It is not uncommon to pick up a newspaper and see the word “food product recall” in an article, or to hear about a “food product recall” in the news. Although the reasons prompting such a recall can vary widely, in most cases the food products at issue are being recalled because of concerns with a foodborne pathogen or undeclared allergen. When most consumers see this coverage, they typically assume that the Federal Food and Drug Administration (“FDA”) or Federal Food Safety Inspection Service (“FSIS”) has mandated the recall. In reality, however, that almost never the case.
Indeed, the initial decision whether to initiate a food product recall always belongs to the company that manufactured the product – not the government. As a result, all such recalls, to the extent they occur, are voluntary. Indeed, FSIS has absolutely no statutory or regulatory authority to compel a meat or poultry establishment to initiate a recall. And, up until recently, FDA didn’t have any such power either. Although Congress provided FDA with “mandatory recall authority” when it passed the Food Safety Modernization Act (“FSMA”), FDA has not (and likely never will) use this power. This is because the decision about which products and which production dates to recall can be fraught with challenges that, if determined incorrectly, could have disastrous political consequences for the agency. As a result, it is unlikely that FDA will ever use these powers, and all recalls will continue to be voluntary.
Thus, the decision to initiate a voluntary recall of a product is in almost every case driven (and will continue to be driven) by the company who produced the product in question. If, however, a company is in denial that their product is adulterated or misbranded when the government believes otherwise, and the company does not issue a recall when the government believes it would be appropriate, then the government may decide to take more drastic actions, such as seizing the product from store shelve and/or seeking court approval to detain any offending product still in inventory. In most cases, because any such actions (and the media and regulatory scrutiny which would follow) would be devastating to the company, the company at issue will voluntarily capitulate and initiate a voluntary recall. Any time you are faced with a potential recall, you should consult immediately with FDA or FSIS Recall attorneys to help determine the most appropriate regulatory response.
Although both FDA and FSIS will almost always play a role in “encouraging” or perhaps “urging” a company to issue a food product recall, the only direct involvement from the government typically involves offering informal advice on the appropriate scope of the recall, and the verifying the effectiveness of the recall itself.
Once the decision to actually recall a product has been made, the government will also determine the classification for the recall. This classification is used, when the recall notice is issued, to communicate the seriousness of the underlying problem to the public. There are three types of food product recalls:
- Class I: This is the most serious of the recall levels. A recall will by characterized by FDA or FSIS as a “Class I Recall” whenever there is “reasonable probability that the use of the product will cause serious, adverse health consequences or death.” Examples include a known presence of a foodborne pathogen such as Listeria monocytogenes in ready-to-eat foods or the presence of a non-declared allergen.
- Class II: This is the second most serious of the recall levels. A recall will by characterized by FDA or FSIS as a “Class II Recall” whenever there is only “a remote possibility of adverse health consequences from the use or consumption of the product,” and the condition that could be caused by the adulterated product is only “temporary or medically reversible.” One example might be a food product that has extremely small pieces of malleable plastic discovered in it.
- Class III: This is the least serious of the recall levels. A recall will by characterized by FDA or FSIS as a “Class III Recall” whenever the use or consumption of the product at issue “will not cause adverse health consequences.” An example would be an improperly labeled food product in which the actual amount of water in the product was not properly declared.
So, what do the above classes really mean? Well, as noted, the primary purpose is to inform the public about the seriousness of the underlying issue which is triggering the recall. In addition, the classifications will also guide FDA and FSIS on how the agencies will verify the effectiveness of the recall.
- Class I recalls require verification activities within 3 days of the recall;
- Class II recalls require verification activities within 5 days of the recall; and
- Class III recalls require verification activities within 10 days of the recall.
These classification also dictate how many effectiveness checks the regulatory authority is required to make. For example, a Class I recall with 10,001 consignees requires 800 effectiveness checks, and a Class I recall with 500,001 requires 1,250 effectiveness checks. In turn, a Class 2 recall with 10,001 consignees requires 91 effectiveness checks and a Class III recall with 1,201 consignees requires 42. Class III checks can also be done over the telephone.
Setting the issue of “recalls” aside, however, it is also critically important to remember that not all actions you take against a product need to be formally classified as a “recall.” Indeed, depending upon the circumstances, the nature of the problem with the product, and the location of the product within the supply chain, it may be that you can retrieve the product within the regulatory requirements without having to formally announce a recall.
If, for instance, you are taking action to remove contaminated products that have not yet left the direct control of the your company or primary distributor, you may be able to characterize the removal as a “Stock Recovery.” Alternatively, if your products are in the market, and those products even if in technical violation would not subject the firm or product to legal action, then you may be able to characterize the removal as a “Market Withdrawal.”
Thus, it will always be critical to consult with knowledgeable counsel in the event you are facing a potential recall so that you are taking the most appropriate action in light of the underlying circumstances so you can adequately comply with the underlying regulations while, at the same time, aggressively protecting your brand.