'Misbranded nutraceuticals': Indian trade body chief calls for partnership, not punishment, from regulators

By Cheryl Tay contact

- Last updated on GMT

According to the FSSAI, a spate of nutraceutical products and health supplements on the market that flout labelling regulations has been reported. ©Getty Images
According to the FSSAI, a spate of nutraceutical products and health supplements on the market that flout labelling regulations has been reported. ©Getty Images

Related tags: Fssai, India, Label, Nutraceutical

A trade association director is calling for better multi-sectoral cooperation in India, to minimise the need for authorities to clamp down on nutraceutical and supplement companies in India for labelling violations.

This comes after the Food Safety and Standards Authority of India (FSSAI) issued a letter about what it terms 'misbranded nutraceuticals', instructing authorised officers to curb sales of such products.

According to the regulatory body, a spate of nutraceutical products and health supplements on the market that flout labelling regulations has been reported.

In particular, it highlighted products that contained gelatine shells or ingredients of animal origin bearing the green dot on their labels to signify they were safe for vegetarians to consume.

In the letter, the FSSAI's joint director of regulatory compliance, Parveen Jargar, stated: "This is in contravention of Food Safety and Standards (Packaging and Labelling) Regulations, 2011, which mandates the applicability of 'vegetarian' or 'non-vegetarian' on the labels of pre-packed food products. It would be considered misbranding if the product fails to comply with the norms.

"All food products falling under the category of nutraceuticals / health supplements shall have to comply with the FSS regulations for health supplements, nutraceuticals, food for special dietary use, food for special medical purposes, functional food, and novel food released in 2016, as well as FSS regulations on packaging. Failing to do so would attract penalties in accordance with the law."

Jargar further said that state authorities had been instructed to "initiate a strong enforcement drive to keep a check on such food products violating the norms"​, and urged these authorities to take appropriate action against food business owners (FBO) found in violation of the law.

Details of deception

Sandeep Gupta, vice chairman of the Indian Drug Manufacturers' Association's (IDMA) nutraceutical committee and director of the Expert Nutraceutical Advocacy Council (ENAC), told NutraIngredients-Asia​: "Under the FSS Act, there are no exclusions. If there is even a trace of animal origin in the processing of any food product or ingredient, it must carry the brown logo (that signifies it is) non-vegetarian.

"Any FBO manufacturing, marketing, distributing or importing products containing ingredients or additives of animal origin but using the green vegetarian logo will be flagged for violation."

 ​He added that there were other chargeable offences regarding packaging and labelling compliances, such as

  • misleading health claims
  • failure to declare the presence or type of food additives used
  • leaving out the name or address of the manufacturer
  • erroneous nutritional values
  • leaving out or stating the wrong shelf-life
  • the absence of the FSSAI logo or FBO licence number
  • not stating the RDA
  • using unspecified ingredients or additives

Industry inspection

To minimise the number of misbranded nutraceuticals on the market, Gupta said, "Industry would need to follow stringent self-regulation by maintaining SOPs on all levels, and to keep monitoringthemselves by referring to a checklist of dos and don'ts.

"There must also be continuous awareness, and training programmes for all employees to ensure quality control and assurance."

He added that trade associations should 'consistently and periodically' conduct specific programmes on food safety compliance, maintaining engagement among industry stakeholders, and spreading education and awareness.

At the same time, he said, "There must be continuous dialogue with the FSSAI to create a framework for a good ecosystem of legitimate compliances to support public interest with no compromises."

Regulatory responsibility

Gupta also noted that unlike other food categories, the nutraceutical sector tended to be considerably well organised, employing highly qualified healthcare professionals, researchers, nutritionists, microbiologists, food technologists and pharmacists.

However, he then added that professional expertise and best practices were not quite enough to curb incidences of misbranded nutraceuticals.

He said, "Whatever expertise and best practices FBOs may adopt in a technical and science-led environment, they should be supported by practical timelines. If the FSSAI expects too many frequent changes, this will disturb the business operation, hampering productivity and creating losses.

"There should be practical timelines and a fixed periodic review — perhaps annually — after which changes should be called for via notifications."

Corporate cooperation

Additionally, he said that with the help of the Standard Review Group, the FSSAI and nutraceutical firms should develop joint awareness programmes for public interest on the benefits of nutraceutical products, "which are important for public health and to prevent the risk of disease burden in the population"​.

Gupta also cautioned against using fear-mongering tactics to ensure compliance.

"The motto of the FSSAI and industry should be to create education, awareness, engagement and networking amongst the stakeholders.

"They should establish a task force to monitor and closely work with each other to continually improvise the practices, rather than create fear via enforcement notifications amongst stakeholders."

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