Building Consumer Trust: How Innovation and Regulation Have Changed the Nutrition Industry　
　

　　According to recent research, the global personalized nutrition market was valued at USD 5.59 billion in 2018 and is expected to reach an astounding USD 11.35 billion by the year 2026. We continue to see an ever-increasing trend toward healthier foods, made from ingredients found in nature that protect the planet and its inhabitants. And, as more and more consumers are selecting food based on their individual definitions of ‘healthy’, enter the age of personalized nutrition where science and technology can dictate what food is right for us—not only for weight management but, more importantly, to support our overall health and wellness. That said, although much of this growth has been driven by an increase in consumer demand for health and wellness products. Historically, this hasn’t always been the case.

　　

　　近期研究显示，2018年全球个性化营养市场规模达到55.9亿美元，预计到2026年将增至113.5亿美元。人们越来越青睐天然食材制成的健康食品，这些食品不仅健康，还能保护地球环境和其它生物。随着越来越多的消费者按照自己的“健康理念”选择食品，人类进入了个性化营养时代。科学技术可以决定哪种食物适合我们，从而不仅实现体重管理，更重要的是提高整体健康水平和幸福感。不同于过去，如今的市场发展在很大程度上是由消费者对健康保健食品的需求而推动的。

　　

　　Herbalife Nutrition, for 40 years, has been helping people live healthy lives through nutrition and we’ve seen numerous changes throughout that time. Changes that have been driven by consumer demand, or by legislation and regulation, or the implementation of innovation and technology. The purpose of these changes have been to improve consumer safety. They have been embraced by the industry and pioneered by companies like Herbalife Nutrition who have taken a leadership role, making great investments in scientific development, technology, analytical science and manufacturing. Companies now have better and safer products and as the numbers show, have helped to increase consumer trust and use of nutritional products.

　　

　　40年来，康宝莱始终致力于通过营养帮助人们实现健康生活。在此期间，我们也注意到，为了更好地保护消费者安全，在消费者需求、法律法规、创新技术等因素的驱动下，营养行业发生了诸多变革，以康宝莱为代表的企业率先践行了这些变革，并在科研开发、技术、分析科学和制造技术方面进行大量投资。营养行业的企业现在可以提供更优质、更安全的产品。数据显示，产品的进步使消费者更加信任，也更多地使用营养产品。

　　

　　

　　The 1980’s was a decade that could be characterized as the “birth of quality management”, partially in response to unforeseen crises and partially because of developments in analyticial and manufacturing technology. While there was much support from consumers, the nutrition business being in its infancy, had few alternative nutrition options. .

　　

　　“质量管理”诞生于20世纪80年代，一方面是为了应对不可预见的危机，另一方面是基于分析和制造技术的发展。尽管当时的消费者给予了大力支持，但是刚刚起步的营养产业可提供的营养方案寥寥无几。

　　

　　At this time, regulations in the United States for foods, and what would later be called “dietary supplements” were much less comprehensive than today. Although there were regulations for approving food additives and for protecting consumers from adulterated and contaminated foods, many quality standards had not yet been developed.

　　

　　当时，美国的食品法规以及后来称之为“膳食补充剂”的产品标准远没有如今全面。虽然已有食品添加剂审批法规以及保障消费者免受掺假和受污染食品侵害的相关法规，但很多质量标准尚未制定。

　　

　　On the manufacturing technology front, smart cameras were developed, and manufacturers began using machine vision systems to identify characters and dates, and conduct code verification.

　　

　　制造技术方面，智能相机已经问世，制造商开始使用机器视觉系统识别字符和日期，进行代码验证。

　　

　　In 1982, in an effort to protect consumers, the FDA issued tamper-resistant packing regulations to prevent poisonings, spurred by deaths from cyanide placed in Tylenol capsules. This was important regulation for all packaged consumer goods manufacturers, leading to the Federal Anti-Tampering Act, approved by Congress in 1983, making it a crime to tamper with packaged consumer products.

　　

　　1982年，鉴于某胶囊产品氰化物致死事件，美国食药监局发布防篡改包装规定，以保护消费者。防篡改包装规定对所有包装消费品制造商都具有重要意义。1983年，美国国会在防篡改包装规定的基础上通过了《联邦反篡改法案》，将篡改包装消费品定性为犯罪行为。

　　

　　It wasn’t until the 1990s that the industry saw some of the greatest advancements in helping build consumer awareness and education.

