Todd Harrison01.06.10
FDA has released a new draft guidance titled “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” This guidance clarifies FDA’s position on the classification of liquid dietary supplements and increases the risk of FDA enforcement action against manufacturers and marketers of such supplements.
Background
The number of liquid dietary supplements on the market has steadily increased over the past few years. Liquid supplements offer consumers a familiar way to obtain desirable nutrients and also may appear as a more natural method of supplementing the diet than consuming tablets or capsules, which resemble drugs. Liquids also appeal to consumers who are overwhelmed by the number of pills they must take on a daily basis. As the U.S. population ages, the proportion of consumers who are already taking multiple pills per day is likely to increase. These factors help to explain the success of liquid supplements in the market, despite the fact that such supplements tend to be more expensive to manufacture than their tablet- or capsule-form counterparts.
Nevertheless, the regulatory classification of liquid supplements poses a challenge for marketers of those supplements. The Federal Food, Drug and Cosmetic Act (FDCA) excludes from the definition of “dietary supplement” products that are “represented for use as a conventional food or as a sole item of a meal or the diet.” (21 U.S.C. § 321(ff)(2)(B).) Beverages and drinks—conventional foods—are excluded from the definition of dietary supplement under that provision. Although dietary supplements technically fall under the broader regulatory category of “food” already, greater limitations apply to conventional foods than apply to the dietary supplement sub-category with regard to both ingredients and labeling claims. Thus, the distinction between dietary supplement and conventional food is a significant one.
As an initial matter, conventional foods must contain only ingredients that are Generally Recognized as Safe (GRAS), or approved as food additives by FDA. Conversely, the ingredients that are used in dietary supplements are not subject to pre-approval by FDA, and need not necessarily be GRAS. Thus, many of the ingredients that may be used in a dietary supplement would not be permitted in a conventional food. Additionally, classification of a product as a conventional food effects the types of marketing claims that can be made for that product. Like dietary supplements, FDA-approved health claims and qualified health claims can be used for conventional foods, as well as approved nutrient content claims. However, while structure/function claims are allowed for both dietary supplements and conventional foods, structure/function claims for conventional foods must be based only on the nutritive value of the food. FDA defines “nutritive value” as “value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.” Claims based on “nutritive value” are much more limited than the structure/function claims to which most dietary supplement marketers are accustomed.
Until now, many marketers have chosen to continue labeling and marketing their liquid products as supplements and to include supplement structure/function claims, while at the same time describing the products as “drinks” or “beverages.” Others have continued to label and market their liquid products as supplements but attempted to prevent FDA classification as a conventional food by avoiding words like “beverage” or “drink” in labeling. Finally, some marketers have chosen to switch the label of their liquid products to a conventional food label, but continue to make claims for those products that likely fall outside the limit of structure/function claims about “nutritive value.”
New Draft Guidance
FDA’s new draft guidance provides several factors that determine whether a liquid product may be labeled as a dietary supplement, or must comply with the requirements for conventional foods. In addition, the guidance suggests the agency may be devoting more attention and enforcement resources to preventing liquid dietary supplements from being marketed as “beverages,” which are conventional foods. Specifically, the guidance states that FDA has “become concerned” about the marketing of beverages as dietary supplements.
Most importantly, the new draft guidance makes clear that FDA is concerned with the marketing of liquid dietary supplements as beverages when they contain ingredients that have not been vetted through the safety review that would be required for conventional food ingredients. Specifically, the agency is concerned about the use of “novel” ingredients, which have not been used in conventional foods before, or have been used previously but not at the same levels, or under the same conditions, as they are currently being used. FDA believes that such ingredients likely constitute unapproved food additives. FDA’s guidance cites botanical ingredients and their extracts as an example of substances that may constitute “novel” ingredients.
In determining whether a liquid product is marketed as a “beverage,” and thus a conventional food, the new guidance states that FDA will consider the product’s packaging, size, product or brand name, and statements about the product in labeling or advertising. Product or brand names that use the terms “beverage,” “drink,” “water,” “juice” or similar terms, will cause FDA to view the product as a conventional food. FDA may also consider whether the packaging and size of a product are made to appear similar to traditional beverages, such as a soda bottle, juice bottle or milk carton.
