INTRODUCTION

Over the past few years, there has been a global shift in the attitude towards healthcare. A large number of people are focused on maintaining a specific body image and weight. This focus has been fueled by factors such as growing awareness about obesity, wellness, and self-care on social media. Consequently, many people have started to explore options beyond traditional exercise and diet, such as weight loss supplements. These supplements are sold in different forms and claim to assist in fat burning and boost overall health. The healthcare supplement market as a whole is expected to grow from INR 63,000 crores in 2023 to INR 1.37 lakh crore in 2030.¹ 

REGULATIONS GOVERNING WEIGHT LOSS SUPPLEMENTS

The Food Safety and Standards Authority of India (“FSSAI”) is the governing body that regulates all kinds of food articles in India. 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 (“Nutra Regulations”) is the healthcare law that regulates articles of food that are specially processed or formulated for specific nutritional or dietary purpose India.² Weight loss supplements specifically fall under the category of foods for specific dietary use under the Nutra Regulations.    

COMPLIANCES UNDER NUTRA REGULATIONS

The Nutra Regulations provide for strict compliance for foods that are used in cases of weight management and obesity. All such food and supplement are only permitted to contain certain ingredients specified in the different schedules under the Nutra Regulations. All such ingredients only to be used at the levels provided by the FSSAI or as per the recommended daily allowances specified by the Indian Council of Medical Research. In cases where the ingredients are in excess of either limit, the manufacturer is required to take special permission from the FSSAI by submitting scientific data. Weight loss supplements can be sold in the form of powders, shakes, granules, tablets, chewables, bars, etc. If the weight loss supplements are intended to act as a replacement for part of the daily diet for weight control, the Nutra Regulations provide for additional legal compliances that must be followed with respect to the ingredients and compositions of the supplements. 

The compliance obligations for manufacturers also extend to the labelling of such products. In addition to general labelling requirements under the Nutra Regulations, weight loss supplements are also required to have additional information on their labels. The front of the label is required to include the words ‘foods for special dietary use’. The back of the label is also required to have a statement on the rationale for use of the product and a description of the properties that make it useful for weight loss, along with information on the nutrients used in the product and how such nutrients will assist in weight loss. 

GLOBAL REGULATIONS ON WEIGHT LOSS SUPPLEMENTS

While the weight loss supplement market is currently showcasing fast growth in India, jurisdictions like the United States of America (“US”) and the European Union (“EU”) already have a strong market. Weight loss supplements in the US and EU are governed by the Dietary Supplement Health and Education Act, 1994 (“DSHEA”) and Commission Directive 96/8/EC (“Commission Directive”) respectively. Much like the Nutra Regulations, the Commission Directive lays down guidelines on compositional and labelling requirements for foods that are to be used in weight reduction.³ On the other hand, the DSHEA along with other Food and Drugs Administration (“FDA”) regulations do not contain compositional requirements like India or the EU. The FDA regulations do have guidelines on the labelling of dietary supplements, and that a manufacturer is responsible for scientifically showing that the supplement is expected to be safe.⁴

CONCLUSION

While there is still a lot of debate in the fitness community about the effectiveness of weight loss supplements, there is no denying that it has become a part of everyday life. In response to the growing popularity of these supplements, the FSSAI has been proactive and introduced various regulations to ensure that only the best quality supplements are available in the Indian market. It may be beneficial for manufacturers to be a step ahead of the game and seek guidance from experienced healthcare lawyers to ensure compliance with the relevant healthcare laws and regulations.

[1]https://www.theweek.in/health/cover/2024/01/27/with-obesity-on-the-rise-and-the-increasing-desire-to-look-fit-and-good-the-weight-loss-industry-in-india-is-booming.html

[2]File No. Std/SP-05/(Nutraceutical 2022) (part-1)- Part (1), ‘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’, accessed at: https://fssai.gov.in/upload/uploadfiles/files/Direction_New_compressed.pdf

[3]https://food.ec.europa.eu/safety/labelling-and-nutrition/specific-groups/food-weight-reduction_en.

[4]https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements#:~:text=FDA%20generally%20does%20not%20approve,in%20violation%20of%20federal%20law