GlaxoSmithKline's petition to the Food and Drug Administration (FDA) to ban dietary supplements from making weight loss claims, has opened a cupboard and only the deluded would deny the presence of one or two skeletons rattling around in there.
The petition seeks to reclassify weight loss health claims as disease claims and by most accounts is unlikely to succeed, but it has brought into focus issues industry has not managed to lay to bed. Inadequate or incomplete scientific substantiation, question marks over efficacy, health claim exaggeration, formula contamination and mislabelling continue to dog the dietary supplements industry despite the best intentions of the 1994 Dietary Supplements Health Education Act (DSHEA) and Good Manufacturing Practice (GMP) regulations enacted last year. It's a situation that leaves industry open to the kind of attack GSK has mounted and drives the urgent need for it to get its house in order. Rogue element A relatively young sector can be forgiven for being mid-task in gathering scientific data backing the efficacy of its wares. But the existence of rogue players hell bent on exploiting consumer weight management concerns only provides further ammunition to critics who caste the industry as being unregulated, unefficacious and unsafe. "We're never short of targets in the weight loss industry," Michelle Rusk, from Federal Trade Commission's division of advertising practices, said at Expo West in Anaheim in March. The FTC, along with the FDA, polices claims and labelling transgressions in the US. The fact the FTC has busted more than 100 companies since 1990 for labelling and claim breaches and is in the midst of a crackdown, is an unhealthy statistic for industry and even unhealthier for its public image. Yet at something like $4bn the market is hardly flagging - consumer interest in weight management is stronger than ever as obesity-related problems have increased. Credible scientific evidence Just as the vitamin E market was delivered a serious blow a few years ago after a meta-analysis questioned the nutrient's efficacy, GSK's action - successful or not - may already have dented sales in the sector. In this sense, industry has taken damage as GSK's industry criticisms seep through to a wary public. GSK says weight loss dietary supplements don't work and that obesity and the secondary diseases like diabetes, cancer and cardiovascular problems it is linked with are too serious a matter for dietary supplements to be making claims about without pre-market, pharma-style, disease claim approval. Make no mistake - GSK's 33-page petition is a very strong one. It is well-researched, well-written and premised on a public safety logic that has many advocates, some of whom are likely to be involved in FDA's decision-making process that has about another five months to run. It assesses a range of ingredients used in weight loss products - from bitter orange to hoodia to CLA (conjugated linoleic acid) - and concludes not one of them has been scientifically proven to manage weight. "There is no credible scientific evidence that would support any type of a claim accompanying a weight loss supplement," the petition states. This then becomes an issue of semantics - as there are many studies that demonstrate botanical and other ingredients can benefit weight loss, but GSK says the trials are not rigorous enough, or numerous enough, and therefore discounts them. Yet companies like DSM, Cognis and Sabinsa possess clinical data supporting their own branded weight management ingredients which may stand up to pharma scrutiny if the petition succeeded. Commercial versus public interest The fact GSK just last year launched the only OTC weight loss drug that is a direct competitor to weight loss supplements has to be considered among its concern for the public's health. It is hard to deny the commercial benefit GSK would gain if FDA accepted its petition and re-classified weight loss claims as disease claims. It's offering, alli, has quickly become the third highest-selling weight management drug in the world, with sales of close to $150m so there is much at stake. That aside, GSK's action has thrown a light on industry that can yield positive results in the form of greater scientific verification. When that is in place there will be less cracks in a predominantly honest industry for unscrupulous players to exist in. Until that happens, however, the bullets will continue to fly from the likes of GSK. The full implementation of GMPs cannot come quickly enough. Shane Starling is the editor of NutraIngredients.com. He has been writing about the nutrition industry for more than seven years.
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