Will consumer based study come under clinical trial?
Consumer based study can be of either interventional or observational. The market research organizations generally undertake such study for FMCG companies to get to know about the product acceptability, consumer expectation etc.,. As far as personal care products are concerned, a new formulation is always tested among consumers vis-à-vis existing product or in-use product. Once the feedback of the consumer is in line with the expectation, the companies proceed with marketing the same.
The question is are these products licensed before placing to the consumers? Dr Ranganathan asked?. What safety date is generated before going for such studies?. How the adverse events are managed or reported. Are these studies come under clinical trial definition as a new product tested among consumers? Being a cosmetic product, very less side effect is only expected. But the claim on the product does it not qualify the product to be not mere a cosmetic?
Post market trail is a different issue. Pre-market trial on human volunteers…. Rigorous guidelines in this regard may affect the very growth of the company and it is also not desired for products under cosmetics. But, involving human volunteers, a study with pure commercial interest, yes some regulation is required, Dr Gokulshankar, professor of Biotechnology, AIMST university, Malaysia said. Dr Ranjith, Professor of Microbiology from AIMST said that regulation is must but should safe guard the interest of the FMCG companies and its business as well
Awarness among consumers and educating them to seek and clarify certain fundamendal question befor taking part in such studies are needed.
Questions and Answers
Everyday we are exposed to a multitude of contaminates and toxins from the air we breathe, the clothes we wear and the personal care products we use. Most of us don’t stop to think about the risk we take when we constantly put chemicals into and onto our bodies and often it is assumed that if it is for sale then it is tested and safe. Not so.
Most consumers are unaware of the doubtless dangerous chemicals found in everyday cosmetics and private care products. Chemicals such as Propylene - Glycol (anti-freeze), Sodium Lauryl Sulfate, and petroleum are all common ingredients in most household and private care products, and have proven to be dangerous upon exposure.
Ethical grocery products are continuing to make headway in the market, especially when contrasted with the relatively flat market for conventional groceries. Indeed, by many accounts, consumer demand is steadily increasing for products that fulfill eco-friendly, natural, organic, local, humane, and fair trade criteria.
Cosmetics and toiletry products are largely dependent on chemicals for their manufacturing. Growing demands for these products in the market for such products has reached nearly $7.6 billion by 2010.
There are already numerous articles written on the hazards of chemicals in personal care products. Even Senator Edward Kennedy has written several letters to Congress regarding the health risks associated with using cosmetics that contain cancer-causing ingredients.
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