Jun 26, 2022
After multiple formula-related infant deaths were reported to the FDA in February, samples from Abbott Laboratories' Sturgis, Michigan baby formula production facility tested positive for cronobacter, triggering a recall and a subsequent formula shortage. In this episode, Jen uncovers monopoly and neglect in the baby formula production industry, lack of oversight by the FDA, and the United States' refusal to adopt the World Health Organization's International Code of Marketing of Breast-Milk Substitutes.
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Abbott. Jun 15, 2022. “Update on Abbott’s Sturgis Plant and Formula Production.”
“Testimony of Robert M. Califf, M.D., Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services, before the Committee on Health, Education, Labor & Pensions, Infant Formula Crisis: Addressing the Shortages and Getting Formula on Shelves.” May 26, 2022. U.S. Senate.
Center for Food Safety and Applied Nutrition. May 18, 2022. “Guidance for Industry: Infant Formula Enforcement Discretion Policy” [FDA–2022–D–0814]. U.S. Food and Drug Administration.
Annie Gasparro and Jaewon Kang. May 12, 2022. “Baby Formula Shortage Could Leave Parents Scrambling for Months.” The Wall Street Journal.
U.S. Food and Drug Administration. Feb 2022. “FDA Investigation of Cronobacter Infections: Powdered Infant Formula.”
Matt Stoller. May 13, 2022. “Big Bottle: The Baby Formula Nightmare.” BIG by Matt Stoler on Substack.
Sam Knight. Apr 23, 2022. “Company Responsible for Tainted Baby Formula Has Monopoly Over Aid Program Sales.” Truthout.
Letter from Rep. Raja Krishnamoorthi to FDA Commissioner Robert Califf. March 24, 2022. U.S. House of Representatives.
House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy Staff. Feb 4, 2021. “Report: Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury.”
Brenda Goodman and Deidre McPhillips. Jun 10, 2022. “How far will Operation Fly Formula shipments really go to fill America's store shelves?” CNN.
The White House. May 22, 2022. “Biden Administration Announces Second Operation Fly Formula Flight.” White House Briefing Room: Statements and Releases.
Bill Whitaker. May 22, 2022. “Medical Middlemen: Broken system making it harder for hospitals and patients to get some life-saving drugs.” 60 Minutes.
The World Health Organization. Apr 28, 2022. “Scope and impact of digital marketing strategies for promoting breastmilk substitutes.”
The World Health Organization. Apr 28, 2022. “WHO reveals shocking extent of exploitative formula milk marketing.”
The World Health Organization. #EndExploitativeMarketing Petition.
La Leche League International. “International WHO Code.”
Bonnie Goldstein. Jul 13, 2018. Paper Cuts: No Match for Mother’s Milk. Project on Government Oversight.
The World Health Organization. Jan 27, 1981. “International Code of Marketing of Breast-Milk Substitutes.”
Katie Porter [@RepKatiePorter]. Jun 15, 2022. “Following yesterday's news of previously unreported infant deaths in Fisher-Price products, I'm calling on the company to immediately recall all…” Twitter.
May 26, 2022
Senate Committee on Health, Education, Labor, and Pensions
The committee concluded a hearing to examine the infant formula crisis, focusing on addressing the shortage and getting formula on shelves.
Robert M. Califf, Commissioner of Food and Drugs, Food and Drug Administration
37:26 Dr. Robert Califf: Frankly, the inspection results were shocking. Standing water, cracks in key equipment that presented the potential for bacterial contamination to persist, particularly in the presence of moisture, leaks in the roof, a previous citation of inadequate hand washing and current poor foot sanitation, bacteria growing from multiple sides, and many signs of a disappointing lack of attention to the culture of safety in this product that is so essential to the lives of our most precious people.
