International Regulation of Dietary Supplements Looms
by Elaine Sullivan
Over 100,000 Americans die every year from adverse reactions to prescription drugs. Contrast this with 10 deaths in 20 years due to adverse reactions of vitamins.
We, of course, have governmental and world agencies to help protect us from such tragedies. The Food and Drug Administration (FDA) is an agency of the US Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.
The Codex Alimentarius Commission, (Codex Alimentarius is Latin for “Food Code”) based in Rome, Italy, and created in 1963, is an international organization jointly run by the Food and Agricultural Organization (FAO) and the World Health Organization (WHO) of the United Nations. One of its 27 committees, the Codex Committee on Nutrition and Foods for Special Dietary Use (CCNFSDU) is responsible for Dietary Supplements and Special Foods. The CCNFSDU meets yearly in Germany. Codex’s published goals are to develop and adopt uniform food standards for its member countries and to promote the free and unhindered international flow of food goods, thereby eliminating trade barriers to food and providing food safety. This is called “harmonizing”. The 29th session of the CCNFSDU (CAC) met in Bad Neuenahr-Ahrweiler, Germany, November 12-16, 2007.
In 1994, President Clinton signed the Dietary Supplement Health and Education Act. The DSHEA acknowledges that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits. Congress’s intent in enacting the DSHEA was to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them. In the findings associated with the DSHEA, Congress stated that there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced health-care expenses, and disease prevention.
The DSHEA established a formal definition of “dietary supplement” using several criteria. A dietary supplement:
• is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.
• is intended for ingestion in pill, capsule, tablet, or liquid form.
• is not represented for use as a conventional food or as the sole item of a meal or diet.
• is labeled as a “dietary supplement.”
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).
The DSHEA was supposed to ensure uniform labeling of supplements, make sure that the amount of ingredients and potency listed on labels is what is actually in the supplement, and that pesticides, contaminants, etc., are not in your supplements. However, the DSHEA also limits what a dietary supplement can put on its label regarding any actual health benefit claim.
The FDA, FAO, WHO and the FTC, as well as, other governmental agencies are very cautious about letting the consumer decide whether or not to take supplements and how much you can take. Every year these groups gather together as a part of the Codex Alimentarius Commission to discuss and decide on these matters, as well as others. What can we expect under Codex? To give you an idea, here are some important points:
• Dietary supplements could not be sold for preventive (prophylactic) or therapeutic use.
• Potencies would be limited to extremely low dosages. Only the drug companies and the big phytopharmaceutical companies would have the right to produce and sell the higher potency products (at inflated prices).
• Prescriptions would be required for anything above the extremely low doses allowed (such as 35 mg. on niacin).
• No dietary supplement sold as a food can exceed potency (dosage) levels set by the commission; common foods such as garlic and peppermint would be classified as drugs or a third category (neither food nor drugs) that only big pharmaceutical companies could regulate and sell. Any food with any therapeutic effect can be considered a drug.
• Codex regulations for dietary supplements would become binding (escape clauses would be eliminated). Codex standards for dietary supplements would become the reference international standard under GATT, and a reference international standard under NAFTA.
• All new dietary supplements would be banned unless they go through Codex testing and approval.
• Genetically altered food would be sold worldwide without labeling.
The Codex Alimentarius proposals already exist as law in Norway and Germany where the entire health food industry has literally been taken over by the drug companies.
The current trend is for countries to adopt the international standards either individually or in regional compacts. If that happened in the US, all new dietary supplements would automatically be banned unless they conform to Codex standards- (which would require going through a very expensive drug like approval process.) The Delaney clause, which used to protect us against carcinogens in our food supply, has already been “harmonized” to a Codex standard which favors pesticide manufacturers, and not a single member of Congress protested against this.
“WTO is using what is known as the Codex Alimentarius Commission (CAC) to further restrict the free use of nutritional supplements within the United States and worldwide. Specifically, the CAC is setting ‘Guidelines for Vitamin and Mineral Food Supplements.’ These guidelines are more restrictive and will supercede current US regulations by dictating to the US which nutrients are safe, the maximum and minimum amounts allowed in a product, and related packaging and labeling requirements.”
The Drug Company Influence on Your Health, Shane Ellison M. Sc., December 5, 2007. This is all part of the “harmonizing” efforts of the Codex.
Certainly it is important to ensure consumers have safe products and there are regulations and standards for prescription drugs also. But it is interesting to look at how differently dietary supplements are treated compared to pharmaceuticals.
Let’s contrast the way the FDA treated ephedrine with the way it treats prescription drugs. In 1999, an estimated 12 million Americans used the supplement, ephedra which was banned in 2003 as an “unsafe risk”. According to the FDA, “No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to FDA enforcement action.” What is ephedra? “Ephedra (also known as Ma huang, Chinese Ephedra and epitonin) is one of the world’s oldest medicines. The Chinese discovered ephedra more than 5000 years ago. Research has shown that ephedra increases metabolism and helps promote weight loss, relaxes the air passages in the lungs to help treat asthma and cough, promotes perspiration to help a person recover from a minor cold and helps promote urination to help relieve edema.” (www.ephedra.com) Native Americans and Mormon pioneers drank a tea brewed from ephedra called Mormon tea.
5000 years of usage and NOW we think it’s unsafe at any dosage? Public Citizen, a consumer advocacy group, says more than 150 deaths occurred between 1995 and 2004 that were “linked” to ephedra. 12 million people over 8 years and 150 deaths – that’s a pretty low risk factor and some of the deaths that were “linked” to ephedra may have had other causes. Ephedra has been used by people on a regular basis for millennia!
In contrast, between 1999 and 2006 as many as 140,000 injuries and 60,000 deaths in the US were caused by patients taking either Vioxx or Bextra. Vioxx, Bextra and Celebrax are in a class of drugs known as NSAIDs (Non-steriodal anti-inflammatory drug). NSAIDs are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation and are used for a variety of ailments. Certain NSAIDs, including ibuprofen and aspirin, have become accepted as relatively safe and are available over-the-counter without prescription. And yet, according to the American Association of Poison Control Centers (AAPCC) 2005 database, there were 25 deaths due to ibuprofen alone in 2005 and only 1 death due to all dietary supplements combined. The report shows that analgesics are the substances most frequently involved in human poisonings. Twenty-five deaths a year over 8 years would be 200 deaths by ibuprofen alone.
Seven years and 60,000 deaths; are NSAIDs found to be “unsafe at any dosage” and banned? No. Vioxx, Bextra, and Celebrex were temporarily pulled from the market because of major heart attack risks. Vioxx was withdrawn from the US market in 2004, Bextra was withdrawn in 2005. Celebrex is still available by prescription.
The deaths occurred because of FDA failure to protect the public. Clinical trials of Vioxx began in 1998. Study “090” conducted by Merck revealed serious cardiovascular problems as compared to patients not taking Vioxx. This study was never published; Merck insisted that it was not large enough to provide definitive data. The FDA approved Vioxx in 1999.
Pfizer first acknowledged cardiovascular risks associated with Bextra in October of 2004. The American Heart Association soon after was presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.
On April 7, 2005, Pfizer withdrew Bextra from the US market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction.
So let’s recap: a dietary supplement that’s been around for 5000 years and is reportedly “linked” to 150 deaths in an 8 year period gets banned while; a manufactured drug, NSAIDs, that have been around for less than 10 years and reportedly causes 60,000 deaths in a 7 year period are not. Even our little bottle of Motrin kills 200 people in a similar time frame. Consumers must feel secure knowing that the Codex is working to keep us safe from dangerous supplements.