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        这家美国公司靠“欧式”奶粉东山再起

        这家美国公司靠“欧式”奶粉东山再起

        Emma Hinchliffe 2021年01月06日
        这家公司的使命是,为无法母乳喂养(或用吸奶器吸奶),又不想让孩子使用美国配方奶粉的妈妈们,提供一种安全、健康的替代选择。

        图片来源:COURTESY OF BOBBIE

        2019年6月的某一天下午,美国食品与药品管理局(Food and Drug Administration,以下简称FDA)的两名检查员来到了位于旧金山的一座仓库。

        这两位身穿制服的女士从公文包里拿出一篇打印好的《财富》杂志文章,文章的标题是《初创公司颠覆吸奶器行业。婴儿配方奶粉会是下一个吗?》。她们在这篇文章中重点圈出了所有出现“婴儿配方奶粉”字样的内容。

        这两位FDA的官员正在约谈Bobbie公司的创始人。Bobbie是一家规模很小的销售配方奶粉的新公司。这家初创公司向约100位湾区客户推出订购计划试点。在之后的10天里,公司创始人一直小心谨慎地在其网站和产品包装上宣传其产品是“幼儿奶粉”或“配方奶粉”。然而,《财富》杂志的文章和其他文章都将这家初创公司描述为“婴儿配方奶粉”行业中的一员。

        这足以引起FDA的关注。该政府部门对婴幼儿配方奶粉的监管,比对其他大部分食品都要严格,甚至高于可以摄入其他食物的儿童使用的其他类型的配方奶粉。在美国,作为婴儿配方奶粉销售的所有产品必须符合《婴儿配方食品法》(Infant Formula Act)的要求,包括对使用配方奶粉的婴儿进行成长监控研究、营养测试和食品安全等规则。在美国境外生产的产品通常无法满足这些规定。Bobbie使用欧洲原材料在德国生产奶粉,其目的就是生产与在欧盟国家销售的配方奶粉接近的产品。Bobbie销售的对象是注重配料的美国父母,他们有时候会通过Bobbie的联合创始人劳拉?莫迪所说的美国经销商“黑市”购买欧洲生产的配方奶粉。

        FDA的检查人员在仓库结束与Bobbie团队的谈话之后,这家公司收到了FDA的警告和召回令。公司创始人猜测,Bobbie是史上规模最小的收到警告和召回令的美国公司之一。当时公司刚刚成立18个月,员工不到15人,他们给100位订阅用户打电话,向用户解释说他们收到了FDA的警告,并被要求停止奶粉生产。公司创始人和员工家里都有刚出生的孩子,他们自己甚至都停止使用公司的配方奶粉。公司的首席执行官莫迪表示:“我从来没有感到如此脆弱。我有时候会觉得这不公平。我们在一个城市进行了试点,但我们还是进行了全国召回。”

        莫迪称,FDA的行动让她倍感意外,因为市场上有许多幼儿奶粉、配方奶粉甚至“夜间”配方奶粉都未受到该部门同等程度的审查。她说,公司最大的错误是侧重于网上传达信息,并没有在产品包装上说明奶粉适用人群是“12个月及以上的”幼儿,而不是新生儿。莫迪说:“现在回想起来,很难让人不感到懊悔,我们本应该注意到这个问题。这只是一个失误而已。”

        对于一家试图颠覆配方奶粉行业的硅谷初创公司,FDA反应如此谨慎,并不令人意外。该政府机构坚持严格履行其职责,以确保将配方奶粉作为唯一营养来源的儿童,所使用的产品是健康、安全的。莫迪表示:“婴儿配方奶粉行业不存在任何被误解的空间。”此外,多年以来,美国的婴儿配方奶粉一直被几家大公司主导,如美赞臣(Mead Johnson)的Enfamil和雅培(Abbott Nutrition)的心美力(Similac)等。在过去五年中,美国市场一直没有新的婴儿配方奶粉品牌出现。

