Five named, ten declared

Exhibit 01

Five names on the advert, ten on the bottle

This is the thing a reader notices first, and it needs no regulation to see. Count the names on the sales material, then the lines on the panel. The two numbers are not the same.

Supplied, not verified

The seller's own ingredient graphic, as supplied

Named here: Bacillus coagulans, chicory root inulin, babchi, lion's mane and ginger root. Declared on the label and absent from this graphic: fennel seed, fenugreek, lemon balm leaf, slippery elm bark and dandelion leaf.

Reproduced from the stock pack supplied with this product; not verified here.

The panel declares ten things in all: the nine botanicals indented under the 430 mg blend, and the Bacillus coagulans line above it. The graphic supplied with this stock frames five.

The obvious defence should be stated, because it is a good one. A sales graphic has finite room, nobody fits ten cards on one image, and leaving names off a picture is not the same as hiding them: all ten are printed on the bottle. The count on its own is a presentation choice.

What makes it worth a post is what the label does to the five names that are on the graphic, which is the subject of the fourth part below.

Exhibit 02

The five the sales material names, with what the label allows each

Five stills arrived with this stock, one for each name on the graphic, each shown here with the most the label lets it weigh.

21 CFR 101.36(c)(2) requires the ingredients in a proprietary blend to be declared in descending order of predominance by weight. That ordering rule is the only quantitative information this blend carries, because no individual figure is printed inside it anywhere.

Only the first of the five carries a printed figure, and it is not a weight: 500 Million CFU is a count of living cells. The fourth post here works through what a count of that kind does and does not tell a reader. The other four carry no figure at all, so the amounts beneath their pictures are maximums produced by the ordering rule. Every figure of that kind is a ceiling: the most an ingredient could weigh, never the amount in the gummy, and the real weight could be very much smaller.

Chicory root inulin shows why to be careful with a picture like this. It is first in the declared order, so its ceiling is 430 mg, the whole blend restated, and that bound rules nothing out: the inulin could be nearly the whole 430 mg or a small fraction of it.

Exhibit 03

The five on the bottle and in none of the sales material

No still arrived for any of these and no sentence in the supplied material mentions them. They are on the label, in the blend, in the printed order, with maximums the ordering rule produces exactly as it does for the rest.

Two are worth a second look. Fennel seed is third in the whole blend, above two of the five names the graphic does show, and is capped at 143.4 mg. Fenugreek is the one entry whose federal page carries a safety line a buyer might want in advance: “Potential side effects of fenugreek include diarrhea, nausea, and other digestive tract symptoms.” ^NCCIH

None of that is a verdict. It is the state of what this desk could read, and The ingredients page sets out each one with its own source or the absence of one.

Exhibit 04

What the ordering rule does to two of the five

Here is the part the count cannot give you. The order of the blend list is a weight order as a matter of regulation, not a house style, and that turns a marketing choice into a measurable claim.

“shall be declared in descending order of predominance by weight, in a column or linear fashion” ^{21 CFR 101.36}

So the list runs heaviest first. Apply that to the five names on the graphic and two of them land in the bottom half of the blend by weight: Ginger root at position 5 of nine and lion's mane at position 7, capped at 86 mg and 61.5 mg.

That is not an opinion about the formula and not a complaint about the pictures. It is where the label put them. Every figure of that kind is a ceiling: the most an ingredient could weigh, never the amount in the gummy, and the real weight could be very much smaller.

It works the other way too. Chicory root inulin and babchi, also on the graphic, are first and second in the order, so the graphic is not wrong about them. What it gives a reader is no way to tell the two cases apart, and the printed order does.

Exhibit 05

What the sources say about the five that are named

A name on a graphic invites a reader to look something up. For three of the five names there is nothing to look up, and that is a finding rather than a gap in the reading done here.

Each was checked against the complete NCCIH index, the NIH ODS botanical list and FDA’s Dietary Supplement Ingredient Directory, rather than searched for once and missed, because a reader is entitled to know the difference between a silence and an omission.

That leaves two of the five named things with a federal source behind it. NCCIH publishes a finding for ginger and no dose: “Research shows that ginger may be helpful for nausea and vomiting associated with pregnancy.” ^NCCIH And FDA’s 2018 review covers inulin-type fructans at “3 to 40 g/day” ^FDA a day, against which the entire 430 mg blend is 14 per cent of the lowest figure. Read that comparison carefully. The effect FDA recognised in that review is on bone mineral density and the absorption of calcium. It is not a gut finding, and no page on this site treats it as one.

No published trial on the finished Renew31 formula was supplied with this stock and none appears in any source this desk opened. Every reference on this site describes a single named ingredient, a category of products, or a labelling regulation. The ingredients page sets each declared thing against its own source, one at a time.