The U.S. House of Representatives in the early morning hours of December 9th considered and passed Senate bill S3546, the “Dietary Supplement and Nonprescription Drug Consumer Protection Act,” requiring manufacturers to notify FDA of all serious adverse events (AEs) for dietary supplements and over-the-counter drugs (OTCs) reported to them. The House passage of the bill followed the Senate’s action of December 6th, creating a law that will benefit consumers as well as responsible industry.
“CRN commends Congress on the passage of the adverse events reporting (AER) bill into law. This law is something responsible industry has supported for a long time and we greatly appreciate the hard work of Congress to make it a reality,” said Steven Mister, president and CEO, Council for Responsible Nutrition (CRN), Washington, D.C. “With this law, consumers can be assured that if they report to a manufacturer a serious adverse event they believe may be associated with a supplement product, that the agency that regulates this industry—FDA—will be made aware of that report. More than 150 million Americans use dietary supplement products and they deserve no less.”
Mr. Mister continued, “We are confident that ultimately the AER system will highlight the strong safety record of dietary supplements and allow consumers to feel increased confidence about the choices they make when taking dietary supplements.”
The bipartisan bill was introduced in June last year by two of the dietary supplement industry’s most ardent supporters in Congress, Sens. Orrin Hatch (R-UT) and Tom Harkin (D-IA). According to the Natural Products Association (NPA), Washington, D.C., there were several provisions key to earning its support. These include requiring that the bill:
Be limited to serious adverse events and not require reporting of just any complaint:
NPA believes that adverse events potentially related to dietary supplements will be minimal and serious adverse events rarer still. Having a reliable and verifiable system that attests to the safety of dietary supplements will end negative speculation by critics of the dietary supplement industry.
Not require retailers to report adverse events from customers to the FDA:
NPA believes adverse event reports should come from the company that manufactured, packaged or distributed the product, not the retailer. With this bill, even retailers who sell products under their own label will not be required to report adverse events to the FDA.
Include OTC drugs:
If dietary supplements and prescription drugs have an adverse event reporting framework, it only makes sense that OTC drugs should as well. Currently, only those OTC products that were once prescription are required to report.
Include a state preemption provision:
In the absence of a federal bill, several states have introduced legislation mandating various reporting requirements for dietary supplement adverse events. Requiring manufacturers to comply with a patchwork of laws for different states would be overly burdensome; this bill will prevent this from happening.
The bill will become effective within one year of its passage into law and requires that FDA issue a guidance to industry addressing the reporting requirements within nine months of enactment.
While NPA understands that the mandatory reporting requirements of the AER bill will add to manufacturers’ recordkeeping responsibilities, the association believes the bill will benefit the industry in the long run. First, by helping to change the perception by critics of the dietary supplement industry that it is not well regulated. Second, over time, the recordkeeping and reporting requirements will substantiate what many in the industry have been saying: that the safety record of dietary supplements is exemplary, especially when compared to other health-related products.