New York Times columnist Thomas Friedman once wrote; “Everything really important happens the morning after the morning after…”

In short, focus on what really changes, not what is said will change.

That is a good lesson for the White House and Congress to remember with the proposed “reforms” of the Food and Drug Administration’s (FDA) foods programs.  Commissioner Robert Califf has promised that the structural, political, and cultural obstacles that have made FDA’s assurance of food safety ring hollow will be changed.

Food safety advocates across-the-board have their doubts.  Consumer Reports’ food safety expert Brian Ronholm said the proposal “essentially cements the current dysfunctional structure at the FDA that led to the infant formula crisis and contributed to other longstanding problems that have plagued the agency.”

How dysfunctional was that structure that led to at least four infant hospitalizations and two deaths linked to tainted infant formula from an Abbott facility in Michigan? It took four months until the FDA would go into the plant to conduct a for-cause inspection months.  A resulting, and much belated, recall then contributed to shelves empty of infant formula across the country, and parents of the richest country on the globe Googling DIY infant formulas.

Dr. Califf is in a long line of FDA commissioners trained in medicine with little to no experience in food safety.  A cardiologist trained in clinical research, Califf is well versed in the risk/benefit approach to drug safety.

But for food safety, the approach needs to be different.  Former President Barack Obama perhaps summed it up best in 2009 when he appointed FDA Commissioner Margaret Hamburg: “When we give our kids peanut butter and jelly, we don’t expect them to make them ill…No parent should have to worry that their child is going to get sick from lunch.”

And certainly, no parent should have to worry that their baby is going to get sick from infant formula.  

When Dr. Califf testified before Congress during the infant formula crisis, he argued that, while serious systemic issues existed in the foods program, reorganization was not required.  In eloquent managerial bureaucratic-speak, he said, “An optimal foods program organization must take into account the FDA’s product areas and centers are not silos, but a matrix of interdependent information and operations encompassing product and regulatory organizations and enterprise-wide support organizations.”

Maybe, he meant to say that unless and until there is a single food safety leader overseeing the entire foods program, consumers will remain at risk.

So, food safety advocates can be excused if that is not the change they see coming from the proposed reforms.  It took the relentless and unified calls for reform from a broad coalition of FDA stakeholders, as well as the extensive investigative reporting by Helena Bottemiller Evich, that finally prompted the commissioner to have the Reagan-Udall Foundation conduct an independent review of the foods program that was chaired by former FDA Commissioner Jane Henney.

The panel’s conclusion? “The lack of a single clearly identified person to leads the human foods program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil,” the review stated.

Precisely what the stakeholders have been telling the agency for years.

And the commissioner’s response, while promising change, delivers the same problems: A new “deputy commissioner” will be put in place, but once again not have authority over the agency’s food safety inspectors or laboratory staff as well as compliance and import oversight functions.  While the commissioner said he is uniting the foods program, animal foods are left out despite the well-established principle that foods for animals and humans are inextricably linked.

As for when these “reforms” will actually happen, the most optimistic timetable is some time in 2024.  The commissioner has stated the Department of Health and Human Services will not have a plan to review until late 2023, and he has also said publicly he is not certain of the support of employees and unions.

The morning after the morning after the proposed FDA food safety reform will not see much, if any, change.

That’s why it’s time for the White House and Congress to act: Create a new, independent federal Food Safety Agency.  Then there really will be a morning after the morning after.

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That is the message that consumer groups, members of Congress, and others have been delivering to the FDA. Just last week, food safety lawyer Bill Marler wrote in his blog that “the time has come for the FDA to reassess what are considered ‘trade secrets’ or ‘confidential’ so that consumers can know which retailers have sold recalled foods.” He pointed out that the USDA’s Food Safety Inspection Service (FSIS) has been routinely doing this for the past decade, “and the sky did not fall.”

FDA commissioner recognizes value of giving consumers more information
Six months ago, FDA Commissioner Scott Gottlieb stated publicly that he wants to do more to make sure that consumers have the information they need to avoid exposure to products that are the subject of recalls. He affirmed that by disclosing information about stores and other locations that may have sold or distributed recalled food, “consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if it were consumed.”

And just last month, the FDA released a list of store locations and retail chains in a recall of pre-cut melons linked to a multistate Salmonella outbreak. In this specific case, the agency determined that providing this information could be made public on the basis that it was necessary “to effectuate a recall.”

FDA is expected to update its policy soon, and those favoring greater transparency are cautiously optimistic. While the agency is required to withhold “confidential commercial information,” it can disclose the information if it determines it is “necessary to effectuate a recall.”

Consumers need to know which retailers sold recalled foods
A fundamental understanding of risk communications principles and literature show that the more “real” and “close to home” a risk appears to be, the more likely consumers will focus on it and take appropriate action. The “appropriate action” of checking for and discarding (or returning) recalled food will improve the effectiveness of recalls and save lives.   

