premeasured packets or containers, as well as solid dosage forms such as tablets or capsules.
The FDA said the guidance did not affect other types of products that might contain caffeine, such as prescription drugs, OTC medicines or conventional foods.
Read all about the strategies of leading OTC players in the OTC Company Strategies 2018 Report published by the OTCToolbox website in March 2018.
– 270 pages
– Executive Summary of key global OTC/consumer healthcare trends
– 18 OTC/consumer healthcare Company Strategy Profiles
Click here to purchase and download.
OTCToolbox Annual Subscription holders can download the report for free by logging into the website.