Company Registration
NGO Registration
Virtual business address
Startup Registration
Shop Act Registration
Annual Compliance
Income tax Filing
Trade License Registration
BIS Registration main
CDSCO Registration
Star Rating Certification
WPC Registration
Brand Registration
Legal Metrology Certification
PESO certification
Factory License Registration
Fire NOC
AERB Certification
PSARA License
Fssai License
RCMC Certification
Import Export Registration
China Food Export
RNI Certification
NSIC Registration
ISO Certification Main
US FDA
ICEGATE Registration Main
CPCB Approval
EIA Environment
CPCB/SPCB
E-Waste Management
Plastic Waste Management
Battery Waste Management
Tue, Aug 18 2026
Raju Karn
Starting a dietary supplement brand in India requires more than a good product formula and attractive packaging. Whether you manufacture protein powder, sell multivitamins, operate an online supplement store, or market products manufactured by a third party, you need to understand the applicable FSSAI licensing and product-compliance requirements.
FSSAI regulates health supplements and related categories under its food-safety framework. The applicable requirements can depend on the product category, ingredients, business activity, manufacturing arrangement, and claims made on the label.
Important 2026 update: From 1 April 2026, FSSAI revised the general turnover thresholds: Registration applies up to ₹1.5 crore, State License applies above ₹1.5 crore and up to ₹50 crore, and Central License applies above ₹50 crore, subject to category-specific requirements that may require a particular license irrespective of turnover.
Dietary or health supplements are products intended to supplement the normal diet by providing nutrients or other permitted substances with a nutritional or physiological purpose. FSSAI's framework covers categories including health supplements, nutraceuticals, foods for special dietary use, foods for special medical purposes, probiotic foods, prebiotic foods, specialty foods containing botanicals, and novel foods.
Common products in the supplement market include:
Because these products are consumed for nutritional or physiological purposes, businesses need to pay close attention to permitted ingredients, product composition, dosage, labeling and claims before launching them in India.
The applicable FSSAI registration or license is determined by the business activity and the revised turnover thresholds effective from 1 April 2026. The general classification is:
FSSAI's revised order specifically states that these thresholds came into effect on 1 April 2026. However, turnover is not the only factor. Certain businesses or activities may require a Central License because of their category or nature of operation.
For dietary supplement businesses, the correct category and operational activity should therefore be checked before applying rather than selecting a license only on the basis of turnover.
An FSSAI registration or license may be required if you are:
If you outsource manufacturing, the licensing position of both the manufacturer and the brand owner/marketer should be properly assessed. The product label, business activity and contractual arrangement should also be consistent with the applicable FSSAI requirements.
FSSAI compliance is important because supplement businesses deal directly with products intended for human consumption. A business operating without the required registration or license can face regulatory action, while non-compliant formulations, labels or claims can create additional problems.
For an online supplement brand, compliance also matters commercially. Marketplaces, distributors, retailers and other business partners may ask for food-license and product-compliance documents before onboarding products. A compliant setup can therefore make it easier to build trust and expand across online and offline channels.
Before submitting an application, businesses should review the product and business model carefully.
Check whether the ingredients and their quantities comply with the applicable FSSAI requirements. A product should not be launched simply because the same ingredient is permitted in another country.
The label should comply with applicable food-labeling requirements. Supplement businesses should also avoid presenting a food product as a medicine or making unsupported disease-treatment or cure claims.
If you manufacture the supplement yourself, the manufacturing premises and applicable hygiene and food-safety requirements must be addressed. If you use a contract manufacturer, verify that the manufacturer has the appropriate FSSAI authorization for its activity and product category.
The exact documents depend on the nature of the business and the license category. Common documents may include:
For supplement businesses, it is particularly important to prepare the product formulation and label information correctly because licensing alone does not automatically establish that every formulation or claim is compliant.
First determine whether you are a manufacturer, marketer, relabeller, distributor, retailer, importer or another type of food business operator. Your operational activity affects the application.
Identify whether your product falls under health supplements, nutraceuticals or another applicable food category. FSSAI's health-supplement framework covers multiple functional-food categories, so product classification should be done carefully.
Review the formulation, ingredient quantities, nutritional information and proposed claims against the applicable FSSAI requirements. This step is especially important for products containing botanicals, vitamins, minerals or other functional ingredients.
Collect the business documents, premises proof, product information, manufacturing details and label artwork required for your particular application.
Submit the applicable FSSAI registration or license application through the FoSCoS system with the required details and documents.
Depending on the application and business activity, FSSAI authorities may scrutinize the documents or conduct an inspection of the manufacturing premises.
After the application is approved, the business receives the applicable FSSAI registration/license. The license details should then be used correctly on applicable product labels and business documentation.
