AER bill defeat in California welcomed

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Related tags: Dietary supplements, Food and drug administration, Dietary supplement, Ahpa

Much to the relief of several trade associations, legislation which
would have altered the adverse event reporting system (AER) for
dietary supplements in the state of California has been defeated by
four votes in the state assembly.

Defeat for bill, victory for industry

After a year long legal battle, both the American Herbal Products Association​ (AHPA) and the National Nutritional Foods Association​ (NNFA) expresed their relief at this verdict in statements yesterday.

The AHPA noted that the proposed "ill-conceived"​ legislation "would have established a burdensome AER system"​, while the NNFA called it an "onerous bill"​ that would have "duplicated federal legislative efforts and caused dietary supplement prices to rise"​.

A spokesperson for the NNFA explained to​that one of the organization's big concerns was that the bill mandated that virtually any adverse experience associated with dietary supplements - even minor or insignificant ones - would be required to be reported.

"This would have placed a financial burden on supplement manufacturers as well as on the California Department of Health, the agency charged with monitoring this legislation,"​ she said.

The Council for Responsible Nutrition (CRN) estimated that it would cost the State of California $250,000 just to get the program going and the final version of the legislation included a budget of $450,000 to implement the program.

"One of the concerns our lobbiest had was that the California Department of Health Services would certainly collect that sum, even if their actual costs were only $150"​ said Michael McGuffin, president of the AHPA. "With California in such a dire financial condition, the bill was an invitation to regulators to collect that amount - there was no accountability for the funds or how they would be collected."

SB 779 was introduced by state senator Jackie Speier in February 2003. The bill moved quickly through two senate committees and was passed by the senate in June 2003. It was then amended on five separate occasions before working its way through the Assembly Health Committee, where it was approved on 15 June by a vote of 11 to five, and the Assembly Appropriations Committee, which passed the bill on 12 August by a vote of 13 to five.

The bill would have established a requirement for any company that manufactures or distributes dietary supplements in California, with the exception of those that consist only of vitamins and minerals, to provide quarterly reports of received adverse events to the state. According to the bill, failure to submit such reports would have been a criminal offense under state law. In addition, companies would have been billed by the state to recover the expense of reviewing submitted reports.

The NNFA concluded that the defeat of this bill has "sent a clear message that consumers and industry alike felt strongly that it was an unnecessary burden"​ to the industry.

Despite the AHPA's atttitude towards this piece of local legislation, which could have opened the door for other states to follow suit, the organization expressed its desire to see a national AER system.

"We must now redouble our efforts to create a legitimate national AER system, so that the inefficient approach proposed by SB 779 does not resurface in other states,"​ said McGuffin.

June hearing

Earlier this year the Council for Responsible Nutrition (CRN) added its voice to the growing swell of support for the supplements industry to develop a national AER system, which is good for the industry as well as the consumer. This development was brought about at the beginning of June when various senators demanded in a hearing before a senate governmental affairs subcommittee that makers of vitamins and other dietary supplements should have to report potential safety risks to the FDA.

While the CRN was in favour of change, it emphasized that a new system would have to be simple and easy for the industry to use, as well as being beneficial for the consumer.

"It is important to develop the right system so that the reporting of serious adverse events will be helpful for the FDA in providing advice to consumers and be workable for industry,"​ said Annette Dickinson, president of the industry body.

At the June hearing, the AHPA also showed itself in favor of updating the system. The organization then agreed that the 10-year-old Dietary Supplement Health and Education Act (DSHEA) that regulates supplements should be modified to help the government better police unsafe products and cited the mandatory reporting of serious health problems in patients as a necessary step.

The FDA however suggested it already had sufficient power to act against risky supplements and was not seeking any changes to the law. The agency is trying to make the most of its current powers under the 1994 law "before we ask for any new authority,"​ said Robert Brackett director of the agency's Center for Food Safety and Applied Nutrition at the hearing.

Before the senate recessed for August, senators Orrin Hatch, Tom Harkin and Richard Durbin agreed to work together to craft the AER language that would be part of a federal bill. As senate returns next week, the industry waits to see what will happen next.

Related topics: Regulation

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