Scientific Advisory

A nine-fold result we advised the client not to claim

A nine-fold result we advised the client not to claim

A nine-fold result we advised the client not to claim

The pharmacokinetic data was real. Transferring it to the finished product was not supportable.

The pharmacokinetic data was real. Transferring it to the finished product was not supportable.

The situation

A functional food brand was evaluating a differentiated omega-3 raw material for use in a protein bar. The supplier package included a randomised crossover pharmacokinetic study showing a substantial increase in fasting absorption against a conventional ethyl ester comparator. The marketing implication was obvious and attractive.

What we found

The study was sound and the mechanism was explicable: the ingredient starts at a stage in the absorption pathway that conventional forms have to reach first. But the study was a fasting, single-dose capsule design in healthy adults. It was not run in a food matrix, it did not test a bar, and it was not evidence that a lower dose would deliver equivalent exposure.

Three things would need demonstrating before the finished product could carry any version of the claim:

  • Process compatibility through the actual manufacturing conditions.

  • Oxidative and sensory stability in the final package.

  • Matrix-specific release behaviour in a high-protein format.

There was also a specification detail worth catching early. The grade designation referred to combined EPA and DHA content, not EPA alone, which is an easy misreading to carry into a label.

Raw-material performance and finished-product performance are two different claims.

Raw-material performance and finished-product performance are two different claims.

What we did

We set out the defensible position rather than the maximal one: a differentiated dosage form with a measured fasting pharmacokinetic advantage in capsule form, described accurately, with the study boundary stated.

We separated what the raw-material data supported from what would require finished-product work, and specified the analytical panel for the latter.

The outcome

The brand had a claim it could stand behind at the point of substantiation, and a clear list of what the finished bar would need to demonstrate before any stronger statement could be made.

Bring us the package before you commit the spend.

Bring us the package before you commit the spend.

Bring us the package before you commit the spend.

A single review cycle is usually enough to establish whether the data in hand describes the product you intend to sell.

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