US Dietary Supplements Not As Safe As Consumers Might Assume

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Main Category: Nutrition / Diet
Also Included In: Regulatory Affairs / Drug Approvals;  Complementary Medicine / Alternative Medicine
Article Date: 04 Aug 2010 - 2:00 PST

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More than half of adult Americans take dietary supplements in the belief they will keep them healthy, help them lose weight, or increase vitality and drive, but according to Consumer Reports, they may not realize there is no obligation for manufacturers to show they are safe and effective, and in their latest report they reveal 12 ingredients that consumers should avoid because they have been linked to health risks, including cardiovascular, liver, and kidney problems.

In their September 2010 report published on Tuesday, the consumer magazine describes how the US Food and Drug Administration (FDA) has little power to regulate dietary supplements under the "industry-friendly" 1994 Dietary Supplement Health and Education Act (DSHEA), and where it does have power, it hardly ever uses it.

The report says that of the 54,000 and more dietary supplement products listed in the Natural Medicines Comprehensive Database, only about a third have any scientific evidence to support some level of safety and effectiveness.

The consumer magazine's report identifies 12 supplements, which they refer to as the "dirty dozen", that are readily available in stores and online, but that they think consumers should avoid because of health risks to heart, liver and kidneys. The following list summarizes their information:

1. Aconite (other names include aconiti tuber, aconitum, radix aconiti), used for joint pain, inflammation, gout, wounds, is described as "unsafe" and has been linked to low blood pressure, nausea, vomiting, problems with heart rhythm, respiratory paralysis and death.


2. Bitter orange (aurantii fructus, Citrus aurantium, zhi shi), taken for weight loss, allergies, nasal congestion, is described as "possibly unsafe" and has been linked with heart problems, stroke and death. Caffeine taken at same time can heighten risks.


3. Chaparral (creosote bush, Larrea divaricata, larreastat), used for infections, detoxification, colds, weight loss, inflammation, cancer, is described as "likely unsafe", and has been linked to liver damage and kidney problems.


4. Collodial silver (ionic silver, native silver, silver in suspending agent), used for rosacea, psoriasis, Lyme disease, HIV/AIDS, food poisoning, chronic fatigue syndrome, fungal and other infections, is described as "likely unsafe" and has been linked with discoloration of the skin (bluish skin), mucous membrane, kidney damage, and nerological problems.


5. Coltsfoot (coughwort, farfarae folium leaf, foalswort), used to treat sore throat, cough, laryngitis, bronchitis, asthma, is described as "likely unsafe" and has been linked with liver damage and cancer.


6. Comfrey (blackwort, knitbone, common comfrey, slippery root), taken for heavy menstrual periods, coughs, chest pain and cancer, is described as "likely unsafe" and has been linked with liver damage and cancer.


7. Country mallow (heartleaf, Sida cordifolia, silky white mallow, malva blanca), used for allergies, asthma, weight loss, nasal congestion, bronchitis, is described as "likely unsafe" and has been linked with heart problems, stroke and death.


8. Germanium (Ge, Ge-132, germanium-132), taken for pain, infections, heart disease, glaucoma, liver problems, arthritis, osteoporosis, HIV/AIDS, cancer, described as "likely unsafe" and has been linked with kidney damage and death.


9. Greater celandine (celandine, chelidonii herba, Chelidonium majus) used for cancer, liver disorders, detoxification, irritable bowel, and stomach upsets, is described as "possibly unsafe" and has been linked to liver damage.


10. Kava (awa, Piper methysticum, kava-kava) taken for anxiety ("possibly effective"), is described as "possibly unsafe" and has been linked with liver damage.


11. Lobelia (asthma weed, Lobelia inflata, pukeweed, vomit wort), taken for bronchitis, asthma, coughing, quitting smoking ("possibly ineffective"), is described as "likely unsafe" and that toxic overdose can cause very low blood pressure, fast heartbeat, coma and possibly death.


12. Yohimbe (yohimbine, Corynanthe yohimbi, Corynanthe johimbi) used as aphrodisiac and also taken for chest pain, diabetic complications, depression, erectile dysfunction ("possibly effective"); is described as "possibly unsafe" when used without doctor supervision because it contains the prescription drug yohimbine. Normal doses can cause high blood pressure and rapid heart beat, and high doses can result in severe low blood pressure, heart problems and death.

Consumer Reports developed the list with the Natural Medicines Comprehensive Database, an independent organization that researches and evaluates the safety and effectiveness of dietary supplements. The data comes from the Natural Medicines Comprehensive Database, Professional Version, June 2010.

They said the supplements are among those linked by clinical research or case reports to "serious side effects" and that unless otherwise noted, there was not enough evidence to "rate their effectiveness for their purported uses", and that the list of dangers does not include all of them.

Wondering why these products are still for sale, Consumer Reports asked two national retailers why they carried certain of the supplements on their list of products, and they said because the FDA has not banned them.

A spokeswoman from the Vitamin Shoppe chain told them the FDA has "the authority to immediately remove them from the market, and we would follow the FDA recommendation".

The consumer magazine said most but not all of the products they bought had warning labels. They bought a bottle of silver that the label said was "perfectly safe", but next to it was an asterisk with a note that the FDA had not evaluated this claim. In fact, points out Consumer Report, the FDA issued an advisory in 2009 warning consumers against using silver (including colloidal silver), sold for supposedly supporting the immune system because it can turn the skin bluish gray, permanently.

One such case was 56-year old Janis Dowd of Bartlesville, Oklahoma who told Consumer Reports that she started taking colloidal silver because she read online that it would stop her Lyme disease coming back. She started taking it in 2000 and gradually, although she did not notice it, her skin started changing color. She said other people kept saying to her that she looked "a little blue".

Although laser treatments have erased nearly all the bluish color from her face and neck, Dowd said it's not feasible to treat the rest of her body.

According to the trade publication Nutrition Business Journal, Americans spent 26.7 billion dollars on dietary supplements last year.

Consumer Reports also describes the case of 55-year old John Coolidge of Signal Mountain, in the southeastern state of Tennessee, who says he took a supplement called Total Body Formula to improve his general health but it turned out to contain hazardous amounts of chromium and selenium.

Coolidge described his symptoms: first he had diarrhea, followed by joint pain, then hair loss, lung and breathing problems, and eventually some of his fingernails and toenails fell off.

"It just tore me up," he said.

After receiving hundreds of reports of side effects to the product, the FDA tested it and found that most of the samples had more than 200 times the amount of selenium shown on the product label, and up to 17 times the recommended intake of chromium.

The distributor voluntarily recalled the products in March 2008, and Coolidge is now suing several companies. He said his hair and nails have grown back, but that he still has serious difficulty breathing.

The consumer organization says that because quality control and inspecton of the supplement industry is not good enough, consumers like Coolidge are unwittingly buying products contaminated with heavy metals, pesticides and even prescription drugs.

And the situation is even worse than you might imagine because the FDA rules that cover manufacturing of supplements don't cover companies that sell herbs, vitamins and other raw ingredients.

For example, a growing problem is the amount of raw supplement ingredients coming into the US from China, who have been caught exporting contaminated products. "The FDA has yet to inspect a single factory there", said Cosumer Reports in a statement.

Source: Consumer Reports.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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