Ever since the signing of FSMA, FDA has had the authority to mandate food recalls. But in the seven years since then, FDA has never done so. Until now. Earlier this month, FDA ordered the mandatory recall of all food products containing powdered kratom that were manufactured, processed, packed, or held by Triangle Pharmanaturals. FDA resorted to the mandatory recall because the company refused to voluntarily recall the products, despite repeated FDA requests and actions when several of its foods were found to contain Salmonella. According to the FDA announcement, Triangle: denied FDA access to the company’s records relating to products potentially implicated in a multi-state Salmonella outbreak. employees refused attempts to discuss FDA’s findings. did not comply with an FDA-issued Notification of Opportunity to Initiate a Voluntary Recall, in which the company was advised that it could be ordered to cease distribution and notify applicable parties if it did not conduct a voluntary recall. did not respond, within the specified timeframe, or request an informal hearing on FDA’s order to cease distribution of the products. Although this was the first time FDA needed to actually mandate recall, it’s not the first time its authority to do so was initiated. In two previous incidents, the companies complied before the full mandate was executed: In a 2013 Salmonella outbreak related to pet treats produced by Kasel Associates Industries, the company recalled some, but not all, of the potentially contaminated product. FDA gave Kasel two days to comply with its full recall requests or it would enact a mandatory recall within two days. The company complied. FDA initiated the mandatory recall process again in November 2013 when dietary supplements distributed by USPlabs were found to be adulterated with aegeline. Again, once FDA began the mandatory recall process, the company complied. In the case of the kratom-product recall, it also will be interesting to see if the incident has elevated FDA’s overall concern with the opioid’s use. That is, while this recall was related to Salmonella contamination, FDA issued a release in February announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements. Stating that kratom is considered to be a new dietary ingredient for use as or in a dietary supplement, for which it is not aware of any evidence of its safety, FDA “encouraged” all companies to take kratom-containing products off the market. In fact, FDA states that the scientific data it evaluated provides conclusive evidence that kratom compounds are opioids; are expected to have similar addictive effects and risks of abuse, overdose and death; and have no safe or effective medical use. So the agency also encouraged companies to submit any evidence they would have for its evaluation “based on the applicable regulatory pathway.” What does all this mean to you? Most critically, I’d say it means that FDA 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. In a mandatory recall, FDA 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. Secondly, the action brings to light the need to fully understand and be able to navigate a regulatory issue with FDA from both the legal perspective as well as a practical one. What criteria must exist for FDA to initiate a mandatory recall? What is the process and how long do you have? How do you request and respond in an informal hearing if you feel the grounds do not exist for FDA to mandate a recall? And what happens if you win … or lose? Finally, there is the issue of evidence of safe use of a “new” dietary supplement or ingredient. What is the “applicable regulatory pathway” by which a company can submit evidence for evaluation? What evidence is required? And what further evidence would FDA need to mandate rather than encourage recall of all kratom products? In general, the FD&C Act requires that before any new dietary ingredient can be used, FDA must receive premarket notification explaining the basis on which it was concluded that it (and the dietary supplement in which it is used) will reasonably be expected to be safe under the conditions of use in the labeling. Past TAG newsletters also have discussed such evaluations and submissions related to GRAS (Need a GRAS Evaluation? and FDA Publishes GRAS Final Rule – Has Anything Really Changed?), some of which would be relevant. Whether based on pathogen, allergen, or foreign-object contamination; mislabeled packaging; USDA product produced without inspection; or any other risk factor “in the interest of public health,” it can be difficult to assess if, when, and how much to recall. Add to that the use of new dietary or GRAS ingredients and as anyone dealing with anything related to standards and regulations knows – none of it is simple! As many of our readers know, TAG works with our clients on recalls and interactions with FDA and CDC on a regular basis. So, as I was reading the announcement of a mandatory recall I had to question, “How could you let it get that far?” As we noted above, being subject to a mandatory recall is both expensive and highly damaging to a brand. I guess we will never know if Triangle Pharmanaturals thought it had a strong case and could win, or if it did not fully understand what the FDA was up to. But either way, there comes a point in any “recall” conversation with FDA that you know you have one of two options – do the voluntary recall or face a mandatory recall. 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. If you are facing any regulatory issues or simply need to understand how to navigate such issues should they arise, TAG is here to help. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