38:14 Dr. Robert Califf: As soon as we receive positive cronobacter results from environmental samples at the facility that we collected during the inspection, we contacted Abbott to ask the company to issue a voluntary recall. The need to take urgent action to protect the most vulnerable of all of our people -- infants -- presented a dilemma. This was the largest plant of the dominant manufacturer, and it was the sole source of a number of metabolic formulas essential for viability of infants with no substitution possible, because Abbott had no backup plan. We knew that ceasing plant operations would create supply problems, but we had no choice given the unsanitary conditions.
50:50 Sen. Richard Burr (R-NC): Why haven't you waived labeling requirements from trusted manufacturers in countries like the UK, Australia or Canada? Couldn't manufacturers provide temporary labels on imported formula? Cans if the label is printed in a language other than English until US manufacturing is restored? Some countries have higher nutritional requirements. Why can't we provide a waiver for their products to come into the country? Dr. Robert Califf: We've waived many of the requirements that are the ones that make sense, but the directions have to be clear to Americans in language that's understandable so the formula can be mixed correctly. An error in mixing up the formula for example, can lead to a very sick infant not getting the right nutrition.
2:16:18 Dr. Robert Califf: We saw the lack of quality in the system and the lack of accountability for the problems that were there. And so we had to invoke the Justice Department to negotiate a consent decree, which is essentially Abbott saying, “Yes, we had all these problems. Here's exactly what we're going to do to fix them.” For legal reasons, I can't discuss the exact details of the negotiation, but let's just say that it took a little armwrestling to get to the point where the Justice Department got Abbott to sign the consent decree.
May 25, 2022 Committee on Energy and Commerce: Subcommittee on Oversight and Investigations
Robert M. Califf, Commissioner, Food and Drug Administration
Frank Yiannas, Deputy Commissioner, Food Policy and Response, Food and Drug Administration
Susan Mayne, Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration
Chris Calamari, Senior Vice President of U.S. Nutrition, Abbott
Robert Cleveland, Senior Vice President of the Nutrition Business Unit for the US and Europe, Mead Johnson Nutrition
Scott Fitz, Vice President of Technical and Production, Gerber
41:55 Robert Califf: Because of the lack of the diversification of this market in the absence of a central hub for integrating supply chains, we concluded early on that getting the Sturgis facility up and running safely was a top priority. But we had no confidence in the integrity of the Abbott quality program at this facility. Accordingly, we initiated proceedings toward a consent decree, which requires Abbott to undertake steps to assure safe production of formula, including hiring an outside expert with reporting to FDA.
43:03 Robert Califf: Despite the overall numbers showing diminished but steady supply, we knew that distribution was an issue. Some areas were experiencing significant shortages, but overall, there was enough formula to go around. About a month ago, the reports of shortages on the shelf proliferated, although there was not a drop in production. This increase in consumption most likely represents heightened concern of parents and caregivers about shortages, leading to an understandable effort to purchase ahead to ensure adequate supply at home. This type of cycle has happened with other products throughout the pandemic, and we realize that the only solution is to have adequate supply to make sure shelves are stocked.
45:57 Robert Califf: Abbott's enormous market share left it with a responsibility for producing safe infant formula that was not met. We will do everything in our power to work with Abbott to make this happen as quickly and as safely possible, but this timing is an Abbott's control.
46:35 Robert Califf: Across the industry we regulate, we are seeing evidence that the just-in-time distribution system, market concentration, and sole-source contracting are leading to shortages. Multiple reports to Congress call for improved supply chain management. Until regulatory agencies have digital access to critical supply chain information and personnel to do the work, we will continue to react to supply chain disruptions rather than intervening to prevent them.
1:01:113 Robert Califf: It’s really important for people to go to the HHS website: hhs.gov/formula. There you'll find the hotline for all the manufacturers and helpful information about where to go.
1:04:12 Robert Califf: You would be surprised to know there's no just-in-time system where all the FDA employees can see what's going on. What we really need is access to the information that the manufacturers have about each of their individual supply chains. They each have their individual supply chains, but there is no national system to make sure the supplies getting where it needs to go.
