By Dr Reuben P Syiem
Cosmeto-vigilance is a new concept of safety monitoring of cosmetic products.The Federal Food, Drug, and Cosmetic (FD&C) Act defined cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” The products covered under this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colours, and deodorants, or any other substance intended for use as a component of a cosmetic product.
The purpose of Cosmeto-vigilance is to collect, analyse and assess the adverse reactions/side effects occurring in consumers to identify any potential health risk. This allows to control or rule out potentially hazardous ingredients that may be present in cosmetic products. Initiated by the French health products safety agency as a part of pharmacovigilance system for cosmetics. Today, it is recognized globally as a concept of public health to address the safety of cosmetic products. Prior to July 2013, the safety of cosmetic products was not reviewed or approved. Since then new legislation has compelled the industry to provide data on products and ingredients before they can be marketed, however the efficacy and safety of cosmetic products are not reviewed or approved by national authorities before they are sold to the public.
In India, cosmetics are regulated as per Drugs and Cosmetics Act 1940 and Rules 1945.Part-XIII (regulates import and registration of cosmetics), part-XIV (manufacture of cosmetic for sale or for distribution) and part-XV (regulates labelling, packing and standards of cosmetics). Rule 145 and 135 prohibits the use and import of arsenic and lead containing compounds. Cosmetics containing mercury are prohibited as per provisions of rules 135A and 145 D. Rule 134-A prohibits import of hexachlorophene containing cosmetics. Rule 134 specifies that cosmetic products should contain colour, dye or pigment as per specified by schedule Q and Bureau of Indian Standards. However, the distinction between drugs and cosmetics is sometimes not clear. In India, the population is huge and similar is the market of cosmetics. Like drugs, adverse effects/side effects of cosmetics are commonly encountered. In a study with 1609 participants, in a period of 5 years, 12.2% suffered from adverse effects of cosmetics and toiletries, out of which 63.3% were women and 36.7% were men. Most common complaint was itching (70.9%), dryness of skin (63.3%), and burning sensation in skin (50%). The duration of suffering ranged from 5.5 months to 3 years. Adverse reactions to traditional agents are also commonly reported, for example, kajal and kumkum dermatitis.
Although lots of adverse effects occur at the population level, reporting to the regulatory authority is very low. A recent study published from Brazil noted that several common allergens and irritants are found in children’s skin care products and additionally were labelled as “dermatologist tested” or “hypo-allergenic.” According to the Food and Drug Administration (FDA), hypoallergenic means “whatever a particular company wants it to mean” and “manufacturers of cosmetics labelled as hypoallergenic are not required to submit substantiation of their hypo-allergenicity claims to FDA.” This allows for unhindered marketing use of the terms “hypoallergenic,” “sensitive skin,” or “fragrance free” without any consequences. There are some organizations, such as the National Eczema Foundation, that perform testing on common skin care products and provide product recommendations, which have passed their testing. Unfortunately, until more consumer-friendly databases are easily available and easy to interpret, adverse skin reactions will continue to be common.
Another major problem in India is the increased sale of misbranded and spurious cosmetics. Cosmetics are called misbranded if they contain an unprescribed colour, inappropriate labelling, or contains false/misleading product information. Cosmetics are labelled as spurious when their name resembles another cosmetic; the product resembles another cosmetic or if manufacturer information is misleading/fictitious or does not exist, which can deceive customers.
Spurious cosmetics are commonly reported in the Indian market. High level of lead is reported in many cosmetic products. Impurities such as high level of heavy metals (lead, zinc, and cadmium) are reported in many cosmetic product (lipsticks, lip glosses, eyeshadows, and henna hair dye).Hair technicians in saloon and parlours are at risk of chemicals in cosmetics and hand dermatitis is quite common among them. Female hair technicians are at particular risk for fertility disorders and adverse pregnancy outcomes, which is of special concern. One study shows that 43% of the India samples of sindoor exceeded the limit of lead content in sindoor compared to US Samples. Even commonly used “kajal” is found to contain high levels of lead.
Cosmeto-vigilance then becomes the responsibility of the consumer and their physician. As consumers, we must be aware that drugs are not the only culprits for side effects but cosmetics like hair dyes, moisturizers, make up products and perfumes etc can also produce side effects. Family medicine physicians and primary care practitioners thus have an essential role to recognize adverse reactions induced by cosmetic products, and thus encourage patients for reporting. Increasing awareness on this new concept will be a valuable remark on global public health. Hence besides proper regulation of these agents, a proper vigilance system is also required to protect the health of the Indian population. Going with words of Vigan and Castelain, proper use of cosmeto-vigilance can help to control or rule out hazardous ingredients in cosmetics and thus improve our confidence on use of these agents.
(Dr Reuben Syiem, MBBS MD is Senior Resident Doctor, Department of Pharmacology NEIGRIHMS)