Since the Codex Alimentarius Commission was formed in 1963, the group has been suspected of conspiracy. Consumers were alarmed that this international regulatory Codex, adopted by the World Trade Organization, would limit their choice in dietary supplements. The controversy keeps popping up online, where outdated information plagues worried readers.

Over the years, consumers have been concerned that this group would force legislation on the United States. The topic is especially inflammatory because, although not related to the Codex, the concern—limited access to supplements—is valid. Confounding the issue is the easy e-mail and long-term data storage of the Internet. According to www.snopes.com, the ubiquitous online myth-busters, two versions of a bill proposing the regulation of dietary supplements that were introduced in 2003 (but not even voted on) gave rise to a 2005 e-mail that continues to circulate, warning that, “your right to choose your vitamin, mineral and other supplements may end.”

The Codex doesn’t really affect dietary supplements, as most countries treat them as drugs. The United States puts vitamins and minerals in the food category, but that is a unique regulatory category. Ultimately, the Codex, formed by the Food and Agricultural Organization of the United Nations (FAO) and the World Health Organization (WHO), is a standardizing force in the international trade of food goods.

It does not trump national regulations, but affects harmonization of international trade. The Codex has developed standards related to foods and guidelines for limits on heavy metals, food additives, pesticides and contaminants in international trade. Sources such as the American Herbal Products Association (www.ahpa.org) and the Natural Products Association (www.npainfo.org)—trade associations whose members have a real interest in selling products—give explanations of the Codex to calm consumers’ and manufacturers’ fears. Search “Codex” on the websites for more information.

Thanks to Steven Foster at The Herb Companion for this informative article.

“The errors and problems in this paper are too numerous to list completely at this time,” said Mark Blumenthal, founder and executive director of the Austin, Texas-based American Botanical Council. “While there are potential and actual interactions that various herbs can have with drugs used by patients with cardiovascular diseases, this paper will do little to improve professional awareness and skill in this area.”

In a press release, the American Botanical Council specified several errors in the published study:

• Latin names for herbs are missing. For example, the authors don’t clarify the species of ginseng discussed. Many ginseng species “cause varying pharmacological effects,” noted Blumenthal in the release.
• Some herbs labeled in the study as “commonly used” are not generally available in the U.S. dietary supplement market.
• Capsicum is listed as being used for shingles, trigeminal, and diabetic neuralgia. But the over-the-counter and prescription drug capsaicin, a compound derived from chili peppers (Capsicum spp.), actually is used for those purposes.

“There are more [flaws],” said Blumenthal, adding that the study “should not have been published in its present form without serious additional edits, revisions and deletions, and the Journal of the American College of Cardiology would be advised to retract it.”

The Washington, D.C.-based Natural Products Association also analyzed the research review, which called for drug-like oversight of herbal therapies. The NPA issued the following comment to NFM’s sister website NPIcenter: “The authors fail to understand that the risk needs to be attributed to the riskier product, which all would agree is the pharmaceutical. The risk they speak of, while nice in theory, in reality does not add up,” said Daniel Fabricant, PhD, vice president for scientific and regulatory affairs at the NPA.

The Washington, D.C.-based Council for Responsible Nutrition, a trade association representing dietary supplement manufacturers and ingredient suppliers, also questioned the accuracy of the study, noting in a press release that the “Dietary Supplement and Non-Prescription Drug Consumer Protection Act, passed in 2006, requires dietary supplement manufacturers to report any serious adverse events to the U.S. Food and Drug Administration. This post-market surveillance tool—in addition to the issuance in 2007 of newly updated Good Manufacturing Practices for all dietary supplements—greatly strengthened regulations for this industry.”

According to the CRN, during the first full year that the law requiring manufacturers to report serious adverse events was in effect, the FDA reported receiving 1,080 adverse event reports, only 672 of which were considered serious, for all dietary supplement products. For the same year, the FDA received more than 526,000 adverse event reports related to drugs and biologic products, more than 300,000 of which were considered serious, including close to 50,000 deaths, according to the CRN.

Thanks to Pamela Bond for this insightful and eye opening article regarding erroneous research studies that many tend to take as fact!

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