The FDA has issued a guidance that bears close watching.
As you may recall, in the arcane world of government regulation, guidance does not have the force of law, but does explain how the agency is interpreting the law.
The US Food and Drug Administration has released “Distinguishing Liquid Dietary Supplements from Beverages.” Its purpose is to help dietary supplement and beverage manufacturers determine whether a product in liquid form is properly classified as a liquid dietary supplement or as a beverage.
Why does this matter? Each ingredient in a beverage must specifically be approved by the FDA unless in the GRAS (Generally Recognized as Safe) category. Reclassifying supplements as beverages may in some cases give the FDA more authority over their ingredients, and we could lose access to some of them.
The guidance does not state anything in categorical terms; the FDA has provided examples and has reserved the right to review liquid dietary supplements on a case-by-case basis. This makes the system rife for FDA abuse, as there is no way for dietary supplement manufacturers to know whether they are in compliance with the law or not.
For example, if a liquid supplement advertises with words such as “rehydrate” or “refresh,” these are considered “beverage” terms and change the regulatory category. Or a graphic that shows a liquid being poured over a green salad would represent the product as a salad dressing rather than a dietary supplement.
Just to remind us how dense this regulatory thicket is, if the product that used the word rehydrate added the words “heat exhaustion or stroke victims” then it would not be either a supplement or a beverage, but rather a drug, and have to be taken through the full FDA drug approval process.
Just to make it a bit worse, this guidance means that supplement makers now have to worry about the size, shape, color, and design of the packaging, the volume of liquid it holds, and whether it is recloseable or designed to be consumed in a single serving (since a dietary supplement cannot be the sole item of a meal or the diet).
We at least agree with the FDA on one point, that the addition of a dietary ingredient does not turn a conventional food into a dietary supplement. For example, adding a botanical such as ginkgo to Kool-Aid or eggnog does not automatically create a product that can be marketed as a “ginkgo supplement.”
The FDA’s guidance is final, and no comment period will be available. Nevertheless, we will keep a close eye on its implementation and will keep you informed of any adverse developments.