Sunday, February 27, 2005

Vitamins: Will they be regulated as drugs?

Some warn of draconian measure by world body, others roll eyes...

Posted: February 25, 2005
By Ron Strom
© 2000

While e-mails circulating about the imminent banning of over-the-counter vitamins and minerals in the U.S. are overly hysterical and in some cases downright false, food-supplement activists still are skeptical about new guidelines likely to be put into effect later this year by a U.N.-linked global commission.
As with many e-mail warnings passed through the ether, the current letters include some accurate information but with overblown conclusions and misleading predictions.
One such warning talks of new global regulations overriding U.S. law. Though they theoretically could be used as a tool by the World Trade Organization, the guidelines under consideration would not supersede regulations that govern what supplements will be available at local health-food stores in the U.S.
Those who distribute the warnings, however, are convinced that Americans could be seeking a doctor's prescription to get their usual vitamin E dosage in the not-too-distant future.
All the anxiety centers around the Codex Guidelines for Vitamin and Mineral Food Supplements, which likely will be finalized in July at a meeting of the Codex Alimentarius (food code) Commission in Rome. The commission, established in 1963 by the Food and Agriculture Organization of the United Nations and the World Health Organization, develops the international food code that intends to ensure the safety of food, and provides regulations for global trade of food products.
The supplement guidelines were finalized in a meeting of the Committee on Nutrition and Foods for Special Dietary Uses in Bonn, Germany, in November. The meeting has been described as a struggle between those nations that see supplements as "food," such as the U.S., and those that see them as "drugs," such as most of the European countries. Observers say the final product saw the Europeans' viewpoints win out on most issues.
"Under Codex authority, these guidelines are optional suggestions, not a mandatory trade standard that must be followed in trade between countries," explains Suzan Walter of the American Holistic Health Association on the group's website.
However, Walter points to powers of the World Trade Organization to use the non-mandatory guidelines in trade disputes, which could compel losing parties to adopt certain global regulations, such as the Codex guidelines.
"Therefore, the regulations in the guidelines must be taken seriously," she writes.
Walter says the biggest concern in the guidelines is that they will limit the dosage amounts of common vitamin and mineral supplements to "safe" levels. It has yet to be determined what those levels are.
Meanwhile, in the European Union, the EU Food Supplements Directive is set to take effect on Aug 1. Though there is a list of 28 "safe" vitamins and minerals that will continue to be sold in EU countries, there are 200 substances that will be restricted. Activists in the U.S. feel such restrictive policies are precursors to what could occur on this side of the Atlantic.
Stateside activists also are concerned about legislation that was introduced two years ago to regulate certain supplements in the U.S. Though the bills died when the 108th Congress ended in December, new versions are thought to be ready for introduction in March or April.
One of the bills from last Congress would have granted the Food and Drug Administration authority to regulate supplements in the same way that it regulates over-the-counter drugs.
These bills would weaken the Dietary Supplement Health and Education Act of 1994, which gave consumers who use supplements certain protections against government regulations.
Many of the warning e-mails mention bill numbers from last Congress that no longer apply. The new bills, assuming they are introduced, likely will have different numbers.
Walter points out her concern about a line included in the Federal Register having to do with U.S. regulations.
She writes: "The United States Federal Register, Oct. 11, 1995, FDA Policy on Standards, states that 'where a relevant international standard exists, or completion is imminent, it will generally be used in preference to a domestic standard. ...' If this is still the FDA policy, once the Codex guidelines are finalized this summer, will we find the FDA working to use this against the Dietary Supplement Health and Education Act?"
Some in the U.S. welcome stricter regulations on supplements., a website that exposes myths and hoaxes, said in an analysis of the Codex scare that Americans should be subject to more safeguards.
"Despite their presence on store shelves, not all dietary supplements are safe for consumers to use, let alone are beneficial to their health," the analysis said. "Products can be 100 percent natural yet deliver a deadly payload, as have some in the past. Lacking regulation of such ingestibles, there is no protection afforded consumers, and authoritative-looking labels are no guarantee that what is being vended in those bottles they envelop is not harmful. Under current law, dangerous supplements get onto the market and stay there, with serious physical harm resulting among those who use them, as was the case with ephedra, which caused strokes, heart attacks, and upwards of 150 deaths before the Food and Drug Administration was finally able to get it out of the stores."
The piece goes on to sing the praises of the legislation introduced in 2003, saying it "looked to regulate dietary nostrums by imposing quality and safety standards on them, and by giving the FDA the ability to take them off the market before a great number of folks have been harmed by them."
The site doesn't see a threat to impose the regulations based on the United States' membership in the WTO, saying the standards would only come into play when American manufacturers of dietary supplements "look to vend them on the international market."
Snopes notes: "What [the Codex Alimentarius Commission] seeks and what it can do are very different things. It has no power to force its will on any nation. Codex standards are voluntary, which means if the U.S. doesn't adopt them, they will not govern the regulation of vitamins, minerals or dietary supplements in the USA."
Some analysts see the new guidelines as another step toward world government and believe the large pharmaceutical companies are behind the effort. If those companies, by working through the World Trade Organization, the argument goes, can get supplements to be regulated as prescriptions, they can cash in on a new and lucrative market.
Consumer advocate Tim Bolen recently pointed the finger of blame at pharmaceutical giant Merck.
The company "controls the manufacturing and distribution of the base ingredients of the only supplements that will be available in Europe – and possibly North America" once international regulations take effect, he wrote.
"This is battle for world domination – period. Either 'we the people' run our governments, and decide world policy, or big multinational corporations will – through the WTO."

Comment: I don't have enough information yet on this to be sure where it's going to end up. I really doubt that U.S. consumers will let this get to the point that supplements will have to be ordered through your doctor by prescription, but if that were to happen, it would be a travesty. I will keep investigating this and let you all know if we begin to go in this direction.