WASHINGTONFDA published a final guidance representing its current thinking on distinguishing liquid dietary supplements from conventional beverages for the purpose of regulatory oversight.
Essentially, the agency said it will look at a range of factors to decide the regulatory status of a liquid consumable product, and offered recommendations for companies developing and marketing such products to best adhere to regulations for either conventional foods or dietary supplement. This final publication follows a draft guidance on the subject published in 2009, as well as numerous requests from Congress and industry to clarify the line between beverage and supplement.
Industry reaction to the guidance was generally upbeat, appreciative of the agency's willingness to reconsider its earlier rigid position. "The Natural Products Association (NPA) applauds the FDA's effort to respond to industry requests for clarification of the more general draft guidance," said John Shaw, CEO of NPA.
Steve Mister, president of the Council for Responsible Nutrition (CRN), said initial industry concern about the 2009 draft guidance was the apparent focus on the volume of the container. "We urged a more flexible approach," he said, adding CRN was pleasantly surprised by the agency's latest position, which shows it listened to comments from industry and others. "In this final guidance, no one factor is dispositive."
In Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages, FDA noted the regulatory distinction of a liquid form product would be determined by numerous factors, including the product or brand name, packaging, serving size and total recommended daily intake (i.e., intended consumption volume), composition, recommendations and directions for use, statements or graphic representations in labeling or advertising, and other marketing practices. For example, use of the terms beverage," drink," water," or soda" in the marketing or the product name would render the product a conventional food.
Representation as a conventional beverage can also be implied by the size, shape, color, and design of the container or other packaging. Its similarity to common beverage packaging and the volume it holds also matter, as does whether it is reclosable.
Another important consideration highlighted in the guidance is labeled serving size: "Liquid products that suggest through their labeled serving size and/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 in the United States are effectively being represented as conventional foods," FDA wrote.
Additional reasons why FDA would consider a product a beverage, not a liquid supplement, focus on marketing:
- comparing the product to a beverage subcategory, such as sodas, via marketing, labeling or advertising;
- touting it as an accompaniment to a meal;
- or featuring typical beverage criteria like taste, refreshment and thirst-quenching ability.
Also, the technical aspects of promotional websites are possible factors, including the use of metatags that place the promotional web pages in search results for sodas, juices, or other beverages. Similarly, paying for the product to be displayed in the beverage section of retail stores would also weigh into FDA's consideration.
As a sign of the times, social media activity can play a part in FDA's decision on beverage vs. supplement, according to the guidance. "The FDA has been steadily looking at social media as evidence of intent," said Justin Prochnow, partner at the law firm Greenberg Traurig, who referenced an FDA warning letter issued to a company at the end of 2012 for liking" a comment.
Shaw said FDA had little choice but to include social media in this guidance. "If this document were finalized four years ago, it might not have the emphasis on social media, but this just demonstrates how much this market has grown for all product categories," he said. (NPA is putting on a webinar next Wednesday that delves into social media and dietary supplement advertising).
The guidance's mention of the use of product representations in publicly available documents, such as patent filings, may be a surprise to some, but Prochnow noted a past FDA warning letter counted an intellectual property filing among regulatory factors for a product being marketed as a liquid dietary supplement. The 2012 letter to Lithia Mineral Water referenced a trademark application that called the product "bottled water" or "mineral water."
Shaw agreed the inclusion of intellectual property filings in the guidance should not be a surprise. "Once youve decided on a regulatory category, you need to be committed to that category," he said. "The FDA doesnt look kindly upon companies flip-flopping their products between conventional foods and dietary supplements."
In the guidance, FDA stressed the role of composition in distinguishing between beverage and supplement status. In short, adding a substance that fits the regulatory definition of a dietary ingredient to a product widely viewed as a beverage does not automatically make that product a dietary supplement. FDA will consider the composition along with other factors when deciding if a product is a beverage or a supplement.
Beyond clarifying how the agency views the differences between conventional beverages and liquid supplements for regulatory purposes, the guidance reminded industry about the different regulatory requirement for ingredients used in these two types of products. In a beverage, ingredients need to be either GRAS (generally recognized as safe) or an approved food additive, whcih both address safety issues and limit approval to specific intended use. In a dietary supplement, any substance considered a new dietary ingredient (NDI) would need to have a premarket NDI notification to FDA; non-dietary ingredientsexcipients, binders, etc.would need either food additive approval or GRAS status or their intended use.
FDA emphasized these ingredient requirements by issuing an accompanying guidance, Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. Mister said this guidance contains nothing new, but is a strong reminder of the different requirements, including GRAS, as well as the importance of concentration.
In this second guidance, FDA stated, "We are concerned that some of the novel substances that are being added to conventional foods, including beverages, may cause the food to be adulterated because these added substances may not be GRAS for their intended use and are not being used in accordance with a food additive regulation."
Overall, the industry's reception to the two guidance publications was positive. CRN released a statement applauding FDA for the guidance for "thoughtfully addressing previous confusion about the distinctions and delivering much-needed clarity for manufacturers and marketers to appropriately classify and label their products."
Mister called this more flexible guidance a better, more-market-driven approach that gives companies a chance to look at the positioning of their products to make sure they are properly classified. "Our members will appreciate the clarity of the guidance and will incorporate the recommendations to make smart decisions," he said.
One section that stood out for Mister was on powder mixes and liquid concentrates, which the guidance said would still be considered dietary supplements if they are labeled as such and are not intended as substitutes for beverages. Though often added to beverages, these supplement premix products are intended to supplement the diet and are not likely confused with beverage premixes, such as lemonades, the guidance explained. "The guidance critically points out supplement mixes and beverage mixes are not the same thing," Mister said. "It is about intentional choices."
What stood out for Prochnow was the reiteration of the policy regarding structure-function claims and that structure-function claims for beverages must relate to taste, aroma, or nutritive value. "While this isnt new policy, the FDA has very rarely split hairs to review structure/function claims and see whether they relate to aroma, taste or nutritive value," he said. "It will be interesting to see whether FDA actually starts to take issue with structure/function claims made for beverage and food products that dont relate to one of those three categories."
While guidance published by FDA are not enforceable regulations and only represent the agency's thinking on various regulatory subjects, industry looks to such guidance as an indication of what to expect in agency oversight, and FDA may increase enforcement once its thinking has been made official. "FDA may feel freer to act after it's made its opinion clear to industry," Mister said, when asked about an uptick in agency activity in the overlap of conventional beverages and liquid supplements. "Some people call this a gray area," he said, referring to the possible combinations of factors cited in the guidance, "but we call it flexibility in the marketplace."
Shaw said the approach outlined in the final guidance certainly provides FDA a certain amount of discretion in deciding a product's status, but it also allows a fair amount of area for product manufacturers to operate in as well. "There isnt often a clear line to distinguish between the two product categories, so the guidance document has to account for this."