        Bobbie公司联合创始人及首席执行官劳拉?莫迪。图片来源:Courtesy of Bobbie

        大公司生产的婴幼儿配方奶粉挤满了药店的货架。这些公司有律师和监管专业人员向FDA报告标签或配料的任何调整,而其他大部分食品或膳食补充剂都不需要这种“上市前通告”。Bobbie是一个小团队,服务半径只有15英里,仅有几天的服务经验,所以在FDA知道这家新婴幼儿配方奶方公司的时候,它还没有与该部门建立起长期的合作关系。

        莫迪认为公司始终坚持的使命是,为无法母乳喂养(或用吸奶器吸奶),又不想让孩子使用美国配方奶粉的妈妈们,提供一种安全、健康的替代选择;父母之所以从欧洲购买配方奶粉,是因为相较于许多美国同类产品中所含的棕榈油、玉米糖浆和传统牛乳,他们更喜欢欧洲奶粉中的乳糖、椰子油和食草牛乳配方。

        莫迪曾经担任爱彼迎(Airbnb)酒店业务总监,她因为自己无法用母乳喂养孩子,才有了创业的想法。莫迪希望自己的公司能够与在吸奶器行业横空出世的Elvie和Willow等初创公司一样,颠覆配方奶粉行业。配方奶粉一直在向不需要它的妈妈们大力推销,而使用它的妈妈们又会产生羞愧感。莫迪在2019年告诉《财富》杂志:“当前喂养孩子的实际情况是我们无法接受的。15%至20%的女性无法产生足够的母乳以进行纯母乳喂养。”

        图片来源:Courtesy of Bobbie

        在FDA发出警告一年多以后,Bobbie重新振作了起来。公司在致客户的信中保证,公司不会批评FDA的决定。公司在写给订阅用户的信函中表示:“我们承认我们的标签和市场营销可能存在误导,对此我们向所有客户致以诚挚的歉意。我们知道这样做很难,但我们必须这样做。安全是重中之重,这关系到我们的下一代,并且作为家长,在为孩子选购产品时,理应得到一份安心的承诺。”

        Bobbie发出的信息引起了多方关注,他们在Bobbie东山再起的过程中发挥了关键作用。Bobbie公司的目标一直是在美国进行生产,但能够生产婴儿配方奶粉的设施有最低订单数量要求,这远高于这家初创公司可以达到的订单量。制造商百利高(Perrigo)专门生产零售商自有品牌的配方奶粉和儿童营养饮品。尽管该公司也有意为千禧一代父母们生产产品,但就在几个月前,当Bobbie曾向百利高发送“冷邮件”,请求其帮忙生产配方奶粉时,百利高还是拒绝了这一请求。而目前,百利高正在佛蒙特州为Bobbie公司生产配方奶粉。百利高的高管艾德里安?谢里甘说:“我们注意到,人们需要一种接受FDA监管的产品,以此满足消费者[对于欧盟配方奶粉]的偏爱。我之所以再次联系劳拉,是因为她们对FDA警告的处理方式打动了我;她们在与消费者沟通的时候非常透明,传达的信息也很明确。”

        之前的产品召回也引起了一位新投资者的注意,她就是Wave Capital的萨拉?阿德勒。当莫迪在爱彼迎任职的时候,阿德勒就已经认识莫迪,但她并没有参与Bobbie最初的240万美元种子轮融资,因为她对向美国市场推出一种新配方奶粉的可行性和这种产品的需求存在质疑。但公司应对召回的做法让她改变了心意。在说到投资Bobbie的最终决定时,阿德勒表示:“公司应对FDA的做法体现出了管理者的成熟度,很显然,投资这家公司是一个正确的决定。”

        一家新制造商和一位新投资者给Bobbie树立了信心,因此公司投入资源开发一款不会引起FDA不满的产品,并与该部门建立了良好的关系。在新任监管负责人克里斯蒂娜?伯布里克的指导下,公司在2019年11月参观了FDA位于马里兰州银泉的办公室,并与官员讨论了公司对美国供应链所做的调整。伯布里克此前曾经在雅培负责婴儿配方奶粉监管调查。

        ?
        Bobbie公司经过修改的婴儿配方奶粉获得了美国食品与药品管理局的批准,于1月5日开始在全国发售。图片来源:Courtesy of Bobbie

