**5. Meal replacement definitions and standards**

In some markets around the world, regulations exist to define MR, both in function and in composition. The definition, specific authorized claims for weight loss or management and composition standards (for both macro‐ and micronutrients) vary by country (**Table 3**). The *Codex Alimentarius* composition standards for MR were established back in 1991 and have served as the basis for the definition in a number of other markets [65]. Establishing regulations and composition standards has served as the basis for sanctioning weight loss benefit claims for MR and has facilitated harmonization in multi‐country regions (e.g., EU). Together with the plethora of data supporting the safety and efficacy of MR, these standards have also led to increased use, research and acceptance of MR by the healthcare professional community [66].


**Table 3.** Comparison of standards and regulations for meal replacements in various markets around the world.

However, in other markets with high obesity prevalence, including the United States, Mexico, China and Russia, no such standards have been established. The reasons for the lack of MR regulations and standards in these countries vary, but are tied closely to the existing food and/or dietary supplement policy and regulatory framework. For example, in the United States, composition or identity standards are not expressly required in order for products to bear health benefit claims. For MR, as with conventional foods and dietary supplements, the ability to bear a weight loss claim is predicated on the availability, quality and quantity of scientific substantiation, not a formal definition for MR or composition standards [67]. In contrast, in the case of Mexico, MR are regulated under the category of food supplements. By regulation, food supplements are not permitted to bear claims of any kind [68], thus eliminating the ability to communicate a weight loss benefit for the category and reducing the need to establish a definition. Finally, in China, MR are regulated under the health or functional food category [69]. Products in this category are required to go through animal and/or human testing (depending on the desired claim) as part of a premarket registration process. This testing requirement to validate the health food product prior to market has precluded the need for a specific MR definition or standard.

Establishing full recognition of the health benefits of MR in these markets may ultimately require a formal definition and composition standards. Indeed, the absence of a formal regulation for MR has allowed the category to be inappropriately targeted with antiobesity policies aimed at, for example, curbing the public's consumption of sugars. In Mexico, MR are subject to the same tax aimed at reducing intake of sodas and other sugar‐sweetened beverages as part of a broader public health initiative [70]. In the United States, similar policy has been proposed at both the Federal [71, 72] and state levels [73] and has passed at the local level [72, 74]. In some cases, MR have been exempted (Berkley, CA), and in others, this exemption has not been expressly granted (Philadelphia). Imposing such policy on MR seems incongruent with the state of the evidence, which clearly demonstrates that MR are part of the obesity solution, not the problem.

The absence of a formal definition for MR may negatively impact the consumer, as products claiming to be a MR may not meet basic compositional expectations. Consumers conceivably stand to benefit from a standard or regulation by receiving properly formulated and consistent products. The absence of a formal definition has also prevented the category from being included in potentially beneficial public policy aimed at obesity and disease prevention. Without a clear standard of identity and recognition of its health benefits, MR cannot be included in government‐sponsored programs such as Flexible Savings Accounts or Health Savings Accounts.
