Durbin: FDA Should Be Better Equipped to Respond to Dietary Supplement Safety Concerns

Amendment would require energy drink makers that currently avoid FDA regulation to submit information about ingredients and register their products

[WASHINGTON, D.C.] - U.S. Senator Dick Durbin (D-IL) today spoke on the Senate floor about his amendment to the Food and Drug Administration (FDA) Safety and Innovation Act which would help ensure that the agency has the information it needs to respond quickly and efficiency when safety concerns about dietary supplements - including those contained in energy drinks - arise.  Durbin’s amendment is based on a provision in the Dietary Supplement Labeling Act which he introduced in 2011 with Senator Richard Blumenthal (D-CT).  Blumenthal is also a cosponsor of today’s amendment. 


“Most dietary supplements available today are safe and are used by millions of Americans as part of a healthy lifestyle,” said Durbin.  “But many people would be surprised to learn that, in spite of the popular use of dietary supplements today, the FDA does not know how many are being sold in the United States.  If a dietary supplement ingredient presented serious health concerns, the FDA would likely not have enough information to track down the product containing that harmful ingredient.  Requiring manufacturers to provide basic information about their product to the FDA and to consumers is common sense.”


A 2009 report by the Government Accountability Office found that the FDA is limited in its ability to respond to safety concerns because manufacturers of dietary supplements aren’t required to provide basic information like product names and lists of ingredients.  Durbin’s amendment would require manufacturers to register dietary supplement products with the FDA and provide a description of each product, its ingredients and a copy of the label.  Manufacturers would also be required to inform the FDA when a product has been removed from the market and provide registration information for new products within 30 days after being marketed.


Durbin recently called for an FDA investigation into energy drinks like ‘Monster Energy’, ‘Rockstar’ and ‘Red Bull’ which contain high levels of caffeine and potentially dangerous ingredients yet are marketed to young people.  Durbin’s call for an investigation comes after learning the story of a 14 year-old girl from Maryland, Anais Fournier, who died last December of a cardiac arrhythmia due to caffeine toxicity after drinking two 24-ounce Monster energy drinks in a 24-hour period.  


“The FDA has the authority to regulate caffeine levels in beverages and to require beverage manufacturers to prove additives are safe, but most energy drinks avoid FDA oversight by marketing their products as dietary supplements,” said Durbin.  “My amendment would ensure that FDA knows about all of the energy drinks being sold in the United States and may provide information about ingredients that could help the agency address potential safety concerns. We can help prevent tragedies by requiring that better information is reported to the FDA when supplements go on the market.”


In June 2011, Durbin and Blumenthal introduced the Dietary Supplement Labeling Act which would improve the information available to consumers, and to curb the prevalence of drinks and foods that are masquerading as dietary supplements as a means of avoiding regulation by the FDA.  The legislation would require FDA to establish a clear definition of which products are foods and should be regulated as such and which products are meant to be regulated as dietary supplements. 


In 2006, Durbin led a bipartisan effort to enact legislation requiring manufacturers to report serious adverse events related to consuming dietary supplements, enhancing the FDA's ability to identify and respond more quickly to potential health problems. The Dietary Supplement Labeling Act would build on that by requiring dietary supplement manufacturers to disclose the known risks of ingredients and display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events. Labels would also have to include the batch number, which would help the FDA identify and recall contaminated product.