Regulations for Nutraceuticals
The Codex Alimentarius Commission was created in 1963 by UN’s Food and Agricultural Organization and World Health Organization to develop international food standards and guidelines. In the changing nutraceutical scenario bodies like Codex Alimentarius, WHO, FAO and International Alliance of Dietary/ Food Supplements Associations are now working closely with international and local regulators to bring focus on nutraceuticals while developing any regulatory policy. The move is necessary as all countries follow different regulations.
Countries like the US, EU and some South Asian countries follow the Codex Alimentarius guidelines for upper safety limits of vitamins and minerals in nutraceutical compositions. Accordingly, these nutraceuticals are marketed for specific anti-oxidant or nutrient properties and not as medicines.
In India companies that are selling vitamin formulations will have to change their formulation as they are presently defined as ‘drugs’ and so cannot be called nutraceuticals.
Some companies have changed the composition of their calcium supplements according to Indian food standards.
Since there is no global agency, to overlook nutraceuticals, all the companies worldwide, work under the national standards and regulations of various countries. Most regulators follow practices in their own country. However, if nutraceutical products are imported the manufacturer is responsible for establishing purity and composition of ingredients in these imported products.
Fair trade practices and complications for new entrants
The rules and regulations for nutraceuticals are different from those for pharmaceuticals. Since theFSSAI has still to come up with a concrete regulatory system for the nutraceutical sector, new entrants into this industry find it confusing. At present the regulations have tried to curb the many ‘tall’ claims about the ‘natural’ ingredients and their almost magical curative effect. Also many nutraceuticals have been included in the Indian Pharmacopoeia, example ‘guggul’ for lowering cholesterol. Since a regulatory framework is yet to be formulated what new entrants need to pay attention to is Section 22 of the Food Safety and Standards Act 2006, and get food product approval from FSSAI and checklist ingredients for the following
permissibility of the ingredient
standards and dosage quantity limits of vitamins/ minerals
product classification according to existing Indian laws
advertising and label claims as per Indian food regulations
permitted additives
Need for Regulatory Framework
FSSA defines nutraceuticals as food products but confusion between a drug & food remains existent because of the usage of them being whether for treatment of diseases or for health & diet supplements purposes.
Nutraceuticals manufactured in form of tablet, capsule or liquids with vitamins and minerals to be taken orally are considered & being sold as drugs on the basis of structure.
However, colours and additives such as binding and granulating agents used in formulating tablets are not listed under permitted additives.
Though there is permitted structure function for drugs there is none for nutraceuticals and dietary supplements.
As the industry is developing rapidly and their requirements are seen as being unique it is necessary to have regulations that are nutraceutical industry specific. FSSAI is already working towards standardisation for nutraceuticals and their announcement is being eagerly awaited by the nutraceutical industry.
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