WASHINGTON — The U.S. Food and Drug Administration, for the first time, has ordered a mandatory recall of food products under the authority conferred on the agency by the Food Safety Modernization Act of 2010. The F.D.A. on April 3 issued a mandatory recall order for all regulated products containing powered kratom manufactured, processed, packed or held by Triangle Pharmanaturals L.L.C., Las Vegas, after several were found to contain Salmonella. The ingredient primarily is used in dietary supplements. The F.D.A. said it took the action after the company failed to cooperate with the agency’s request to conduct a voluntary recall.
“This action is based on the imminent health risk posed by the contamination of this product with Salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated request and actions,” said Scott Gottlieb, Ph.D., F.D.A. commissioner. “We continue to have serious concerns about the safety of any kratom-containing products, and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen. Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority.”
Kratom is a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. The agency said it received several negative reports about the safety of kratom, including evidence of deaths associated with its use.
But in this instance, two samples of kratom products manufactured by Triangle Pharmanaturals sold through the retail location Torched Illusions in Tigard, Ore., and collected by the Oregon Public Health Division, tested positive for Salmonella as did four additional samples of various types of kratom product associated with the firm collected by the F.D.A.
Adding to the concerns, in the course of investigating a multi-state outbreak of Salmonella infections linked to kratom products in conjunction with local officials, F.D.A. investigators were denied access to the Triangle Pharmanaturals’ records relating to potentially affected products, and Triangle employees refused attempts to discuss the agency’s findings.
The F.D.A. provided a timeline of actions leading to the mandatory recall. On March 30, the F.D.A. issued Triangle Pharmanaturals a “notification of opportunity to initiate a voluntary recall,” a formal request that advised the company that the agency could order the company to cease distribution and notify applicable parties within 24 hours if the company did not conduct a voluntary recall. Triangle Pharmanaturals did not comply with the request.
"The F.D.A. is serious about mandating recalls if you do not comply with requests to voluntarily recall implicated food. Not only will you have to conduct the recall anyway, but it also can cost you significantly more." — David Acheson, the Acheson Group
On March 31, the F.D.A. ordered the company to cease distribution of the products, and the company was provided with an opportunity to request an informal hearing. The company did not respond within the timeframe specified and thereby waived its opportunity for an informal hearing, and the agency ultimately issued the mandatory recall order in the interest of public safety.
The F.D.A. said it was the third time it had started the process of using its mandatory recall authority but the first time the agency reached the step of ordering a mandatory recall because a company had opted not to voluntarily recall.
David Acheson, president and chief executive officer of the Acheson Group, in his company blog addressed the issue of what the recall means to the food industry.
“Most critically, I’d say it means that F.D.A. is serious about mandating recalls if you do not comply with requests to voluntarily recall implicated food,” Mr. Acheson said. “Not only will you have to conduct the recall anyway, but it also can cost you significantly more. In a mandatory recall, F.D.A. can collect fees for time it spends conducting recall activities, including technical assistance, follow-up effectiveness checks, and public notifications; and it can assess civil monetary penalties as well.”
The action illustrates the need for food manufacturers to fully understand the recall process from a legal as well as practical perspective and know their rights and responsibilities, which should guide how they respond if the F.D.A. requests they voluntarily recall a product because of health concerns, Mr. Acheson said.
“There comes a point in any ‘recall’ conversation with F.D.A. that you know you have one of two options — do the voluntary recall or face a mandatory recall,” Mr. Acheson said. “My advice every time is that when you hit that wall, take the voluntary recall road — it is much less costly and much less brand damaging.”