On April 16th we posted a story (here) on the FDA guidance document titled Highly Concentrated Caffeine in Dietary Supplements (here). That post detailed the FDA’s position on highly concentrated caffeine powder and liquid products sold to the consumer and the potential public health issues that they present. In that guidance, the FDA also discussed how a firm could address FDA’s concern by including proper warnings and addressing proper use of the product by consumers and also addressed packaging considerations (limits in amount – unit dose packaging, etc.) that would mitigate the FDA’s concern.
Also on April 16, 2018, the FDA denied a petition asking the Agency to ban these products and caffeine for inhalation from marketing. The petition and FDA’s response can be found here. The response states much of what is outlined in the guidance and reasons the denial on the fact that the Agency believes the guidance document referenced above will address the concerns raised in the petition but leave the door open for further enforcement action should the guidance be insufficient to address the issues raised. FDA also notes that caffeine for inhalation cannot be considered a dietary supplement because it does not meet the “for ingestion” requirement to be considered a dietary supplement under the law.
Please take a few minutes to review the FDA’s petition denial response as it provides clarity in regard to how the Agency may treat dietary supplements and how it views the data it found in its current market survey undertaken to reach a decision on the petition which prompted its guidance to industry. I suspect we will continue to see enforcement action for firms that do not comply with the provisions outlined in the guidance.
