“It’s candy and I’m allowed to eat it during class,” my fourth grade classmate bragged to me. His parents wrote a note to the teacher saying that he was allowed to have cough drops during school to help with his cold. Little did my fourth grade self know that I was witnessing FDA regulation at work: a mentholated cough drop is both a food (candy) and a drug (suppressing a cough).

What is a Cough Drop Anyways?

A menthol cough drop is a rather simple thing to make: a syrup, a sweetener, a thickener, and menthol, pressed together in a lozenge or drop (technically they are different). For variation, a cough drop may have other flavorants (honey or eucalyptus oil) or colorants.

It’s a Food! 

A food is an “article[] used for food or drink for man or other animals.” FDCA, Section 201(f). Congress broke my fourth grade teacher’s rule that you cannot define the word using the word. So the law tells us that food is food, and under the moniker food there are countless different categories of food. FDA identified 43 of them in 21 C.F.R. 170.3(n) and one is “hard candy and cough drops.” In other words, FDA admitted that a mentholated cough drop is really just candy.

It’s a Drug!

A drug is an article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” (among other definitions). FDCA, Section 301(g)(1)(b). In simpler words, a drug is anything that the person who sells the thing tells you that it’ll cure you or at least make you feel better. A cough drop is advertised as stopping a cough (go figure) — thus mitigating the affect of a disease like a cold. Thus it’s a drug too and recognized as such in 21 C.F.R. 341.14(b)(2) (referred to as an “antitussive” – let’s hear for vintage words).

What Makes the Mentholated Cough Drop Curious?

First, a mentholated cough drop is one of the very few lawfully marketed products that is both a food and a drug (baking soda is another example, but that’s a discussion for another time). Second, it is a food but the label does not have a Nutrition Facts Panel, even though it is technically required to have one as no exemption applies (enjoy reading through 21 C.F.R. 101.9(j)). Third, it is a drug that is manufactured according to the good manufacturing practices for a food (21 C.F.R. 211.3(c)). This is good, because, fourth, they have commonly been manufactured by candy makers.

So this fall through spring as you are dealing with that cold or flu, know that the cough drop you are taking is a regulatory curiosity!

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