The 20-page report looked at existing regulations across a wide range of nutraceuticals, including vitamins, minerals, amino acid supplements, Foods for Special Dietary Uses (FSDU), Foods for Special Medical Purposes (FSMP), pre-, probiotics, and botanicals.
The report was put forth by an inter-ministerial committee consisting of eight experts.
They include heads of both Food Safety and Standards Authority of India (FSSAI) CEO Shri. G. Kamala Vardhana Rao and Central Drugs Standard Control Organisation (CDSCO) Drugs Controller General of India Dr. Rajeev Singh Raghuvanshi.
One of the suggestions was for nutraceuticals making disease risk reduction (DRR) related claims to be regulated by the CDSCO – a point that has sparked discussion from the nutraceutical industry.
The committee also proposed that the FSSAI would regulate only nutritional and health claims listed under the Food and Safety Act FSS (Claims and Advertisement) Regulations, 2018.
It said that this was to address the current situation where food business operators (FBOs) have been making DRR claims without having adequate scientific evidence.
“FBOs are making disease related claims without having adequate scientific evidence. Many FBOs are doing high end claims, and several supplements are marketed with disease management/ disease risk reduction claims…” the committee said in the report.
“DRR claims are more widely used by manufacturer without approvals as well as these claims are manipulated in such a way that mimics treatment, cure, mitigation or prevention of any specific disease, disorder or condition in Nutraceutical products,” it added.
At present, there is an expert committee within the FSSAI to provide recommendations on approving any claims to general health benefits and disease risk reduction, beyond those that are already permitted.
More than 25000 FBOs, including manufactures, re-labeller, re-packer, importer etc, are licensed.
The committee also suggested a separate provision of Good Manufacturing Practices (GMP) requirements for health supplements and nutraceuticals.
How does it affect companies?
If this suggestion was to be taken up by the government, existing products making DRR claims might need to change their label or cut down on their claims, Dr. Vaibhav Kulkarni, honorary secretary and board member of India’s Health Foods and Dietary Supplements Association (HADSA) told NutraIngredients-Asia.
“The product labelling may need to undergo a change; you may have to cut down certain DRR claims if you are stating it on the label. There is probably a pressure on the operation and supply chain,” he said.
However, he agreed that the move could deter against false and exaggerated health claims.
“The purpose of the suggestions is to provide clarity and proper product to the end consumers or patients. We have seen during the COVID period where companies have taken advantage of the system and make exaggerated claims. But once those products enter the market, it becomes very difficult to manage them.
“Some of the claims can be very strong. I have some food companies making claims like 30 per cent reduction in diabetes…If you don’t have clinical study done, how can you claim 30 per cent reduction in diabetes?”
Moving the review of DRR to the drug authority also means that companies would need to submit clinical trial evidence.
In this case, former FSSAI director Pradip Chakraborty said that smaller FBOs would be more affected due to a lack of capability in conducting clinical trials.
“In light of my long experience in food safety and as director at FSSAI, I believe that food business operators will have to submit clinical trial evidence for disease risk reduction claims when the regulatory purview goes to CDSCO.
“And clinical trials are costly, as well as time consuming, and it have to be reviewed by the CDSCO expert committee, so FBOs will suffer from this for getting the claims approval.”
At present, he said that the expert committee within FSSAI would only request for clinical trial evidence from companies making DRR claims on a case-by-case basis.
He also said that the clinical trials submitted for evaluation need to involve the Indian population.
At the same time, involving the CDSCO into nutraceuticals could mean “multiplicity of requirements” for importers, he added.
“The importers will have to get DRR claim approval from the CDSCO, and when the consignment reaches, they have to apply for an import clearance from the FSSAI. This means it will be multiplicity of the authorities, with both CDSCO and the FSSAI involved,” he said.
Clinical evidence evaluation: CDSCO could fill in the shoes
While the industry’s preference is to stick with the existing framework, with the FSSAI continuing to assess clinical evidence for DRR claims, Dr. Kulkarni said that the FSSAI would have to increase their capability for doing so.
This is because comparatively speaking, the FSSAI might not have the bandwidth as compared to the CDSCO in evaluating DRR claims and clinical evidence.
“The FSSAI has to do a lot of work on it, they have to increase their capability even if DRR were to remain with the FSSAI.
“Otherwise, it is a disadvantage to the authority and the industry because there can be good companies with good clinical studies on their products, but just because you don’t have a capable team to evaluate those studies the way it has to be looked into, you may face a rejection or questions on those studies.
“This may cause delays, or companies may be frustrated and never launch the product at all,” he said.
The drug authority, in contrast, would be in a better position when it comes to evaluating clinical evidence.
“The drug authority is capable of validating stronger claims, like those that are about mitigating, curing diseases because day in and out, they are looking at those products…
“And these clinical evidence needs to be evaluated fairly, because people have spent money, time and energy on getting those studies done on their products,” he said.
What’s next?
Nothing is set in stone yet and the committee’s recommendations would need to be debated at the parliament. The existing FSS Act would also need to be amended before the any new changes could take effect.
“You have to first amend the particular sections which you want to amend in the FSS Act. It’s a long-term procedure and the amended Act has to be passed in both the houses of the parliament, both the lower house Lok Sabha and the upper house Rajya Sabha,” said Chakraborty.
It could take one to two years to pass a regulation, he said. In certain cases, the process might be even longer.
He gave the example of the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations 2022.
Although it was introduced in 2022, it has not yet been gazetted and had to be re-operationalised for a few times last year and this year because the ministry involved did not give their final approval.
Meanwhile, Dr. Kulkarni suggested that the industry – should they refute any points on the proposal – should back up their points with strong substantiation.
“If the industry view that DRR review should not go to the drug side of the authority, then the ‘why’ question needs to be answered by the industry with a stronger substantiation.”