While on one side mounting evidence is demonstrating the benefits of health foods in disease prevention and health promotion, several safety concerns have been recently raised particularly with regard to the seemingly indiscriminate addition of botanicals to food. A plethora of cereals including rice, maize, wheat, jowar, and drinks, soups, teas, noodles and flours are being enhanced with botanicals, some of which may pose a risk to certain consumers. Several herbal products are prone to be contaminated with pesticides, heavy metals, etc., especially when the herbs used are through improper cultivation/collection practices. While many herbs are considered safe, some have hazardous side effects. Not much is known of the short-term and long-term benefits and risks of many herbs. Many are shown to be toxic and in some cases addition of small amounts of herbs, even those found in teas has serious effects.

Though herbs are being used like drugs for health-related benefits, they are not tightly regulated like drugs and other medications. Regulation of this category of products differs in different parts of the world. The availability of herbal products world over depends upon regional changes in regulatory strategies. In European countries herbal drugs are even prescribed and a lot of industrial standards are applied to those products. Still herbs unlike drugs are not standardized in terms of the same amount of active ingredient. A single herb can be standardized to different ingredients by different manufacturers. Also doses differ between products and from product to product. The active ingredient may vary depending on the plant part (flower, root, stem etc.), plant form (dried extract, tincture, tea) and plant species.

Thus the safety issues related to herbs are complex and the issue of herb-drug interaction has received increasing attention. Herbs may interact with prescription medications, OTC drugs, vitamins and minerals. For example, ginkgo taken with ibuprofen may lead to spontaneous/excessive bleeding. High doses of garlic may enhance the effects and adverse effects of anticoagulant and anti-platelet drugs, including aspirin, clopidrogel, enoxaparin and others.

In the wake of such data there is growing concern about the sale of such foods enhanced with herbs such as St.John’s wort, guarana, gotukola, ginseng, ginkgo, echinacea, kavakava and spirulina in the United States. Following the Government Accountability Office (GAO) report in 2000 that raised concerns about safety of certain functional foods – significant regulatory changes followed:

• Nutritional Labelling and Education Act of 1990 (NLEA) enabled the use of FDA pre-approved health claims that characterize the relationship of any food/food components to a disease/health condition.
• Dietary Supplement Health and Education Act of 1994 (DSHEA) regulates dietary supplements as foods (not food additives) defining them as vitamins, minerals, herbs or botanicals, aminoacids and other dietary substances for use by man to supplement the diet including concentrates, metabolites, constituents, extracts or any combination of the above.

As per US FDA herbs cannot claim to prevent, diagnose, treat or cure a condition or disease. This requires sound scientific evidence and significant scientific agreement. What counts as significant scientific agreement is outlined in a guidance document issued by the US FDA in 1999. This would require the support of a body of consistent relevant evidence from well-designed clinical, epidemiological and laboratory studies and expert opinions from a body of independent scientists. Herbs may carry health-related claims about effects on the ‘structure or function’ of the body or ‘general well-being’ that may result from the product. Examples of structure/function claims include ‘helps support a healthy immune system’ for dietary supplements containing echinacea and ‘maintains cholesterol levels that are already in the normal range’ for a combination product containing fish oil, flaxseed oil and garlic. Manufacturers using structure/function claims must simply notify the FDA within 30 days of marketing the product that displays the claim. Each such claim must be accompanied by a disclaimer stating that the claim has not been evaluated by the FDA and the product is not intended to diagnose, treat, cure or prevent any disease. Structure/function claims may also appear on conventional foods without displaying the disclaimer that must appear on dietary supplements. When used on conventional foods, the claims must include an indication of how the nutrient in question affects the structure or function of the body. The DSEA has thus opened up a favourable regulatory environment for herbal products. This opportunity to make statements on food labels related to the health benefits of functional foods has resulted in major companies venturing into foods for the health and wellness market.