Protein powders are among the most common products sold by supplement brands. Businesses manufacturing, marketing, distributing or selling protein products should first establish the correct food category and applicable licensing requirements.
If you manufacture protein powder yourself, your manufacturing premises and product category need to be covered appropriately. If a third-party manufacturer produces the protein powder for your brand, both the manufacturing arrangement and the brand's role should be correctly reflected in the compliance documentation.
Do not assume that having an FSSAI license automatically approves every protein formulation or marketing claim. Product composition, labeling and claims must separately comply with the applicable requirements.
Running an online supplement store does not remove your food-safety obligations. If you sell packaged dietary supplements through your own website or an e-commerce marketplace, you should ensure that the business has the appropriate FSSAI registration/license and that the products and labels comply with applicable requirements.
Before listing products, keep your FSSAI details, invoices, product information, labels and manufacturer/marketer documentation organized. This can help reduce compliance issues during marketplace onboarding or regulatory checks.
Many supplement brands do not own manufacturing facilities. Instead, they work with contract manufacturers and sell products under their own brand names.
In such cases, the business should identify its correct FSSAI operational role and maintain appropriate documentation with the contract manufacturer. The agreement, product details, label information and licensing records should be consistent.
This is particularly important when the brand controls the packaging and marketing but another company manufactures the product.
The revised turnover thresholds are important, but certain activities and categories can have specific licensing requirements. Always assess the business activity as well as turnover.
An ingredient being legally sold in another country does not automatically mean that the same formulation is compliant in India.
Food supplements should not be marketed in a manner that improperly presents them as medicines or makes unsupported claims to cure, treat or prevent diseases.
The packaging should be reviewed for applicable declarations, nutritional information, warnings, claims and other mandatory requirements.
A contract manufacturer having an FSSAI license does not mean the brand can ignore its own applicable food-business obligations.
The old ₹12 lakh / ₹20 crore thresholds should not be used for a 2026 article without qualification. The general revised thresholds took effect from 1 April 2026: ₹1.5 crore for Registration, above ₹1.5 crore to ₹50 crore for State License, and above ₹50 crore for Central License.
Supplement businesses can face regulatory action when products are marketed with claims that go beyond what is permitted for food products. FSSAI's framework distinguishes health supplements and nutraceuticals from drugs, and the applicable regulations are intended to establish requirements for composition, safety and labeling.
For this reason, a supplement brand should review the formula, ingredient status, dosage, label and advertising claims together before launching a product. Getting only the FSSAI license while overlooking product-level compliance can still expose the business to regulatory problems.
Launching a supplement brand involves more than submitting an online license application. You need to identify the correct business activity, understand the applicable product category, prepare documents, review labels and ensure that the proposed product fits the applicable FSSAI framework.
PSR Compliance can assist businesses with FSSAI registration and licensing, product-category assessment, documentation, application support and compliance guidance for dietary supplement businesses.
Planning to manufacture, market or sell protein powder, vitamins, herbal supplements, nutraceuticals or other dietary supplements in India?
Get professional assistance from PSR Compliance to identify the applicable FSSAI requirements and prepare your application correctly.
📞 Call: 8796104190📧 Email: support@psrcompliance.com
Yes. Businesses selling packaged protein powder and other food supplements commercially must comply with applicable FSSAI registration or licensing requirements. The correct category depends on the nature and scale of the business.
Yes. Many brands use contract manufacturers. However, the manufacturer and brand owner's respective food-business activities should be correctly assessed, and the applicable licensing and documentation should be maintained.
From 1 April 2026, the general turnover thresholds are Registration up to ₹1.5 crore, State License above ₹1.5 crore up to ₹50 crore, and Central License above ₹50 crore. Category-specific requirements can also affect the applicable license.
Yes. Selling food supplements online does not exempt a business from FSSAI requirements. The appropriate registration or license should be obtained based on the business activity and applicable criteria.
Businesses should not market food supplements as medicines or make unsupported disease-treatment, cure or prevention claims. Claims must comply with the applicable FSSAI framework.
Common documents include business registration details, identity and address proof, premises proof, product information, manufacturing details, label artwork and contract-manufacturing documents where applicable.
Not automatically. The manufacturer's license relates to its own licensed activity. A brand owner or marketer should separately assess its applicable FSSAI obligations.
Processing time depends on the application, document completeness, business activity, queries and whether an inspection is required. Therefore, businesses should avoid relying on a fixed approval period.
A gym that commercially sells packaged food or dietary supplements must comply with the applicable FSSAI requirements for its food-business activity.
An FSSAI registration/license can be checked through the official FSSAI/FoSCoS system using the relevant license or registration details.
Book your free consultation with our specialists today.
PSR Assistant