Health Supplements Under Maha FDA Scanner

Mumbai : Following the directions of the Food Safety and Standards Authority of India (FSSAI), the Maharashtra Food and Drug Administration (FDA) has started a special enforcement drive to check the quality and safety of nutraceuticals and health supplements being manufactured and sold in the market.

Manufacturers/distributors found breaching the norms and selling supplements with misleading and/or exaggerated health claims will face stern action, officials said.

Arjun Bhujbal, joint commissioner of FDA (food) Pune region, said that the team has started inspecting shops selling dietary supplements and nutraceutical products. “Till now, we have inspected over seven to eight shops, the licenses, products and product labels of which were checked. The inspections were carried out in Hadapsar, Sadashiv Peth, Narhe and Ambegaon among others. All of them had the required licenses and labelling as per the norms,” Bhujbal said.

In one particular case however, the health supplement was found being sold with misleading and exaggerated health claims. A case has been filed as it is in contravention of the Food Safety Standards (Advertisement and Claims) Regulations, 2018. “The hearing of the case will be held in front of the adjudication officer (joint commissioner FDA) and if the charges are proved, the violator can be fined up to Rs10 lakhs,” Bhujbal said.

The nutraceuticals market in most parts of India including Pune has grown over the last few years and got a boost from the Covid-19 pandemic, resulting in the mushrooming of several shops selling such products in major metros.

According to various market research estimates, the Indian dietary supplements market is expected to grow to Rs84,790 crores by 2027, up from Rs37,630 crores in 2021.

Earlier, the FSSAI came across various nutraceuticals and health supplements being sold in the market that were not compliant with the provisions of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022. Moreover, these products were being marketed with false/misleading and exaggerated health claims in contravention of the Food Safety Standards (Advertisement and Claims) Regulations, 2018. Last month, the FSSAI urged the state FDA to conduct a special enforcement drive to check the quality and safety of nutraceuticals and health supplements being manufactured and sold in the respective jurisdictions, and take strict action against manufacturers/ distributors violating the norms.

Accordingly, the FDA has now started inspection of vendors and licenses, and product- quality and labelling. If the quality of a product is in doubt, samples would be sent to the laboratories for further analysis to assess if the product is substandard, unsafe or spurious, officials said. Bhujbal said that the staff shortage at the FDA is the reason behind not being able to inspect a large number of such vendors and products in the city. However, the drive would continue, he assured.

Sushil Shah, president, Chemist Association of Pune District, welcomed the FDA’s enforcement drive and said it was the need of the hour. “There are several shops selling such products that have mushroomed in the city and their license status and product quality is unknown. This poses a risk to public health at large. Our association has chemists who are all registered pharmacists and possess the required licenses and qualifications. The products are taken from the company distributors and wholesalers. The drive will ensure that citizens get the right products from the right vendors possessing the right qualifications,” Shah said.

Dr Abhijit Lodha, physician at Ruby Hall clinic, said that there should be a governing body for standardisation of the manufacturing, storage and distribution of such products. The same products could be processed differently by different manufacturers, making all the difference, he said. “Many a time, the labelling is not exact and the status of the purity of the product remains unknown. Depending on the climatic conditions and processing techniques, there can be contamination of plant parts which can be injurious to health forget not having any medicinal value. During the process of manufacturing, there is no control on heavy metal adulteration which is often found to have harmful effects on the liver and kidney,” Dr Lodha said.

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