To the extent that consumer interest in age-defying skincare increased, so became regulatory scrutiny towards the marketing claims made about consumer products within the European Union (EU) in the year 2025. The EU reaffirmed, as has been said above, the precepts of truthfulness, substantiation, and non-misleading claims—especially in fast-growing segments like anti-aging cosmetics.
Dietary supplements are regulated in India, utilizing a strong legal and safety structure managed by the Food Safety and Standards Authority of India (FSSAI), which operates under the Ministry of Health and Family Welfare (MoHFW) of the Government of India. This framework is meant to establish that dietary supplements are safe, effective, and of high quality in accordance with the Food Safety and Standards Act, 2006.
The obligation for companies involved in the manufacture, import, distribution, and sale of dietary supplements, is compliance with various legal requirements, such as:
2.1 Licensing and Registration
All manufacturers and distributors must obtain a current license via the FSSAI’s online portal known as FOSCOS. Licenses may vary by business model and encompass the manufacturing, repackaging, and labeling usages as per the terms of the Act.
2.2 Product Approval
Dietary supplements, which are included under “Health Supplements,” must obtain FSSAI approval before their sale in the market. FSSAI will grant approval after providing sufficient safety data, documentation of the formulation, and intended health benefits.
2.3 Labelling and Advertisements
FSSAI has imposed restrictions on labelling which require:
2.4 Ingredients Acceptability
Only ingredients approved by FSSAI may be used in formulations. These ingredients must be documented in terms of their origins, purity and safety. For any product marketed under Ayurveda, Unani, Siddha or Homeopathy (AYUSH) claims, proof of AYUSH compliance will also be necessary.
Steps undertaken in the regulatory process: The FSSAI is the primary base responsible for:
MoHFW oversees the FSSAI and public health policies in general that affect dietary supplements. The FSSAI will ultimately have 25% visibility on regulatory oversight per the plan of action.
5.1 Steps to Obtain a License for Manufacturing
FSSAI is responsible for ensuring compliance with GMP and other good practices through adherence to current national standards or international standards which is based on IS 14433:2018 and Food Safety and Standards (Dietary Supplements) Regulations, 2019
6.1 Important Components of GMP
6.2 Certifications and Audits
FSSAI Licensing is mandatory in all circumstances for all operations.
The option for third-party GMP Certification (e.g. NSF International) would be encouraged for marketing and consumer confidence.
ISO 9001:2015 certification will allow companies to officially validate their quality system.
Although not required, companies should proceed with routine internal and external audits to remain compliant and get external verification of compliance.
The ramifications of being noncompliant could lead to:
India’s regulatory framework for dietary supplements — from the national level to FSSAI — is extensive and rooted in science. It focuses on product safety, scientific substantiation, labelling, and quality of manufacturing practices. By complying with these requirements, a manufacturer is complying with Indian Laws and contributing to consumer safety while also remaining competitive globally.
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