Very Low Energy Diet will be Supervised as FSMP in Australia and New Zealand

FSANZ proposed to include the very low energy diet products in the scope of food for special medical purposes. In addition, the product standard is drafted. Enterprises will have a three-year transition period after the promulgation of the standard.

According to Notice No. 194-22 issued on March 21, 2022, Food Standards Australia and New Zealand (FSANZ) announced that the very low energy diet (hereinafter the VLED products) will be supervised as food special medical purposes in Australia and New Zealand. Additionally, its product standard was drafted. The draft standard will be implemented after a 60-day review period, and there will be a three-year transition period after the promulgation of the standard.

The main contents of the drafted standard are as follows:

1. Food Standards Australia and New Zealand Code is amended that the VLED products is newly included in the scope of food for special medical purposes;

2. Nutrient requirements are set for VLED products, and details are listed below:

Nutrient	Unit	Nutrient Composition^
Energy	kJ/day	1880 – 3345^
Protein	g/day	50
Protein Quality	PDCAAS	1*
LA	g/day	3
ALA	g/day	0.5
LA:ALA	ratio	5:15
Carbohydrate	g/day	50
Vitamin A	µg retinol equivalents/day	600
Vitamin D	µg/day	2.5
Vitamin E	mgTE/day	10
Vitamin C	mg/day	30
Vitamin B6	mg/day	2
Vitamin B12	µg/day	1
Niacin	mgNE/day	11
Riboflavin	mg/day	1.2
Thiamin	mg/day	0.8
Folic Acid	µg/day	200
Calcium	mg/day	500
Phosphorus	mg/day	500
Iron	mg/day	16
Iodine	µg/day	140
Magnesium	mg/day	350
Copper	mg/day	1.5
Zinc	mg/day	6
Potassium	g/day	1.6
Sodium	g/day	1
* Protein digestibility-corrected amino acid score (PDCAAS) - Essential amino acids may be added to improve protein quality only in amounts necessary for this purposes. ^ The nutrient composition regulates minimum amounts per daily intake, expect for energy which is regulated as average energy content.

3. VLED products shall follow the labeling requirements of FSMP. Apart from that, it is subject to some additional labeling requirements.

Current labeling requirements applicable to FSMP (apply to VLED products as well), for example:

The label should indicate the product name reflecting the food's true nature, lot identification, date marking, directions for use and storage, allergen declarations, etc.
It should follow the labeling requirements of irradiated food
It is not allowed to indicate therapy functions.
The nutrition information should be provided on a per serving basis (rather than per 'given amount'), with the average quantity of the serving size stated

Please refer to the Notice No. 194-22 for more details.

Additional requirements for VLED products;

Enterprises are prohibited from labeling health claims or advertising VLED products
Mandatory labeling of the importance of maintaining an adequate daily fluid intake while consuming VLED products
The label shall mark that the product is not recommended for pregnant, nursing, or lactating women or used by infants, children, adolescents and elderly.(except for special cases)

What is a Very Low Energy Diet (VLED)?

VLED products are formulated for the dietary management of overweight and obesity and are developed to be used under medical supervision. They are recommended for individuals who are obese (BMI 30+) or overweight (BMI 27+) with health conditions.

The imported VLED products have been sold in Australian and New Zealand markets for more than 20 years, whose major regulatory reference is CODEX STAN 203/1995. To better regulate the product compliance and ensure the food safety, FSANZ decided to develop their own standard for VLED products to make up the legislation vacancy.