Durbin and Blumenthal Introduce Legislation Designed to Protect Consumers of Dietary Supplements

Bill includes provision that would clarify FDA's authority to regulate additives in foods such as "Lazy Cakes"

[WASHINGTON, D.C.] – U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) today introduced legislation that would ensure that consumers have the information they need to distinguish between products that are safe and others that contain potentially dangerous ingredients which haven't been approved by the Food and Drug Administration (FDA). The Dietary Supplement Labeling Act 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 reviews and regulation by the FDA.


“Walk down the aisle of your local convenience store and you will see products targeting young people with names like Lazy Cakes, Drank and Monster Energy Drink,” said Durbin.   “These products market themselves as dietary supplements that are safe ways to relax or get a boost of energy, when in reality they are foods and beverages taking advantage of the more relaxed safety standards for dietary supplements.  My bill would help curb this unsafe practice.”


“Consumers deserve to know what adverse effects these products can have on their health and well-being,” said Blumenthal.  “Truth in labeling and honest marketing is critical to consumer safety- especially in products targeted towards young people - and should be required as an industry standard.”


Today’s 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 health aids and should be regulated as dietary supplements. 


Last month, Durbin raised concerns with the Food and Drug Administration (FDA) about baked goods – such as Lazy Cakes, Kush Cakes, and Lulla Pies – containing melatonin that, because they are marketed as dietary supplements, do not require approval by the FDA for use as additives in food.  Under current law, it is the choice of the manufacturer as to whether a product is classified as a food or as a dietary supplement.  In January 2010, the FDA issued a warning letter to the manufacturer of Drank for selling a beverage containing melatonin. The manufacturer responded by changing the labeling of Drank from a “beverage” to a “dietary supplement” which do not require approval by the FDA for use as additives in food. 


This is not the first time the FDA has been asked to clarify their authority to regulate certain dietary supplements and food additives. In January 2000, the FDA issued a 10-year plan to implement the Dietary Supplement Health and Education Act of 1994 (DSHEA), which identified the need to clarify the distinction between conventional foods and dietary supplements. Moreover, U.S. General Accountability Office (GAO) reports in July 11, 2000 and January 29, 2009 recommended FDA clarify the boundary.


“It’s important to note most products labeled as dietary supplements are legitimate health aids. I take a daily vitamin just as millions of Americans do,” said Durbin.  “My gripe is not with the array of vitamins available at health stores across the nation; my gripe is with products labeled as ‘dietary supplements’ whose ingredients have not been deemed safe by the FDA but are found on store shelves right next to conventional food and beverages. The current system favors the manufacturers of these products to the detriment of consumers – and that needs to change.”


Today’s legislation would also improve the information available to consumers by requiring dietary supplement manufacturers to register dietary supplement products to the FDA and provide a description of each dietary supplement, a list of ingredients, and a copy of the label.  This would allow the FDA to track how many dietary supplements are on the market and how many products contain certain ingredients, increasing their capacity to inform manufacturers of possible safety concerns.  It would also require product labels to include warnings associated with adverse events of specific ingredients, weight of those ingredients per serving, and a batch number for easier recall.


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.