FSSAI Rules for Nutritional Supplements & Health Drinks in India

Starting a business in the nutritional supplement and health drink industry in India is a lucrative opportunity. However, to ensure safety and compliance, businesses must follow the guidelines set by the Food Safety and Standards Authority of India (FSSAI). Whether you are launching a protein shake brand, herbal supplements, or vitamin drinks, you need an FSSAI license to operate legally.

Understanding FSSAI registration online, the central FSSAI license, the central food license, the FSSAI state license, and the FSSAI food registration is crucial for entrepreneurs and startups in this industry. Let’s explore the key FSSAI rules for nutritional supplements and health drinks in India.

Importance of FSSAI for Nutritional Supplements & Health Drinks

FSSAI ensures that healthy drinks and supplements are safe for consumption. Since these products impact health directly, FSSAI regulates their ingredients, labeling, and manufacturing standards. Without an FSSAI license, selling these products is illegal, and businesses may face penalties or shutdowns.

Types of FSSAI Licenses for Nutritional Supplements & Health Drinks

Before applying for an FSSAI License, businesses need to understand the different types available:

1. FSSAI Basic Registration

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• Suitable for small businesses or startups with an annual turnover of less than ₹12 lakh.
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• Required for small-scale supplement manufacturers or local health drink sellers.

2. FSSAI State License

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• Required for businesses with an annual turnover between ₹12 lakh and ₹20 crore.
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• Applicable to mid-sized manufacturers, distributors, or suppliers of health drinks and supplements.

3. FSSAI Central License

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• Mandatory for businesses with an annual turnover above ₹20 crore.
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• Required for businesses involved in large-scale manufacturing, import, or export of nutritional supplements.
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• Also necessary if the business operates in multiple states.

4. Central Food License for Importers

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• If you plan to import health drinks or supplements, you must obtain a central food license from FSSAI.
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• This ensures that imported products comply with Indian food safety regulations.

Key FSSAI Rules for Nutritional Supplements & Health Drinks

FSSAI has laid down several rules to regulate the manufacturing, labeling, and marketing of health drinks and supplements. Here are some key guidelines:

1. Approved Ingredients & Additives

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• Nutritional supplements must contain only FSSAI-approved ingredients.
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• Harmful substances such as steroids, heavy metals, and artificial hormones are strictly prohibited.
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• The use of permitted vitamins, minerals, amino acids, and herbal extracts must comply with FSSAI standards.

2. Proper Labeling & Packaging

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• Labels must clearly mention the product name, ingredients, nutritional value, and dosage instructions.
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• The packaging should include an FSSAI logo and license number.
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• It should also display a warning if the supplement is not suitable for children, pregnant women, or people with certain medical conditions.

3. Scientific Claims & Advertisements

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• Brands cannot make false or exaggerated health claims about their supplements or drinks.
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• Statements like “Cures diabetes” or “100% guaranteed weight loss” are not allowed.
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• Claims must be backed by scientific research and approved by FSSAI.

4. Manufacturing Standards

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• All manufacturing units must maintain proper hygiene and follow GMP (Good Manufacturing Practices).
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• The water used in health drinks must be of potable quality.
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• Regular quality testing and record-keeping are mandatory.

5. Registration & Licensing

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• Businesses must complete their FSSAI registration online before launching their products.
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• Large-scale manufacturers must obtain a Central FSSAI License.
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• Those operating in multiple states need both FSSAI state license and central food license as per their business structure.

How to Apply for FSSAI License for Nutritional Supplements & Health Drinks

Step 1: Determine the Type of License

Identify whether you need an FSSAI food registration, FSSAI state license, or central FSSAI license based on your business turnover and scale.

Step 2: Prepare Required Documents

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• Business registration proof (Company incorporation certificate, partnership deed, etc.)
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• Identity and address proof of the business owner
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• Details of the manufacturing unit (for large-scale businesses)
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• Product details, including ingredients and formulation
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• Food safety management system plan

Step 3: Apply for FSSAI Registration Online

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• Visit the official FSSAI website and apply for FSSAI registration online.
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• Fill out the application form (Form B for state and central licenses).
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• Upload the necessary documents.
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• Pay the required fee and submit the application.

Step 4: Inspection & Approval

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• FSSAI officials may conduct an inspection of the premises before approving the license.
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• Once approved, you will receive your FSSAI license, which is valid for 1 to 5 years.

Consequences of Not Having an FSSAI License

Running a health drink or nutritional supplement business without an FSSAI food registration can lead to:

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• Heavy fines and legal action
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• Seizure of products and shutdown of the business
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• Loss of customer trust and brand reputation

Benefits of Having an FSSAI License

1. Legal Protection – Your business remains compliant with food safety laws.
2. Consumer Trust – An FSSAI-certified product is trusted by customers.
3. Business Expansion – Helps in scaling the business and entering new markets.
4. Export Opportunities – Essential for exporting supplements and health drinks internationally.

Conclusion

Starting a nutritional supplement or health drink business in India requires strict compliance with FSSAI license regulations. Whether you need an FSSAI registration online, a central FSSAI license, or an FSSAI State License, obtaining the right approval is essential. By following FSSAI guidelines on ingredients, labeling, and manufacturing, businesses can ensure product safety and build consumer trust.

If you’re planning to launch a health supplement brand, get your FSSAI food registration today and operate legally in the Indian market!

FAQs

1. Is an FSSAI license mandatory for selling protein supplements in India?

Yes, any business selling protein supplements, vitamins, or health drinks must obtain an FSSAI license based on its business size.

2. How long does it take to get an FSSAI license?

The processing time varies, but generally, it takes 15-45 days to receive an FSSAI registration online approval.

3. What happens if my FSSAI license expires?

If your FSSAI food registration expires, you must renew it immediately. Delayed renewal may result in penalties or suspension of your license.