In 2009, Dr. William Hallman of Rutgers Food Policy Institute, and a former chair of FDA’s Risk Communications Advisory Committee, wrote in a report entitled “Food Recalls and the American Public: Improving Communications:”

“Simply telling people about a food recall is often not enough to motivate them to look for and discard recalled products. Instead, getting people to take action requires that they are aware of the recall, believe it applies to them, believe that the consequences are serious enough to warrant action, can identify the affected products, and believe that discarding (or returning) the product is both necessary and sufficient to resolve the problem.”

A critical element required to motivate people to act during a recall is to help them see that the recall may be personally relevant to them.

Unfortunately, this can be challenging, as people tend to assume that if there is a food recall, it will affect others, and not them. This tendency is known as the “optimistic bias” and results in people erroneously believing that they are at less risk than others for something adverse happening to them.

A 2008 Rutgers national survey assessing consumers’ responses to food recalls found that while 92 percent of Americans agree that food recalls save lives, only 17 percent think it is likely that they have recalled foods in their homes.

Informing consumers that a store where they regularly shop was identified during a food recall increases personal relevancy, and, in so doing, makes consumers more likely to check the foods in their homes.

That, in fact, was the rationale FSIS used when finalizing its policy to regularly release the names of retail locations. The agency stated that providing such information serves as “an additional mechanism for prompting consumers to examine products stored in their refrigerator, freezer, or cupboard when there is a reasonable probability that the product will cause adverse health consequences.”

Disclosing retailers will improve recall effectiveness and increase consumer confidence
The FDA has been under mounting pressure to release the names of retailers that have sold recalled foods to consumers, a practice that USDA has been doing since 2008.  In December 2017, FDA Commissioner Gottlieb stated his desire to release such information, recognizing that it would increase the likelihood that consumers would not be exposed to recalled food.

I have confidence that FDA will work to provide this important information to consumers. Since the commissioner’s statement, the agency already has, on a case-by-case basis, named retailers. The risk communications literature provides a scientific basis to justify FDA providing information to consumers that will make it more personally relevant to them and increase the likelihood that they will not be exposed to recalled food.

Identifying individual stores throughout the country that have sold recalled foods will have the added benefit of increasing local media coverage, thereby raising consumer awareness. Further, 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 protect consumers.

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In my tenure at the Food and Drug Administration, leading communications for the foods program, I was usually involved in recalls tied to major outbreaks or to complex, potentially high-risk food safety situations that were proving difficult to address quickly.  These recalls were the ones that generated a lot of media coverage, Congressional interest, and consumer concern.   

But, these recalls were — and are — the exceptions.  

Most food recalls are not linked to illnesses and are relatively straightforward. And that was the case with the recall I was being asked to advise on.

That said, even the most routine recall, can be challenging for a firm. So, in my first conversation with the CEO, we talked about how to undertake a recall that would protect the public, the brand, and the firm. I emphasized the need to act promptly, put consumers’ health first, and work closely and cooperatively with FDA.  

He agreed, and we quickly got to work. When he asked me to prepare the press release announcing the recall, I informed him that FDA actually posts model press releases on its website for industry to use. They’ve developed models for recalls related to allergen alerts, Clostridium botulinim, Listeria monocytogenes, Salmonella, and E-coli 0157:H7.  I sent him the link and his staff used it to draft the release. I advise any firm to do the same rather than paying consultants to draft their own releases!      

After reviewing the press release the firm pulled together using the model release, I urged them to include photographs of the products. The FDA recall coordinator later confirmed that the agency considers photographs to be an important way to help consumers know which products are recalled. The agency posts online its cadre of experienced food recall coordinators alongside the states for which each coordinator oversees.

I also advised him to post the press release on the company’s website and explained that FDA does not prescribe how and where to post the information but rather states that “it should ensure that the warning is prominently displayed and accessible from both its home page and a web search.”

This information comes directly from a January 2018 draft guidance FDA issued that provides practical information and recommendations about the use, content, and circumstances for industry to issue press about a recall. I found this guidance very helpful to share with the CEO, which I admit pleased me as I had helped develop the guidance the year before leaving the agency.  

The good news? The food company and its law firm moved promptly. They worked closely with FDA’s recall coordinator who reviewed the press release and the plan for disseminating and posting the information that we had developed. I worked with a national news service to disseminate the press release, with the photos, and the company simultaneously posted the announcement prominently on its own website.  The release was picked up in local markets across the country, and the public was alerted.

For years at FDA I had heard that most firms do what they are supposed to during recalls and that they go as planned. Now, from outside FDA, I saw evidence of that for myself. The CEO listened closely to his legal and communications advisors and made decisions quickly and responsibly. He coordinated closely with FDA and communicated promptly and transparently about the recall. That’s the way recalls are supposed to work, and it’s the best way to preserve and strengthen consumer confidence in a firm and its brands. 

About the author: Sharon Natanblut now consults on policy and communications issues. Until February 2018, she served as senior advisor to the FDA Deputy Commissioner for Foods and Veterinary Medicine and Director of Strategic Communications and Stakeholder Engagement for the foods program. She previously served as deputy director of the FDA’s tobacco program and associate commissioner for strategic initiatives.

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