FDA彻底修改营养标签的设计和内容
出自识林
FDA彻底修改营养标签的设计和内容
笔记 2016-05-28 Sidley 2016年5月20日，美国FDA发布两个最终规定修订其营养标签法规（官网通知及相关信息）。规定实现了许多变更，包括更新营养和膳食补充成分标签的设计和内容，修订影响某些食品食用份量的法规。通过这些行动，FDA建议对营养标签转变管理方法，包括承认其规定应反映营养科学的进步。规定建议了随着科学的不断发展未来更新的可能性。 规定将要求制造商对每个食品披露以克为单位的“添加糖”量，以及相关的每日需求量百分比。添加糖的披露将被置于营养成分标签中先前存在的“糖”（现在成为“总糖”）的成分说明之下。在新规定发布几天后，FDA定稿其对声明为蒸发甘蔗汁成分的指南，确认FDA强烈持有的观点，使用术语“蒸发甘蔗汁”描述来源于甘蔗的甜味剂是错误的或具有误导性的。FDA鼓励制造商在描述此类添加糖成分时任选准确的描述，而不是使用术语“糖”。 FDA在营养成分标签中对新的添加糖的披露的根本理由的主要前提是含糖食品和不含糖食品的不同，而不是添加糖和内在糖之间的具体区别。这种推论代表了对FDA一直侧重于具体营养成分和其特征以建立营养标签要求这一惯例做法的背离。这一做法备受争议，一些人认为添加糖和内在糖之间没有科学支持的区别，因为两种形式的糖对体重增加和其它健康问题具有相同的作用。此外，一些人认为，添加糖和内在糖之间不存在任何实质性差别，强制披露经不起第一修正案的审查，根据是披露是误导性的，不能促进合法政府利益，过于沉重的负担或者比必需的要求更加广泛。FDA在很大程度上通过以下论点反驳这些争议：主张添加糖披露是实事求是的和没有争议的，并且与政府在促进公众健康、防止误导性标签和提供落实健康膳食实践的信息方面的利益合理相关且有直接推动作用。法院是否会同意企业或FDA提出的论点仍是一个尚未解决的问题。尽管如此，添加糖所隐含的概念预示着FDA可能改变其对营养成分披露的观点，更专注于整个食品而不是食品中的个别营养成分，可能会打开其它类似的新的食品标签要求的大门。 此外，营养标签将不再要求声明“来自脂肪的卡路里”。FDA的立场是，科学研究表明，脂肪类型比脂肪摄入总量更重要。另外，根据FDA，对于来自脂肪的卡路里的“额外强调”没有任何依据，因为，目前的膳食建议和共识报告承认食用适量脂肪是有益的。 值得注意的是，在这些变化之前，FDA于5月10日宣布计划重新评估其对营养成分含量声明的监管，包括有关在产品标签上使用“健康”字样，这是以在宣称健康的食物中限定脂肪、饱和脂肪和胆固醇含量为前提。这一公告伴随着FDA声明已关闭其对KIND公司的警告信，警告信中引述了其对营养成分含量声明规定的违反。（Statement on FDA's Actions on Labeling of KIND Products）重新评估似乎与KIND公司2015年12月的请愿 修订营养和膳食补充成分标签的最终规定还实现了对营养标签“更新设计”，将使卡路里和食用份量信息更为突出。FDA在最终规定的起草说明中解释了其目的是强调卡路里的重要性，并总结认为卡路里和食用份量声明以加大加粗字体显示会作为营养标签的“支柱”，使消费者关注这一信息并帮助消费者在标签作为一个整体的情况下加以有效利用。 FDA还修订了某些习惯消费参考量（RACCs），RACCs用于确定食用份量，更准确地反映目前的消费模式。在修订过程中，FDA强调RACCs和食用份量必须基于典型消费，而不是推荐用量。对RACCs的修订（以及有必要作为结果的对营养成分含量和健康声明的变更）要求制造商分析产品并对产品标签做出比格式变化更为显著的变更。此外，所有含有一份到两份食用份量之间的食品，例如20盎司的苏打水，现在必须标为一份，因为这些食品通常会被一次性消耗，可能一次或多次被消耗或分享的产品必须具有双列标签。FDA的既定目标是让消费者更方便地了解食品包装上有关个人食用份量和整体份量的卡路里和营养成分含量。 最后，FDA将不再要求维生素A和维生素C的披露，理由是因缺乏这些维生素引起的疾病现在非常罕见了。取而代之，FDA将要求维生素D和钾的声明，包括实际克数和相关每日需求量百分比，理由是有信息显示消费者没有消费足够量的这些营养成分，使得他们患慢性疾病的风险增加。 制造商有两年的时间完成标签更换，将从2018年7月26日起要求新的标签。年食品销售额低于1000万美元的制造商则被宽限在3年内完成，到2019年7月26日执行新标签。 总而言之，新规定并不只是营养和膳食补充成分表的焕然一新。而是表现了对FDA营养标签长期政策的改变，并且可能会迎来更多变化。 翻译：识林-椒 英文原文 FDA Overhauls Design and Content of Nutrition Labeling On May 20, 2016, the Food and Drug Administration (FDA) announced the release of two final rules amending its nutrition labeling regulations. The rules implement numerous changes, including updating the design and content of the Nutrition and Supplement Facts labels and revising regulations affecting serving sizes for certain foods. With these actions, FDA has suggested a shifting approach to nutrition labeling, including a recognition that its regulations should reflect advances in nutrition science. The rules suggest the possibility of future updates as science continues to evolve. Significantly, manufacturers will be required to disclose the amount of “added sugars” in grams as well as the related percent Daily Value for each of their food products. The added sugars disclosures will be placed in the Nutrition Facts label under the pre-existing declaration for “sugars,” now called “total sugars.” Within days of releasing the new rules, FDA finalized its guidance on ingredients declared as evaporated cane juice, confirming the agency's strongly held view that use of the term “evaporated cane juice” to describe sweeteners derived from sugar cane is false or misleading. The agency encourages manufacturers to instead use the term “sugar,” optionally accompanied by an accurate descriptor, in describing such added sugar ingredients. FDA's underlying rationale for the new added sugar disclosures in the Nutrition Facts label is largely premised on differences between sugar-sweetened foods and their non-sweetened counterparts, rather than specific differences between added and intrinsic sugars. This reasoning represents a departure from FDA’s customary practice of focusing on specific nutrients and their characteristics to establish nutrition labeling requirements. This departure has not been lost on industry and other observers, some of whom maintain that there is no scientifically-supported distinction between added and intrinsic sugars because both forms of sugar have the same effect on weight gain and other health outcomes. Further, some have argued that absent any material differences between added sugars and intrinsic sugars, the mandated disclosures do not withstand First Amendment scrutiny on the basis that the disclosures are misleading, do not advance a legitimate government interest, are unduly burdensome or otherwise more extensive than necessary. The agency counters these arguments in large part by asserting that the added sugar disclosures are factual and uncontroversial, and are reasonably related to and directly advance the government’s interest in promoting public health, preventing misleading labeling and providing information to enable healthy dietary practices. Whether a court would agree with the arguments raised by those in industry or FDA remains an open question. Nonetheless, the