1:05:11 Rep. Cathy McMorris Rodgers (R-WA): Did FDA not have a data analytics tool to monitor the supply chains of various products, including infant formula? Robert Califf: We requested funding for a tool and because we didn't get the funding, we cobbled it together. It's a start, but it's nowhere near — you know, again, I was at Google for five years. The technology at FDA, and in many federal agencies is outmoded and needs an upfit, there's just no question about.
1:07:33 Susan Mayne: We have been in discussion with infant formula manufacturers throughout COVID, but discussion is not the same thing as data and we do not have the authorities to demand data from the companies to get necessarily all the information that you would want to have to really monitor the supply chains as Dr. Califf indicated.
1:10:30 Robert Califf: But given what we saw, the only way we could have confidence was through a consent decree, where we literally have oversight of every single step. When we met with the CEO yesterday, there were hundreds of steps that they went through that they're having to do, many of which have already been done. So it's only if we have direct oversight over it that I would have confidence, but I do have confidence that we are seeing every single step both physically in-person, and also through following the documentation and the outside expert.
1:10:53 Rep. David B. McKinley (R-WV): How will the passage of last week's FDA Bill increase the production of baby formula? Robert Califf: Production is increasing already — Rep. David McKinley The criticism, that they said that on these various tweets — it was not just one there were several — that said it was unnecessary. So I want to know, how do we increase, how do we get back to production? How to put in $28 million? How would that how's that gonna increase production? Robert Califf: Well, remember, the Abbot plant needs to get up and running, we’ve got to oversee and micro detail to make sure that it's done correctly. And as we bring in supply from other countries, remember, we already have overseas plants that we import from on a regular basis, almost double digits. So as we bring that product in, we’ve got to inspect it, make sure it's of the quality that we expect in America of formula and we need to upgrade our information systems, as I've already said, to make sure that as all this goes on, we can keep track of it and make sure that we're coordinated.
1:44:55 Rep. Kim Schrier (D-WA): Is there any early warning system for products like baby formula? And not just the ingredients but for formula itself or manufacturer would let you know if they're running short or anticipate a shortage? Robert Califf: First of all, let me thank you for being a pediatrician. I sometimes call the Academy of Pediatrics just for the positive vibes that you all exude as a profession. But no, there is not such a warning system. We've repeatedly asked for that authority and have not been granted it. The industry by and large has opposed it.
1:52:21 Susan Mayne: What the data show is, we can't rule in or rule out whether or not those infants, their cronobacter was caused by this plant. The data just simply can't be used to inform it. Rep. John Joyce (R-PA): But the genetic testing you did. It does not match from the plant, correct? Susan Mayne: That is correct. But what we did not have is any sampling done at the same time that the product was manufactured that was consumed by the individuals who got sick, so we didn't have that every director
2:08:57 Rep. Ann Kuster (D-NH): I know that in this part of the country, I'm in New Hampshire, we have milk banks of mother's breast milk. And I'm wondering what is the regulation by the FDA? And can we assure our constituents that breast milk from milk bank is safe and is thoroughly vetted by the FDA? Robert Califf: You're asking some very good questions. I'm gonna refer this to Dr. Mayne who probably would have the best answer. Susan Mayne: Thank you, Congresswoman. So human breast milk is regulated as a food. And so that is reassuring and they have to have proper screening protocols and things like that in place to make sure that the donors that are donating the milk, get that, that's critical for human food safety. So that's how I would respond. Thank you.
2:26:28 Robert Califf: You would think that a critical industry like this would have resilience plans, redundancy, but we don't even have legal authority right now to require that the firms have a plan for potential failures and resilience. That’s something we've asked Congress for every year for a while, and we're asking for it again. So I hope that it happens this time. I'd also add that this is not unique to this industry. We are seeing this across the entire device and medical supply industry with frequent failures as exemplified by the 60 minutes show and the contrast medium problem that I talked about. We have gone to a just-in-time, large single source contracts that lead to lack of diversification in the industry and the industry has fought us tooth and nail on requiring that there be insight into their supply chains, so that the sum of all of the industries leads to the the avoidance of preemption. We'd like to be able to stress test and prevent these things from happening rather than waiting until they happen, and then scrambling.