　　

　　20世纪90年代，营养产业在建立消费者意识和教育消费者方面取得了长足的进步。

　　

　　It wasn’t until the Nutrition Labeling and Education Act was signed into law in 1990 that all packaged foods were required to bear nutrition labeling and all health claims for foods to be consistent with terms defined by the Secretary of Health and Human Services. The law preempted some state requirements for food standards, nutrition labeling, and health claims and, for the first time, authorized some health claims for foods. As part of the act, food ingredient panel, serving sizes, and terms such as "low fat" and "light" were standardized.

　　

　　1990年，《营养标签和教育法案》签署生效，规定所有包装食品必须使用营养标签，食品的所有保健功能声称必须符合卫生和公共服务部部长规定的条件。《营养标签和教育法案》先人一步，早于某些州一级的食品标准、营养标签和保健功能声称要求，首次批准了部分食品的保健功能声称。《营养标签和教育法案》还对食品成分表、份量以及“低脂”、“清淡”等用语进行了标准化。

　　

　　In 1994, the Dietary Supplement Health and Education Act (DSHEA) established specific labeling requirements, provided a regulatory framework, and authorized FDA to promulgate good manufacturing practice regulations for the industry. This act defined "dietary supplements" and "dietary ingredients" and classified them as a subset of foods. The act also established a commission to recommend how to regulate claims. Additionally, it confirmed that manufacturers and distributors of dietary supplements and dietary ingredients were prohibited from marketing products that were adulterated or misbranded.  That meant that these firms were responsible for evaluating the safety and labeling of their products before marketing to ensure that they met all the requirements of DSHEA and FDA regulations. Together with the passing of the Food and Drug Administration Modernization Act in 1997, we saw the birth of the nutrition industry as we know it today.

　　

　　1994年颁布的《膳食补充剂健康和教育法案》提出了具体的标签要求，规定了监管框架，并授权美国食药监局颁布行业GMP（生产质量管理规范）法规。《膳食补充剂健康和教育法案》定义了“膳食补充剂”和“食品原料”，将其归入食品子集。在该法案下还成立了一个委员会，负责功能声称的监管建议。《膳食补充剂健康和教育法案》还禁止膳食补充剂和食品原料的生产商和经销商销售掺假或假冒伪劣产品。也就是说，膳食补充剂和食品原料的生产商和经销商负责在销售前评估产品安全和标签，确保产品符合《膳食补充剂健康和教育法案》和美国食药监局的全部规定。1997年，《食品药品管理现代化法案》出台，营养产业就此成形并发展至今。

　　

　　As the new millennium rolled around, the impact of the previous decade’s regulations helped build a foundation for consumer trust as companies continued to beef up their quality assurance processes. Government agencies continued to refine rules and regulations to help protect and educate.

　　

　　在20世纪90年代出台的多项法规的影响下，企业不断改善质保流程。在千禧年之际，行业已经具备了建立消费者信任的基础。政府机构也继续完善规章制度，促进对消费者的保护和教育。

　　

　　It was not until 2006 that the industry would begin experiencing true change. On December 22, 2006, the President signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). For the first time in US regulatory history, the Nutrition industry would be held accountable for safety surveillance and mandatory serious adverse event reporting to FDA (effective December 22, 2007). In addition, the FDA issued in June 2007 the Dietary Supplement Current Good Manufacturing Practices (cGMP). In essence, the cGMP required that the proper controls be in place for dietary products during manufacturing, packaging, labeling, and holding operations. Large companies manufacturing and/or distributing dietary products, were expected to comply with the new regulations. And by 2009, all companies manufacturing and/or distributing dietary products, were required to comply. These two major regulatory milestones would pave the way for industry to develop more comprehensive and standardized practices for ensuring consumer safety and product quality, both critical components for building consumer trust and regulatory parnterships for good stewardship.

　　

　　2006年，营养行业开始迎来真正的变革。2006年12月22日，时任美国总统签署了《膳食补充剂和非处方药消费者保护法案》，对《联邦食品、药物和化妆品法》进行了修正。美国监管史上首次要求营养行业需承担安全监督责任，并强制向美国食药监局报告严重不良事件（2007年12月22日生效）。2007年6月，美国食药监局发布《膳食补充剂现行良好生产规范》(cGMP)，要求在食品的生产、包装、标记和保管作业中落实适当的控制措施，同时要求大型食品生产企业及/或经销商遵守新法规。2009年，所有食品生产企业及/或经销商都必须遵守新法规。这两大监管里程碑为营养行业制定更全面的标准化规范、保障消费者安全和产品质量铺平了道路，而消费者安全和产品质量是建立消费者信任和良好管理监管合作关系的关键要素。

　　

　　Along with the industry, Hebalife Nutrition experienced great change during these years. Founded in 1980 to sell food and nutrition products, the company had a clear desire to lead the industry in quality, and eventually invested more than $300 million into scientific development, manufacturing facilities and technology, and by 2009 it established its second innovation and manufacturing facility, in Lake Forest, California.

