Every week I pore over the warning letters the Food and Drug Administration has sent to food firms. These letters are sent to food companies in the U.S. and companies importing into the U.S. They list  violations based on findings from FDA inspections. 

The recipients are given 15 days to respond to the letters and inform the FDA how they plan to adequately address the violations.

The warning letter news stories on Food Safety News are supposed to show the companies violations and remove some of the legal code and technical jargon for our readers. We hope that this is a step toward improving transparency between companies and consumers. However, there are often key facts in the warning letters that have been redacted by the FDA. We include these “redacted” markers in the warning letter news stories because we think it is important for consumers to see what is being hidden.

This past March I attended the Global Food Safety Initiative (GFSI) 2020 conference. Charlie Arnot, CEO of the Center for Food Integrity led a session on “How to communicate with consumers about food safety.” 

Arnot explained how questions about food safety have become an issue of trust between companies and consumers. He told the corporate and food safety leaders at the conference that more than one in four consumers strongly believe small food companies will put their interests ahead of public interest, and more than half of consumers strongly believe that large food companies will put their own interests first. 

Are consumers right not to trust food companies? The number of redactions in the FDA’s warning letters would seem to back this perception. The legal rights of companies to protect “trade secrets” are in conflict with the public’s right to transparency.  

Why are things being hidden?
 Let’s start by taking a look at what is keeping companies and the FDA for being completely transparent — Trade Secret Information and Confidential Commercial Information.

The Freedom of Information Act and Title 21 of the Code of Regulations, government agencies and specifically, the FDA is told to exempt trade secrets and commercial information from any of their releases. Here is the exact letter of the law: 

  • “The FDA cannot disclose Trade Secret Information (TSI) to the States pursuant to §20.88 without the express written authorization from the owner or submitter.”
  • (a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the trade secret and the productive process.

The full public information exemption can be found here.

  • “Confidential Commercial Information (CCI) can be disclosed without the owner’s authorization pursuant to §20.88, but the state must agree to protect the information against further disclosure, and it must be in the interests of public health for FDA to share the information.”
  •  (1) Confidential business information is information which concerns or relates to the trade secrets, processes, operations, style of works, or apparatus, or to the production, sales, shipments, purchases, transfers, identification of customers, inventories, or amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or other organization, or other information of commercial value, the disclosure of which is likely to have the effect of either impairing the Commission’s ability to obtain such information as is necessary to perform its statutory functions, or causing substantial harm to the competitive position of the person, firm, partnership, corporation, or other organization from which the information was obtained, unless the Commission is required by law to disclose such information.

The full law can be found here.

Confidential consumer information can include raw material supplier lists, finished product customer lists, traceback information and more. 

The FDA is able to make public recall notices, including pictures of affected products. They even use their social media accounts to try to reach consumers as quickly as possible.

In some cases, the FDA can release certain information that is exempt from disclosure if it is needed to initiate a recall. However, the agency and industry say it is most efficient for the food company to directly notify its distributors so they can remove items from shelves immediately.

The FDA can interpret these regulations differently than other federal food safety agencies. This is why we see disparities in the information released. These agencies are forced to weigh the interests of private food companies against risks to the public.

The FDA often does not specify which stores, centers or schools the recalled food has been distributed to, because that would violate its interpretation of the trade secret rule. In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and should not be available to the public.

In contrast, the U.S. Department of Agriculture’s Food Safety and Inspection Service posts retail locations that have the recalled product —this is especially true for Class I recalls. A Class I recall “involves a health hazard situation in which there is a reasonable probability that eating the food will cause health problems or death.”

Who is putting consumer safety first?
Industry will argue it doesn’t want to turn over who they sell to, because it may give the competition a chance to undercut them. That makes sense and everyone understands that under normal circumstances. But should those rules really apply to a product that could cause people to become ill?

When a company does issue a recall, it has a lot of decision making power in the amount of information it shares. Recalls that are made public often contain only a description of the product and an explanation of the problem. However, these companies are not required to reveal where the product was sold. Consumers don’t know what store, school, or restaurant that product went to.

If the FDA began identifying individual stores throughout the country that have sold recalled foods it will have the added benefit of increasing local media coverage and raising consumer awareness. As consumers come to count on the agency to provide this valuable information, they will have increased confidence in the FDA and its commitment to protecting consumers. 

It seems clear that there should be more transparency. The question is, who will fight for it. If consumers want fewer redactions in FDA warning letters, they will have to put pressure on the FDA to increase transparency, or things will remain the same.

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