U.S. dietary supplement labeling is governed by the Federal Food, Drug, and Cosmetic Act together with FDA's labeling regulations at 21 CFR Part 101, and the current Good Manufacturing Practice rule for dietary supplements at 21 CFR Part 111. Part 111 is where storage obligations actually live, and it places the obligation on the manufacturer's holding conditions, not on a specific sentence the label has to carry. 21 CFR 111.455(a) requires that components and finished dietary supplements be held “under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected.”
Read closely, that is an outcome-based requirement, not a prescriptive one. It does not mandate a specific storage sentence, a refrigeration icon, or a temperature range printed on the front of every bottle, and it does not require a dietary supplement to carry an expiration or best-by date at all. What it requires is that whatever storage conditions the manufacturer actually uses — and, by extension, whatever it tells a buyer to replicate at home — keep the product's identity, purity, strength and composition intact. The regulation names the outcome and leaves the manufacturer to decide, and disclose, whatever handling conditions actually get it there. For an ordinary capsule with no live organisms and no heat-sensitive actives, “store in a cool, dry place, away from direct sunlight” is a common and sufficient way to describe that. For a product carrying organisms the manufacturer wants to keep viable, a stronger instruction — refrigerate after opening — is a voluntary addition on top of that floor, not a substitute for it.
So the honest way to describe Sodatide's label is this: the cool-dry-place line and the heat/light/humidity line are the kind of general stability guidance 21 CFR 111.455(a) contemplates every supplement label carrying in some form, aimed at the capsule shell and the two non-living ingredients. The refrigeration line is an additional, more specific instruction layered on top of that floor, aimed narrowly at the probiotic content. Nothing in the regulation forbids a label from carrying both a general rule and a more specific one for the ingredient that actually needs it — and a great deal of supplement and food labeling does exactly that, because general stability advice and an ingredient-specific handling instruction are answering two different questions.