        如今,Bobbie从1月5日开始,向全美销售价值24美元的“欧式配方”婴儿奶粉。这一代配方奶粉被认为与之前招来警告的奶粉截然不同;FDA的发言人证实,前一代奶粉“没有重新进入市场”。

        一家消费品初创公司很少会遭遇监管挑战。Bobbie的新投资者阿德勒将公司应对监管部门的做法与莫迪在爱彼迎见到的模式进行了对比。爱彼迎虽然有时候依旧会规避政府的限制,但相比于常常被拿来对比的Uber,爱彼迎在成长阶段更有可能与监管部门达成合作。阿德勒说道:“她们本可以尝试反抗,并继续向市场销售她们努力推广的产品。但她们却这样反思:从商业的角度,我们的长期目标到底是什么?”

        Bobbie有12名员工,她们共有19个孩子,其中有6个婴儿,她们很激动能够再次使用自己公司的产品。莫迪和她的团队相信,相比于坚持推广“配方奶粉”,公司现在处在更有利的位置。阿德勒说:“如果当初FDA没有因为那篇新闻报道找上门来,她们也不会有今天这样好的局面。”(财富中文网)

        翻译:刘进龙

        审校:汪皓

        2019年6月的某一天下午,美国食品与药品管理局(Food and Drug Administration,以下简称FDA)的两名检查员来到了位于旧金山的一座仓库。

        这两位身穿制服的女士从公文包里拿出一篇打印好的《财富》杂志文章,文章的标题是《初创公司颠覆吸奶器行业。婴儿配方奶粉会是下一个吗?》。她们在这篇文章中重点圈出了所有出现“婴儿配方奶粉”字样的内容。

        这两位FDA的官员正在约谈Bobbie公司的创始人。Bobbie是一家规模很小的销售配方奶粉的新公司。这家初创公司向约100位湾区客户推出订购计划试点。在之后的10天里,公司创始人一直小心谨慎地在其网站和产品包装上宣传其产品是“幼儿奶粉”或“配方奶粉”。然而,《财富》杂志的文章和其他文章都将这家初创公司描述为“婴儿配方奶粉”行业中的一员。

        这足以引起FDA的关注。该政府部门对婴幼儿配方奶粉的监管,比对其他大部分食品都要严格,甚至高于可以摄入其他食物的儿童使用的其他类型的配方奶粉。在美国,作为婴儿配方奶粉销售的所有产品必须符合《婴儿配方食品法》(Infant Formula Act)的要求,包括对使用配方奶粉的婴儿进行成长监控研究、营养测试和食品安全等规则。在美国境外生产的产品通常无法满足这些规定。Bobbie使用欧洲原材料在德国生产奶粉,其目的就是生产与在欧盟国家销售的配方奶粉接近的产品。Bobbie销售的对象是注重配料的美国父母,他们有时候会通过Bobbie的联合创始人劳拉?莫迪所说的美国经销商“黑市”购买欧洲生产的配方奶粉。

        FDA的检查人员在仓库结束与Bobbie团队的谈话之后,这家公司收到了FDA的警告和召回令。公司创始人猜测,Bobbie是史上规模最小的收到警告和召回令的美国公司之一。当时公司刚刚成立18个月,员工不到15人,他们给100位订阅用户打电话,向用户解释说他们收到了FDA的警告,并被要求停止奶粉生产。公司创始人和员工家里都有刚出生的孩子,他们自己甚至都停止使用公司的配方奶粉。公司的首席执行官莫迪表示:“我从来没有感到如此脆弱。我有时候会觉得这不公平。我们在一个城市进行了试点,但我们还是进行了全国召回。”

        莫迪称,FDA的行动让她倍感意外,因为市场上有许多幼儿奶粉、配方奶粉甚至“夜间”配方奶粉都未受到该部门同等程度的审查。她说,公司最大的错误是侧重于网上传达信息,并没有在产品包装上说明奶粉适用人群是“12个月及以上的”幼儿,而不是新生儿。莫迪说:“现在回想起来,很难让人不感到懊悔,我们本应该注意到这个问题。这只是一个失误而已。”

