Today, the Senate will vote to reauthorize and modify the Food and Drug Administration’s (FDA) prescription drug and medical device user-fee program (S. 3187). During debate on the measure, Senator Dick Durbin (D-Ill.) announced plans to introduce an amendment to give the FDA more power over supplements such as vitamins and energy drinks. While Sen. Durbin is selling the amendment as moderate, commonsense legislation, its passage would significantly increase the financial and regulatory burden on supplement companies — especially small ones. Worst of all, it would do nothing to increase consumer safety.
Durbin’s amendment is a scaled back version of previous attempts to regulate supplements. It would require manufacturers to submit a report to the FDA disclosing the name of each product they make, a list of ingredients for each product, and a copy of the label. Durbin claims that these requirements are not onerous, but any increase in operation costs will in fact hurt these businesses. With an estimated 50,000 supplements on the market (not including energy drinks), the increase in paperwork would certainly be a burden for the already overworked FDA, which has a backlog of drugs waiting in the approval process.
In addition, this is an unnecessary and redundant measure. The FDA already has the power to pull harmful supplements off the market if it can show that they are harmful. Why should we give the already overwhelmed FDA more responsibility if it cannot use the power it already has effectively? The backlog and costs associated with the drug approval process are prompting companies to make fewer drugs, especially generics that are less profitable. There are about 215 medications currently listed on the American Society of Health-System Pharmacists’ (ASHP) drug shortage bulletin.
This amendment may sound innocuous, but those familiar with Durbin’s past attempts to regulate the vitamin and energy drink market know that he has much bigger plans. Last year, Durbin introduced a measure that would have forced supplement manufacturers to go through an approval process similar to that of pharmaceutical companies.
Amendments that increase the regulatory burden on America’s businesses, no matter how small a lawmaker thinks they are, will have an impact on the cost of doing business. As a result, supplement companies may have to lay off workers or increase their prices. While Dick Durbin probably wouldn’t mind if his daily multivitamin increased by a dollar or two, for some families it may mean they have to stop taking vitamins altogether. At a time when businesses and families are struggling just to stay afloat, these small burdens can add up.
If the Senate really wants to improve the nation’s economy and physical well-being, it should reject proposals that duplicate regulations and do nothing to protect American consumers.