Senator Dick Durbin (D-IL) plans to reintroduce a disastrous bill called the Dietary Supplement Labeling Act, which is aimed at further regulating the dietary supplement industry. The bill was originally introduced in 2011 as S. 1310.
The bill requires food facilities that manufacture dietary supplements to submit the following information when registering with the FDA pursuant the Bioterrorism Act: (1) a description of each dietary supplement the facility manufactures; (2) a list of each such dietary supplement’s ingredients; and (3) a copy of each such dietary supplement’s label. This information would have to be updated when the facility markets a new dietary supplement, reformulates a dietary supplement, or stops manufacturing a supplement. Additionally, the bill requires FDA compile a list of ingredients and proprietary blends of ingredients that could potentially cause serious adverse events, drug interactions, contraindications, or potential risks to subgroups such as children and pregnant or breastfeeding women. FDA would also have to contract with the Institute of Medicine to have the Institute prepare a report on the safety of such dietary supplement ingredients. Then, within two tears of the report, FDA would have to establish mandatory warning label statements for those ingredients and require the amounts of those ingredients to be listed on the label. Lastly, the bill requires FDA to define “conventional food,” while taking into account conventional foods marketed as dietary supplements.
Sen. Durbin’s bill is intended to address what he sees as dangerous energy drinks being marketed as supplements. It does little to alleviate his concerns, however, and is duplicative and unnecessary. For instance, Monster Beverage Corporation recently announced it will begin marketing its products as conventional foods, not dietary supplements, which would take them outside the reach of Sen. Durbin’s dietary supplement focused bill. Moreover, the safety of energy products in the marketplace that will continue to be marketed as supplements is already adequately regulated. Current laws, for example, prohibit a dietary supplement from containing an ingredient that presents a significant or unreasonable risk of illness or injury under recommended conditions of use, and required dietary supplement companies to submit serious adverse event reports and a copy of the suspected dietary supplement’s label to FDA. If FDA determines that a dietary supplement is unsafe, it can take action. For instance, under the Food Safety Modernization Act, FDA could demand a recall or could detain products. Plus, FDA has determined that the amount of caffeine in energy supplements is comparable to other products containing caffeine and is not harmful to healthy adults. The real problem is people misusing the products and Sen. Durbin’s bill does not address this.
The last time the bill was introduced, it never made it to the Senate floor for a vote. Hopefully that will happen again when the bill gets reintroduced.