Para-aminobenzoic acid or PABA is a precursor of folic acid and exists in dairy products such as eggs, milk, and meat. It is usually used in dietary supplements to improve skin health. In an order dated June 29, 2018, Food Safety and Standards Authority of India (FSSAI) banned the use of PABA in the products covered under Nutraceutical Regulations with immediate effect due to safety concerns. In the same order, FSSAI had directed that further manufacturing of products using PABA will be prohibited. Additionally, they had indicated the manufacturers and importers to immediately withdraw any product containing such ingredients from the market. Although there was no data provided by any authorities about any research backing this ban.
Dr. Riddhima Batra, a clinical dietician and founder of health and fitness initiative, Nutrition Defined, said that these supplements are still available in the market because of the marketing strategies applied to them. “Since it is not a prescribed drug, anyone can buy it.”
Dr. Batra explained that the ingredients lacked enough data and hence many of them were prohibited like PABA. “It is usually used in sunscreens, for darkening grey hair and other skin-related problems,” she said. However, despite them being over-the-counter drugs, she deters from prescribing them.. Another dietician, Dr. Pinky who has been practising at the IBS hospital, Faridabad since past four years echoed Batra’s advice. She mentioned that “if taken above a certain dosage it can cause toxicity in the body, tissue build-up, skin hardening, and can even affect liver and kidney.”
FSSAI has been facing problems in regulating the market ever since the ban. “Online is an open system and is difficult to regulate,” said Dr Anish Desai, founder and CEO at Intellimed Healthcare Solutions – a firm that provides solutions in the area of medical affairs and regulatory services for pharmaceuticals.
“FSSAI bans certain ingredients solely because there is no data on them,” he added.
Sandeep Gupta, the director and CEO of Nutraworks, agreed with Desai. He emphasised that the supplements were unavailable at his firm and refrained from commenting on their sale at other platforms.
The Commissioner of Food Safety and Health from Sheshadri Road office, Bangalore, Leelavathy said that there is no data collected on sale and import of PABA supplements ever since it got banned. Even the office head at Magadi Road, Kumaresan C had “never heard of PABA supplements before.” “India has too many open ports and it might be difficult to track where they(PABA supplements) were getting shipped from.”
However, he assured that Bangalore was not involved in any such imports or sales.
Despite his assurance, the supplements are available on various online pharmacies like 1mg, Apollo Pharmacy and others. Then there are foreign websites, like iherb, Dailyvita wherein you can make purchases and receive these supplements within 15 to 20 days. A fee of Rs. 961 for shipment and customs is to be paid to receive a doorstep delivery of these restricted products. We verified this by placing an order on March 25, 2022 for Bangalore which was delivered to the Bangalore Airport Authority and was later cleared by the customs.
A supplier at a Bangalore-based nutraceutical manufacturing company, Kiran said that he was aware of the ban but could still manufacture PABA supplements to order. Nevertheless, he added that he would require approval from the FSSAI to process the order. However, the order from FSSAI clearly mentions that it prohibits the manufacturing of nutraceutical products containing PABA.
“India is a huge market and the food safety officers in proportion are way less. Hence, it becomes difficult to regulate the market. There are too many open sources and many products despite being banned end up being available in the market,” he concluded.
Another letter dated July 24, 2020, readdressed the issue of the pharmaceutical market not being regulated despite the ban on PABA products.
As of now, India has 15 central designated officers and 33 food safety officers. Like Kiran pointed out, food safety officers are way less in proportion to the market span; the regulation thus becomes a challenge, even more so in the offline market due to lack of proper paper records.
The Ministry of Health and Family Welfare’s website shows that there are vacancies in the food regulation section and other departments as well. A recent report stated that very few food samples were being tested in labs in the state of Karnataka. The four food testing laboratories, Bengaluru, Mysuru, Belagavi and Kalaburgi in the State tested 7,324 samples or about 11 samples a day in the period between April 2019 and December 2020, of which 553 food samples were found to have been adulterated.
It also stated that certain upgradation of the facilities and infrastructure had to be made to get the NABL accreditation. “In the next three months, upgraded laboratories will start functioning in Bengaluru, Mysuru and Belagavi. The Kalaburagi laboratory will take time since a new building has to be built. The number of sample collection and testing in these laboratories was low due to staff shortage. As against a sanctioned strength of 424 personnel, 139 personnel are working in these four laboratories.”
The report included the data placed before the Legislative Council on Monday regarding two FSSAI approved private laboratories between January 21, 2021, and February 2020 had tested 6,549 samples of which 153 samples were found to have been adulterated.
FSSAI, customs and other related departments keep no data of complaints regarding selling, imports or manufacturing of these supplements. This adds to the volatility of PABA products in the market.
In an RTI filed by this reporter with the customs department of Bangalore dated March 16, 2022 and Chief Commissioner of Customs, Delhi, Mumbai, Kolkata and other states also replied saying no record of PABA was kept in the offices. Central Drugs Standard Controls Organization of Karnataka replied saying that no data is collected on the sale, manufacture or import of PABA supplements. In another RTI filed with the Ministry of Health and Family Welfare of India (MOHFW/R/E/22/01082) had no data about the adverse impacts of PABA overdose on consumers.