On April 12, the International Alliance for Dietary/Food Supplement Associations (IADSA; Brussels) commented in a press release that India’s recently-rolled-out regulations for its 2006 Food Standards and Safety Act (FSSA) “will boost foreign investment in the sector now that health supplements are clearly featured in the country’s food laws.”
As IADSA explained, the 2006 Act requires India’s Food Safety and Standards Authority (FSSAI) to develop specific regulations covering the following: novel food, genetically modified articles of food, irradiated food, organic food, food for special dietary uses, functional food, nutraceuticals, health supplements, and proprietary foods. In part to fulfill the 2006 Act, in August 2011 FSSAI released both India’s “Food Safety and Standards Rules” and “Food Safety and Standards Regulations.”
It is believed that these regulations collectively will eventually provide a greater measure of security for India’s food industry. However, as several in the industry explain, how the law will handle dietary supplements remains to be seen.
What about Supplements?
The timing, by the way, for more-specific regulations couldn’t be better, as India shows tremendous signs of growth in this market. With a food processing sector valued in 2005 at $65.5 billion by Frost & Sullivan, and a latent market in nutraceuticals and functional foods valued at between $1.6 to $3.1 billion by the Federation of Indian Chambers of Commerce and Industry (FICCI), India has nearly 148 million potential customers, and an 18% growth rate that is being driven by functional food and beverage categories.
Says M. Deepak from Bangalore, India–based Natural Remedies, a manufacturer of botanical-based extracts and proprietary nutraceutical formulations, “By implementing the 2011 regulations, which are geared to providing better food safety, we now have enforcement and regulations relating to import, export, development, storage, transport, and sale, which were not covered by other central acts before.” He says the 2006 FSSA repeals previous laws, such as the Prevention of Food Adulteration Act (PFA) of 1954.
Both the “Food Safety and Standards Rules” and “Food Safety and Standards Regulations” documents—only the latter of which is presently available in English—go into detail regarding safety and labeling requirements for food processors, vendors, and retailers. They do not, however, appear to specifically elaborate the avenues that are available to food supplement marketers in making any sort of health claims, such as for dietary supplements. As Deepak says, “There were no specific regulations for supplements.”
So what will happen to supplements? That is the $64,000 question.
Deepak adds that an effort was made with the new regulation to marry the original food standard provisions of the PFA with the trade-promoting goals of the FAO-WHO Codex Alimentarius guidelines. Deepak says India is committed to “harmonizing [its regulations] in line with the Codex Alimentarius Commission guidelines and European Food Safety Authority (EFSA) rules and regulations relating to food supplements and ingredients.”
Interestingly, although FSSA was widely hailed by industry companies and trade associations in 2006 as having DSHEA-like provisions and opening up “tremendous opportunities for dietary supplement companies throughout the world,” according press at the time, nearly all observers and experts now point out that FSSA’s regulatory framework is looking more like a European model as it is erected.
“FSSA aims to set up systems like EFSA’s to control and regulate dietary supplements,” says R.V. Venkatesh, the Hong Kong–based managing director of herbal extracts manufacturer Gencor Pacific.
When asked when all of the required rules and regulations, including for supplements, will be developed and released, Venkatesh says, “Right now, there is a lack of clarity about the whole system and procedures, and this is something which will take time to crystallize into a proper form.”
Attorney Scott Tips, who is president of the Monrovia, CA–based National Health Federation, agrees with Venkatesh: “India is making the same mistake that the European Union has made when it comes to supplements. By focusing, as food and drug bureaucrats and regulators do, on ‘food safety,’ they miss the big picture that would necessarily include the incredible safety record of supplements.”
He continues, “By [setting the stage for] micromanaging supplements with well-intentioned but nevertheless costly and burdensome rules and regulations, India will simply price healthy and beneficial supplements out of the hands of the very people who need them the most—the poor and less-well-off. This law forgets the cost-benefit analysis that must always be first conducted when enacting any new law or regulation. In this case, for saving maybe a handful of lives, how many hundreds of thousands, even millions, of Indians will suffer worse health or die because they could not afford to take supplements that would have staved off death and disease? That is the real question that this law never addresses.”
IADSA remains more sanguine. In an interview with Nutritional Outlook, the organization’s communications director, Estelle Marais, says, “The Act is a positive step for the clear regulation of dietary supplements in India as it has clearly categorized health supplements under food law....The specific regulations...under the Food Safety and Standards Act of 2006 that [are] still being developed will provide clarity as to whether or not special conditions will be imposed on market access for supplements.”