California, August 31, 2002.
Governor Has Indicated That He Will Likely Sign Bill
Dietary Supplement Warning Bill Also Passes Legislature
Over this past weekend, the California Legislature passed two bills that, if signed by the Governor, will affect the sale of dietary supplements in the state. One of the bills (S.B. 1884) concerns ephedra and steroid precursor hormones (this includes, but may not necessarily be limited to, dietary supplements containing androstenedione, pregnenolone, or dehydroepiandrosterone (DHEA)) and the other bill (S.B. 1948) concerns the conspicuousness of warning language that appears on dietary supplement labels.
Governor Davis has until the end of September to take action on the bills and can do so at any time. Assuming that the Governor signs the bills, the new law will take affect on January 1, 2003. We assume that the Governor will sign the bills as his office issued a statement on August 17th, basically stating, that while he vetoed an ephedra warning language bill two years ago he would sign a bill if one crossed his desk now.
The Governor’s statement was issued at about the same time that the Department of Justice criminal investigation of Metabolife was announced. The Los Angeles Time reported that Governor Davis had accepted $150,000 in donations from Metabolife two years ago before deciding to veto the earlier bill. At that time the Governor had announced that he would wait for federal action on ephedra.
On August 15th, Governor Davis directed the head of the state Department of Health Services to send a letter to FDA Deputy Commissioner Lester Crawford that included the following statement:
New legislation that would impose labeling requirements and prohibit the sale of ephedra to minors is being advanced by the California Legislature and is expected to reach the Governor's desk again in the next few weeks. Absent significant immediate action by the federal government to protect the public health, I intend to recommend that the Governor sign this legislation.
If signed by the Governor, S.B. 1884, will require warnings on ephedra and steroid hormone precursors, in addition to a prohibition on sales to persons under the age of 18. The ephedra warnings contain some language in addition to that presently required by Texas, some of the warnings must be capitalized and the following statement will also be required, “To report any adverse events call 1-800-332-1088."
In addition to the foregoing, the dietary supplement warning bill, S.B. 1948, also passed the Legislature and seems likely to get the Governor’s approval. While this bill seems simple enough it could have teeth when applied to the products that were the subject of the previous bill.
S.B. 1948 requires that warning labels included on dietary supplements manufactured or sold in California be “clear and conspicuous.”
Violations of this bill are deemed, “an infraction,” punishable by a fine not to exceed the following: A) $1,000 for the first violation; B) $2,000 for the second violation; and, C) $5,000 for the third and each subsequent violation.
As this would apply to all dietary supplements sold in the state including the aforementioned dietary supplement products that will now have mandatory warnings (assuming the Governor does not veto the bills), a concise determination of what “clear and conspicuous” means will need to be obtained. For example, will 1/16 inch type size be sufficient and will fold-out labels be permitted?