Moreover, both will help improve public health, according to Sandeep Gupta, vice chairman of the India Drug Manufacturers' Association's (IDMA) nutraceutical committee.
Speaking to NutraIngredients-Asia, he highlighted the importance of considering TUL — in addition to the recommended daily allowance (RDA) — in establishing guidelines for the supplement and nutraceutical industry, saying this would better aid the process of self-regulation.
With this in mind, a 20-member industry committee recently compiled and submitted a report on regulatory suggestions to the Food Safety and Standards Authority of India (FSSAI).
Gupta said, "In the past, it was difficult to determine the safety of the vitamins and minerals used in health supplements. Now, those responsible for evaluating this safety will have clear guidelines for doing so, and manufacturers will not be allowed to go beyond the RDA, unless they have been approved to produce FSMP (foods for special medical purposes).
"However, the TUL concept has already been established in other parts of the world, especially Europe and the US, just never in India."
He added that the proposed TUL framework would offer helpful guidelines for businesses in India to determine the safety of different amounts of vitamins and minerals.
"In the US, the industry has a category for medical foods and medical nutrition, (which falls) between pharmaceutical drugs and dietary supplements. Right now, India has a category for drugs, and another for health supplements. But the RDA is for healthy individuals — there is basically one RDA per supplement or drug category per healthy individual.
"The updated regulatory system will help regulators carve out a niche to address the medical food and nutrition category, where TUL will play a critical role in designing the regulations for such foods. This is in line with global practices, and it is within the FSSAI's authority to institute and implement the principles of TUL in the country."
Global standards for local regulations
India's rapidly growing supplement and nutraceutical industry is expected to be worth USD$10bn by 2025, and in preparation, the FSSAI has taken steps to amend the regulatory system, primarily by using international best practices as an example.
In December 2016, it introduced a set of regulations for health supplements, nutraceuticals, foods for special dietary use, foods for special medical purposes (FSMP), functional foods, speciality foods containing plants or botanicals, foods containing probiotics and / or prebiotics, and novel foods, covering details such as composition, claims, labels and so on.
To support the effective enforcement of these rules, the FSSAI has been looking to global best practices to aid in regulatory harmonisation, especially with regards to vitamin and mineral content in supplements and nutraceuticals.
As a result, the Confederation of Indian Industry (CII) collaborated with the International Alliance of Dietary / Food Supplement Association (IADSA) to set up the Resource Centre for Health Supplements and Nutraceuticals (ReCHaN), which has begun scientific dialogues on global best practices between industry stakeholders and international experts.
ReCHaN had previously issued two guidance documents on compliance and good manufacturing practices (GMP), followed by a training manual and presentation deck on food safety management under the FSSAI’s Food Safety Training and Certification (FoSTaC) initiative, all of which are applicable to both food businesses and regulators..
Good for business…and public health
Gupta added that while the exisiting guidelines cover the safety and permitted concentrations of ingredients, labelling, and general claims, guidelines on health claims would be announced separately in the near future.
"We've been working very closely with the FSSAI, the basic idea (of these changes) being that people should know what is and isn't allowed, and should then be able to practise self-regulation.
"The FSSAI is asking stakeholders to share any health claims that have been accepted elsewhere, based on scientific studies and tests, so they can adopt global standards. In response, we are sending claims that have been approved by EFSA, FDA and other such bodies in Europe and the US to the FSSAI, so they can be reviewed and adopted in India.
"This so that when the new health claim regulations are released, companies do not need to approach the FSSAI individually for approval of these claims on their products.
"However, they must ensure the ingredients and their quantities, as well as the health claims, are identical to what has been approved in Europe and the US. It's a balanced approach in terms of public health, stakeholder interests, and prospective industry growth."
He added that the regulatory progress in India's supplement and nutraceutical industry so far has been encouraging, with rules having been made more practical.
However, he also advised businesses to be prepared for evolving challenges, emphasising constant cooperation between companies and the authorities.
"We need to maintain regular dialogue between regulators and industry stakeholders. Nothing is constant — we must keep reviewing the regulations and making sure businesses take responsibility in keeping with the guidelines of the current regulations.
"There's a big opportunity for the industry to grow, and the FSSAI has already predicted the kind of growth it's expecting by 2025. There will be many new entrants, mergers and acquisitions, and new product launches. Many start-ups will be introduced to the Indian nutraceutical sector.
"Ultimately, the nutraceutical industry will be driven by innovation, science, and excellence in manufacturing. I believe self-regulation would fit well into these dynamics and provide the necessary support."