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Posted 20 July 2018 | By Jesús Muñiz, MS, Linh M. Bui, PhD
This article reviews and discusses the regulatory status of meal replacement products internationally with an emphasis on 1991 Codex Alimentarius Commission (CODEX), relevant product categories, intended purposes and consumer confidence. Restructuring some of the regulations in the US may be useful to both manufacturers and consumers.
“Meal replacement” is a term used in the US and other parts of the world to describe a type of product used to replace a person’s meal or meals during a day. Besides offering a nutritious meal, many of these products are also formulated for -and claim to provide an additional functional benefit, such as weight loss, weight control or gaining a performance benefit.
Typically, meal replacements are offered in the form of flavored powder mixes to which water, milk or fruit juice may be added for consumption. Another common presentation of these products is in the form of edible bars. They also can be available as ready-to-drink beverages.
Meal replacement products typically provide about 200-250 kcal per serving and contain most of the essential vitamins and minerals in nutritionally meaningful amounts. In addition, some products contain other ingredients, such as enzymes, botanicals, caffeine and other bioactives that offer additional benefits to the consumer. Given their primary intended purpose of providing the consumer with several of the main constituents in a normal diet, such as carbohydrates, fats, protein and vitamins and minerals, most of these products have a scientifically sound rationale for their use.
Meal replacements have been marketed in the US and in international markets for many years. Originally, they were used mainly by consumers, such as the elderly, who suffered from a nutritional deficiency, or those unable to eat solid foods due to an illness or other conditions. Over several decades, meal replacements have become an attractive option to a broader demographic when these products are marketed as a nutritious and convenient alternative when an actual meal is not available or for a specific purpose, including weight management, in which meal replacement products have been shown to be safe and effective.1
Given the relatively long history of these products and also due to their proven nutritional benefits, it is not surprising that a standard for meal replacement products has been developed. The Codex Alimentarius Commission (CODEX), a body established by the Food and Agriculture Organization of the United Nations, establishes guidelines for use as a reference, if desired, for each member country to develop their own standard according to their specific needs and unique regulatory framework. In 1991, CODEX finalized a standard for Formula Foods for Weight Control Diets.2 The standard is for products represented to be a replacement for all or part of the total daily diet and includes recommendations on composition, labeling, packaging and quality parameters. In 1995, CODEX developed another standard for Formula Foods for use in Very low Energy Diets for Weight Reduction, intended for products represented to be the sole source of nutrition.3
Although the CODEX standards do not cover some important aspects relevant to meal replacement products currently marketed (e.g., the standard does not mention whether other nutrients not in the standard may or may not be added), the standards have been very useful and subsequently adopted in many countries over the years.
Today, many countries have specific set of regulations or standards for meal replacement products based on the CODEX standards. Most importantly, the standards help to ensure products manufactured and marketed under these regulations adhere to a specific set of requirements, thereby reassuring the consumer about the safety and quality of the products. Under these regulations, meal replacement products are acknowledged to be beneficial for weight management, provided they meet the requirements stated in the standards. As well as being acknowledged by relevant health authorities, meal replacement products also have a certain degree of credibility with both average consumers and with healthcare professionals.
Meal replacement products are usually regulated as foods under a specific subcategory such as “foods for special dietary use” or “foods for special medical purpose.” Depending on the product and its recommended use, most countries also place additional specific requirements going beyond what would normally be required of a conventional food. For example, in Brazil products represented for weight control and are meant to replace the total diet are required to have a cautionary statement on the label indicating the product should be taken under the supervision of a doctor or nutritionist.4 Some countries also require the marketing company to develop a meal plan and make it available for the consumer to ensure that when taking the product, whether to replace one or more meals in a day, the consumer obtains adequate nutrition from the diet.5 In Europe, products intended as meal replacement for weight control must follow the regulations for “health claims” and foods intended for ‘total diet replacement for weight control’ have their own set of rules set by a specific regulation.6,7
When looking across the regulations established for meal replacements, it appears the scientific principles guiding the applicable regulatory framework for these products are consistent and relevant authorities want to ensure products aimed at replacing a meal are formulated to deliver the energy and nutrients a consumer should have in a meal as based on local established guidelines for caloric intake, and recommended intakes for macro- and micronutrients.
