FDA Issues First Mandatory Recall Order, Exercising FSMA Authority Over Food Products Containing Kratom

On April 3, 2018, FDA announced that it had issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC (Triangle). FDA issued this order based on its finding that several Triangle products contained kratom that tested positive for salmonella.   FDA issued the order after the company failed to respond to FDA’s request that it conduct a voluntary recall.  This is the first time FDA has issued a mandatory recall order for food products.

In 2011, section 206(a) of the Food Safety Modernization Act (FSMA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to add section 423, granting FDA the authority to order the recall of food products (other than infant formula) when it determines that there is a reasonable probability that the food product is adulterated under section 402 or misbranded under section 403(w) and that the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals.  Once FDA makes this determination, the Agency must give the responsible party the opportunity to voluntarily recall the food product at issue (discussed previously here and here). If the responsible party refuses to or does not voluntarily recall, FDA has the authority to initiate a mandatory recall by issuing a mandatory recall order.

In this instance, according to the Agency’s press release, FDA found that two samples of kratom products manufactured by Triangle and collected by the Oregon Public Health Division as well as four samples of various types of kratom product associated with Triangle and collected by FDA tested positive for salmonella.  Additionally, Triangle denied FDA investigators access to records relating to potentially contaminated products, and company employees refused attempts to discuss FDA’s findings.

On March 30, 2018, FDA issued a Notification of Opportunity to Initiate a Voluntary Recall to Triangle, formally requesting that the company cease distribution and notify applicable parties within 24 hours if it did not conduct a voluntary recall. Triangle did not comply with FDA’s request.  As a result, on March 31, 2018, FDA ordered the company to cease distribution and offered an opportunity to request an informal hearing.  According to FDA, Triangle did not respond to FDA’s request within the required timeframe and thus waived its opportunity for the informal hearing.  Ultimately, FDA issued the mandatory recall order.

Although this is the third time FDA has started the process of exercising its mandatory recall authority by issuing a Notification of Opportunity to Initiate a Voluntary Recall, it is the first time the Agency has actually ordered a mandatory recall due to a company’s refusal to voluntarily recall after receiving such a notification. The first time FDA issued a Notification of Opportunity to Initiate a Voluntary Recall was on February 13, 2013 to Kasel Associates Industries, Inc., regarding pet treat products found contaminated with salmonella. The second time FDA issued a Notification of Opportunity to Initiate a Voluntary Recall was on November 6, 2013 to USPlabs LLC, regarding its OxyElite Pro-branded products found linked to liver illnesses.  After FDA started the process of exercising its mandatory recall authority, both companies voluntarily recalled their products according to FDA’s request.  Triangle, however, failed to comply with FDA’s request to initiate a voluntary recall.

Noncompliance with a mandatory recall order can trigger the following provisions of the FDCA:

• Section 743(a)(1)(B), which authorizes FDA to collect fees from a responsible party for a domestic facility as defined under 415(b) and an importer who does not comply with a food recall order under section 423.

• Section 301(xx), which prohibits the refusal or failure to follow an order under section 423.

• Section 303(f)(2)(A), as amended by FSMA, which permits FDA to assess civil money penalties to any person who does not comply with a recall order under section 423.

We’ll be following this matter to see how this first exercise of FDA’s mandatory recall authority unfolds.