The actions will go a long way to easing the regular criticism that the FDA, along with the Federal Trade Commission, fails to adequately police claim-making.
Crime and punish
“This is what removes bad behavior, knowing there will be consequences,” said Daniel Fabricant, PhD, vice president of scientific and regulatory affairs at the Natural Products Association (NPA).
“While certainly the words, ‘be careful what you wish or wish for’ are always at the back of your mind, its what we have been saying for years – that the Federal Drug and Cosmetics Act is a strict liability statute, and it should be used as such to enforce the laws. Not guidance documents, not hyperbole, the understanding that there is a significant price to pay if you violate the law in a criminal manner.”
The 17 letters were backed by an open letter to industry from FDA commissioner, Margaret A Hamburg, MD, who said she had, “made improving the scientific accuracy and usefulness of food labeling” one of her priorities as the head of an Obama-backed, more pro-active agency.
Companies to receive warning letters included Sunsweet Growers (dried fruit mix antioxidant claims); PBM Products (calcium and other nutrient content claims for baby foods); Pompeian (olive oil-based cancer and other claims).
Regulators should regulate
New York-based food lawyer Marc Ullman from Ullman, Shapiro and Ullman, also welcomed the action while wondering if the food companies in question would draw as much mainstream media fire as would dietary supplements companies, if they had been the target of the warning letters.
“The mainstream press would be all over the dietary supplements industry for being irresponsible but I wouldn’t expect Nestle will be taken to task in the same way,” he said.
“That aside, these kinds of actions are over long overdue and reflect the agenda of the Obama administration that regulators should regulate and not in the sporadic manner that has typified the FDA in the past. And looking through the letters it is hard to quibble with the agency’s logic.”
Ivan J Wasserman, of Washington DC law firm, Manatt, Phelps, Phillips said the actions would gain wide publicity and indeed they have with the likes of the New York Times picking up on the story.
“This is the FDA taking highly publicized actions to show the industry and consumer groups that it is not just a watchdog barking with no bite,” Wassernan said.
“By citing a wide variety of claims and products, from disease claims to nutrient content claims and from baby food to pie, this effectively reminded industry of how important it is to understand the complex regulations applicable to claims across all product categories.”
Forest for the trees
Fellow attorney, Jonathan W Emord, of Emord and Associates in Virginia, welcomed the action but questioned the target.
“The agency can’t see the forest for the trees,” he said. “It lacks common sense. It condemns with severity companies that err in technical ways or make unapproved claims that present no threat to human health rather than devote its enforcement resources to arresting and removing from the market contaminated products.”
The full list of warning letters can be found here.