2:58:58 Susan Mayne: What we've seen is, first the strain of the COVID 19 pandemic, then the strain of the recall, and now we've got the Russia-Ukraine conflict. And one of the things that we know is the Ukraine region is one of the world's biggest exporters of products like sunflower oil. Sunflower oil is used as an ingredient in many food products, including infant formula. And so we have been working with the manufacturers should they be unable to maintain their supply of sunflower oil, what they would replace it with and make sure that that would meet the nutritional requirements for infant formula.
3:26:28 Chris Calamari: We plan to start production at Sturgis the first week of June. We will begin with the production of EleCare, before turning to the production of other formulas and Similac. From restart, we estimate that it will take six to eight weeks before product is available on shelves.
4:28:51 Rep. Paul Tonko (D-NY): Your testimony also mentions global supply chain challenges as a factor the company has had to contend with. What, if any, steps has Gerber taken to maintain its production and distribution supply? Scott Fitz: Thank you for the question. Certainly, our industry is not immune to the global supply chain challenges brought on by the pandemic. We struggled with materials supply issues, intermittent materials supply issues, whether it be ingredients or packaging components, we struggled struggled with the material quality issues related to the pandemic, we've had transportation and logistics issues, just getting trucks and truck drivers available to move the products and supplies that we need. And we've had COVID related labor challenges and higher turnover than normal are all things that have impacted us. Through the course of the pandemic though we've we've resolved these on an ongoing basis, one at a time as they've come up. We are putting trying to put in more robust business continuity plans in place for critical components and ones that we know we will have challenges with in the future.
4:30:50 Rep. Paul Tonko (D-NY): Did you not think the FDA should be notified or at least aware of your struggle? Scott Fitz: Should FDA be aware of our struggle? Rep. Tonko: Yeah, should you have shared those concerns for supply chain? Scott Fitz: If it could help, we would certainly be willing to do that. Yes. Rep. Tonko: What should you have told us during the last year? Scott Fitz: Well, as I testified, the issues that have come up for us, we've been able to resolve. Through the last six months our in-stock rates have averaged 86%.
4:35:55 Chris Calamari: On the horizon, we see in the manufacture of infant formula agricultural oils are absolutely essential, paper is absolutely essential, the cost of fuel to supply and distribute the product is essential. So I would call out those key elements ranging from agricultural oils to the cost to deliver the product would be the biggest areas of focus.
4:41:42 Robert Cleveland: We reached out and spoke to the USDA almost immediately seeking flexibility, for example in the size format. And while that sounds small, it's very significant because what that means is the WIC consumer doesn't have to look for one particular size of product at the shelf. They can find any size of the shelf to fulfill their their benefits with and that's allowed us to continue production and step up to meet the requirements of those consumers. We've since worked with the USDA to find a number of other ways to flexibly administer the program, because really, the focus for the WIC consumer is the same as the others, making sure she has safe access to formula and doesn't have to compete with non-WIC consumers to get it. So the more sizes, the more formats, the more manufacturers that the program can support, the more likely she is to have her needs met.
4:47:35 Rep. Kim Schrier (D-WA): The baby formula industry in our country is really unique in that about 90% of the product is made right here in the United States. And the vast majority is made by your three companies [Abbott, Gerber, and Mead Johnson]. And so it should be no surprise that when something goes wrong, like what happened in Sturgis, it really rocks the whole industry and the facility in Sturgis is responsible for 40% of Abbott's formula on the market and makes up about 20% of the total formula on the market in the US, and that is really significant, especially when this year Similac has the contract with WIC.
5:10:40 Rep. Buddy Carter (R-GA): Okay, the supply chain issues, is that because some of the ingredients were coming from other countries? Chris Calamari: Representative, yes, so global supply chains are such that we have ingredients coming from global sources and that is the nature of our supply chain.