        对于一家试图颠覆配方奶粉行业的硅谷初创公司,FDA反应如此谨慎,并不令人意外。该政府机构坚持严格履行其职责,以确保将配方奶粉作为唯一营养来源的儿童,所使用的产品是健康、安全的。莫迪表示:“婴儿配方奶粉行业不存在任何被误解的空间。”此外,多年以来,美国的婴儿配方奶粉一直被几家大公司主导,如美赞臣(Mead Johnson)的Enfamil和雅培(Abbott Nutrition)的心美力(Similac)等。在过去五年中,美国市场一直没有新的婴儿配方奶粉品牌出现。

        大公司生产的婴幼儿配方奶粉挤满了药店的货架。这些公司有律师和监管专业人员向FDA报告标签或配料的任何调整,而其他大部分食品或膳食补充剂都不需要这种“上市前通告”。Bobbie是一个小团队,服务半径只有15英里,仅有几天的服务经验,所以在FDA知道这家新婴幼儿配方奶方公司的时候,它还没有与该部门建立起长期的合作关系。

        莫迪认为公司始终坚持的使命是,为无法母乳喂养(或用吸奶器吸奶),又不想让孩子使用美国配方奶粉的妈妈们,提供一种安全、健康的替代选择;父母之所以从欧洲购买配方奶粉,是因为相较于许多美国同类产品中所含的棕榈油、玉米糖浆和传统牛乳,他们更喜欢欧洲奶粉中的乳糖、椰子油和食草牛乳配方。

        莫迪曾经担任爱彼迎(Airbnb)酒店业务总监,她因为自己无法用母乳喂养孩子,才有了创业的想法。莫迪希望自己的公司能够与在吸奶器行业横空出世的Elvie和Willow等初创公司一样,颠覆配方奶粉行业。配方奶粉一直在向不需要它的妈妈们大力推销,而使用它的妈妈们又会产生羞愧感。莫迪在2019年告诉《财富》杂志:“当前喂养孩子的实际情况是我们无法接受的。15%至20%的女性无法产生足够的母乳以进行纯母乳喂养。”

        在FDA发出警告一年多以后,Bobbie重新振作了起来。公司在致客户的信中保证,公司不会批评FDA的决定。公司在写给订阅用户的信函中表示:“我们承认我们的标签和市场营销可能存在误导,对此我们向所有客户致以诚挚的歉意。我们知道这样做很难,但我们必须这样做。安全是重中之重,这关系到我们的下一代,并且作为家长,在为孩子选购产品时,理应得到一份安心的承诺。”

        Bobbie发出的信息引起了多方关注,他们在Bobbie东山再起的过程中发挥了关键作用。Bobbie公司的目标一直是在美国进行生产,但能够生产婴儿配方奶粉的设施有最低订单数量要求,这远高于这家初创公司可以达到的订单量。制造商百利高(Perrigo)专门生产零售商自有品牌的配方奶粉和儿童营养饮品。尽管该公司也有意为千禧一代父母们生产产品,但就在几个月前,当Bobbie曾向百利高发送“冷邮件”,请求其帮忙生产配方奶粉时,百利高还是拒绝了这一请求。而目前,百利高正在佛蒙特州为Bobbie公司生产配方奶粉。百利高的高管艾德里安?谢里甘说:“我们注意到,人们需要一种接受FDA监管的产品,以此满足消费者[对于欧盟配方奶粉]的偏爱。我之所以再次联系劳拉,是因为她们对FDA警告的处理方式打动了我;她们在与消费者沟通的时候非常透明,传达的信息也很明确。”

        之前的产品召回也引起了一位新投资者的注意,她就是Wave Capital的萨拉?阿德勒。当莫迪在爱彼迎任职的时候,阿德勒就已经认识莫迪,但她并没有参与Bobbie最初的240万美元种子轮融资,因为她对向美国市场推出一种新配方奶粉的可行性和这种产品的需求存在质疑。但公司应对召回的做法让她改变了心意。在说到投资Bobbie的最终决定时,阿德勒表示:“公司应对FDA的做法体现出了管理者的成熟度,很显然,投资这家公司是一个正确的决定。”

