NBC Dateline unveils dry labbing and its potential dangers
On March 18th, 2012 the US TV-show 'Dateline NBC' was dedicated to dietary supplement safety, labeling, formulation and testing, the core being a case from two years ago involving consumers who fell seriously ill after taking a product with mislabeled and dangerously high levels of selenium.
They also started a fake 'company' and created two adulterated products, supposedly produced by this company. They shipped these products to several industry labs to see whether the labs would conduct appropriate tests and would find the obvious adulterants or if they 'dry labbed' the tests and would return clean results without actually conducting the tests.
The core of the program was the case of Total Body Formula, a weight-loss product that caused hair loss, joint pain, kidney failure and heart problems in customers who took the liquid supplement, about four years ago. The product was sold at GNC stores, featured a detailed ingredients list and was marketed as being backed by scientific testing. At some point after people fell ill, GNC removed the product from the stores. After numerous serious adverse event reports surfaced, the FDA warned consumers, (March 2008) to avoid taking this product. FDA conducted lab tests on the product, looking for a reason behind the health problems, including possible high selenium content. Results showed high selenium (over 200 times the label claim) and chromium (17 times more than recommended intake). The product was recalled in 2008.
Total Body Essential Nutrition of Atlanta, the producer and distributor of this product stated its contract manufacturers mistakenly put higher amounts than requested, but those companies, Texamerican and Wright Enrichment, said they produced the product to the specifications provided. NBC Dateline said the mistake was a substitution of mg for what was supposed to be mcg. They said after reports of illness surfaced, a supervisor noticed the selenium levels were too high. But instead of issuing an immediate recall, the product was distributed.
More than 200 lawsuits against the companies were settled in 2010. In a statement submitted to Dateline, Wright Enrichment made it clear they produced the product for Total Body for years without any incidents, but in 2007 Total Body changed its contract manufacturer to TexAmerican in order to cut costs.
Wright Enrichment said TexAmerican tried to reverse engineer the product blend, rather than pay to secure the original premix blend. Wright also reported TexAmerican gave their reverse engineered blend to several employees who immediately got sick; when seeing this, other employees refused to take the supplement.
'In sum, TexAmerican failed in its attempt to reverse engineer the vitamin-premix blend it asked Wright to produce, then, with the knowledge the product it had manufactured made people ill, they released it to Total Body as fit for human consumption,' Wright said in its statement.
Wright also noted that while both Total Body and TexAmerican accepted no responsibility in the lawsuits, Wright admitted it should have raised questions about the potentially unsafe mineral levels being ordered and should have refused to blend the product as ordered.
GNC said the product was only offered for sale in 50 of its 5,000 stores. They emphasized the problems were due to a manufacturing error, not a contamination issue. They also made it clear this error was before the dietary supplement good manufacturing practices (GMPs) went into effect. GNC said it removed the product from store shelves as soon as it found out about the problems (2008), and hasn't sold the product since.
Dry Labbing ?
Dateline investigated how a grossly high and unsafe level of an ingredient could make it all the way through the entire chain of production to the retailer and consumer. An analysis by the product's certification lab, Atlas Bioscience, didn't detect those dangerous selenium and chromium levels.
An expert on the show said one of the problems is dry labbing, meaning that when a sample comes into a lab for testing, it is cast aside without testing, and the final results are made to match or closely adhere to what the customer wants or what is on their supplied Certificate of Analysis (CoA).
For investigative purposes, Dateline created a fake supplement company, Life Root Naturals, and two adulterated products — Burn, a natural weight-loss product, purposefully spiked with very high amounts of selenium and sibutramine, and Kelp, a green foods product, spiked with very high levels of the heavy metals arsenic and lead.
Numerous labs were asked to test the formulations, even indicating which potential contaminants to look for. Most of the labs found the contaminants and some pointed out the potential problems with such contaminants and levels.
Only Atlas Bioscience (Tucson, Arizona), the same lab involved in the Total Body Formula case, returned results almost identical to the initial fabricated CoA provided by NBC's Chris Hansen, (masquerading as a Life Root Naturals' executive), and no report of the presence of the adulterants was made.
About the contamination levels, Dinesh Patel, Ph.D., chief chemist at Atlas Bioscience, told Hansen, 'Absolutely, these levels are all perfectly normal.' When told the company was really Dateline posing as a real company, Patel accused NBC of misleading him.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), challenged the assertion that dry labbing is widespread. 'Over 150 million Americans are using dietary supplements each year and there is little evidence of widespread adulteration, contamination of ingredients, or serious adverse events,' he said. 'We don't think the practice of dry labbing is widespread.'
Cara Welch, Ph.D., VP of scientific & regulatory affairs for the Natural Products Association (NPA), said it would be difficult to set up a qualification program for laboratories and that such an initiative would take time. 'It really is up to the manufacturers to go the extra step and audit not only their suppliers but also the testing facilities. Throw them a false sample every once in a while and see if they catch it. I think that is good practice. We support government and industry actions to both produce dietary supplements according to GMPs and eliminate drugs wrongly labeled as supplements,' she added. 'Products that contain undeclared drug ingredients are not dietary supplements.'
By law, every single bottle of dietary supplements should contain what is on the label and what is on the label should be in the bottle.
The supplements label can tell consumers a lot, be it by inclusion or omission of ingredients. We advise consumers to choose wisely when purchasing supplement products; ask e.g. your healthcare practitioner what supplements are right for you, and buy from certified companies with strong reputations. Compare the products' description in the ads to what is actually written on the label - is there a 100% match ? In ads one can say things like 'contains over 200 phytonutrients!' but this is not allowed on the label, unless you can name those ingredients and prove this statement with a CoA.
Check the producers GMP certification, and if possible verify they are complying with ISO and HACCP standards as well. Because of the high costs involved in acquiring these production certificates, most companies don't have these. This does not automatically mean that they are all suspicious, but it might be worthwhile to choose one that is fully certified, if possible.
This link will show you an overview of what the FDA calls 'Tainted Supplements'.
This link will show you the FDA's Dietary Supplement Alerts and Safety Information.
Better be safe than sorry!