The 20-page report examines existing regulations across a wide range of dietary supplements, including vitamins, minerals, amino acid supplements, foods for special dietary uses (FSDUs), foods for special medical purposes (FSMPs), prebiotics, probiotics, and botanicals. did. .
The report was compiled by a cross-ministerial committee consisting of eight experts.
They include Food Safety and Standards Authority of India (FSSAI) CEO Shri. Mr. G. Kamala Vardhana Rao and Dr. Rajeev Singh Raghuvanshi, Drug Controller General of India, Central Drugs Standard Control Organization (CDSCO).
One proposal is that dietary supplements that make disease risk reduction (DRR)-related claims be regulated by CDSCO, a point that has sparked debate from the dietary supplement industry.
The committee also suggested that the FSSAI should only regulate nutrition and health claims listed under the Food Safety Act FSS (Claims and Advertisements) Regulations, 2018.
This is said to be in response to the current situation where food business operators (FBOs) are making disaster prevention claims without sufficient scientific evidence.
“FBOs make disease-related claims without sufficient scientific evidence. Many FBOs make high-end claims and some supplements are marketed with disease management/disease risk reduction claims. It has been…” The committee stated in its report:
“DRR claims are widely used by manufacturers without approval, and these claims do not imply that the dietary supplement is intended to imitate the treatment, cure, mitigation, or prevention of a particular disease, disorder, or condition. It’s being manipulated.” he added.
There is currently an expert committee within the FSSAI that makes recommendations for approving general health benefit and disease risk reduction claims beyond what is already allowed.
More than 25,000 FBOs are licensed, including manufacturers, relabellers, repackers, importers, and more.
The committee also proposed establishing separate Good Manufacturing Practice (GMP) requirements for health and dietary supplements.
How will it impact businesses?
If the proposal is adopted by the government, existing products that make DRR claims may have to change their labels or reduce their claims, said the Health Foods and Dietary Supplements Association of India (HADSA). said Dr. Vaibhav Kulkarni, Honorary Secretary and Director. ) said NutraIngredients-Asia.
“You may need to change the label of your product. If you have a specific DRR claim on your label, you may need to reduce that claim. Perhaps there is pressure on your operations and supply chain. There will be.” he said.
But he agreed that the measure could deter false and exaggerated health claims.
“The purpose of the proposal is to provide a clear and relevant product to the end consumer or patient. But as we’ve seen, once those products hit the market, they become very difficult to manage.
“Some of the claims are very strong. “There are some food companies that are making claims like 30% reduction in diabetes. How can they reduce diabetes by 30% without any clinical studies? Can you insist that I do it?”
Moving the review of DRRs to medicines authorities also means that companies will need to submit evidence of clinical trials.
Commenting on this, former FSSAI director Pradip Chakraborty said smaller FBOs would be more affected as they lack the capacity to conduct clinical trials.
“Given my many years of experience in food safety and as Director of FSSAI, food operators will need evidence from clinical trials to make disease risk reduction claims if regulatory powers are transferred to CDSCO. I think it is necessary to submit.
“And because clinical trials are expensive, time-consuming, and require review by a CDSCO expert panel, FBOs will have a hard time getting claims approved.”
He said that at present, the expert committee within the FSSAI will request clinical trial evidence on a case-by-case basis only from companies claiming DRR.
He also said that clinical trials submitted for evaluation must involve Indian citizens.
At the same time, involving CDSCO in nutritional supplements “Many requirements” For importers, he added.
“Importers need to get approval for the DRR application from CDSCO and once the consignment arrives, they need to apply for import clearance to FSSAI. This is a multi-authority process involving both CDSCO and FSSAI. It means.” he said.
Assessing clinical evidence: CDSCO can play a role
Dr Kulkarni said that while the industry would like to maintain the existing framework, the FSSAI will need to increase its capacity to do so as it continues to assess clinical evidence for DRR claims.
This is because, relatively speaking, FSSAI may not have the bandwidth to evaluate DRR claims and clinical evidence compared to CDSCO.
“FSSAI has a lot of work to do and even if DRR remains with FSSAI, its capacity needs to be improved.
“Not doing so would be a disservice to the authorities and the industry, because there may be good companies doing good clinical studies on their products, but how should those studies be considered? You could face rejection or questions about those studies simply because you don’t have a competent team to evaluate them.”
“This can cause delays or companies may become so dissatisfied that they don’t launch the product at all.” he said.
In contrast, pharmaceutical authorities may be in a better position when it comes to assessing clinical evidence.
“Drug authorities are able to verify stronger claims, such as those about disease reduction or treatment, because they examine those products every day…
“And this clinical evidence needs to be fairly evaluated, because people are spending money, time and energy to conduct research on their products.” he said.
What’s next?
Nothing has been decided yet, and the committee’s recommendations will need to be debated in parliament. Existing FSS legislation will also need to be amended before the new changes come into force.
“First, we need to amend the specific provisions we wish to amend in the FSS Act. This is a long process and the amended Act will need to be passed by both houses of Parliament, the House of Representatives and the Senate.” Chakraborty said.
He said it could take one to two years for regulations to be passed. In some cases, the process may take longer.
He gave the example of the FSS (Health Supplements, Dietary Supplements, Special Nutritional Foods, Foods for Special Medical Purposes, Functional Foods, Novel Foods) Regulations of 2022.
It was introduced in 2022, but it had to be published in the Official Gazette because it was not yet published in the Government Gazette. It was restarted several times last year and this year. This is because the relevant ministries and agencies did not give final approval.
Meanwhile, Dr Kulkarni suggested that if the industry disputes a point in the proposal, it needs to back it up with strong evidence.
“If the industry believes that DRR review should not be on the drug side of the agency, then the industry needs to answer the question ‘why’ with stronger evidence. ”
