Recent petitions 'driven by economic motives,' says top legal expert
The US functional-ingredients sector is facing a fresh challenge via the Food & Drug Administration's citizen-petition procedure, which enables individuals and companies to call for changes in the regulatory status of products used in food and dietary supplements.
Just a few months after a group including pharma giant GlaxoSmithKline (GSK) Healthcare filed a petition calling for weight-loss claims for supplements to be treated as disease claims, another has been filed demanding steviol glycosides, or stevia, be classed as a drug and not permitted for use as a food ingredient.
In the most recent case, the petitioners have invoked Section 301 (II) of the US Federal Food, Drug and Cosmetic Act, which prohibits the marketing of food to which an approved drug, or a drug for which substantial clinical investigations have been carried out and publicised, has been added.
They claim stevia, which is already permitted for use in supplements in America, something which is not challenged by this petition, fits into this category because clinical studies have been carried out demonstrating its effectiveness in controlling hypertension and blood-sugar levels.
If granted, the petition would be a blow to those who believe stevia has great potential as an all-natural zero-calorie sweetener. With two GRAS notifications pending with the FDA right now, there's a lot at stake.
But should ingredients companies worry about these challenges to their products? And are the number of petitions filed on the increase? It's hard to make a call on the latter. An FDA spokesman admits: "Over the past?three years?we have?received?approximately 10-15?citizen petitions per year." But that's all the agency will say on this matter.
Marc Ullman, an industry regulatory attorney, who drafted ingredients supplier Sabinsa's response to the GSK petition, says he hasn't noticed an upward trend. But he warns that this doesn't mean there won't be one in the future.
"Depending on how the FDA interprets new section 301(ll), there may be many more of these in the future," he says. "To the extent that they are indicative of some sort of effort to box in supplement claims and limit expansion of the market for dietary ingredients, we can also expect to see more of these."
The tone of suspicion in the second part of his answer can be traced to the fact that the GSK petition, which was filed in conjunction with the American Dietetic Association, the Obesity Society and Shaping America's Health on April 17, has faced allegations of being founded not on concern for consumers but on commercial grounds.
GSK markets an over-the-counter weight-loss drug, Alli, and sceptics say this is why the company would like to see the back of weight-loss supplements.
The stevia petition has been filed by a Washington, DC law firm, Coburn and Coffman. It is not clear whom the firm is representing, if anyone. Nonetheless, the belief among some is that this petition, like the GSK petition, has industry links.
Ullman says both petitions "seem to be driven by an economic motive — Glaxo seeking a monopoly on OTC weight-loss products and someone else seeking to remove competition from a zero-calorie all-natural sweetener."
Whatever the true motives behind these petitions, Ullman urges businesses to sit up and take notice of the threat they pose. "It is important that companies remain vigilant, and not only support their trade associations but be willing to participate in issues that concern their ability to market their products," he says.
Steven Mister, president and CEO of the Council for Responsible Nutrition, says he has faith that the FDA will handle citizen petitions appropriately. "Anyone can submit a citizen petition, but the FDA has the final authority on whether the requested actions are approved or denied. We trust that the FDA will carefully consider all citizens' petitions and make the appropriate decision as to whether to approve or deny each individual petition."