Table 1 presents a topline summary of the main regulatory requirements in several countries and regions for meal replacement-type products intended to partially replace the daily diet (i.e., one to two meals a day). There are typically additional requirements for products intended for total diet replacement. In addition, some regulations have further quality and compositional requirements not in the chart, but are mentioned briefly in the preceding paragraphs. Also, some regulations permit the addition of other bioactives while others do not.
There are currently no specific regulations for meal replacement products in the US for either partial replacement or total diet replacement, and the term is not defined in current statutes. Depending on the intended purpose, these products may be marketed and regulated as conventional foods, foods for special dietary use, medical foods or even as dietary supplements under some circumstances, but with some restrictions on labeling and claims.
For example, a product with the nutritional profile characteristic of a meal replacement product as covered in CODEX may be marketed as a dietary supplement in the US, but it cannot claim to or represent to be a “meal” because dietary supplements may not be represented as conventional foods or as the sole item of a meal or diet.14 As a regulated category, this specification makes dietary supplements in most cases an impractical option for a meal replacement product.
“Medical foods” is another category under which some meal replacement products may fall. According to the Orphan Drug Act, a medical food is “…formulated to be consumed or administered enterally and under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."15 Many meal replacements do not meet this definition because they are usually not required to be taken under medical supervision and are not typically recommended for disease management.
The majority of meal replacement products sold in the US are marketed as “conventional foods” and must bear a Nutrition Facts Panel to comply with all relevant regulatory requirements for foods. As previously discussed, many meal replacement products are intended to support weight management, while others are formulated with additional ingredients to provide functional benefits, such as optimizing performance while exercising. When represented for weight-loss or weight maintenance, the product label needs to include the basis upon which it claims to have that benefit as well as other applicable requirements, as indicated in the regulation for foods for special dietary use.16 Depending on the intended purpose of the product and its formulation, other regulatory requirements may apply.
Meal replacements are widely available in the US and consumers seem to have many brand options. This suggests the US regulatory framework for foods is adequate to regulate these types of products.
However, given the long history of use of meal replacements as a means to obtain sound nutrition and use for weight management, some regulatory adjustments could further boost the potential of this category of products and increase the potential impact it could have on public health, particularly for those looking for healthy meal options or looking to manage their weight.
As discussed previously, in some countries with established specific regulations for meal replacements the products are permitted to be marketed for weight management purposes and have specific regulatory requirements. While specific regulatory requirements for a product may seem like an additional burden on the manufacturers in those markets, those same regulatory requirements accomplish several objectives. First, they define the product and in doing so, grant the product a certain degree of recognition. Second, the specified requirements help ensure that products available in the market meet basic nutritional quality standards. Third, the specific requirements also help provide the product category the essential regulatory space, in the form of permissible claims, so it can be marketed effectively and enable the manufacturer to provide the consumer with information necessary for using the product safely and effectively.
The current regulatory environment for meal replacement products in the US may benefit from increased regulation and perhaps more importantly, a re-structuring of some existing regulations. While many of the typical regulatory requirements seen in other markets aimed at ensuring the quality of meal replacements products are already in place in the US, the regulatory environment could be more effective to further ensure the nutritional quality of these products. This would enable companies to more effectively develop and market meal replacement products and at the same time, boost consumer confidence.
Jesús Muñiz, MS and Linh M. Bui, PhD are co-founders of MBui Consulting LLC, providing services in regulatory affairs, regulatory policy and intelligence to the food, dietary supplements and pharmaceutical industries. They can be contacted at firstname.lastname@example.org and email@example.com.
Cite as: Muñiz J and Bui LM. “Regulatory Requirements for Meal Replacement Products: An International Review.” Regulatory Focus. July 2018. Regulatory Affairs Professionals Society.
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