Meal replacements win first EFSA weight management claim approval

Significant effects, study products that matched those on-market and biologically plausible mechanisms were cited by the European Food Safety Authority (EFSA) as the major reasons why meal replacements won a rare article 13.1 positive opinion last week.

EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found meal replacements could be effective in two ways:

  • reduction of body weight
  • maintenance of body weight after weight loss.

The opinion found causality had been demonstrated for these two affects in food items that contain a maximum of 250kcal per serving and comply with specifications laid out in the European Union directive on energy restricted diets for weight loss.

Two meals should be replaced per day among the target group of overweight subjects seeking to reduce their body weight, the NDA said.

“The Panel took into account that in the first meta-analysis provided, weight loss achieved with meal replacement products was significantly greater (almost double) than with conventional energy restricted diets prescribed with the same calorie content,” the NDA said.

“…biologically plausible mechanisms have been proposed by which meal replacements could exert the claimed effect, mostly in relation to their controlled energy content and relatively high protein, low fat content.”

Unilever, the owner of leading meal replacement brand, Slim.Fast, welcomed the opinion.

“This confirms the conclusions of over 40 clinical studies that Unilever’s Slim.Fast brand has conducted. Official approval of these claims would enable products in the Slim.Fast portfolio that comply with the required conditions to make a claim that relates these meal replacement products to effective weight management," the company told NutraIngredients.com.

The opinion characterised meal replacements as providing between 25 per cent and 50 per cent of their energy in protein, not more than 30 per cent as fat, not less than 1g of linoleic acid (in the form of glycerides), and at least 30 per cent of the dietary reference values for adults of a range of vitamins and minerals, and at least 500 mg of potassium per meal.

The claim also benefitted from the fact the target population was not considered to be a diseased section but rather overweight members of the general population – the same population section used in the majority of the trials and therefore removing the need for any extrapolation to occur.

“Weight loss can be interpreted as the achievement of a normal body weight in previously overweight subjects,” the NDA said. “In this context, weight loss in overweight subjects without the achievement of a normal body weight is considered beneficial to health.”

The NDA observed a similar effect for the maintenance of weight after weight loss, for which 14 references were submitted.

For the reduction in body weight claim there were two meta studies that featured six randomised, controlled trials and 47 intervention trials respectively,

Of the 47 intervention trials, four specifically related to commercial products being consumed twice daily by 470 women and 133 men with average Body Mass Index ranging from 28 to 34 kg/m2.

In the studies women lost an average of 9.3 per cent of their initial weight while men lost 8.6 per cent.

“These effects were comparable to intensive lifestyle interventions including conventional energy-restricted diets with an intensity factor (integrating number of visits with a doctor, clinic visits, and class hours) three times lower,” the NDA said.

The opinion, which was published among the second batch of 416 article 13.1 opinions, can be found here.