Tuesday, October 30, 2018

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


  1. I like the helpful info you provide in your articles. I’ll bookmark your weblog and check again here frequently. Im quite certain I will learn lots of new stuff right here! Best of luck for the next! botanical extract

  2. Alovera extract under herbal extract require fssai liscence

  3. Alovera extract is prescribed under Part B of Nutraceutical regulations and hence if you want to market this product as food, you may require FSSAI license. For more details please share your details in the Contact Us form.
    Team SmartComplianz

  4. Sir I start busness of stringing nettle giloy herbal tea.requeried licence pls rpl.

  5. I was impressed with the site that you created, so memotipasi many people to be more advanced, there also kunjugi me, as a comparison ginkgo biloba 120mg

  6. This information is meaningful and magnificent which you have shared here about the herbal extract manufacturer. I am impressed by the details that you have shared in this post and It reveals how nicely you understand this subject. I would like to thanks for sharing this article here.

  7. To know wisdom and instruction, to perceive the words of understanding

  8. More specifically, Ayurvedic healers used the tree bark's gummy resin, called salai guggal. Nevertheless, researchers identified that the gummy resin is high in compounds known as boswellic acids, which have anti-inflammatory actions similar to NSAIDS, but boswellia doesn't seem to cause stomach irritation and bleeding problems commonly buy CBD gummies online

  9. I admire this article for the well-researched content and excellent wording. I got so involved in this material that I couldn’t stop reading. I am impressed with your work and skill. Thank you so much. Bone Fort

  10. We read your blog , share most useful information in blog . Liquid laundry wash manufacturer

  11. the information you have updated is very good and useful, please update further.
    if you require any info regarding TAX & GSTR please visit
    Fssai Registration in Bangalore
    Food Safety License in Bangalore

  12. I have seen some great stuff here. Worth bookmarking for revisiting. I surprise how much effort you put to create such a great informative website. Your work is truly appreciated around the clock and the globe. Impaired Driving Lawyers

  13. Note. Umulilu liquid is from herbal extracts use for animals
    Wether above liquid comes under Fassai licensed
    Pl.anybody anwer me

    1. Let me know the Composition of the liquid I will be able to tell you if FASSAI is required

    2. Let me know the Composition of the liquid I will be able to tell you if FASSAI is required

  14. Hi,
    I intend to set up a plant to manufacture herbal extract, to sell to dietary supplement manufacturer, food and beverage manufacturer and pharma companies to add in their formulation.

    Can you let me know which liscence do I need for the plant FSSAI or Ayush ?

    Also would it make sense to take FSSSI liscence and Ayush facility liscence both .

    I am only making herbal Ingredients here and not finished product.

    Thank you

    Kartik Mohta

  15. I intend to start a company selling herbal infused tea. I intend to source herbal ingredients from certified manufacturers, package & sell it in tea bags. What kind of licenses are required to execute this? Please help!

  16. Yes, I am entirely agreed with this article, and I just want say that this article is very helpful and enlightening. I also have some precious piece of concerned info !!!!!!Thanks. JustKratom Store

  17. This is very interesting, but it is necessary to click on this link: Kratom

  18. Interestingly you write, I will address you'll find exciting and interesting things on similar topics. JustKratom Store

  19. Hi, I want to process raw herbs into powder for selling. Which license I need fssai or ayush. I am starting a very very small unit.

  20. Hi, I want to process raw herbs into powder for selling. Which license I need fssai or ayush. I am starting a very very small unit.

  21. I simply want to tell you that I am new to weblog and definitely liked this blog site. Very likely I’m going to bookmark your blog . You absolutely have wonderful stories. Cheers for sharing with us your blog. cbd gummies 500mg