Rejected: EFSA tells Glanbia its whey “weight loss peptides” claim is “not characterised”

After receiving the article 13.5 application under the EU nutrition and health claims regulation (NHCR), EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) demanded that Glanbia clarify the hydrolisation process that produced the peptides in the ingredient.

Glanbia provided an overview of the manufacturing process including steps to derive the hydrolysed protein components including degree of hydrolysis and results from an angiotensin-converting enzyme (ACE) inhibitor assay).   

“the full manufacturing process was not described”​​

But this was not satisfactory to the NDA, which said, “the full manufacturing process was not described, no information was provided on  the enzyme used  for hydrolysis  or on the specific conditions applied,  the amount of the hydrolysed whey protein component  that is present in the final product  was not specified, and  no  further  information was ​available on the characterisation of the peptides.”​

Glanbia told the NDA some of that data was confidential.

The NDA therefore concluded that, “a cause and effect relationship cannot be established between the  consumption of Prolibra and ‘helps to reduce body fat while preserving lean muscle’ in the context  of energy restriction for weight loss.”​

Since 2004, Glanbia has released the results of numerous studies supporting the weight loss benefits of Prolibra.

These demonstrate that the ingredient can help decrease fat mass while maintaining lean body mass in combination with a hypocaloric diet.

One trial found that Prolibra reduced body fat by almost 6% (with 79% of the weight loss being fat) compared to just over 2% in the control group (where 51% of the weight loss was fat).

Prolibra has also been shown to reduce post-prandial glycemic response.

Glanbia was not available for comment at the time of publication.

The NDA opinion can be found here.​