We hear about them so often these days–recalls of all kinds of products, from foods, to medications, to kids toys–that “recall” has become a working concept in everybody’s vocabulary. But what is a recall? Who has the legal obligation to announce them? And, what legal ramifications are there of being involved in one?
First, despite having recently the legal authority to actually recall products, the FDA seldom does. FSIS (food safety arm of the USDA) does not have the authority.
The FDA defines three kinds of recall actions that can fairly be included under the same umbrella. A “Class I recall” should occur in “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” (Note: “should” is italicized because sometimes food product manufacturers do not issue class I recall even when circumstances require it.) Under this definition, a Class I recall should occur any time a food product is known or suspected to be contaminated with any foodborne pathogen, whether bacterial or viral. The reason: bacteria and viruses make people sick, and as a result, food contaminated by them will make people sick.
A “Class II recall” should occur in “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” This is a little less clear than the definition of a Class I recall, but I certainly believe that the consequences of foodborne disease are simply too extreme for food companies to play fast and loose under these definitions.
A “Class III recall” is defined as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
A Class I recall should occur every time a food manufacturer knows, or has reason to know; that a product it has produced is or may be contaminated with a foodborne pathogen. Every time!
Finally, a “market withdrawal” occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
A “market withdrawal” has no place in the world of food contamination. Again, Listeria, Salmonella, E. coli, Campylobacter and Hepatitis A and every other foodborne pathogen are simply too dangerous for companies to try to avoid their obligations by calling what should be a recall a “market withdrawal”–something done purely to avoid the media ramifications of saying that you’re product has been recalled. However, this has been done before under circumstances where a Class I recall was surely warranted.
So, who has the legal obligation to recall a food product when it is known or suspected to be contaminated with something that will make people sick? The answer is that it is not the USDA for most meat, but not fish (except catfish). And, it is only the FDA until recently. Nor, is it any other state or federal regulatory body. The answer is that the company who produced the contaminated product is the only entity with the legal authority to recall a product. The CDC can announce that the product has caused an outbreak (remember the Foster Farms Outbreak), but the company itself is the only entity that can truly and effectively act.
A recall is a firm’s action to remove product from commerce (e.g., by manufacturers, distributors, or importers) to protect the public from consuming adulterated or misbranded products. Although it is a firm’s decision to recall product, the FSIS and FDA coordinates with the firm to ensure it has properly identified and removed recalled product from commerce by verifying the effectiveness of the firm’s recall activities. FSIS and FDA also notify the public about product recalls.
Aside from lawsuits (which are an insufficient check, by themselves, on food safety because they are largely reactive rather than preventative) FSIS and FDA may issue public health alerts or perform product detentions and seizures, to mitigate the risk to the public when firms have inadequately removed recalled product from commerce. The Agency will investigate if it appears that a firm’s recall strategy or execution of that strategy is ineffective and, based on its findings, FSIS and FDA may seek enforcement action against the recalling firm or its consignees.
Finally, with regard to the legal ramifications of announcing a recall, again the real threat comes from the private sector. Penalties and fines are not necessarily assessed simply because a recall happens. Often, it is only private citizens who have been injured by the contaminated product that take legal action against a company that has recalled its product.