When we lawyers tell opponents in litigation they are wrong, we tell judges they are wrong, and smart lawyers even tell their clients they are wrong when necessary. Why do we do it? Well, correcting people makes us feel superior, and after all, everyone needs a hobby.
So in keeping with the legal tradition, I will explain everything for you about the world of nutraceuticals, functional foods, and dietary supplements, which are the subject of widespread misunderstandings. Not on your part, of course, I said, smiling.
1) “Nutraceuticals.” There’s no such thing as ‘nutraceuticals.’ Not legally anyway. It’s not a recognized term from the Food and Drug Administration’s point of view, because the agency recognizes only “dietary supplements”—products taken by mouth and intended to supplement one’s intake of this or that—and “foods”—of which dietary supplements are a subset and the rest are referred to as “traditional” foods or beverages—and “drugs”—articles other than foods that are intended to do something with respect to a disease or to affect the structure or a function of the body.
The source of much confusion is the fact that both dietary supplements and traditional foods are permitted by law to make claims on their labels of effects on the structure and function of the body, as drugs are, and even in rare instances to make claims about reducing the risk of some diseases, as one commonly thinks of drugs as doing.
“Nutraceuticals” is a marketing term, one that combines parts of two words “nutrition,” because they look and taste like ingested foods with nutritional value, and “pharmaceuticals,” because they are intended to give some health benefit like a drug does.
I get it, and marketing is important, so as a marketing term, bless its heart, it’s a fine term. But just be careful: How a product is regulated depends primarily on what type of product FDA thinks it is, and the term “nutraceutical” has no legal meaning as such, should you run into a stickler about such things who has “FDA” in their title. Same goes for….
2) Functional Foods, which is another marketing term that usually refers to a subset of nutraceuticals. It is intended, I think, to refer to foods or beverages in traditional form, as opposed to being tablets or liquids intended as and labeled as dietary supplements, but which tout their health and wellness benefits, thus serving a “function” above a food’s traditional ones of providing taste, aroma, and nutritive value. Many such products are boosted with extra vitamins or other substances to goose up that function.
This term may have emerged after traditional foods started making claims of benefit to the body’s structure or function in reaction to the proliferation of dietary supplements making such claims in the 1990s, when the Dietary Supplement Health and Education Act gave packagers of dietary supplements explicit legal authority to make such claims.
So you can call ‘em “functional foods” in marketing meetings, in ads, and around the water cooler, but just remember it isn’t a legally recognized term describing a category of foods.
What this all means is that when you are confronted with an edible product you’re not familiar with and wonder what legal obligations apply to it, the best first question about it is whether it’s a food and if so if it’s a dietary supplement, or whether it’s a drug, rather than wondering if it’s a nutraceutical or functional food.
3) “Dietary supplements are not regulated.” Please, don’t ever say this. Even though most dietary supplement ingredients and products require no approval by FDA before they are marketed, dietary supplement safety is regulated, dietary supplement manufacturing controls are regulated, dietary supplement labeling is regulated, and dietary supplement adverse reactions are regulated. And when I say they are regulated, what I mean is that each of those areas is the subject of provisions of law and actual regulations dictating requirements for those products.
And hey, don’t wink at me about the low odds you’d get caught: If in reality FDA lacks the resources to enforce all these obligations to the full extent possible, the fact remains that the obligations do exist. And on top of them, the prospect of civil product liability cases being filed by consumers over injuries or even just misleading label statements should by itself inspire careful compliance in all respects.
Please let me know if there are any other topics you would like me to correct you about. What’s that you say? CBD? OK—watch for bossy commentary on that in next month’s column.
INFORMATIONAL ONLY, NOT LEGAL ADVICE.