        一家新制造商和一位新投资者给Bobbie树立了信心,因此公司投入资源开发一款不会引起FDA不满的产品,并与该部门建立了良好的关系。在新任监管负责人克里斯蒂娜?伯布里克的指导下,公司在2019年11月参观了FDA位于马里兰州银泉的办公室,并与官员讨论了公司对美国供应链所做的调整。伯布里克此前曾经在雅培负责婴儿配方奶粉监管调查。

        如今,Bobbie从1月5日开始,向全美销售价值24美元的“欧式配方”婴儿奶粉。这一代配方奶粉被认为与之前招来警告的奶粉截然不同;FDA的发言人证实,前一代奶粉“没有重新进入市场”。

        一家消费品初创公司很少会遭遇监管挑战。Bobbie的新投资者阿德勒将公司应对监管部门的做法与莫迪在爱彼迎见到的模式进行了对比。爱彼迎虽然有时候依旧会规避政府的限制,但相比于常常被拿来对比的Uber,爱彼迎在成长阶段更有可能与监管部门达成合作。阿德勒说道:“她们本可以尝试反抗,并继续向市场销售她们努力推广的产品。但她们却这样反思:从商业的角度,我们的长期目标到底是什么?”

        Bobbie有12名员工,她们共有19个孩子,其中有6个婴儿,她们很激动能够再次使用自己公司的产品。莫迪和她的团队相信,相比于坚持推广“配方奶粉”,公司现在处在更有利的位置。阿德勒说:“如果当初FDA没有因为那篇新闻报道找上门来,她们也不会有今天这样好的局面。”(财富中文网)

        翻译:刘进龙

        审校:汪皓

        On a June afternoon in 2019, two inspectors from the Food and Drug Administration visited a warehouse in San Francisco.

        The uniformed women pulled out of a briefcase a printout of a Fortune story headlined: "Startups disrupted breast pumps. Is infant formula next?" On that piece of paper, they had highlighted every place the words "infant formula" appeared.

        The FDA officials were there to speak to the people behind Bobbie, a very small, very new company selling formula. In the 10 days since the launch of the startup's pilot subscription program serving about 100 Bay Area customers, the company's founders had been careful to refer to their product on their website and packaging only as "toddler formula" or "companion formula." However, Fortune’s story—and a few others—discussed the startup as part of the "infant formula" industry.

        That was enough to grab the FDA's attention. The governmental agency closely watches infant formulas, overseeing the product with a keener eye than it does most foods, or even other types of formula aimed at children old enough to also be consuming other foods. All products sold as infant formulas in the United States must meet the requirements of the Infant Formula Act, which include a growth monitoring study for babies who consume the formula, nutrient testing, and food safety rules. Products made outside the U.S. often don't meet those exact regulations. Bobbie's offering was made in Germany with European ingredients and was meant to approximate the kind of formula sold in European Union countries. The company was marketing to ingredient-conscious American parents who sometimes buy European-made formula on what Bobbie cofounder Laura Modi calls a "black market" of U.S. distributors.

        After the FDA inspectors spoke with the Bobbie team at the warehouse, the startup became, its founders suspect, one of the smallest U.S. companies to ever go through an FDA warning and recall. The then-18-month-old business with fewer than 15 employees called its 100 subscribers, alerting them to the FDA's warning, and shut down its production. Bobbie's founders and employees, who had new babies of their own, even stopped using the powder formula themselves. "I'd never felt more vulnerable," says Modi, the company's CEO. "I had a moment of feeling like it wasn't fair…We had a pilot in one city, but we had a national recall."

        Modi says she was taken aback by the FDA’s action because several toddler formulas, companion formulas, and even "nighttime" formulas on the market had not attracted similar FDA scrutiny. The company's biggest mistake, she says, was focusing on its messaging online and not specifying on the product's packaging that it was for children "12 months and up," rather than infants. "It's hard not to look back now and say, We should have seen it," says Modi. "It was just a miss."

        It's not surprising that the FDA reacted cautiously to a Silicon Valley startup attempting to disrupt the formula space. The governmental agency takes seriously its responsibility to ensure children who rely on formula as their sole source of nutrition are fed a healthy, safe product. "When it comes to infant formula, there's zero room for misinterpretation," Modi says. Furthermore, the infant formula space in the United States has been dominated for years by just a few large players—Mead Johnson's Enfamil and Abbott Nutrition's Similac—with no new infant formula on the market in the past five years.

