The FSSAI has already begun operationalization of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. However, the standards will be enforced from 1 January 2018.
Health Supplements are meant to augment the normal diet of an individual above the age of five years. The regulation states that Health Supplements must contain concentrated source of one or more nutrients, namely, amino acids, enzymes, minerals, proteins, vitamins, other dietary substances, plants or botanicals, prebiotics, probiotics and substances from animal origin or other similar substances with known and established nutritional or beneficial physiological effect, which are presented as such and are offered alone or in combination, but are not drugs as defined in the clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 [23 of 1940) and the rules made there under.
The number of nutrients in Health supplements must not exceed the recommended daily allowance (RDA) as specified by the Indian Council of Medical Research (ICMR). If standards are not specified then the FBOs must use nutrients according to international standards as laid down in the Codex Alimentarius Commission. Therefore the capsules, tablets, pills, sachets; jelly or gel, semi-solids and other similar forms or any other forms of liquids and powders must be designed so that the nutrient amount is neither below nor over RDA but according to the requirement needed on any particular day.
Here it is important to point out that according to the latest surveys by the National Nutrition Monitoring Bureau (NNMB) Indian consumers can be branded into two types and they can either suffer from ‘under-nutrition’ or ‘over-nutrition.’ All FBOs must be aware of this fact so that the Health Supplements they make are well researched and science-based so consumers can get the full benefits of the nutrients in these foods. The problem of under-nutrition continues to be a major problem but an emerging issue is that of over-nutrition which is especially prevalent in urban areas. Health supplements must be prepared to keep this factor in mind so that they do not cause over-nutrition.
Surveys carried out by the NNMB indicate that the daily intake of all foods except cereals and millets in Indian households is lower than RDA.
- The average consumption of pulses and legumes like dals, which are an important source of protein, is less than 50% of RDA.
- Consumption of green leafy vegetables and other vegetables which are rich sources of micronutrients like beta-carotene, folate, calcium, riboflavin, and iron was also quite inadequate.
- Intake of visible fat was also less than 50% of the RDA. Energy deficiency in most households was about 70% and protein deficiency 27 percent.
Therefore, it is important to prepare Health Supplements which will help consumers meet their physiological needs without having excess nutrients. RDA must also be included in such a way as to maintain a margin of safety taking into considerations the variations between individuals as well as regional diets of sections of the society.
Since the Health Supplements are meant for people over the age of five years manufacturers must have nutrients that can fulfill the requirements of various age groups like children, adolescents, pregnant women, lactating mothers, and adult men and women taking into account their lifestyles which can be sedentary or active. It is possible that adequate amounts of nutrients may not be available through diet alone so health supplements must make good the inadequacy.
The new regulations have also emphasized the need to have correct labeling which
- specifies the target group the health supplement is meant for,
- what condition it will address
- duration of the usage
- each package must contain the words ‘Health Supplement’
- the prominent display must mention ‘Not for medicinal use’
- state clearly a warning of any known side effects
- A statement which states that it must be stored out of the reach of children.
Ingredients in Health Supplements
The health supplements shall contain any of the ingredients specified in Schedule I or Schedule II or Schedule IV or Schedule VII or Schedule VIII or enzymes only of Schedule VI outlined in the new regulation.
- Schedule I lists vitamins and minerals like vitamin A, pro-vitamin A, Vitamin B, B2, B6, B12, Vitamin C, D and E, Vitamin Ki, K2 (MK-7) and K2 (MK-4). Biotin, Folic Acid, Niacin, Pantothenic acid. Minerals like calcium, chloride, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorous, potassium, selenium, sodium, boron as appropriate for the health supplement and targeted consumer group.
- The regulation also specifies how much percentage of overage the supplements can contain. Overage is the number of excess nutrients added above label claim during manufacture as a means of maintaining at least the claimed amount of the ingredient(s) for the normal shelf life of the product to compensate for the expected manufacturing/storage loss and to allow for variation in assay performance.
- Schedule II contains the list of essential amino acids and other nutrients
- Schedule IV List of plant or botanical ingredients
- Schedule VII List of strains as probiotics (live micro-organisms)
- Schedule VIII List of prebiotic compounds
- And Schedule VI only for enzymes