DSHEA Faces New Challenges at 10th Anniversary

Nearly 10 years after passing into law, the Dietary Supplement Health and Education Act is facing criticism on both coasts.

The California Senate is scheduled to hear today a bill that would require supplements manufacturers to file reports of any adverse events associated with their products. California Senate Bill 779 has the support of the California Medical Association, but is widely opposed by the supplements industry, which cites logistic and financial concerns.

And on June 8, in a hearing of the Subcommittee on Oversight of Government Management, Sen. George Voinovich, R-Ohio, and Sen. Richard Durbin, D-Ill., criticized DSHEA and its enforcement by the U.S. Food and Drug Administration and the industry. Durbin, who requested the hearing, is sponsoring a bill that would make changes to the law, including establishing a standard for good manufacturing practices, and adding labeling and testing requirements for supplements.

"Unfortunately, not all players in the market are responsible; it is these bad players that bring us here today," said Voinovich. "We need to ensure that they are held accountable and that Americans can depend on the existing regulatory agencies to protect their well-being with regard to dietary supplements."

Michael McGuffin, president of the American Herbal Products Association, said the hearing helped AHPA communicate that it doesn't oppose adverse-event reporting, although the group does not support Durbin's proposed legislation without any changes.

"I think this hearing was very clarifying for our chief congressional critic [Durbin]," McGuffin said.

Durbin also reportedly is attempting to add a clause to the Defense Authorization Bill that would require adverse-event reporting for any stimulants sold as dietary supplements through the U.S. military system.

But paralleling the congressional criticism of DSHEA, Charles Bell, programs director for Consumers Union, the nonprofit publisher of Consumer Reports, testified in the hearing, saying current DSHEA enforcement allows unsafe supplements to stay on the market for years.

"Under DSHEA, the burden of proof for removing unsafe products has been inappropriately shifted from manufacturers to government," Bell said in his testimony before the committee.

Bell suggested changes to DSHEA requiring a preventive safety system for supplement manufacturing, requiring products to be reviewed for safety before marketing and sale, as well as more specific labeling requirements, in addition to adverse-event reporting.

Bell said consumers want more protection from supplements, citing a survey Consumers Union conducted in May. The results showed fewer than one in five respondents feel supplements are sufficiently regulated. More than nine out of 10 respondents want the sale of supplements to be conditioned on safety and efficacy, with almost everyone surveyed agreeing that supplement producers should be required to report adverse events.

However, when the Intelligence Agency, a Traverse City, Mich.-based research and consulting group, interviewed core naturals shoppers, more than half said they either completely agree or somewhat agree that "herbal products are generally safe and rarely cause negative side effects."