Supplement manufacturers scored a legislative victory in California when the state Assembly voted against a bill that would have established a mandatory adverse event reporting system.

Four Assembly members who initially voted for SB 779 in committee meetings earlier this summer abstained from the final vote and were key in turning away the legislation. The final vote of 37-34 on Aug. 27 was only four votes short of the 41 affirmatives needed for approval. Nine Assembly members abstained from voting.

The bill appears to be dead for the remainder of the year, since the state legislature is not scheduled to reconvene until January. However, some industry members say sponsor Jackie Speier (D) is likely to bring the issue back at some point in the future.

Under the legislation, supplement manufacturers and certain distributors would have been required to submit quarterly reports listing all adverse events relating to the supplements they sell to California's Department of Health Services (DHS). Products that contain only vitamins or minerals would have been excluded from the provisions.

SB 779 would have defined an adverse event as a "negative physical effect on a person who has taken a dietary supplement which may or may not be caused by the dietary supplement."

The bill also would have imposed a fee on firms to cover DHS' cost of reviewing the submitted reports. The amount charged would depend on the size of the company, number of employees and percentage of the business devoted to dietary supplements.

The Assembly Committee on Health estimates that initiating a system to process the reports would cost the state $250,000. Annual ongoing costs would total up to $450,000.

The Council for Responsible Nutrition says the bill would have established an "overly broad adverse event reporting program" that would have included a "huge number of unsubstantiated and insignificant events."

CRN also maintains that the related fees essentially would have imposed a tax on the supplement industry that would be passed on to consumers in the form of higher prices.

The American Herbal Products Association joined CRN in asserting that adverse event reporting should be addressed at the federal level.

"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," AHPA President Michael McGuffin says in a statement.

A number of federal bills addressing mandatory adverse event reporting are part of the debate surrounding a nationwide policy on AERs for the supplement industry. In March 2003, Sen. Richard Durbin (D-Ill.) introduced S 722, which would provide $10 mil. in annual funding to HHS for establishment of a mandatory AER system.

More recently, Durbin and Sen. Orrin Hatch (R-Utah) agreed to work together to attach provisions on AERs to S 1780 - a bill sponsored by Sen. Joe Biden (D-Del.) and Hatch - that would classify androstenedione as a controlled substance (¹ Also see "Senators Durbin, Hatch To Work Together On AER Plan" - Pink Sheet, 28 June, 2004., p. 3).

In addition to CRN and AHPA, the Consumer Healthcare Products Association and the National Nutritional Foods Association opposed the California bill. Bayer, Leiner, Natrol, NBTY and Pharmavite were among the firms resisting the legislation.

SB 779 was introduced in February 2003 and passed the Senate 25-14 in June 2003 (² 'The Tan Sheet' June 30, 2003, In Brief). Since June 2004, the bill has been amended by the Assembly five times.

The bill endured nine hours of debate and several votes on the Assembly floor - a process that continued well into the morning of the next day - before it failed to pass.

The four Assembly members who voted in favor of the bill during earlier committee meetings but then abstained from the final vote were Ellen Corbett (D), Paul Koretz (D), Glora McLeod (D) and Simon Salinas (D).

Joe Nation (D), who previously had voted affirmatively for the bill in the Assembly Appropriations Committee, switched his position in the floor vote.

Dietary Supplement AER Bill Fails To Pass California Legislature

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