Dietary Supplement Delivery Formats Offer Strong Appeal and Unique Challenges
Meeting Dietary Supplement Definitions: Not as Easy as Meets the Eye
With the anticipation that several finished product companies in the dietary supplements space may soon be experimenting with more novel delivery formats, Ivan Wasserman, managing partner at Amin Talati Wasserman LLP, said that greater attention from regulators might be placed on format-related issues.
Dietary supplements and conventional foods are regulated under different sets of standards, and the agency is concerned about products which pass off as conventional foods that contain ingredients only approved for use in dietary supplements.
“DSHEA (the Dietary Supplement Health and Education Act)—you need to know it, love it, and dream it. You need to know how this legislation defines what a dietary supplement is,” Wasserman said.
There is little legislative history involving the interpretation of what a dietary supplement is by DSHEA’s definition, and there can be room for ambiguity.
“Dietary supplements are intended for ingestion and cannot be represented for use as a traditional food or as a sole item of a meal or the diet,” he noted. The legislation specifically mentions capsules, powders, soft gels, gel caps, and liquid forms. If a product does not meet one of those forms, it is still unlawful to be represented for conventional food use.
Dietary supplements need to be fully ingested, and so, many delivery formats on the market today are in a bit of a gray area when it comes to meeting the definition, Wasserman said. Those in the “maybe” category include sprays, lozenges, chewing gums, or any supplement that instructs the user to put it under the tongue.
“Factually, a product might function as a dietary supplement, but with the FDA, it’s more about what you say. If you mention the oral mucosa, or say the word sublingual, FDA doesn’t like it. A good argument can be made, however, if you instruct users to swallow the product. It’s also important to say where the effect of a given product takes place. So, if you say that your product can have an effect pre-digestion, that could land you in trouble with the FDA,” Wasserman said.
He pointed to a guidance document that FDA issued on the subject of energy drinks, which he said largely showed the agency is primarily concerned with the representation of products, more so than formulations. With the advent of more food-like dietary supplements, this will likely be the key area of potential enforcement focus.
In the guidance document, the agency listed the factors it would consider when determining if a liquid dietary supplement meets its criteria and is not misleading: labeling; advertising; product name; packaging; serving size; recommended daily intake; recommendations and directions for use; marketing practices; and other representations of a product.
“It’s a very interesting read, and while it’s beverage-specific, this could be applied to other areas,” Wasserman said. “Talking about a product being refreshing, delicious, or hydrating—words normally associated with drinks or foods—could be an issue. If you call yourself a drink, like a milk, or a soda, FDA will say the product is a food. If your can sort of looks like a soda can, in terms of graphics and size, they’d take that into consideration over whether or not a given product is a conventional food.”
When it comes to recommended serving size, “if you say ‘take one shot’ or ‘drink half of a can’ that’s a supplement kind of thing. But if the directions say, ‘you can drink this all day, it’s delicious, drink it as much as you’d like,’ FDA will obviously consider that,” Wasserman continued.
There are some less obvious issues when it comes to marketing that FDA mentioned in this guidance document. Wasserman said. One example is where a product is located in proximity to other foods.
“FDA said that if a retailer, on its own, decides to put your supplement on a shelf with non-supplement products, they’re not going to hold it against a manufacturer,” he said. “But, if there’s evidence that a manufacturer directed a retailer to put something on a shelf with food products, they could use that against you. So, be careful in your communications with retailers.”
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