Lawmakers Push for Ephedra BanMar 17, 2003 | The Daily Illini The U.S. Food and Drug Administration has proposed stricter regulations for dietary supplement manufacturers, but state Rep. Sara Feigenholtz said it’s not enough to combat the problems in the drug industry.
Illinois lawmakers like Feigenholtz, D-Chicago, have already begun a push to become the first state to ban the sale and purchase of ephedra, with a bill unanimously approved Friday by a House committee.
The proposed FDA regulations would for the first time establish standards to ensure that dietary supplements and ingredients do not contain contaminants or impurities, and would be labeled to accurately reflect the active ingredients and other ingredients in the product, according to a March 7 press release from the FDA. The FDA has encountered products that are being labeled incorrectly or contain harmful substances such as lead.
Feigenholtz said she thinks the proposed regulations would place more of a burden on the manufacturer, when the burden should be on the FDA to check the safety of drugs.
“Consumers walk into a store and they don’t think the government would allow a dangerous product to be put on the shelf, but they’re wrong,” she said.
She said until now, dietary supplements have been part of an almost non-regulated industry. Manufacturers follow the Dietary Supplements Health and Education Act of 1994, but the act’s guidelines are not enough to prevent “dangerous combinations” of drugs such as ephedra and caffeine from being marketed under misleading labels, she said.
Feigenholtz said the manufacturers of Yellow Jackets, which contain the controversial ephedra drug, refer to caffeine as “extract of cocoa leaves” on the label to “skirt around the issue that they contain caffeine.”
Feigenholtz, along with state Rep. Bill Mitchell, R-Forsyth, is sponsoring a bill to ban the sale and purchase of ephedra drugs in Illinois. While many states already have some limitations on the product, Illinois would be the first state to completely ban it.
An FDA official said the regulations were developed to safeguard consumers and ensure consistency in all dietary supplements. She said the regulations were not prompted by any one event, but Dave Clarken, a spokesman for Feigenholtz, said he thinks the FDA is “definitely responding to public pressure over ephedra (regulation) from all over the country.”
Wyatt Consumer Healthcare spokesman Fran Sullivan said he doesn’t think the company, which manufactures Centrum vitamins as well as several other products, would be greatly affected by the regulations because it has followed its own pharmaceutical practices for many years to ensure consistency in its products.
The action would also permit more research on dietary supplements to improve their safety. The FDA will collect comments from the public and from manufacturers for a 90-day period, after which they will take the comments into consideration and change the regulations if necessary.