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FSSAI license for herbal extracts

Need for registering herbal extract manufacturers with food Authority in India

FSSAI  (food) License for Herbal Extracts 


Traditionally, the manufacturers of herbal extracts in India were under the purview of Drugs and Cosmetics Act of 1940 and recently Ministry of AYUSH was formed to regulate the herbs with medicinal values. Considering the long history of herbs consumption in India, these products are given approvals by the above departments without large emphasis on the safety and efficacy studies. With rampant use of these products to promote health and wellness by Industry, herbal extracts eventually ventured into the food framework (besides health supplements and functional foods products like herbal teas, infusions and carbonated beverages are prevalent in the market prior to food regulations in India). 

Accommodation of herbals in food regulations

Evolving regulatory framework in India has resulted in many hardships to the Industry in both new product launches as well as marketing existing ones. Hence, there was a vacuum in the market in 2015-16 (post Honurable Supreme court squashing FSSAI product approval procedures), especially for the products classified as health supplements, food for special dietary use, functional food and nutraceuticals. Although, few players continued to market without appropriate approvals, a collegial representation was submitted to FSSAI to recognize and approve the ingredients for herbal products. Finally, after due considerations the Indian food authority in 2017-18 approved approximately 800 herbal ingredients in the form of regulations. As a result, products which were once required approval were given licenses by FSSAI without a lengthy approval process

Advantages of classifying herbal ingredients under food

1. Firstly, during the interactions with manufacturers, the common reason many cite for getting into food framework is alignment with vendors. With increased usage of herbal extracts in food industry, it is becoming imperative for the herbal brand owners to own a FSSAI license to complete the compliance loop. For instance, the exporting nations mandates the FSSAI logo and license number on the label

2. Secondly, when classified as medicine there is price regulating authority that monitors the price (NPPA) of these products in the market. Although, it is paradoxical, only due to the inherent nature and consumption history, herbs are ingested as both food and medicine

3. Lastly, it makes business sense, as food these products caters to large consumer base resulting in decent upside. Moreover, when branded as health & wellbeing these products are consumed recurring unlike a medicine which is required only during cure of illness

How to apply a FSSAI (food) license ?

Product evaluation: Review the composition of the product against the approved ingredient database of FSSAI i.e. in all the 4 schedules mentioned in the nutraceuticals regulations. In addition to the ingredients, the product label (or artwork) shall be reviewed with the specifications mentioned in the food packing and labeling regulations

Categorization: It is prudent that the herbal manufacturers should categorize the product appropriately as there is only subtle difference defined between supplements and nutraceuticals. A holistic view of end use, form or nature etc., shall be considered before categorization. 

Claim validation: Although, validations for claims are not mandated for application process, these documents often become indispensable during the enforcement process. Hence, substantive documents like Ayurvedic transcripts (example: Raja Nighantu Moolakadivarga, Charaka Samhita) and research studies from credible sources would be largely accepted as claim validation documents by FSSAI

To sum up, there is an increasing influx of applications requesting for food license in the recent times and it is essential for herbal manufacturers (unlike Ayush there is no loaned license concept in FSSAI) to register with food authority for sourcing their ingredients to food manufacturers. 

Please write us at  or call us at 040-48560467 for more guidance on the product approval and FSSAI licensing purposes

(All content provided on this blog is for informational purposes only. The owner of this blog makes no representations as to the accuracy or completeness of any information on this site or found by following any link on this site)

Issue 26


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