Durbin Bill Targets DSHEA

WASHINGTON--On March 26, Sen. Richard Durbin (D-Ill.) introduced a bill (S.722) titled the "Dietary Supplement Safety Act of 2003" that would amend the Federal Food Drug and Cosmetic Act (FDCA) and shake the foundation of the Dietary Supplement Health and Education Act (DSHEA). The bill would not only require manufacturers to report adverse events to the federal government, but also pre-market approval for dietary supplements carrying stimulants. As written, the bill would also categorize products promoting muscle growth as anabolic steroids rather than dietary supplements.

"A small number of products--primarily stimulants and steroids masquerading as herbal compounds--have proven lethal to consumers," Durbin said in a press release. "My bill provides that before you can sell these high-risk products, you must prove they are safe. This bill will save lives and restore America's confidence in the use of dietary supplements."

In terms of adverse event reports (AERs), the bill would require dietary supplement manufacturers report AERs to the Food and Drug Administration (FDA). The act considers applicable AERs to include any event that resulted in a congenital anomaly in pregnant women, a persistent or significant disability or incapacity, inpatient hospitalization, a life-threatening condition or death. It also applies to any medical or surgical intervention that would prevent any of the aforementioned. S.722 would require all such events be reported, and that all manufacturers submit an annual report that would disclose all information received with respect to these complaints.

Each manufacturer, packer or distributor of a supplement (whose name appears on the supplement's label) would have to develop written procedures for the surveillance, receipt and evaluation of adverse events and submit these reports to the secretary of Health and Human Services (HHS) no later than 15 days after receiving the adverse event complaint. As the bill is currently written, the secretary would then follow up with the patient who had reported the adverse event. However, the secretary would not be required to follow up on cases in which the adverse event reporter would be unwilling cooperate. No later than 30 days after receipt of a response from the secretary, a manufacturer must submit a plan for surveillance of the health impacts of the dietary supplement in question. Under the bill, surveillance may last up to three years.

HHS would, under this proposed legislation, establish a system to receive these reports, to refer the reports to the appropriate FDA officials, store and retrieve reports; and store and retrieve HHS responses to these reports.

According to the bill, if a dietary supplement or dietary ingredient appears to present a significant or unreasonable health risk, the secretary may require a manufacturer to submit data demonstrating the supplement containing a suspect dietary ingredient is safe.

Interestingly, only days before this bill was introduced, the American Herbal Products Association (AHPA) filed a Citizen Petition with FDA asking the agency to establish, through rulemaking, mandatory reporting of AERs associated with dietary supplements. (For more on that story, visit www.naturalproductsinsider.com/hotnews/33h25161654.html.)

After this lengthy section of AER reporting, the bill segued into a section labeled "Stimulants." The bill's language reads as follows: "No person shall introduce or deliver for introduction into interstate commerce a dietary supplement containing a stimulant unless an approval of the dietary supplement under this section is in effect."

The bill, as written, would require the HHS secretary to give pre-market approval to dietary supplements containing stimulants--and that approval would only be given if the manufacturer of the product could demonstrate the supplement is safe under ordinary or frequent conditions of use. The secretary would have 180 days to approve or disapprove an application. The bill would give manufacturers two years to come into compliance with this act.

In a section labeled "Steroid Precursors," the definition of anabolic steroids would be amended from "that promotes muscle growth" to "that promotes muscle growth or is advertised or used to promote muscle growth." This amendment would boot many products marketed for promoting muscle growth out of the dietary supplement arena.

Durbin estimated $10 million of appropriated monies would be needed to carry out these activities. "We should not have to wait for the Bush administration, which is dragging its feet on this issue," he said. "[The experiences reported by the media] with ephedra should convince everyone the law should be changed in order to protect the American consumer. Congress can make those changes, and I will work to pass this important measure to protect the public health."

The Council for Responsible Nutrition (CRN) stated that it would be holding a meeting March 31 to determine a course of action regarding this bill. Other industry organizations were still reviewing the bill at press time and were expected to give comment next week.