　　

　　康宝莱与行业一起经历了这一巨变。康宝莱是成立于1980年的营养品公司，致力于打造行业一流品质，在科学研发、制造设施和技术方面投入3亿多美元，并于2009年在加利福尼亚州森林湖成立了第二个创新制造中心。

　　

　　The Company has made significant investments in technology, purchasing advanced testing equipment that was not currently being used by the industry, including a nuclear magnetic resonance (NMR), Mass spectrometry high performance liquid chromatography equipment (LCMS) , next-generation sequencing (NGS) equipment and other cutting edge technologies. The recent investment in these sequencing technologies has diversifyied the Company’s Genomic/DNA laboratory to improve  DNA analytical techniques for processed botanicals, including extracts, making it  one of the only nutrition companies in the world to have its own comprehensive program to completely characterize botanical ingredients.

　　

　　康宝莱还投入大量资金进行技术研发，购买核磁共振（NMR）、高效液相色谱质谱联用仪（LCMS）、新一代测序（NGS）设备等业界尚未使用的先进检测设备以及其它尖端技术。测序技术的引入增加了康宝莱基因组/DNA实验室的多样性，改善了植物提取物等的DNA分析方法，这也使得康宝莱成为全球唯一拥有植物成分鉴别整体方案的营养品公司。

　　

　　This most recent decade has been a wake-up call for those manufacturers who have not seized the opportunity to invest and improve their manufacturing processes, product claims and quality control systems.  The FDA kicked off the decade in 2011 by introducing one of the most sweeping regulations, 21 CFR Part 117. This regulation, also known as the Food Safety Modernization Act (FSMA), provided the FDA with new enforcement authorities related to food and food safety standards, also giving them the tools to hold imported foods to the same standards as domestic foods, and directing FDA to build an integrated national food safety system in partnership with state and local authorities.

　　

　　近十年来，那些未抓住机会投资和改善制造工艺、产品功能声称和质量管控系统的制造商纷纷醒悟过来。2011年，美国食药监局出台了最全面的法规之一——《美国联邦法规》第21章第117部分，又称《食品安全现代化法案》。该法案赋予美国食药监局关于食品和食品安全标准的新执法权，赋予美国食药监局确保进口食品符合国内食品标准的工具，指导美国食药监局与州和地方当局合作，建立一个整合的国家食品安全体系。

　　

　　But regulations and legislation alone are not the answer to improving food quality and food safety. It is imperative that companies, academia and government partner up for the greater good and the benefit of the consumer. Those who can, have an obligation to the industry and consumers to commit to scientific research, transparency and accountability. Examples of such partnerships include The Research Alliance, a partnership with The University of Guelph, a comprehensive public research university in Canada and leader in food science investigation. The Research Alliance, of which Herbalife Nutrition is a founding member, is designed to develop new, mutually agreed standards for the industry, including:

　　

　　但是，仅靠法律法规并不能解决食品质量和食品安全的问题。企业、学术界和政府必须通力合作，为消费者创造更大的利益。有能力者有义务为行业和消费者开展科学研究，提升透明度，加强问责制。这种政产学合作的其中一个范例就是研究联盟(The Research Alliance)，该联盟是与加拿大综合性公立研究型大学、食品科学调查研究领域的翘楚圭尔夫大学合作成立的，康宝莱是其创始成员之一。研究联盟旨在为营养行业制定相互认可的新标准，具体包括：

　　

　　Creating new industry standards for botanical species ingredient authentication, as current standards rely on testing protocols that identify chemicals, not necessarily species in the ingredients.

　　

　　制定新的植物物种成分鉴定行业标准，因为现行标准所依赖的测试协议以识别成分的化学物质为主，不一定识别植物物种成分。

　

　　Developing the Standard Reference Materials (SBRM) library for natural ingredients.

　　

　　建立天然原料的标准参考物质库。

　　

　　Producing a portable molecular diagnostic tool that can be used on-site by industry stakeholders, thus reducing the costs associated with species testing.

　　

　　生产便携式分子诊断工具，供业界人士现场使用，以降低物种测试成本。

　　

　　I believe that companies who have committed great amounts of resources, including manpower and financial investment to these systems, have created an atmosphere of transparency and earned consumer trust, positioning themselves for the next decade as industry leaders.

　　

　　我相信，在相关体系中投入大量人力财力等资源的企业已经创造了透明的氛围，赢得了消费者的信任，能够让自己在未来十年中处于行业领先地位。