Iovate Sciences’ voluntary recall of 14 products within its Hydroxycut brand due to potential safety issues is raising questions in the dietary supplement industry and causing some to wonder whether the recall—which was triggered by a consumer warning issued May 1 by the U.S. Food and Drug Administration—will stir the regulatory waters. “This is a big deal for the dietary supplement industry because it will inevitably invite comparison to the ephedra AER [adverse event reporting] episode, and critics of the industry will no doubt call for some review of DSHEA [the Dietary Supplement Health and Education Act] as a result,” said Loren Israelsen, executive director of the United Natural Products Alliance and a member of Nutrition Business Journal’s editorial advisory board.
“I predict we will see hearings,” said one attorney, who has worked with dietary supplement companies for many years. “I don’t know if it will be the FDA that initiates things. It probably will be an oversight committee in Congress” that moves to better fund FDA so that it can fully enforce DSHEA.
The media and blogosphere are already buzzing with calls for stricter controls on dietary supplements. “Ongoing problems with products like Hydroxycut clearly illustrate the need to tighten up regulations,” wrote the Minneapolis-St. Paul Star Tribune in a May 5 editorial on the subject. “But Congress has a lot on its plate right now: the recession, swine flu, health care reform.
Supplement regulation may not be a priority. In the meantime, consumers can protect themselves. No pill can shave off pounds, so why buy these products?”
Iovate Sciences recalled its Hydroxycut products after the FDA warned consumers to immediately stop using the popular weight-loss offerings following the reporting of 23 adverse health events—including a number of cases of serious liver damage and one death—in people who had taken the products. In issuing the warning, the agency was acting on the expanded authority it received under the 2007 Dietary Supplement and Non-Prescription Consumer Protection Act, or SAER law. But rather than yank the products from the market, the FDA chose to allow Iovate Sciences to conduct a voluntary recall.
According to Nutrition Business Journal research, consumers bought $1.67 billion worth of weight-loss pill-form supplements in 2007, and Hydroxycut was the top-selling weight-loss supplement brand sold at supermarkets, drug stores and mass merchandise outlets (excluding Wal-Mart). Weight-loss supplement sales have been hurting since the 2004 ephedra ban, and this event is likely to take a hefty toll on 2009 sales. “This is a significant recall because this is a significant product line,” Israelsen said. “The alleged adverse reactions are also serious enough to warrant a full internal corporate review.”
Because the Hydroxycut formulas each incorporate numerous ingredients—all of which have been on the market for many years—it has been difficult for FDA to “zero in on the source of the problem, if there is indeed one,” Israelsen added. “There has been a lot of Hydroxycut sold over a number of years, and the question of incidence of use versus incidence of injury complicates the forensic analysis. Why have only a few people reported injury in view of millions of units used? This is one of the challenges presented by this case.”
One supplement executive whose company also sells weight-loss formulas said the Hydroxycut situation underscores the importance of doing multiple independent studies on a product or formula itself, and not relying on the pieced-together data of studies performed on individual ingredients.
In the end, Israelsen said he sees the Hydroxycut warning and recall as an example of the SAER law working as it should. With this law now in place, “FDA has authority to move faster and gain access to more records,” Israelsen said. “GMPs are fully coming into effect shortly, and when an episode like this happens—and all industries have such events—the tools are available to investigate and resolve the matter as quickly as possible.”
“That is the story,” Israelsen added. “Safety incidents can and do happen—and when they do, all hands are now on deck to solve them as fast as possible.”
Related NBJ links:
Industry Making Strides in Improving Tarnished Image of Weight-Loss Supplements
SNWL Category Turns In Respectable But Not Stellar 2007 Performance
Weight Loss Category Dwindles in Size in Post-Ephedra Era