A recent U.S. Food and Drug Administration (FDA) guidance document affirms that certain pure or highly-concentrated caffeine products marketed as dietary supplements are “adulterated” under the Federal Food, Drug, and Cosmetic (FD&C) Act, effectively prohibiting their sale in the U.S. market.
FDA determines that highly-concentrated powder or liquid caffeine supplements sold to consumers in bulk quantities meet the Act’s definition of “adulteration” in that they “[present] a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or…under ordinary conditions of use.”
What Risks Do These Supplements Present?
Many of these supplements are intended to either be taken in very small quantities or diluted prior to consumption. Some bear warning statements on their labeling urging to not consume more than the recommended serving. Despite this, FDA maintains that simple measurement errors can result in consumption of toxic or lethal doses of caffeine.
For example, FDA explains that 1 teaspoon of pure or highly concentrated powdered caffeine product can contain approximately 3200 mg of caffeine, nearly two and a half times the amount of a toxic dose (1200 mg). Additionally, safe serving sizes for these products are generally 1/16 of a teaspoon (200 mg) or less, but the smallest standard kitchen measuring spoon is typically 1/4 of a teaspoon (800 mg). Given this example, an erroneous measure of just 1/8 of a teaspoon (400 mg) is twice the amount of a safe serving.
Does FDA Consider All Caffeine Supplements Adulterated?
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.
Registrar Corp’s Regulatory Specialists are well-versed in FDA supplement regulations and can conduct a full review of your product’s labeling and ingredients for compliance. In addition to a thorough report of recommended revisions, you will receive a print-ready, FDA-compliant label incorporating these changes. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.