From the ingredients inside a supplement to the contents on its packaging, Maharashtra’s Food and Drug Administration (FDA) is preparing to widen scrutiny of nutraceuticals.

 

Speaking to The Indian Express, Maharashtra FDA Commissioner Tukaram Mundhe described the department’s findings as “disturbing”. “Products claim to contain an ingredient that is not actually there,” he said, flagging misleading claims and inappropriate consumption.

 

Asked whether it would address only labelling or also test contents, Mundhe told the newspaper it would cover “everything”, from content and consumption to prescription and selling.

 

Mundhe’s latest proposal was already identified by the Advertising Standards Council of India (ASCI). According to the advertising industry’s self-regulatory body, nutraceuticals are classified as food under Indian regulations, but their advertisements often make therapeutic or quasi-medical claims, blurring the distinction between food and medicine.

  

Why are supplement advertisements under scrutiny?

 

In a statement accompanying its annual complaints report for 2025-26 released in May this year, ASCI said nutraceuticals accounted for 52 per cent of the food-and-beverage advertising cases it examined, making them the largest subcategory. Within nutraceuticals, 96 per cent required modification.

 

It flagged misleading or unsubstantiated claims relating to metabolic health, chronic disease, child development, fertility and organ function. Products included weight-loss supplements and growth formulas.

 

Are nutraceuticals foods or medicines?

 

Under the Food Safety and Standards Authority of India’s (FSSAI’s) framework, nutraceuticals are intended to provide physiological benefits and help maintain health. The framework permits formats such as tablets and capsules; their appearance alone does not make them medicines.

 

FSSAI’s Advertising and Claims Regulations, 2018, prohibit claims that food can prevent, alleviate, treat or cure a disease, unless specifically permitted under its regulations. Claims about nutritional or health benefits must have scientific backing.

 

What must supplement labels disclose?

 

FSSAI’s requirements call for the product category, such as “NUTRACEUTICAL” or “HEALTH SUPPLEMENT”, the amount of relevant ingredients and recommended usage. Labels must prominently state “NOT FOR MEDICINAL USE” and warn against exceeding the recommended daily usage.

 

They must also disclose applicable precautions, known side effects, circumstances in which consumption is unsuitable, and interactions with medicines. A statement requiring the product to be kept out of children’s reach is mandatory.

 

Composition is regulated, too. In a January 2020 clarification, FSSAI reiterated that vitamins, minerals and amino acids added to health supplements and nutraceuticals should not exceed the applicable recommended dietary allowance. It referred to standards specified by the Indian Council of Medical Research and, where these were unavailable, the international food standards body Codex Alimentarius Commission.

 

Other nutraceutical ingredients are subject to permitted-ingredient lists and specified usage levels. FSSAI’s framework also requires products intended for children aged two to five to be given only under medical advice from a physician or certified dietitian or nutritionist.

 

Has FSSAI acted against nutraceuticals before?

 

Maharashtra’s proposed scrutiny follows an earlier national enforcement initiative addressing similar concerns.

 

On March 7, 2023, FSSAI directed food-safety commissioners in states and Union Territories, its central licensing authorities and regional directors to conduct a special enforcement drive covering nutraceuticals and health supplements.

 

The regulator said it had been alerted to products that did not comply with nutraceutical regulations and were being marketed with false, misleading or exaggerated health and label claims. It asked authorities to closely monitor manufacturing and sales, check compliance and take strict action against violations.

 

The direction addressed both product compliance and marketing claims—the two concerns Mundhe has now raised in Maharashtra.