We have previously warned about the lurking dangers of herbal supplements. International trade in herbal supplements is a profitable market with increasing demand in both developing and developed nations. There are currently more than 1,000 companies producing a bewildering 29,000 different medicinal plant products with annual revenues in excess of US$60 billion.
We have reported about Canadian results of testing 44 bottles of popular supplements sold by 12 companies. They showed that pills labelled as popular herbs were often diluted by cheap fillers or included herbs other than what was claimed on the label. Some herbal supplements were adulterated with potentially toxic ingredients that could pose serious health risks to consumers. Product substitution occurred in 30 of the 44 products tested and only 2 of the 12 companies had products without any substitution, contamination or fillers. Quite a bad situation.
Now similar alarming findings have been reported in an American study. The U.S. Food and Drug Administration (FDA) is responsible for looking after the dietary supplement legislation. Between January 2009 and December 2012 the FDA recalled 274 dietary supplements under the class 1 recall legislation for adulteration with pharmaceutical ingredients. Earlier research had found that even after an FDA recall, the dietary supplement remained available on store shelves. However, it was not known if the supplements on sale after FDA recalls were free of the adulterants.
In the new survey, 27 of the 274 recalled supplements met inclusion criteria for the study and were analysed using the same methods at the FDA’s laboratories. Of the 27 products, 20 were produced by U.S. manufacturers and the rest fully imported. About two-thirds of the recalled dietary supplements analysed still contained banned drugs at least 6 months after being recalled, according to the survey, irrespective of their origin. Most still contained the same adulterant identified by the FDA. Six supplements contained one or more additional banned ingredients not previously identified by the FDA. Some supplements contained both the previously identified adulterant as well as additional pharmaceutical ingredients.
Illegal substances identified in recalled supplements included:
- sibutramine and sibutramine analogs (oral anorexiants prescribed as an adjunct in the treatment of obesity but have been associated with increased cardiovascular events and strokes and have been withdrawn from the market in many countries),
- sildenafil (trade name Viagra, is a drug used to treat erectile dysfunction and pulmonary arterial hypertension),
- fluoxetine (trade name Prozac, is an antidepressant),
- phenolphthalein (has been used for over a century as a laxative, but is now being removed from over-the-counter laxatives because of concerns over carcinogenicity),
- aromatase inhibitor (a class of drugs used in the treatment of breast cancer and ovarian cancer in postmenopausal women), and
- various anabolic steroids (increase protein in skeletal muscles with androgenic and virilizing properties, including growth of the vocal cords, testicles and body hair).
A revered previous Prime Minister of Australia, Gough Whitlam, passed away on 21 October 2014. His slogan in winning the election was “It’s time”. I think it is high time that someone takes some serious action in preventing the sale of potentially harmful herbal supplements worldwide.