        At the massive companies that produce the kind of baby formulas that dominate drugstore shelves, lawyers and regulatory professionals are responsible for updating the agency on any labeling or ingredient changes—a "pre-market notification" not required for most other food products or supplements. Bobbie, with its skeleton team and mere days of experience serving customers in a 15-mile radius, had no such longstanding relationships by the time the FDA became aware of its new entrant into the space.

        For Modi, the startup's mission was always to provide a safe, healthy alternative for mothers who can't breastfeed or pump breast milk and don't want to feed their children the formulas on American shelves; the parents who buy from Europe prefer the region's lactose, coconut oil, and grass-fed dairy formula to the palm oil, corn syrup, and conventional dairy found in many U.S. products.

        Modi, a former Airbnb director of hospitality, came up with the idea when she couldn't breastfeed her own child. Just as startups like Elvie and Willow have burst onto the scene in the breast pump space, Modi wanted to disrupt formula—a product that has been both pushed on mothers who don't need it and accompanied by shame for many of those who do. "We are not accepting the realities of feeding your child in today’s world,” Modi told Fortune in 2019. "Fifteen to 20% of women physically cannot produce enough breast milk to exclusively breastfeed."

        Over the year following its FDA wake-up call, Bobbie regrouped. In its messaging to its customers, the company made sure not to cast aspersions on the FDA's decision. "We accept that our labeling and our marketing may have been misleading, and for that we truly apologize to all of our customers. We anticipated this would be hard, and it should be," the company wrote in a letter to its subscribers. "When it comes to our kids, safety comes first and every parent deserves peace of mind."

        That messaging caught the eye of a few players who have proved crucial in Bobbie's second act. The company's goal had always been to manufacture in the U.S., but the facilities capable of producing infant formula imposed minimum orders that were higher than the early-stage company felt it could commit to. The manufacturer Perrigo, which makes store-brand formulas and pediatric nutrition drinks, had declined a cold email request to make Bobbie's formula months earlier—even though it was interested in producing a product for millennial parents. "We noticed there was a need for an FDA-regulated product that served consumers' preference [for an EU-style formula]," says Adriane Sherogan, an executive at Perrigo, which is now producing Bobbie's formula in Vermont. "What made me reach out to Laura again was the way they handled the FDA advisory; they were very transparent and clear in communications to consumers."

        The recall, too, caught the eye of a new investor, Sara Adler at Wave Capital. Adler knew Modi from Airbnb but decided not to invest in her company's original $2.4 million seed round—questioning the feasibility of bringing a new formula to market and the demand for such a product. But the company's handling of the recall won her over. "The level of maturity they brought to their approach to the FDA made it a no-brainer," Adler says of her eventual decision to invest.

        With the confidence of a new manufacturer and a new investor, Bobbie put its resources behind creating a product that wouldn't draw the ire of the FDA and building goodwill with the agency. Under the guidance of a new head of regulatory, Christina Berberich—who previously handled infant formula regulatory findings at Abbott—the company visited the FDA's offices in Silver Spring, Md., in November 2019 and spoke to officials about the company's revamped U.S. supply chain.

        Now Bobbie is set to ship its $24 "European-style recipe" infant formula nationwide starting Jan. 5. This iteration of its formula is considered a different product than the one that led to a consumer warning; that formula "did not return to market," confirms an FDA spokesperson.

        The regulatory challenges are unusual for such a young consumer goods startup. Adler, Bobbie's new investor, compares the company's approach to regulators to the model Modi saw at Airbnb, which, while still sometimes working around government restrictions, was more likely in its growth stage to cooperate with regulators than was its frequent point of comparison, Uber. "They could have tried to fight it and continued to sell the product they'd worked to bring to market," Adler says. "Instead they said, from a business perspective, what's our long-term goal?"

        The 12 employees at Bobbie, who altogether have 19 kids, including six infants, are excited to once again be able to use their own product. Modi and her team believe they're in a stronger position now than they would have been if they had moved forward with their "companion formula." "Had they not had the FDA coming to them because of press," Adler says, "they wouldn't be where they are now."

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