Giving the FDA the Information It Needs to Protect Consumers

As we debate the FDA Safety and Innovation Act (FDASIA) in Congress, one of my priorities will be an important provision that protects consumers from potentially dangerous dietary supplements. For nearly half of Americans, dietary supplements are part of a daily health and wellness routine. Consumers deserve to know that regulation of these products is virtually nonexistent. Hazardous ingredients not approved by the FDA can easily be included in products categorized as dietary supplements. Lack of oversight of these products puts millions of consumers at risk every day.

This week, I joined Senator Durbin in introducing an amendment to FDASIA that would require facilities that manufacture, pack, or hold dietary supplements to register their products with the FDA. These facilities currently have no obligation to register their products, leaving the FDA with little knowledge about what dietary supplements are on the market and limited ability to respond to safety concerns related to these products. This amendment would also require the facilities to give the FDA a description of the product, including a detailed list of ingredients and a copy of the product’s label. These requirements will provide the FDA with an understanding of what products and ingredients are on the market. The FDA can then identify potential health concerns for consumers, such as a negative reaction with certain prescription drugs, or certain subsets of the population, such as pregnant women or individuals with compromised immune systems.

Although many dietary supplements may be safe, the complete lack of oversight and information is extremely concerning. This amendment is necessary because it provides a needed safeguard. Consumers deserve to know what these products contain, and they need to be protected from the negative effects on their health and well-being.