History Behind Inception Of The Regulations
As a country that has long believed in the healing abilities of herbal or natural remedies, it is easy to understand why the present health crisis in India has triggered a sharp increase in the demand for Ayurvedic products by citizens across the sub-continent. Such products are believed to strengthen immunity against diseases in general and in some misleading cases, coronavirus. The apex food regulator, Food Safety & Standard Authority of India (“FSSAI”) via a notification dated June 30th 2021, has issued the Food Safety and Standards (Ayurveda Aahar) Regulations 2021 (“Regulations”) for Ayurvedic food products and sought responses from the stakeholders. The regulations have been implemented for the purpose of aiding the public to practice Ayurvedic medicine safely and responsibly by establishing a regimented method of preparing products in accordance with general food safety standards
Historically, Ayurveda has been a branch of alternative medicine that places great emphasis on diet and lifestyle – both of which, even today, are increasingly considered the main criteria by which to gauge a person’s well-being and/or susceptibility to diseases. As a result of this belief in diet and lifestyle, Ayurveda places special emphasis on food (aahar) and believes that healthy nutrition nourishes the mind, body, and soul.
The regulations are considered important as they distinctly define the logistics of Ayurveda aahar. Regulation 2, clause 3 defines it as “food prepared in accordance with the recipes or ingredients and/or processes as per methods described in the authoritative books of Ayurveda”. These regulations also list 68 specific books in Schedule A which food businesses can refer to for preparations of Ayurvedic food products.
Why Are These Regulations Necessary?
The Ministry of Ayush (“Ministry”) is the apex body responsible for Ayurveda and the growth of this particular sector. The Ministry seeks to bring about the global acceptability of these products. Subsequently, the Ministry is keen on regulating and improving the food and health safety standards for Ayurvedic aahar, especially as a distinct category in the regulatory framework of food supplements.
The FSSAI had already implemented a comprehensive regulation in 2018 that provided guidance on some regulatory standards for food and health supplements, nutraceuticals, foods concerning special dietary uses for special medical purposes. . The alliance between the two bodies has led to the formulation of this notification that will now focus on bridging the gap in the regulation of Ayurveda products and their manufacturing.
Crux Of The Regulations
- Prohibition of the manufacturing or selling of Ayurveda treatments intended for infants up to the age of 24 months.
- Products covered under the regulations must contain solely natural food additives as specified under schedule C of the regulations. These additives include acacia gum, rosemary oil, honey, jaggery etc.
- To determine the safety precautions for Ayurveda aahar these regulations list some contaminants under Schedule D. The raw materials used for the manufacture of Ayurveda aahar must also meet the requirements specified in Schedule D of these regulations.
- Only the ingredients and recipes listed in specified textbooks and the original editions of texts published before 1940 will be considered for approval as Ayurveda aahar and no additional text or appendix can be acknowledged under this act.
- Products under Ayurveda aahar with standards that are not specified within the cast of these regulations will be manufactured and made available for sale only after prior approval from the Food Authority in accordance with the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulation 2017.
- The regulations also cover products that have other botanical ingredients in accordance with the concept of Ayurvedic aahar but do not include Ayurvedic drugs or proprietary Ayurvedic medicines and medicinal products, cosmetics, narcotic or psychotropic substances, herbs listed under Schedule E of Drug and Cosmetic Act 1940 and Rules 1945; specifically, metal-based Ayurvedic drugs or medicines.
- The addition of vitamins, minerals, and amino acids to Ayurveda aahar is not permitted.
Germane to Labelling and Advertisements:
- To be transparent with the modern-day consumer, matters pertaining to labelling, presentation and advertisement of products must strictly abstain from claiming that the Ayurveda aahar has any preventative or curing property.
- The labelling of Ayurveda aahar will need to be in accord with the Food Safety and Standards (Labelling and Display) Regulations, 2020, and the specific labelling requirements as mentioned in the regulations.
- It is mandatory to declare any inclusion of natural vitamins and minerals if present in the Ayurveda aahar on the label to maintain transparency.
- To establish guiding principles for packaging, Ayurveda aahar will need to conform to the Food Safety and Standards (Packaging) Regulation, 2018.
Mandate for Food Business Operators:
- The manufacture of Ayurveda aahar will be established by Food Business Operators following Schedule 4 of Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations 2011.
- All Food Business Operators (FBOs) must make claims following the Food Safety and Standards (Advertising and Claims) Regulations 2018. The regulations will allow Food Business Operators to make claims as per the description or indications specified for the recipe or ingredient in the authoritative books listed in Schedule A. Any claims must be factual, not misleading or exaggerated and must display a documented history of usage. Any claims regarding disease risk reduction and/or claims of health benefits will have to necessarily be pre-approved by the Food Authority.
- FBOs must inform the licensing authorities in writing if any of their existing food products duly licensed need to be assigned as an Ayurveda aahar product and the licensing authority shall permit the same with applicable modifications (including labelling) as specified in these regulations. The Food Authority may specify the validity period of such applications.
- Owing to the lack of a proper regulatory body for Ayurveda Aahar, the Ministry will establish an Expert Committee for providing recommendations to the Food Authority on approval of claims and products. Such committee will also be responsible to empower to address concerns regarding registration/ licencing/ certification/ laboratory accreditation/ testing/ quality issues related to Ayurvedic Aahar
- To ascertain better governance practices, the words “AYURVEDA AAHAR” are required to be printed in the immediate proximity of the name or brand name of the product and these regulations also prescribe a logo for such products and microbiological standards which will help them have a diverse identity.
There is a substantial growth in the domestic as well as the international market of herbal products. Owing to the ideologies of health and wellness, the demand is on a constant rise. The larger part of the market for these products is highly unregulated causing more harm than before. These regulations will serve as a strict prescript for dealing with any such problematic nuances. It is necessary to regulate an unproven but popular natural science to help lower any maltreatments or malpractices commonly associated with it; perhaps even lend it more legitimacy as an issue strictly regulated by an official authority. There are numerous cases where such herbal products have been mixed with harmful chemicals or promoted with false claims or assigned unrealistic healing properties. Establishing proper standards and assigning the field a regulatory body could possibly aid in reducing such unfortunate instances.
The regulations ought to act as deterrents against any false claims regarding the healing properties of Ayurveda – general concerns stem from the misinformation spread around concepts of such products being “immunity boosters” against COVID-19; such concepts are rather scientifically misleading and are used to market unsafe products. It is thus apropos to note that these regulations will undoubtedly act as stepping stones in creating a distinct brand name for the food industry concerned with Ayurveda.
This article seeks only to provide readers with clarity on the new regulations regarding Ayurvedic products and does not promote or recommend their use in any way to individuals. Please consult your doctor or health practitioner for any guidance or advice on the same.
Contributed by – Raj Dev Singh, Partner, Ragini Sharma, Associate & Vidhi Krishali, Intern