BURLINGTON, VT. – Walking into Perrigo Company’s Nutritionals laboratory in Burlington, Vermont, is no simple affair.
Visitors must remove their shoes, vigorously clean their hands with a powerful disinfectant, don white lab coats, wear protective suits, goggles, hair nets, and surgical masks before even approaching the lab itself.
Once inside the sprawling, state-of-the-art facility, guests are told not to touch anything, and that they must wash their hands upon entering each new room manufacturing the product.
The reason for the alarm is clear: Baby formula, produced for the world’s most vulnerable consumers, is made there. And there is no margin for error in terms of introducing bacteria or deficiencies of any kind into the highly-guarded, multi-million- dollar facility where it is created.
Moreover, 13 years after Israel’s Remedia baby formula took the lives of three infants and caused irreversible neurological and heart damage to 23 others, Shufersal Ltd., which will distribute Perrigo’s formula in Israel, isn’t taking any chances.
Established in 1958, Shufersal is Israel’s largest retail chain, with 280 stores and more than 13,000 employees.
Noting that the Remedia formula did not contain a vital element, vitamin B1, Yaffa Schiff, a nutritionist and scientific adviser for Shufersal Baby Formula – visiting the lab with a press corps from Israel in May – said the safety of the product is of paramount importance.
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“It’s the only food for a baby, it’s very important, and we had the crisis of Remedia [in 2003],” said Schiff during a tour of the US facility. “The formula was vitamin B1 deficient, and resulted in the deaths and developmental disorders to many infants.”
The tragic consequences, Schiff said, scarred the psyche of millions of Israelis, especially fearful new parents.
“This will be the fourth baby formula introduced to Israel, and it’s as good as the other companies, and is perfectly healthy,” she said. “This is as good as advanced formula in Israel.”
Additionally, according to Shufersal vice president of trade and marketing, Uri Kilstiin, the company will considerably lower the cost for parents in Israel’s NIS 570 million baby formula market, 90 percent of which is presently dominated by Materna and Similac.
Indeed, at NIS 40 per unit, Shufersal’s formula is half the cost of Similac’s NIS 80 sticker price, and one-third less than Materna’s NIS 60.
Asked if parents should be concerned because Shufersal’s is generic, Schiff said no.
“It’s a private label, but not just for Israel – it is sold to infants in 26 countries, and there has never been a problem,” she said. “I recommend this to parents as much as any other quality formula.”
Perrigo, a top-five global overthe- counter consumer goods and pharmaceutical company, is a leading US manufacturer and supplier of infant formula.
During a briefing by its top executives and scientists, “safety” and “safe” were the words most commonly used to describe the process of making the closely guarded formula.
Sean Walsh, vice president of operations, who is responsible for infant formula manufacturing at Perrigo, said that he has fed each of his children with the same product coming to Israel.
“All we make in this division of Perrigo is baby formula, and we feed it to our own children,” said Walsh.
“I myself have four children, and every one of them has been fed formula from this factory over a 25-year span. We fully believe in the quality of our formula – it’s all we do, and if we get it wrong, we would be out of business.”
Walsh continued: “We take it very, very seriously. Our clients are infants; they are the most delicate group of human beings on earth, and deserve the very best nutrition.”
He added that Perrigo’s laboratory is always FDA-compliant and enjoys “great regulatory relations with the FDA,” and the equivalent of the FDA in the 26 other countries it also sells the product.
“We have a great quality team and we uphold the highest standards internally, even higher than the regulatory standards,” he said.
Matt Sliva, senior director of quality, noted that the formula is halachically and organically certified, and undergoes over 2,000 tests during the course of production for every batch.
“That includes raw materials coming in the door, to final testing,” he said. “Regulations require that we test every single batch... and we test every nutrient.
“The key laboratory for us is the microbiology lab,” Sliva continued, adding that it is considered the enterprise’s central nervous system, and maintains such high safety regulations that few are allowed to enter it.
“I’ve been here for five years, and I’ve been in it twice,” he said. “People who have been here for 30 years have never been in there... That’s how we approach food safety: Only those who need to be near the product get to be near the product.”
Brook Anderson, director of product development and technical services, is one of a select few senior employees who are permitted in the micro-laboratory.
“When we talk about comprehensive product development, in my team of 14, I have a group of formulators, a sensory panel, a tech-service group, and a group of scientists that do analytic research and development,” he said.
“And what we do is take the formula from concept and we follow it right through commercialization.”
That team, Anderson emphasized, ensures that throughout the extensive process, nothing is left to chance.
During a Monday press conference in Tel Aviv announcing that Shufersal has begun selling the product at its retail chains across the country, CEO Itzhak Aberkohen said that Perrigo’s meticulous, granular approach is what attracted him to their baby formula.
“The Shufersal Baby formula launch is the culmination of relentless quality standards, because quality and safety are our first priority,” Aberkohen said.
“We chose the American Perrigo Company due to its expertise in drugs in general, and its vast experience in manufacturing infant formula for more than 30 years. Due to our direct relationship with Perrigo, we can offer baby food at the lowest prices in Israel, and we look forward to passing this benefit to our customers.”
Aberkohen said Shufersal Baby formula will include formulas for three stages of development. The categories include stage one infant formula with iron (for babies 0-6 months); stage two follow on formula with iron (for infants 6-12 months); and stage three toddler supplement with iron (for ages 1-3 years).
All three milk-based, staged formulas are compliant with the Codex Alimentarius Commission, established by the Food and Agriculture Organization of the United Nations, and the World Health Organization, which sets international food standards, guidelines and codes of practice to protect the health of consumers and ensure fair trade practices globally, he added.
“This is a highly anticipated collaboration between our supplier Perrigo and the Shufersal Baby brand,” said Aberkohen.
Remarking on the strong relationship Perrigo has with Israel, CEO John A. Hendrickson described the collaboration as “promising.”
“We are excited to announce the entry of Shufersal Baby staged formulas – stage one, stage two, and stage three – in the Israeli marketplace,” said Hendrickson. “Israel is a promising market for Perrigo, and a country in which we have many employees. Shufersal is the largest retailer in Israel, and their brand, Shufersal Baby, is trusted by parents throughout the country.”
According to Euromonitor data, sales of baby formula in Israel exceeded $132 million in 2013. Annual baby supplies sales at Shufersal were approximately $30m. before the introduction of Shufersal Baby.
“Our customers recognize quality in our Shufersal Baby, and high-quality formulas from a highly regulated nation such as the United States will be attractive to our customers,” added Aberkohen.
“We can leverage our substantial commercial presence in Israel for this fast-growing market.”
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