FDA states that they do not expect caffeine supplements containing pre-measured or pre-diluted safe quantities of caffeine to be adulterated. These products may contain caffeine in the form of tablets, capsules, packets, and significantly diluted bulk quantities. Such products prevent the need for a consumer to precisely measure a safe quantity. As a result, they “would not normally be expected to lead to toxic or life-threatening symptoms”.
Companies should ensure they are packaging and labeling their caffeine supplements as discussed above in order to avoid potential adulteration charges. Adulteration charges may result in Warning Letters, Import Alerts, refusal at the U.S. border, and other public information that can damage a brand’s reputation.