Take-Aways for Industry
The risk of FDA enforcement action against liquid dietary supplements in general is greater since the publication of this draft guidance. However, FDA’s enforcement is generally safety-based. Therefore, products containing non-GRAS ingredients that the agency may view as “novel,” unapproved food additives bear the greatest risk of enforcement action. High-profile liquid supplements, such as those marketed on television or in widely distributed publications, are also relatively high risk. To reduce the risk of enforcement action against a liquid supplement under FDA’s new guidance, companies should consider either making the product conform to the requirements for a conventional food and re-label the product as a conventional food, or revising those elements of the product label, packaging and marketing that may cause FDA to view it as a conventional food.
Depending on the ingredients in the product, it may not be possible to make the product conform to conventional food ingredient requirements without reformulating. The first step in determining whether the product can be marketed as a conventional food is to conduct a GRAS-review of all ingredients. In addition, the marketer of the product must determine whether it is feasible to limit claims for the product to nutritive value-based claims. If it is not feasible to limit claims, then the product cannot be marketed as a conventional food without at least some risk of FDA objection.
On the other hand, it may prove difficult to revise a supplement product’s label, packaging and marketing sufficiently to avoid classification as a beverage under FDA’s new guidance. Not only can the product name and labeling not use “drink,” “beverage” or similar words, but the product packaging also may not be shaped like that of a conventional beverage. The goal should be to reduce the number of elements that suggest classification as a beverage such that the overall impression is of a dietary supplement rather than a conventional food. For example, avoid key words like “drink” and “beverage,” and using a package shape that resembles a beverage.
Ultimately, a risk-strategy for liquid supplements based on FDA’s new guidance should be developed on a product-by-product basis, depending on a particular product’s ingredients and the intended marketing claims for that product. Furthermore, the strategy will need to consider the capacities of all the entities involved in manufacturing the product, since good manufacturing practices (GMPs) for foods differ from dietary supplement GMPs.
Background
The number of liquid dietary supplements on the market has steadily increased over the past few years. Liquid supplements offer consumers a familiar way to obtain desirable nutrients and also may appear as a more natural method of supplementing the diet than consuming tablets or capsules, which resemble drugs. Liquids also appeal to consumers who are overwhelmed by the number of pills they must take on a daily basis. As the U.S. population ages, the proportion of consumers who are already taking multiple pills per day is likely to increase. These factors help to explain the success of liquid supplements in the market, despite the fact that such supplements tend to be more expensive to manufacture than their tablet- or capsule-form counterparts.
Nevertheless, the regulatory classification of liquid supplements poses a challenge for marketers of those supplements. The Federal Food, Drug and Cosmetic Act (FDCA) excludes from the definition of “dietary supplement” products that are “represented for use as a conventional food or as a sole item of a meal or the diet.” (21 U.S.C. § 321(ff)(2)(B).) Beverages and drinks—conventional foods—are excluded from the definition of dietary supplement under that provision. Although dietary supplements technically fall under the broader regulatory category of “food” already, greater limitations apply to conventional foods than apply to the dietary supplement sub-category with regard to both ingredients and labeling claims. Thus, the distinction between dietary supplement and conventional food is a significant one.
As an initial matter, conventional foods must contain only ingredients that are Generally Recognized as Safe (GRAS), or approved as food additives by FDA. Conversely, the ingredients that are used in dietary supplements are not subject to pre-approval by FDA, and need not necessarily be GRAS. Thus, many of the ingredients that may be used in a dietary supplement would not be permitted in a conventional food. Additionally, classification of a product as a conventional food effects the types of marketing claims that can be made for that product. Like dietary supplements, FDA-approved health claims and qualified health claims can be used for conventional foods, as well as approved nutrient content claims. However, while structure/function claims are allowed for both dietary supplements and conventional foods, structure/function claims for conventional foods must be based only on the nutritive value of the food. FDA defines “nutritive value” as “value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.” Claims based on “nutritive value” are much more limited than the structure/function claims to which most dietary supplement marketers are accustomed.