5:19:29 Rep. Diana DeGette (D-CO): Let's say my daughter, who has a six-week-old baby, called me up and said, “I need to get some formula for my baby. And my store shelves are bare.” What can we tell them between now and all of the emergency measures we put into place to start putting formula on the shelves? Who should they call? Where can they go to try to get some of this limited product right now? What's the practical suggestion? Robert Cleveland: It's very unfortunate that you have to answer that question or ask that question, but let me do my best to answer it. I think the shelves — the reality is they don't have anywhere near the product that they do. So one of the things I've often said during this crisis is it takes a village to raise a child. In this case, sometimes it's taking a village to find infant formula. So the first thing to do is work with your network of family and friends, and as they go to the stores, look for the product that's there. And I've seen many mothers and grandmothers and fathers and cousins doing this on the shelf. You can call our Consumer Response Center. Now to be fair, those folks are doing a phenomenal job of fielding waves and waves of calls. But we will help you if you call. That's one other resource. The physician's office is another. Sometimes they do have the samples that are required, and they can help transition between finding product on the shelf. And then I would be sure to look online as well as in-person at the store and be open to other formats. Many mothers and fathers have a particular type of format they like. You may need to be more flexible in the format that you use. But all infant formula regulated by the FDA is safe for your infant, whether it's a liquid or a powder or what size it's in. And so I would say shop widely. See your doctor or enroll your family friends, give us a call if you need to, and be flexible.
May 25, 2022
Committee on Appropriations: Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Ginger Carney, Director of Clinical Nutrition, St. Jude Children’s Research Hospital
Sarah Chamberlin, Executive Director, National PKU News
Michael Gay, Owner and Manager, Food Fresh
Brian Ronholm, Director of Food Policy, Consumer Reports Linkedin
32:29 Michael Gay: WIC’s rigid rules have made it difficult for the program to be responsive to critical shortages throughout the pandemic and now during the formula crisis. Substitutions may be easily available when situations like this arise. The emergency waivers instituted by the USDA during the pandemic have provided flexibility in some states, but those waivers were only available because of the pandemic. To prevent this issue from happening in the future, Congress should allow WIC vendors operating during severe supply shortages, disasters or public health emergencies to automatically substitute limited WIC approved products impacted by supply chain disruptions. The USDA should direct states to include product substitutions for WIC in their emergency preparedness plan. These changes would have allowed families to immediately switch to another formula in states with shortages allowing for smooth continuation of feeding infants.
33:27 Michael Gay: Secondly, there's a significant need for USDA to examine the long term effects of cost containment, competitiveness and peer grouping formulas for WIC vendors. States operate a peer group system to monitor vendor prices and determine reimbursements are cost competitive. These cost containment measures have led to reduced retail embursement and reduced retailer participation in the program, leading to fewer locations for families to access formula.
33:55 Michael Gay: WIC infant formula cost containment measures have led to extreme consolidation in the formula marketplace, leaving it highly vulnerable to supply disruptions like we are experiencing now. These contracting policies must be reviewed to ensure future food security of the nation's babies and families.
41:50 Brian Ronholm: The evidence suggests that the agency was too slow to act, failed to take this issue seriously, and was not forthcoming with information to parents and caregivers. The infant formula crisis exposed a greater structure and culture problem that has long existed FDA. This was merely one symptom of the overall problem, and it is clear that confidence in the food program at the FDA is eroding. A big reason for this is the food program has second class status within FDA, and it's resulted in serious problems. The FDA also lacks a single, full-time, fully empowered expert leader of all aspects of the food program. As you know, in recent decades, most FDA commissioners have been medical specialists who naturally focus on the programs impacting medical products. This is certainly warranted considering the impact these programs have on public health. And the pandemic is a perfect example of this. However, this usually results in intense competition for the commissioner’s time and support and focus on the food program is typically what has suffered under this dynamic. It has become impossible for an FDA commissioner to possess the bandwidth to provide leadership and accountability to a set of offices that regulates 80% of our food supply.
