After a four-year delay, FDA has at last released a final version of its guidance on liquid dietary supplements. The document doesn’t much change the line of thinking offered in the draft version but does offer more detail and clarification and in general was greeted as a positive step by industry observers.
“We are just really pleased to see this. This is so much better than the draft guidance,” Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN) told NutraIngredients-USA.
“I’ve always told any company when they are looking at a product that everything has to fit within a category. And FDA has given you here a whole road map as to whether you are going to go the beverage route or whether you are going to go the supplement route, with just about everything to consider,” said Steven Shapiro, an attorney with Ullman, Shapiro and Ullman who counts many food and beverage companies among his clients.
“We’ll see how its enforced, but I think it’s a much better statement of what the DSHEA requirements are versus conventional foods.”
The guidance, called Distinguishing Liquid Dietary Supplements from Beverages , lays out all of the factors that FDA will use to decide whether a product is being represented to (and, by implication, understood by) consumers as a dietary supplement or a conventional food. Some products in recent years seem to have sought to occupy a borderland-type region between the two realms, being offered first as a supplement, and then, after a repackaging and branding effort, as a food or vice versa. The guidance draws a more definitive line in the sand demarcating the two realms.
The distinction is an important one, and bears on what can be said about a product, what kind of ingredients can go into it and what can kind of claims can be made about it. The key point is that supplements are just that, products meant to supplement the diet in some way. If they are represented as a major portion of a consumer’s daily caloric intake—a meal replacement shake, for example—FDA could consider such a product to be a food even if the label says ‘supplement.’
FDA says in the guidance: “Products in liquid form can be represented as conventional foods as a result of factors such as their product or brand name, packaging, serving size and total recommended daily intake (i.e., the volume in which they are intended to be consumed), composition, recommendations and directions for use, statements or graphic representations in labeling or advertising, and other marketing practices.”
Panoply of factors
The guidance looks at all of those factors in detail, and gives some examples for how its thinking could be applied in the marketplace. For instance, on the subject of serving size and total recommended intake, while a large can or bottle doesn’t automatically make a product a beverage as opposed to a supplement, the agency notes that a product with a large volume that encourages multiple servings per day might end up accounting for the majority of a consumer’s daily fluid intake, and that doesn’t look like ‘supplementation’ to the agency.
And the language that is used to refer to the product—on labels, in marketing materials and even in FTC and patent filings—will be used by FDA to decide if the product is fish or fowl.
“It’s definitely more specific than the draft guidance. And it gets into more examples, such as some of the statements made on a supplement label might be evidence of an intent to represent a product as a beverage if it uses words such as ‘refresh’ or ‘rehydrate,’ ” said Justin Prochnow, a shareholder in the firm Greenberg Traurig.
As with the draft guidance, the final version does not state in absolute terms what is a supplement and what is a food. That will still be a case-by-case scenario. But it does add a lot more color to the palette FDA will use to make the eventual determination.
“FDA is saying, we’ll look it holisticly. We will look at your entire product to make a decision," Shapiro said.
Mister said CRN was grateful that the agency seemed to have taken to heart comments made on the draft guidance and crafted a final version that addressed many of industry’s concerns.
“The draft guidance seemed to focus pretty single-mindedly on the volume of the product. We told the agency that you really need to look at a lot of different factors to decide if a product is a supplement or a beverage and we are pleased they heard that message. We think this provides a lot of clarity for the industry,” Mister said.
Draft guidance on ingredients
In addition the final guidance, FDA also released a short draft guidance on the use of ingredients in a liquid supplement as opposed to a beverage. Observers agreed that much of what is in this short document is found elsewhere in regulations or guidance. This newest guidance reiterates what factors a company should consider for its ingredient choices depending on whether the product is a beverage or a supplement, such as GRAS status, whether the ingredient is a new dietary ingredient, etc.