Until now, many marketers have chosen to continue labeling and marketing their liquid products as supplements and to include supplement structure/function claims, while at the same time describing the products as “drinks” or “beverages.” Others have continued to label and market their liquid products as supplements but attempted to prevent FDA classification as a conventional food by avoiding words like “beverage” or “drink” in labeling. Finally, some marketers have chosen to switch the label of their liquid products to a conventional food label, but continue to make claims for those products that likely fall outside the limit of structure/function claims about “nutritive value.”
New Draft Guidance
FDA’s new draft guidance provides several factors that determine whether a liquid product may be labeled as a dietary supplement, or must comply with the requirements for conventional foods. In addition, the guidance suggests the agency may be devoting more attention and enforcement resources to preventing liquid dietary supplements from being marketed as “beverages,” which are conventional foods. Specifically, the guidance states that FDA has “become concerned” about the marketing of beverages as dietary supplements.
Most importantly, the new draft guidance makes clear that FDA is concerned with the marketing of liquid dietary supplements as beverages when they contain ingredients that have not been vetted through the safety review that would be required for conventional food ingredients. Specifically, the agency is concerned about the use of “novel” ingredients, which have not been used in conventional foods before, or have been used previously but not at the same levels, or under the same conditions, as they are currently being used. FDA believes that such ingredients likely constitute unapproved food additives. FDA’s guidance cites botanical ingredients and their extracts as an example of substances that may constitute “novel” ingredients.
In determining whether a liquid product is marketed as a “beverage,” and thus a conventional food, the new guidance states that FDA will consider the product’s packaging, size, product or brand name, and statements about the product in labeling or advertising. Product or brand names that use the terms “beverage,” “drink,” “water,” “juice” or similar terms, will cause FDA to view the product as a conventional food. FDA may also consider whether the packaging and size of a product are made to appear similar to traditional beverages, such as a soda bottle, juice bottle or milk carton.
Take-Aways for Industry
The risk of FDA enforcement action against liquid dietary supplements in general is greater since the publication of this draft guidance. However, FDA’s enforcement is generally safety-based. Therefore, products containing non-GRAS ingredients that the agency may view as “novel,” unapproved food additives bear the greatest risk of enforcement action. High-profile liquid supplements, such as those marketed on television or in widely distributed publications, are also relatively high risk. To reduce the risk of enforcement action against a liquid supplement under FDA’s new guidance, companies should consider either making the product conform to the requirements for a conventional food and re-label the product as a conventional food, or revising those elements of the product label, packaging and marketing that may cause FDA to view it as a conventional food.
Depending on the ingredients in the product, it may not be possible to make the product conform to conventional food ingredient requirements without reformulating. The first step in determining whether the product can be marketed as a conventional food is to conduct a GRAS-review of all ingredients. In addition, the marketer of the product must determine whether it is feasible to limit claims for the product to nutritive value-based claims. If it is not feasible to limit claims, then the product cannot be marketed as a conventional food without at least some risk of FDA objection.
On the other hand, it may prove difficult to revise a supplement product’s label, packaging and marketing sufficiently to avoid classification as a beverage under FDA’s new guidance. Not only can the product name and labeling not use “drink,” “beverage” or similar words, but the product packaging also may not be shaped like that of a conventional beverage. The goal should be to reduce the number of elements that suggest classification as a beverage such that the overall impression is of a dietary supplement rather than a conventional food. For example, avoid key words like “drink” and “beverage,” and using a package shape that resembles a beverage.
Ultimately, a risk-strategy for liquid supplements based on FDA’s new guidance should be developed on a product-by-product basis, depending on a particular product’s ingredients and the intended marketing claims for that product. Furthermore, the strategy will need to consider the capacities of all the entities involved in manufacturing the product, since good manufacturing practices (GMPs) for foods differ from dietary supplement GMPs.
