Dietary supplements containing pure caffeine are unlawful when sold in bulk quantities directly to consumers, due to the high risk that they will be erroneously consumed at excessive doses, according to the FDA.
The following is an excerpt from the latest NCA Member Alert
The U.S. Food and Drug Administration (FDA) recently issued a new guidance to clarify that selling dietary supplements containing pure or highly concentrated caffeine in bulk quantities directly to consumers is “considered unlawful,” because of the high risk that they will be accidentally consumed at excessive, potentially dangerous doses.
Read the FDA press announcement.
With respect to pure or highly concentrated powdered or liquid caffeine, the National Coffee Association (NCA) supports the FDA’s common-sense measure to protect consumers. But it is important to remember that these products have very little relation to coffee: a single teaspoon of powdered caffeine has as much caffeine as 20 to 28 cups (3,200 mg).
In fact, drinking coffee – and the natural caffeine it contains – is perfectly safe for most people. It may even be good for you.
The first major compliance deadline for larger businesses (> 500 employees) to comply with the Food Safety Modernization Act (FSMA) Preventive Control rules for human and animal foods has arrived. FSMA was “a call for a new, prevention-oriented safety system.” This new focus on prevention requires food facilities to have written food safety plans encompassing both Good Manufacturing Practices and applicable Hazard Analysis and Preventive Controls.
As of September 19, businesses involved in the production of human foods must comply with both the Hazard Analysis and Preventive Controls regulations as well as adhere to the current Good Manufacturing Practices published in 21 CFR Part 117 Subpart B. Animal food businesses are only required to comply with current Good Manufacturing Practices described in 21 CFR Part 507 Subpart B.
This is a new era for food safety regulation and is being met with some expected angst and trepidation. Continue reading