To Register or Not to Register. Is there a Question?
Updated: Nov 22, 2018
Q. True or False: You operate a warehouse that holds food to be consumed in the U.S., so you have to register the facility with the FDA.
A. True. According to the provisions of the Bioterrorism Act and FSMA, all “facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States” must submit registration information to FDA, “including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.”
… Unless, apparently, you are Amazon. In which case, you simply tell FDA that you don’t think it’s necessary to register your food warehouses because you are a retailer. The dispute between FDA and Amazon has been going on for nearly a decade, but it came to a head again with Amazon’s purchase of Whole Foods Market.
Here is where the lines may appear blurred and where Amazon is, apparently, huddling: According to FDA’s 2012 industry guidance on registration of food facilities, facilities that don’t have to register include:
Retail food establishments, such as grocery stores, delis, roadside stands that sell food directly to consumers as their primary function, meaning that annual food sales directly to consumers are of greater dollar value than annual sales to other buyers.
I believe FDA wrote the guidance to mean the actual grocery store, deli and roadside stand locations themselves, but Amazon seems to be taking it to mean any facility of the business that owns a grocery store/deli/roadside stand.
As we discussed in a previous TAG newsletter when FDA finalized the new FSMA registration rule (New FSMA Rule Amends Food Facility Registration), the definition of a retail food establishment was expanded to include more establishments making it consistent with the FSMA definition. While the new definition added the roadside stand, farmers' market, community supported agriculture program and other such direct sales platforms – three key words, I believe are direct sales platforms. And before you, or Amazon, say it does do direct sales, a fourth key word is establishment.
Although there are various definitions of establishment, the business and legal definitions of the word tend to see “establishment” as being a single physical location:
According to BusinessDictionary.com, the definition of establishment is: “Economic unit that produces and/or sells goods or services and operates from a single physical location. If a firm has several such locations, each is termed an establishment.”
The USLegal.com definition follows a similar vein: “A business establishment is defined as a location where business is conducted, goods are made or stored or processed or where services are rendered. It may include a commercial and/or institutional land use. It is generally a site where the main objective is the receipt or generation of a financial return in exchange for goods or services.”
As such, Amazon could claim only its actual grocery stores as retail food establishments under the law, and thus be exempted from registration. This, I would then see, as putting the food warehouses squarely within the registration requirement.
So what can FDA do? According to its Compliance Policy Guide for registration required by the Bioterrorism Act, if the agency has advised the facility that it is required to register, it can issue an “Untitled Letter” requesting the owner, operator, or agent-in-charge of the facility to register within 30 working days. If there is no response within that time frame and the facility remains unregistered, a Warning Letter can be issued. If the facility still remains unregistered, the issuing FDA district can make an injunction recommendation to CFSAN or CVM, as appropriate.
According to the guidance, failure to register a facility as required is a prohibited act under the FD&C Act. So, at this point:
The Federal government can bring civil action against persons who commit a prohibited act.
The government also can bring criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act.
If it is a foreign facility that is unregistered, the food being imported or offered for import into the U.S. from that facility, the article must be held at the port of entry, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is registered.
All that said, however, it doesn’t appear that FDA is being very aggressive with Amazon, as a July 2008 Untitled Letter (obtained through a public records request made by MarketWatch), was issued for Amazon’s Lexington, Kentucky, warehouse. The letter requested that the facility be registered within 30 days – however it remained unregistered in May 2010, and just last month, a company PR manager told Food Safety News that he sees no problem with Amazon refusing to register the food warehouse.
My purpose for writing this newsletter is not to be critical of Amazon but rather to remind our readers of the requirement to register with FDA. If you don’t register with FDA as needed, there can be consequences that could get unpleasant if FDA chooses to push on you. Amazon has taken a stance on this one that they don’t seem to want to budge on – which is their prerogative to do! So my focus is not on Amazon but on FDA – with a request for some urgent clarification around this issue to keep lots of other establishments from making the same claim and thus preventing an appropriate level of regulatory oversight.
So FDA: Please take a stance on this issue and add clarification one way the other so we all know where we stand.
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