The first cases of liver problems linked to a popular weight loss supplement called OxyElite Pro began in Hawaii last May.
April 30, 2014 (New York Times)
But is wasn’t until four months later that the Food and Drug Administration, the agency responsible for getting dangerous products off the market, learned of the outbreak, and the product was finally recalled in November.
Flaws in the way that dietary supplements are monitored and reported are causing potentially life-threatening delays in how long dangerous products linger on store shelves, said Dr. Pieter Cohen, an assistant profession at Harvard Medical School who has studied supplement safety problems. They are also, he said, setting the stage for similar episodes to occur again.
Writing in a recent editorial in The New England Journal of Medicine, Dr. Cohen said that one of the more significant problems in such instances is that many cases of harm are reported to doctors and poison control centers but are either delayed in reaching the FDA or do not make it to the agency at all.
Many doctors who suspect a supplement has injured a patient neglect to submit a timely report to MedWatch, the online portal that the FDA maintains to help identify clusters of injury linked to harmful products, Dr. Cohen said.
Dr. Cohen said that many doctors simply do not find the FDA or MedWatch very helpful in dealing with patients who have ingested a tainted product. So instead they turn to poison control centers, which offer medial advice in cases where a patient ingested something toxic. Indeed, in a report last year, the Government Accountability Office noted that from 2008 to 2010, more than 1,000 adverse events related to dietary supplements were reported to poison control centers – but not to the FDA.
“Because data are not routinely shared between the centers and the agency,” Dr. Cohen wrote, “the FDA did not have access to these reports.”
Critics of the $32 billion a year supplement industry argue that the FDA is hampered by a federal law that, they say, was written largely to protect the industry, the 1994 Dietary Supplement Health and Education Act.
The law, which gives companies much leeway in how they manufacture and advertise supplements, allows them to put products on the market without FDA approval. As a result, the agency has little power to stop tainted products from landing on store shelves in the first place, even though research suggests that adulteration and mislabeling are widespread.
Supplement regulation in the US is based on food quality. That is, the government regulates how “clean” the supplement is. It limits the contaminants like rat feces and cockroach parts, but pays no attention to the ingredients.
According to Consumer Labs, an independent laboratory funded by members like me, 80% of the Echinacea sold in the US either contains no Echinacea or contains ingredients from the wrong parts of the plant or wrong species.
Echinacea is the best selling herb in the US. Supplement companies are not generally interested in more regulation. If it says Echinacea, it flies off the shelf, so why mess with a market model that works so well?
I purchased my herbs from Australia, where by law, herbal quality is pharmaceutical grade. The supplement companies are required to test the raw product and every step of processing to ascertain that each tablet contains the same amount of the target and marker compounds known to be of therapeutic value. It is the same high standard we hold the drug companies to here in the US.
Echinacea is native to North America. So the Echinacea I use is grown here, shipped to Australia for processing, and then shipped back to the US for sales and distribution. Yes, it drives up the cost, but it is the only way I can guarantee I am using a viable, safe product.
The European countries have guidelines that a similar to those in Australia. However, the supplement companies voluntarily developed these guidelines without government regulation.
Red yeast rice is an example of a dangerous supplement available at any health food store. It is used to reduce cholesterol. It contains lovastatin, the same drug used in the manufacture of statin drugs. However, the lovastatin content in red yeast rice varies from tablet to tablet, and brand to brand. Some tablets contain none while others have been found to contain more than 20mg, twice the normal prescription strength used for initial treatment of high cholesterol.
In addition, red yeast rice often contains a toxin that can be fatal. Only a few supplement companies endeavor to remove the toxins from red yeast rice. Despite these serious risks, health food stores continue to sell this product. A least twice a month, I have a new patient who’s MD has recommended red yeast rice in lieu of statin drug therapy.
THE BOTTOM LINE:
Be very careful buying over the counter supplements. Consult a qualified nutritionist rather than a clerk at the local health food or drug store. Avoid products that contain a “proprietary blend”. That generally means, they put a bunch of stuff in it, but didn’t bother to measure how much of each ingredient. That may be a sign of a good chef, but not a good supplement.