You are what you eat, but who gets to say what that is? Should you be allowed the freedom to ingest vitamins and supplements as you see fit? Or does the FDA have a say? How about an international body via a collectively agreed upon Codex Alimentarius?
In Salt Lake City a U.S. District judge ruled that the Federal Drug Administration's 2003 ban on ephedra was too broad. The suit, brought by Nutraceutical International of Park City, Utah, challenged the removal of all ephedra products on the market, on the premise that the FDA had not shown any danger for low dose (less than 10 milligrams) ephedra products. It also questioned whether the FDA had the jurisdiction to demand that dietary supplements prove their safety, as is demanded of pharmaceutical drugs. Here is one reaction to the ruling:
"The court provided a very rational decision that the amount of an ingredient must be considered when evaluating the safety of that ingredient," said Michael McGuffin, president of the American Herbal Products Association. McGuffin said the ruling should not be misinterpreted as permission to put high-dose ephedra products like Metabolife 356 back on the shelves. The decision is narrowly focused on the low-dose product sold by Nutraceutical, he said.
However Public Citizen, a Washington watchdog group, takes a different side. The group fought to have ephedra banned for years. Among many informational documents available on their website is an article by Sidney Wolfe, M.D. published in the April 18, 2003 issue of Science magazine, that details arguments for banning ephedrine alkaloids, posted here at the Public Citizen website. The article lists some health risks linked to over-the-counter (OTC) drugs containing ephedra alkaloids and ephedrine. It criticizes the FDA for dawdling rather than banning these substances in the light of multiple ephedra linked deaths, and notes the multi-million dollar political lobbying efforts employed by some of the ephedra products companies.
There are obvious incentives on the part of for-profit companies to challenge the FDA's authority and scope. However vitamins and supplements comprise a multi-billion dollar industry that is largely unregulated and certainly many OTC supplements can be dangerous if misused. Many others are unstudied and potential toxicity is undetermined.
Should someone be overseeing products on behalf of public safety? Should the FDA be regulating the manufacture and sale of herbs, minerals and vitamins or perhaps an international body such as the World Health Organization. There is support, concern and confusion about the Codex Alimentarius, whose level of jurisdiction over vitamins and minerals (potentially US nutrient industry) is currently being debated. Participating in this important public debate is elementary, after all, it's your body.