concepts underlying the added sugar disclosures signal that FDA may be shifting its views on nutrient disclosures to focus more on whole food products rather than individual nutrients found in such products, potentially opening the door to other similar new food labeling requirements. In addition, nutrition labels will no longer be required to declare “Calories from fat.” FDA's position is that scientific research demonstrates that the type of fat is more significant than the total amount of fat consumed. Further, according to FDA, there is no basis for “extra emphasis” on calories from fat because current dietary recommendations and consensus reports acknowledge that consuming moderate amounts of fat may be beneficial. Notably, these changes come on the heels of FDA’s May 10, 2016 announcement that it plans to reevaluate its regulation of nutrient content claims, including those pertaining to the use of “healthy” in product labeling, which are premised on limited fat, saturated fat and cholesterol content in the food for which the claim is made. This announcement accompanied the agency's statement that it had closed out its warning letter to KIND LLC, which had cited violations of the nutrient content claim regulations, and the reevaluation appears to be tied to KIND’s December 2015 petition requesting that FDA conduct a comprehensive overhaul of its nutrient content claim regulations to bring them in line with the current dietary recommendations. KIND asked FDA to exclude fats contributed to food products by whole “fruits, vegetables, nuts, seeds, legumes, whole grains, and seafood” in determining whether the food meets the conditions to make a “healthy” claim on the basis that such foods are recognized as healthy by scientific experts. Taken together, the agency’s decision to remove “Calories from fat” from the nutrients required to be declared (along with the other changes announced on May 20) and its statement that it will reevaluate the nutrient content claim rules suggest that FDA intends to continue to update its nutrition labeling requirements to keep pace with developments in nutrition science. The final rule revising the Nutrition and Supplement Facts labels also implements a “refreshed design” for the nutrition label, which will make calorie and serving size information more prominent. FDA explains in the preamble to the final rule that its goal was to emphasize the importance of calories, and it concluded that the declaration of calories and servings per container in larger, bold type would serve as an “anchor” to the nutrition label for consumers, focusing attention on this information and helping consumers to utilize it in the context of the label as a whole. FDA also amended certain Reference Amounts Customarily Consumed (RACCs), which are used to determine serving sizes, to more accurately reflect current consumption patterns. In doing so, the agency emphasizes that RACCs and serving sizes must be based on typical consumption, not recommended amounts. Revisions to the RACCs—and changes to nutrient content and health claims that may be necessary as a result—may require manufacturers to conduct product analyses and make more significant changes to product labels than format changes. Further, all foods that contain between one and two servings, such as a 20-ounce soda, now must be labeled as one serving because they are usually consumed in one sitting, and products that may be consumed in a single sitting or over multiple sittings, or be shared, must have dual-column labeling. FDA’s stated goal is for consumers to more easily understand the calorie and nutrient content of a food package with respect to individual servings and the container as a whole. Finally, FDA will no longer require disclosures for Vitamins A and C on the basis that deficiencies of these vitamins are rare. Instead, the agency will require declarations for Vitamin D and potassium, including the actual gram amount and related percent Daily Value, based on information indicating that consumers are not consuming sufficient amounts of these nutrients, putting them at increased risk of chronic disease. Manufacturers have two years to comply, requiring the new labels to be in place by July 26, 2018. Manufacturers with less than US$10 million in annual food sales will have another year, until July 26, 2019, to implement the required changes. All told, the new rules are not just a new look for the Nutrition and Supplement Facts panels. Rather, they demonstrate changes to FDA’s longstanding approach to nutrition labeling and suggest that there may be more changes to come. |
相关，请愿请求FDA对其营养成分含量声明规定开展全面审查以使之符合当前的膳食建议。KIND公司要求FDA在这些食物被科学专家认为是健康的基础上决定食物是否符合做出“健康”声明的条件中，排除全部“水果、蔬菜、坚果、种子、豆类、全谷类和海鲜”中的脂肪对食品营养成分含量的贡献。综上所述，FDA决定从所需要声明的营养要求中移除“来自脂肪的卡路里”，并表示将重新评估营养成分含量声明规定，表明了FDA计划继续更新其营养标签要求以跟上营养科学发展的步伐。
