Requests that the FDA ban the retail distribution of pure and highly concentrated caffeine as a dietary supplement. CSPI also requests that FDA limit the form in which caffeine is sold to prevent unreasonable risks to adolescents and others from overdoses of caffeine.
2015-51 Caffeine Powdered Caffeine Dietary Supplement Overdose Ban
2015-12-10
FDA-2015-P-0059-0009
05:00:00
https://api.regulations.gov/v4/comments/FDA-2015-P-0059-0009
Anonymous
Anonymous
October 6, 2015Dr. Stephen Ostroff, M.D., Acting CommissionerFood and Drug Administration (FDA) 10903 New Hampshire AvenueSilver Spring, MD   20993Re:  Petition to Ban the Retail Distribution of Pure and Highly Concentrated Caffeine Sold in Powder Form as a Dietary Supplement, FDA-2015-P-0059-0003Dear Acting Commissioner:We applaud FDA for issuing warning letters to five companies distributing pure powdered caffeine.  On September 1, 2015, FDA found that the products presented a significant or unreasonable risk of illness or injury to consumers, and directed recipients of the letters to cease distribution of these products  FDA indicated that a reason powdered caffeine is dangerous is the concentration of the product, making the difference between a safe amount and a toxic dose exceedingly small.  The agency also wrote that safe quantities are nearly impossible to measure accurately with common kitchen measuring tools.  FDA stated that it will continue to aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.  We appreciate these preliminary efforts and FDAs clear commitment to ongoing oversight and action on this issue.  However, we urge FDA to press forward on a ban on the sale of caffeine powder in bulk for the reasons presented below.  We also write to alert FDA that one company that did not receive an enforcement letter is still selling powdered caffeine in the United States, that a company that did receive a letter is still selling a related and risky product, and to raise concerns about related products that remain unaddressed by the agencys actions.  