In what some consider to be fallout from a US District Court?s partial overturning of the Food and Drug Administration?s ephedra ban, a US Representative from California has proposed an amendment to the Dietary Supplement Health Education Act.
Under the proposal, which Rep Susan Davis introduced in late June, ?even a relatively small risk of a serious adverse health effect? from a supplement would be judged unreasonable in the absence of a ?sufficient benefit.?
The FDA would be able to ban any dietary supplement ?even though there are uncertainties as to the levels of a dietary ingredient that may present a risk.?
HR 3156 was sent to the Committee on Energy and Commerce before the House of Representatives disbanded for summer recess in July.
?You have to understand, this actually isn?t a totally new bill,? said Brenna Hill, executive director of The American Association for Health Freedom, a nonprofit that represents health care practitioners and consumers. ?This is basically a bill they introduced in 2003 that failed — only they?ve added these changes to the ?unreasonable risk? clause. We?re hopeful such a harsh bill won?t have much chance of being passed, but it?s hard to say.?
So far, every major industry group has come out in opposition to HR 3156, including the National Health Federation and the National Nutritional Foods Association. American Herbal Products Association president Michael McGuffin reacted by calling the proposal ?bad science and bad law,? because the new bill specifically ignores the quantity of compounds within any given supplement. It was precisely this issue that caused the Utah district court to conclude in April that the FDA?s blanket ephedra ban was too sweeping, reopening the door to sales of ephedra in dosages of 10mg or less. Adverse reactions to ephedra use were largely related to high-dose ephedra supplements that also contained caffeine.
Frank Cuny, executive director of California Citizens for Health Freedom, shared the concern that the partial overturning of the ephedra ban will make legislation like HR 3156 an easier sell in Congress.
?Ephedra is an emotional issue that keeps being brought up,? he said. ?With the FDA ban being partially overturned, opponents (of the industry) will come back and keep trying to use this to argue that the nutritional industry is dangerous.?
Despite this, Hill believes it is not in the lawmakers? interests to try to rush this specific legislation through Congress.
?I don?t see this being passed in 2005, but it could happen during this session,? she said. ?If another supplement like ephedra is found to be harmful, energizing public opinion, the measure would have a greater chance of success, but as things are right now, it wouldn?t have much chance at all. There is some political maneuvering involved in waiting — waiting to see what happens.?