Calif. Ephedra Laws To Be Implemented With Help From NNFA
This article was originally published in The Tan Sheet
Executive Summary
The National Nutritional Foods Association is working with the California Department of Health to help create standardized education programs for retail employees to enforce the state's new ephedra laws
|
The National Nutritional Foods Association is working with the California Department of Health to help create standardized education programs for retail employees to enforce the state's new ephedra laws. Senate Bill 1884, signed into law by Governor Gray Davis (D) Sept. 27, prohibits the sale of ephedrine alkaloid products to minors and requires more stringent warnings, as well as the FDA MedWatch number, on product labeling. The legislation was sponsored by Sen. Jackie Speier (D-Hillsborough). Companion legislation SB 1948, also signed by Davis Sept. 27, requires warning labels on dietary supple-ments be "clear and conspicuous." The bill was sponsored by Senator Liz Figueroa (D-Fremont). The Food & Drug Branch of the California Health Department will be responsible for ensuring the implementation of these laws by the Jan. 1 effective date. The health department plans to conduct inspections of supplement manufacturers based in the state to guarantee compliance and will work with trade groups to get the message to out-of-state manufacturers. Under SB 1948, the "clear and conspicuous" standard applies to both required and voluntary warnings. The Food & Drug Branch said this equates to a font size of at least 1/16 of an inch. Warnings on fold-out labels must be placed on the outside of the product so the cautions can be read without manipulating the label, the department added. SB 1884 (formerly SB 1750) mirrors a similar bill vetoed by Davis in 2000. At the time, the governor called the issue "a matter of interstate commerce" (1 (Also see "California Ephedrine Alkaloid Supplement Labeling Bill Veto Unexpected" - Pink Sheet, 9 Oct, 2000.), p. 14). However, in an Aug. 15 letter to FDA, California Department of Health Services Director Diana Bonta, PhD, said she would encourage Davis to sign the legislation if the agency did not take similar restrictive regulatory measures on ephedrine supplements (2 (Also see "Metabolife Proposes NIH “Blue Ribbon” Commission To Complement RAND" - Pink Sheet, 26 Aug, 2002.), p. 11). The Ephedra Education Council said it supports the new laws, noting it "opposed an earlier version of the bill, which would have unreasonably restricted the placement of ephedra dietary supplement products in California retail outlets." |