Herbal products Playing with people's health with tall claims

Manufactures of herbal products should be subjected to strong regulation to ensure they evaluate safety of their products before marketing them, says the writer Dinesh C Sharma

The market of herbal medicines, food supplements, tonics and personal care products has grown tremendously in the past few years. It is a well known that the herbal product market in India is poorly regulated. Guidelines for quality control and good manufacturing practices have been developed but they are hardly enforced and manufacturers – many of the in small scale sector – conveniently ignore them.

No clear regulatory system for evaluation or clinical trials of herbal medicines is in force in India. The Drugs and Cosmetics 4th Amendment Rules 2008 provide for guidelines on evaluation of herbal drugs, classifying them into four broad categories for clinical study requirement. However, ground realities show that such rules exist on paper.

A survey conducted among manufacturers published in 2013 showed that nearly half of the total companies were carrying out general safety studies for medicines and only 12% were conducting formal clinical trials at various medical colleges.

Since most traditional medicinal and food supplement products are sold ‘over the counter’, they are heavily advertised. Mass promotion and customer preference are the major factors that drive the herbal market, as opposed to prescription medicines where the choice of physician matters. That’s why print media and television channels are full of advertisements and sponsored programmes on herbal products. Most such ads make tall claims about curing pr preventing diseases, and improving health. Some of these products make absurd claims like increasing height of children and curing cancers.

Recent complaint6s heard by the Advertising Standards Council of India (ASCI) show that large herbal manufacturers too are making unfounded and unscientific claims about their products. The companies which have been pulled up for misleading advertisements include Patanjali Ayurveda and Sri Sri Ayurveda Nature Foods. For instance, the claim of Patanjali that its mustard oil was safer than others was found exaggerated and unsubstantiated. The company had claimed that refined oil of other brands used a cancer-causing substance. The advertising council also found that claims made in advertisements of other Patanjali products like hair oil, tooth paste, washing powder and hair cleanser were also without any basis.

Now the advertising regulator has upheld a complaint against advertisements of Ojasvita, a product of Sri Sri Ayurveda. The complaint was filed by the Breastfeeding Promotion Network of India (BPNI) which argued that the advertisement gave misleading information to consumers putting the lives of children at risk. The product also has high amount of sugar (41.9 gram per 100 gram) and is actually a processed food. All this information was not provided in advertisement and no specification instruction was given of age group for which the product is meant. The complaint was considered by the Consumer Complaints Council and the company was offered an opportunity of hearing but it did not do so but sent a written explanation.

The company claimed that the food supplement was ‘enriched’ with herbs like ashwagandha, brahmi , bringaraj etc. The council noted that the manufacturer did not give any evidence to show that contents of the product or any technical rationale or clinical evidence to substantiate the claim that the ingredients support ‘daily mental fitness needs’ of people. In view of this, the council has held that the claim of Ojasvita meeting ‘daily mental fitness needs’ is not substantiated and is misleading. The advertisement contravened rules laid in the ASCI Code. The company has agreed to comply with the order.

While complaints regarding misleading claims of herbal products are being upheld and ads suitably modified, such misbranded products continue to be in the market. India needs stronger food safety law that cover food supplements too, because at present harmful food supplement are being sold by direct marketing companies. The US food and drug regulator regulates both finished dietary supplement products and dietary ingredients, under its Dietary Supplement Health and Education Act of 1994. Under these rules, companies and distributors of dietary supplements and ingredients are prevented from marketing products which are adulterated or misbranded.

In India, adulteration of raw materials is a major problem. About 600 medicinal plants, 52 minerals and 50 animal products are commonly used in traditional herbal preparations, according to the government. Medicinal plants can get contaminated during growth, collection, and processing. Unless this is checked, one can’t assure quality of the end product. Product manufactures should be made responsible for evaluating safety of their products and proper labeling before marketing products. That’s the only way misbranded and unsafe products can be prevented from reaching consumers. Misleading ads are just one part of the problem.