It’s labeled a supplement and sold as a soda. That flip turns the hero ingredient into an unapproved additive.
Regularity™ wears a Supplement Facts panel but is named, priced, and marketed as a drink-all-day soda — which makes it a conventional food. And in a food, the ashwagandha that is the whole brand promise isn’t a “dietary ingredient” — it’s an unapproved food additive, and the product is adulterated.
A file like this follows a pattern we know well. Not this company — Wildroot, its founder, its co-packer are invented — but the pattern: a buzzy better-for-you beverage brand that reached for the Supplement Facts panel because it lets the actives and the structure/function claims on, never asking whether the product is a supplement at all.
It isn’t. A soda you’re told to drink all day is a conventional food — and that one classification call, taken wrong at the formulation table, flips the rulebook: every added active becomes a food-additive question, and the hero ingredient fails it.
So we built the case, because the lesson is worth more than the recall it usually arrives with — the kind you can’t relabel your way out of.
- You put a Supplement Facts panel on something named and sold like a beverage.
- You cleared your actives on a dietary-supplement or self-affirmed-GRAS basis.
- You add caffeine, adaptogens, or amino acids to a sweetened drink.
- Your co-packer ran your thermal process off a prior product’s recipe, with no process authority.
If two or more are true, this case is describing your operation, not a stranger’s.
The file, as it arrived
Every record behind the brand — the ingredient GRAS-basis memo, the marketing site, the thermal-process batch record, the finished-product spec and COA. Each one, read on its own, looks like a careful beverage launch.
A product like this fails at the food-vs-supplement line, never inside one panel. Open the file and read what you’d catch — then see what we found, just below.
What the records showed, together
No single page is alarming — read apart, each record looks like a clean beverage program. Read together, the same file resolves into four threads, all turning on one call taken wrong: which rulebook the product lives under.
A conventional beverage, on the wrong rulebook.
By FDA’s own representation factors, this is a conventional food — so it can’t ride DSHEA, and the panel and disclaimer it carries are the wrong ones.
The flip turns the hero ingredient into an unapproved additive.
As a food, every added active is a food-additive question — and the ingredients the brand is built on were cleared on a supplement basis that doesn’t reach a food.
Added caffeine and fortification, outside the lines.
The Focus Shot stacks its own food-additive problems on top of the classification flip.
A thermal process no one validated — and a deviation released anyway.
Underneath the legality problem is a food-safety one: the acidified-food question was never asked, and the process was carried over and overridden.
Read apart, every record looked like a careful beverage launch — a GRAS memo, a marketing site, a batch record, a spec sheet. Read together, they describe a conventional food wearing a supplement’s panel, whose hero ingredient is an unapproved additive, whose shot is far outside the caffeine listing, made on a thermal process nobody validated and a deviation nobody escalated. The panel said “supplement.” The can, the 12-pack, and the “drink all day” said “food” — and the food rulebook said “adulterated.”
None of it needed a new fact to see. It needed the classification call made first — food or supplement — at the formulation table, before the actives, the panel, and the claims were all built on the wrong answer.
What was at stake
A recall you can’t relabel away
The defect isn’t the panel — it’s the formula. A retailer query or a single FDA look at “Supplement Facts on a soda” triggers a national stop-sale; the stock matches an unlawful formula, so it’s frozen and recalled, not quietly relabeled — while the disease testimonials add a drug-claim and processor-freeze exposure on top.
The classification call, made first
A conventional-beverage-vs-supplement determination, then an ingredient-by-ingredient GRAS/additive analysis and an acidified-food filing — done at the formulation table — means you reformulate or petition before launch, not recall after.
If this is your operation
You don’t need us to find out whether your beverage has the same blind spot. Most of it you can check yourself, this week, with the file you already have.
- Is your product a conventional beverage or a dietary supplement — by how it’s represented and sold?— the name, the serving, the “drink all day” decide it, not the panel you chose.
- Is each added active GRAS or approved for a food?— or cleared on a supplement / self-affirmed-GRAS basis that doesn’t reach a beverage?
- Is your added caffeine within the cola-type GRAS listing?— or far outside it, with no safe level for your use?
- Did a process authority set your thermal process and your acidified-food status?— or was it carried over and deviations waved through?
Nothing here is built around this one brand — each door points somewhere bigger, and no one of them is the “right” one. The case is just where they all meet.
A Supplement Facts panel was never the same thing as being a supplement.