If you are launching a supplement brand, the first compliance question is usually about the FSSAI license for nutraceuticals: which one do I need, and do I need one at all if a manufacturer makes my product? The short answer is that health supplements and nutraceuticals are regulated as foods in India, so both the manufacturer and the brand that markets the product need to be registered or licensed with the Food Safety and Standards Authority of India (FSSAI).

This guide explains which license applies to you under the turnover limits that took effect on 1 April 2026, what you typically need to apply, and the mistakes that most often slow founders down.

This is general guidance for founders, not legal advice. Always confirm your exact category on the FSSAI portal before applying.

Are nutraceuticals and health supplements regulated as food or medicine?

In India, health supplements and nutraceuticals are regulated as foods by FSSAI, not as drugs. In simple terms:

• Health supplements are concentrated sources of nutrients such as vitamins, minerals, proteins or amino acids, taken to supplement the normal diet.
• Nutraceuticals contain extracts, isolates or purified compounds that offer a physiological benefit and help maintain health.

Neither is meant to treat or cure a disease. That one line shapes everything from your formula to your label and ads. If your product is positioned to treat a medical condition, it falls outside the food rules entirely.

Do you need an FSSAI license if a manufacturer makes your product?

Yes, in almost every case. Your manufacturer holds its own FSSAI license for manufacturing. That license covers its factory, not your business. As the brand owner, you are the food business that markets the product under your name, so you need your own registration or license for your activity and premises.

On the FSSAI licensing portal, FoSCoS, a marketer or relabeller is linked to the manufacturer that produces its products. Your manufacturer typically confirms on the portal that it makes the product for you, so choose a partner who is licensed for the right food category and handles this step quickly.

Registration, State or Central license: which one applies?

FSSAI revised its turnover limits through an order dated 13 March 2026, effective from 1 April 2026:

Turnover is not the only test. The kind of business also matters. Manufacturing of health supplements and nutraceuticals has been placed under central licensing by FSSAI since 2021, and activities such as importing, operating across several states or selling through certain channels can change your category too. FoSCoS has an eligibility check that asks about your kind of business and suggests the right category. Use it, and keep a record of the answer.

Many new D2C brands start with a lower category based on turnover and move up as they grow. What matters is that your license matches your actual activity and turnover today, and that you upgrade before you cross a limit.

Documents you will typically need

Exact requirements depend on your category, but most brands should keep these ready:

• Identity and address proof of the proprietor, partners or directors
• Proof of your business constitution (incorporation certificate, partnership deed or similar)
• Proof of possession of your premises (rent agreement or ownership document)
• The list of food products and categories you will market
• Details of your manufacturer and its FSSAI license, plus your manufacturing agreement
• Your product label artwork, once finalised
• A food safety management plan, where your category requires it

How to apply on FoSCoS: step by step

1. Create an account on the FoSCoS portal.
2. Run the eligibility check by selecting your kind of business (for example, marketer of health supplements) and entering your turnover.
3. Fill in the application for the suggested category, with your premises, products and manufacturer details.
4. Upload documents and pay the government fee shown on the portal.
5. Respond to queries quickly. The licensing authority may ask about ingredients, labels or claims. Slow replies are the most common cause of delay.
6. Inspection, if applicable. Some categories involve an inspection of the premises.
7. Download your registration or license and add the number to your labels.

Under FSSAI’s 2026 amendments, registrations and licenses have perpetual validity, subject to risk-based inspections. You no longer renew every few years, but annual fees and compliance obligations continue. Check FoSCoS for the current requirements for your category.

When do you need separate product approval?

Most supplements made from permitted ingredients, within the prescribed limits, do not need a separate product approval. You may need one if your product uses an ingredient not on FSSAI’s permitted lists, a novel ingredient, or a claim beyond what the regulations allow. This is where an experienced manufacturer saves you time: a formula built from permitted ingredients and limits avoids an approval process that can take months.

Label rules linked to your license

• Show the FSSAI license or registration numbers required on the label, including the manufacturer’s and, where applicable, the marketer’s.
• Give the names and addresses of both the manufacturer and the marketer.
• Include the ingredient list, nutritional information, recommended daily use and the required advisories.
• Never claim to treat, cure or prevent a disease. Describe how a product supports general health, and only make claims the regulations permit. Read more in our guide to supplement categories and permitted claims.

Five common FSSAI mistakes founders make

1. Assuming the manufacturer’s license covers the brand. It covers the factory, not your business.
2. Choosing the category by guesswork. Use the FoSCoS eligibility check and match your real activity and turnover.
3. Finalising labels before the license number exists. Plan the timeline so the number is ready before you print.
4. Using unapproved ingredients or doses copied from foreign products. What is allowed abroad may not be allowed in India.
5. Making disease claims in ads and listings. The same rules apply to your website and marketplace pages as to your label.

How MAC Biosciences supports your FSSAI journey

MAC Biosciences holds a Central FSSAI license and is GMP, WHO-GMP and ISO certified. Since 2013 we have manufactured for 400+ clients and built 300+ formulations, so we know which ingredients and limits work under FSSAI rules. We share the manufacturer details and documents your application needs, review your formula for compliance before production, and typically deliver within 30 to 40 days of formula and artwork approval. Learn more about our nutraceutical manufacturing in India, or read how nutraceutical contract manufacturing works.

Frequently asked questions

Is an FSSAI license mandatory for selling supplements online?

Yes. Any business that markets health supplements or nutraceuticals in India, including D2C brands selling only online, needs an FSSAI registration or license. Marketplaces also ask for your FSSAI details before they list your products.

Which FSSAI license do I need for a new supplement brand?

It depends on your turnover and your kind of business. From 1 April 2026, registration covers turnover up to ₹1.5 crore, a State license covers ₹1.5 crore to ₹50 crore, and a Central license applies above ₹50 crore. Certain activities can require a Central license regardless, so confirm on FoSCoS.

Do I need a new FSSAI license for every product?

Not usually. Your license covers your business and the food categories you list. When you add products, update the product details on your license if required. Products using non-permitted or novel ingredients may need separate approval.

How long is an FSSAI license valid?

Under FSSAI’s 2026 amendments, registrations and licenses have perpetual validity, subject to risk-based inspections, payment of annual fees and continued compliance. Check FoSCoS for the conditions that apply to your category.

Can my manufacturer apply for the license on my behalf?

The license must be in your business’s name, so you or your authorised representative apply. A good manufacturer supports you with its license details, the documents you need and its confirmation on the portal.

Planning your supplement launch?

Tell us about your product idea and launch timeline. Our team will help you choose a compliant formula and share everything your FSSAI application needs. Contact MAC Biosciences to get started.