The Food Safety and Standards (FSS) Act, 2006, and FSS Rules and Regulations, 2011 require many changes and updates, and it would be advisable to plan for reconstruction by the FSSAI earlier.
Currently, only the Diet Allowed for Prescribed Vitamins is equal to or less than the Recommended Food Intake (RDA) levels, while for many ingredients such as Vitamin C and Biotin, which are required in more than RDA levels and have no toxicity, simple and better Dose limits are required. For example, a nutraceutical with lemon balm extract may not be brought onto the market because it has not been updated in the Nutraceutical Ordinance.
“Many ingredients on the market are very useful to people but not available to people. Even if we try to get evidence, it will be a lengthy process of 1 to 1.5 years to get clearance where we have to submit an application to the ex-committee with ingredient-based research and clinical trial results. We tried the same for one of our products and the composition has yet to be tested, ”said Divij Bajaj, CEO of PowerGummies.
PowerGummies is a nutritional supplement brand headquartered in New Delhi. Instead of tablets and pills, the company has developed chewable dietary supplements that are vegan, gelatin-free and gluten-free, with no sugar, no pesticides and no artificial colors.
Regarding the policy interventions required today in relation to the RDA and TUL values required today, “There is no clarity as to when the reforms would take effect, but some policy changes are strongly recommended. First, there needs to be more relaxations and quick additions to new formulations and ingredient updates related to RDA and TULs. At first there was TUL in the old Nutraceuticals Act, but eventually they lifted all these upper tolerance limits and just kept a single roll simple, if it is equal to or less than RDA it falls under FSSAI and if you exceed RDA there is no TUL ”, explained Bajaj.
In biotin it was previously defined that there was no TUL so that much biotin could be added and it is safe, given research presented to the FSSAI, that even 2lc micrograms of biotin per day is non-toxic. There is no upper tolerance limit for biotin anywhere in the world.
“As a responsible brand, we want to ensure that the science behind every product and the right consumer education is communicated to the end user through our 360-degree touch base. We actively try to explain to our customers what role each ingredient plays, what the benefits are, how to properly ingest it through our product packaging, social media campaigns and more. Once a knowledgeable consumer knows the implications, it is a chance to have a long-term customer without falling for mischievous prey from illegitimate entrants, ”says Bajaj.
“Anything in the form of a pill is a drug for everyone, and so we say that if people bring alternatives to this ecosystem, they are actually ready to try it and be ready to get involved” , he says. In the western countries, the category of dietary supplements takes precedence over the pharmaceutical possibilities of pills in the everyday life of their citizens. In AC countries, the first barrier is the difficulty associated with pills and the second is that OTC nutraceuticals are still associated with doctor’s recommendation.
“Likewise, at PowerGummies, we’re doing the same thing to bring nutrition to millennials and adults. We have identified barriers that are hindering the growth scope for nutraceutical marketing, so we have created a brand to accomplish the same and develop a nutritional alternative that can be a convenient lifestyle routine for anyone, such as: B. in the form of gummy bears, ”said Bajaj on a final note.