The Dr. Oz Show has again made a splash in the natural products industry, except this time in a negative way. A segment on weight loss supplements—long indentified by the U.S. Food and Drug Administration (FDA) as a problem category—showed that all of the products featured on the show tested positive for undeclared pharmaceutical ingredients.
One of the guests on the show was Jim Neal-Kababick, director of Oregon-based Flora Research Laboratories, which conducted the tests. He described the spiking problem in the weight loss category as “worse than it’s ever been.”
The weight loss products were purchased in New York, according to what Dr. Oz said on the show, though he emphasized that similar products could be purchased anywhere. Most of them featured Chinese characters on the labels and had poorly translated label language and incomplete lists of ingredients.
The chief adulterant was the weight loss pharmaceutical sibutramine and its analogue versions. This drug was marketed in the U.S. under the name Meridia until it was pulled from shelves because of safety concerns. It has long been identified by FDA as an undeclared pharmaceutical contaminant in weight loss products. One of the products also was found to contain a prescription antibiotic, which Neal-Kababick attributed to sloppy manufacturing practices.
Why is supplement spiking getting worse?
Neal-Kababick attributed the rising tide of spiking problems in part to the ease with which chemists can synthesize new analogue forms of pharmaceuticals such as sibutramine or sildenafil in the erectile dysfunction category. As soon as a testing signature is worked out for the latest analogue, the spikers are on to the next, he said.
Most pharmaceutical research has been outsourced to India and China so there are thousands of PhD-level scientists getting paid a fraction of what their North American and European counterparts command. With the huge demand for weight loss and erectile dysfunction products—and the large amounts of cash in play—some of that demand is satisfied with analogues that go out the back door of these chemical labs, Neal-Kababick said.
How can the natural industry combat spiking?
For manufacturers it comes down to one word: test. Manufacturers are required under Good Manufacturing Practices (GMPs) to vet their suppliers, and a large part of Flora Research’s business is conducting tests to verify source materials. It's up to manufacturers to ensure that their subcontractors are not augmenting their own supplies with unverified materials from a second supplier. It’s expensive, but is part of the cost of doing business under GMP regulations.
What is not needed, Neal-Kababick said, is what the other guest on the show, Dr. Pieter Cohn, called for: new laws to mandate premarket approval from FDA for dietary supplements. “I think DSHEA is fine,“ Neal-Kababick said. “I think we have all the tools we need for FDA to enforce the GMPs and the industry is growing up through that. We’ve come a long way from where we were 20 years ago.” He said Flora Research is working with industry to develop more rapid and cheaper methods of testing to ameliorate the spiking issue.
Neal-Kababick and other industry observers agreed that Dr. Oz gave a good summary of what consumers can do to protect themselves against these potentially dangerous weight loss products:
Avoid products that claim they have “prescription strength” ingredients. No quality manufacturer of dietary supplements will use language like this on a label.
Avoid products making miracle claims. There is no silver bullet for weight loss, and if a product’s label makes outlandish claims for the amount of weight you can lose, or advertises that no lifestyle or food choice changes are needed, don’t buy it.
- Don’t purchase a product if you can't read the label. If it isn’t in English or is poorly translated, avoid it. And avoid products that do not include company name and contact information like a website address or a phone number.