FDA Says Drinks Are Not Supplements

Unless I am reading the latest guidance from FDA incorrectly, there are probably a lot of people in the "functional beverage" world that could use a drink today. FDA states very clearly that products being sold as supplements in the form of conventional beverages are, in fact, not supplements. And this makes these products misbranded and out of compliance with the law. If you sell a liquid dietary supplement, or a functional  beverage (though that is not an actual category of goods under the law), or if you sell any ingredients or services to a company in this sector, you must read this FDA guidance document. Here are a few excerpts that will raise an eyebrow:

"Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement in section 201(ff) of the FFDCA (21 U.S.C. 321(ff)) and must meet the regulatory requirements that apply to conventional foods..."

"Under section 201(ff)(2)(B) of the FFDCA (21 U.S.C. 321(ff)(2)(B)), the term “dietary supplement” means a product that, among other requirements, “is not represented for use as a conventional food or as a sole item of a meal or the diet.”  Beverages are conventional foods under the FFDCA.  Even when the label of a liquid product characterizes it as a dietary supplement, the product may not in fact be a dietary supplement.  Liquid products can be represented as conventional foods as a result of factors such as their packaging, the volume in which they are intended to be consumed, their product or brand name, and statements about the product in labeling or advertising.  For example, the packaging of liquid products in bottles or cans similar to those in which single or multiple servings of beverages like soda, bottled water, fruit juices, and iced tea are sold, suggests that the liquid product is intended for use as a conventional food..."

"FDA is concerned that some of the novel ingredients that are being added to beverages and other conventional foods may cause the food to be adulterated because these added ingredients are not being used in accordance with an approved food additive regulation and may not be GRAS for their intended use..."

I'm drinking a Monster "Energy Supplement" as I write this, and based on this FDA guidance, that product is out of compliance. The same can be said for any other supplement sold in a form that looks like a beverage. And, even for those "enhance" beverages that are labeled as food and not supplements, the use of ingredients that are not approved food additives or GRAS for that intended use also causes them to be out of compliance. Pay attention to this one folks, it's big. The agency is taking comments for the next 60 days before it works on its final guidance document on this subject.