The Renew31 Supplement Facts panel, and the 4 lines that do not reconcile

Part A

The panel, transcribed line for line

This is the one document supplied with this stock that is legally required to be accurate, so everything below is transcribed from the photograph.

Tap to enlarge

Because the serving is one gummy, every amount above is also an amount per day. The dagger footnote, as printed: † Daily Value Not Established

Part B

Finding one: Calories 4 is not a value this panel may print

The first finding needs no arithmetic: one printed digit against one sentence of regulation. 21 CFR 101.9 governs calorie declarations and 101.36(b)(2)(ii)(A) applies it to a Supplement Facts panel.

Calories are “expressed to the nearest 5-calorie increment up to and including 50 calories” ^{21 CFR 101.9}, with the provision for the other end of the scale that declarations run in a “10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero.” ^{21 CFR 101.9} Below 50 calories this panel had three values available and printed none of them.

Two readings, and this page gives both rather than choosing. Either the serving holds under 5 calories, in which case the lawful declaration was 0. Or it holds 5 or more, and it was 5 or 10. Over a bottle the whole quantity in dispute is 120 calories, so this is a labelling finding rather than a safety one. It matters twice, because the same digit turns the missing fibre line into a contradiction.

Part C

Finding two: the missing fibre line and the calorie figure cannot both be right

Omitting a Dietary Fiber line is lawful under one condition, contradicted by the digit immediately above it.

21 CFR 101.9(c)(6)(i) requires dietary fibre to be declared “except that if a serving contains less than 1 gram, declaration of dietary fiber is not required” ^{21 CFR 101.9}. Under a gram the line may come off, so its absence is a statement: this serving holds less than one gram of fibre. Now the calories. 21 CFR 101.9(c)(1)(i)(C) sets the factors: digestible carbohydrate at 4 calories a gram, and for the non-digestible part, “A general factor of 2 calories per gram for soluble non-digestible carbohydrates shall be used.” ^{21 CFR 101.9} No express factor is set for the insoluble part, so this page carries it in its own column and treats it as zero, which is a reading of the quoted sentence.

One row of four lands on 4, and it needs a full gram of insoluble non-digestible carbohydrate. A full gram is not less than a gram, so the only split that produces the printed figure is the one that would have required the missing line.

At 4 calories per gram for digestible carbohydrate, 2 g is 8 calories. Reaching 4 requires about a gram of non-digestible carbohydrate - which would have required a Dietary Fiber line the panel does not print. This page does not decide which statement is wrong, because nothing published settles it, and it does not follow that the gummy contains a gram of fibre or none. FDA publishes a plain-language page on which carbohydrates count as dietary fibre, and it is in the references below.

Part D

Finding three: the probiotic is quantified in CFU and in no weight

The panel prints Bacillus coagulans 500 Million CFU on a line of its own. That is a count of living cells, not a weight, and the binding regulation asks for a weight.

21 CFR 101.36(b)(3)(ii)(A) covers the amounts of other dietary ingredients: “These amounts shall be expressed using metric measures in appropriate units.” ^{21 CFR 101.36} A colony-forming unit is not a metric measure of quantity in that sense. NIH ODS describes what it is: “The number of viable cells in a probiotic supplement is indicated by the number of colony-forming units (CFU) listed on the label.” ^{NIH ODS}

The industry asked FDA to change that. In September 2018 FDA issued draft guidance on labelling dietary supplements containing live microbials and denied the request to let CFU replace weight; what it offered was enforcement discretion for declaring CFU in addition to weight, where the quantity is first listed in terms of weight. Here it is not. Two things follow and this page says both together: the guidance is draft and non-binding, so it is not a rule this panel has broken, and the regulation it offers discretion against is binding and asks for a weight this panel does not carry.

The count, against the only federal description of one this desk could open

500 Million CFU is 500,000,000 colony-forming units. NIH ODS describes the market: “Many probiotic supplements contain 1 to 10 billion CFU per dose, but some products contain 50 billion CFU or more.” ^{NIH ODS} This count sits below that band by a factor of about 2. In the same fact sheet, immediately afterwards: “However, products with higher CFU counts are not necessarily more effective than products with a lower CFU count.” ^{NIH ODS} Both halves travel together here, and no federal source this desk opened publishes any dose for Bacillus coagulans.

Part E

Finding four: added sugars at 0% against total sugars of 1 g

The fourth finding is the shortest. The panel prints Includes Less Than 1g Added Sugars with 0% beside it, under a total sugars line of 1 g, and the ingredient list names two added sugars.

The Daily Reference Value for added sugars is 50 g, set in 21 CFR 101.9(c)(6)(iii), so 0% means under about 0.25 g, which is 0.5 per cent of it and the boundary below which rounding still produces zero.

The first Other Ingredient is Glucose Syrup and the third is Sucrose, both added sugars by definition. For the declaration to hold, those two would have to account for under about a quarter of a gram of the 1 g, and nothing else on the ingredient list is a sugar. The only sugar sources in the ingredient list are glucose syrup and sucrose, and both are added sugars by definition. 0% of a 50 g Daily Value is under about a quarter of a gram. At 1 gummy a day a bottle is 30 g of total sugars across 30 days.

Part F

What this panel does properly, and what it does not publish

Stopping at four findings would leave out the half that is to the label’s credit.

• The blend runs heaviest first, as 21 CFR 101.36(c)(2) requires, which is the only reason any figure here can be worked out.
• The dagger convention is used correctly against both lines with no established Daily Value.
• The allergen line is volunteered. No Allergens is the manufacturer’s own statement, not a format FDA prescribes.
• The servings arithmetic resolves exactly, at 30 days.

Against that, four absences bear on how this panel can be read: the weight of the organism, the individual weight of any blend member, a Dietary Fiber line, and any extract ratio.