What is the difference between a conventional beverage and a liquid dietary supplement? While many consumers might not know (or care) about the distinction, the difference is crucial for manufacturers because conventional beverages and dietary supplements are subject to different federal regulations on labeling, advertising, manufacturing, and composition, among others. The Food and Drug Administration (FDA) recently finalized its draft guidance on liquid dietary supplements representing its current thinking on the topic.
FDA’s 2009 Draft Guidance—A Vague Start
The Federal Food, Drug, and Cosmetic Act (FDCA) provides that a dietary supplement cannot “be represented for use” as a conventional food, but provides little guidance on how to distinguish between the two categories. Does it depend on the product name or claims about the product? The size or shape of the container?
In 2009, FDA issued draft guidance to assist beverage and supplement manufacturers with some of these questions: “Guidance for Industry: Factors That Distinguish Liquid Dietary Supplements from Beverages and Other Conventional Foods.” In the draft guidance, FDA explained that it considers factors such as labeling and advertising, product name, product packaging, serving size, recommended daily intake, directions for use, marketing practices, and composition in determining whether a product is a beverage or supplement.
While a welcome step, FDA’s draft guidance did not discuss the factors with specificity. For example, the FDA did not elaborate on when a product’s name, labeling, or packaging would suggest the product is being represented for use as a conventional food or dietary supplement. As a result, companies were left to navigate between the two regulatory landscapes without any real direction.
FDA’s Final Guidance—More Detail, More Flexibility
After numerous requests from Congress and the industry to clarify the line between a conventional beverage and liquid supplement, FDA published final guidance representing its current thinking on the subject in January 2014. FDA issued two documents: “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.”
In contrast to the 2009 draft guidance, the final guidance on liquid dietary supplements provides concrete examples to assist in determining whether a given product is a conventional beverage or a liquid dietary supplement. For example:
- Labeling and advertising. FDA will consider statements and graphics on product labels, labeling, and advertising, including websites and social media. In this regard, a product with a Supplement Facts panel (as opposed to the Nutrition Facts panel found on conventional foods) may still be a conventional food if the product includes statements that it is intended to “refresh” because such a statement represents that it is intended for use as a beverage (or, in other words, a conventional food).
- Product name. Product or brand names that use conventional food terms such as “beverage,” “drink,” “water,” or “soda” indicate that the product is a conventional food.
- Product packaging. Packaging a liquid product in a red twelve-ounce pop-top aluminum can bearing a silver stripe with the name “cola supplement” printed in script on the can could be considered an implied representation that the product is a cola-flavored soft drink that is intended to be consumed in a single serving like other canned soft drinks, and therefore is a conventional beverage.
- Serving size and recommended daily intake. Liquid products that suggest through their labeled serving size or recommended daily intake (e.g., “Drink up to three 16-ounce bottles per day”) that they are intended to be consumed in amounts that provide all (or a significant part) of the entire daily drinking fluid intake of an average person are effectively being represented as a conventional food.
- Recommendations and directions for use. Recommendations or directions to use a product as a “thirst quencher” suggest the product is a beverage. In comparison, recommendations or directions to use a liquid product to supplement the diet in a manner consistent with other dietary supplements (e.g., by taking one tablespoon three times a day) suggest the product is a dietary supplement.
- Marketing practices. A product is likely to be considered a conventional food if the marketing compares the product to beverages or markets the product based on typical beverage criteria (e.g., taste, refreshment, and thirst-quenching ability), markets the product as an accompaniment to a meal, uses html tags that cause the product to appear in the results of an electronic search for sodas, juices, or other beverages, or pays for the product to be displayed in the beverage section of retail stores. That said, promoting a liquid vitamin C supplement as an alternative to drinking orange juice would not represent the product as a conventional food because this would be promoting the product as a more convenient source for vitamin C, not as a beverage to “While FDA’s final guidance is not a regulation, a company’s noncompliance with the guidance can have legal ramifications. Companies in the food and dietary supplement industries should review the FDA’s final guidance carefully, and assess existing labeling and marketing practices.” quench thirst, provide fluids, or accompany a meal.
- Composition. FDA recognizes that there is an overlap between the ingredients in some dietary supplements and conventional foods (e.g., amino acids, proteins, vitamins, water). Simply adding an ingredient listed as a dietary ingredient in the FDCA to a product universally recognized as a beverage does not by itself transform the beverage into a dietary supplement. For example, adding a botanical such as ginkgo to Kool- Aid would not automatically create a product that could be marketed as a “ginkgo supplement.”
- Other representations about a product. Other representations about a product could suggest that it is being represented as a conventional food, such as a patent filing describing the product as a type of “bottled water.”
FDA notes that while a single factor may be determinative of whether the product is represented as a conventional food, in most circumstances a combination of factors would be considered. Accordingly, FDA has signaled it will conduct a case-by-case analysis to determine whether a product should be properly labeled as a conventional food or beverage as opposed to a dietary supplement.
The second document issued by FDA in connection with its final guidance—“Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements”—serves to remind manufacturers and distributors about the FDCA’s existing requirements regarding substances added to conventional foods and dietary supplements, such as GRAS status of those substances, and whether they are a dietary ingredient.
Why Does the Guidance Matter?
While FDA’s final guidance is not a regulation (and therefore not binding on the agency or industry), a company’s noncompliance with the guidance can have legal ramifications. For example, if FDA believes a product is misbranded as a dietary supplement, the agency may issue a warning letter referring to this guidance, or take other enforcement actions. In addition, private plaintiffs may bring a class action lawsuit based on alleged noncompliance with the guidance under various states’ unfair competition or health and safety laws. As readers may be aware, there has been a surge of class action lawsuits filed against food companies based on alleged misbranding under the FDCA, including lawsuits alleging products misbranded or mislabeled as dietary supplements when they are conventional foods, and vice versa.
Companies in the food and dietary supplement industries should review the FDA’s final guidance carefully, and assess existing labeling and marketing practices. Changes to labeling and marketing may serve to minimize legal risk.