51:45 Ginger Carney: I would want to warn parents not to make homemade formulas — the American Academy of Pediatrics warns against that — they should not dilute the formula, as both of these situations can lead to disastrous results and lead possibly to hospital admissions.
56:40 Brian Ronholm: Splitting out the food safety functions of the agency as it exists now and creating separate agencies while still remaining under the HHS umbrella would be an effective approach that would get to the issues that I think everyone has become aware of during this crisis.
59:32 Rep. Rosa DeLauro (D-CT): We now have 15 agencies at the federal level who deal with some form of food safety, the principal ones are USDA and FDA. It should be one single agency!
1:06:30 Michael Gay: In a rural area such as ours, probably 85-90% of my formula is WIC formula, which is just down to one type of formula. So even like today, for example, or my truck Monday, I got about 20 cases of Gerber formula in a different variety, but that's not approved on what and the Georgia WIC office just approved some substitutions for formulas that were, you know, prescribed by the doctor with the contract formula. So therein lies the problem is there's no easy way to substitute that for the customer.
1:23:29 Brian Ronholm: Four companies that control 90% of the market and only three of them actually bid on WIC rebate contracts. Abbott is by far the largest one and I believe they have contracts in 30 or 31 states, I think it was the latest figure. So when those contracts come up, these companies submit based on their ability to meet the demand in a particular state, and Abbott is usually the only one that's big enough to do that. We mentioned that they have a large part of the market, I think when it comes to the WIC market, they have approximately 55 to 60% of the WIC market. So that's a significant size of the market that it really needs to be examined so when situations like this hit, how does it impact that particular….And it's obviously going to have a bigger impact because these companies use the WIC market to get into the overall non-WIC market to even increase the share of their market, so that creates further shortage problems.
1:40:35 Ginger Carney: One thing that we really haven't talked about is the WHO code for marketing breast milk substitutes. And that's what these formulas are, they’re breast milk substitutes. So if we look at the WHO code in other countries, other developed countries are abiding by the WHO code and this gives guidelines for how companies can market their infant formulas in a safe way. So maybe we should go back to that and think about what is it about the WHO code that would benefit all of our families in the country so that they are assured when they do have to reach for infant formula when breastfeeding cannot be an option or will not be an option? What are the things that are marketed directly to our families that tell them about the formula?
1:44:20 Rep. Debbie Wasserman Schultz (D-FL): Half of all US formula consumption goes through the WIC program, which provides free infant formula as we've been talking about today, where states negotiate bulk discounts in exchange for market exclusivity. Now, I'll take you back to 1989 when Republican President George Bush enacted legislation requiring all state WIC programs to use competitive bidding for the purchase of infant formula. In practice, this means that the state of Florida for example is required to use a single supplier for the entire state supply of WIC baby formula. The competitive bidding process has yielded $1.3 billion to $2 billion a year in savings and allowing WIC to serve about 2 million more participants annually because of the discounts. However, when there's a supply shock caused by one of the four market participants, like what happened with Abbott in this case, it creates a serious risk to infant health across the country.
1:48:00 Rep. Debbie Wasserman Schultz (D-FL): We know that in Europe, they consistently produce a baby formula surplus. But there are rigid labeling and nutritional requirements for formula containers here in the US that the FDA requires and they prohibit the sale of many European-made products, even though the formulas themselves meet FDA nutritional and purity standards. So what sort of policy changes would you like to see undertaken to ease restrictions on baby formula imports, while still ensuring that the product meets our safety standards? Brian Ronholm: Yeah, I think it's critical that we maintain those safety standards that FDA has set on infant formula, that's absolutely critical. There's a comfort level with consumers when they're able to purchase something that they know is an FDA inspected facility overseas. But to your point, sometimes these regulations, these really strict regulations are thinly disguised trade protection measures. And so you know, that's certainly an issue that we'd have to examine carefully to make sure that we can have that access.
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