Monday, June 11, 2012

Cosmetic Labels 101: The Game Of Cosmetic Regulation

Hi everyone :)

So,here's the second post of the series "Cosmetic Labels 101"-The Game Of Cosmetic Regulation.If you haven't read the first post in which i explained about the cosmetic regulatory bodies of India and the USA then click HERE and please read it first.In this post we are going to learn about how the regulatory bodies work,what they do/can do and what they don't/can't.

Let's start with the cosmetic regulation game of The USA first.Why? because in this case our indian regulation is a little dependant on their's as we learnt in the previous post.

So,as we learnt in the first post,the FDA is not just the government regulatory body that regulates the cosmetics but also is just the figurehead! (*Figurehead: A nominal leader or head without real power.)  

FDA has a program for the cosmetic companies called "Voluntary Cosmetic Registration Program" (VCRP).The VCRP collects information on product ingredient listings and registration of manufacturers, packers and distributors.They can register with the FDA through this program.However,it is not mandatory and the participation in the program is entirely voluntary.

And there are these cosmetic industry trade organizations called PCPC and CIR which we talked about in my first post.

So, based on this,first let's see what the FDA can not do.

What the FDA can not do:
  • The FDA doesn't test  everyday personal - care products for safety before they hit the market.
  • The FDA doesn't require companies to provide safety data about it's products or ingredients.
  • The FDA can't require product recall.The agency must go to court to remove misbranded and adulterated products from the market.
  • The FDA can't effectively and efficiently regulate cosmetics products without facing cumbersome legal proceedings with manufacturers.
  • The FDA can't require manufacturers to register their cosmetic establishments,file data on ingredients,or report cosmetic-related injuries.Instead,FDA relies on voluntary reporting of ingredients, injuries and establishments.
  • The number and location of companies that manufacture and distribute personal care products. The FDA’s primary enforcement tool is facility inspections, but they can’t inspect facilities they don’t know exist.
  • The extent of health impacts from harmful ingredients. Companies are not required to report adverse health effects to the FDA or share studies they may have conducted on chronic health effects.
  • The presence or potential health impact of nanomaterials in cosmetics.
According to "The Federal Food, Drug and Cosmetics Act (FFDCA) includes 112 pages of standards for food and drugs, but just a single page for cosmetics."

As you can see,FDA's rules about cosmetics barely even exist.It doesn't even have the authority to give pre-market approval of finished products.So,When a company says that it complies with FDA's rules,don't trust them blindly because there is not a whole lot they are complying with.

So what does/can the FDA do regarding cosmetics?

Nothing at all!!!

Now comes the PCPC-Personal Care Product Council & CIR-Cosmetic Ingredient Review.

So,as we learnt in the previous post,PCPC is a powerful industry group that represents more than six hundred cosmetic companies.It is madeup of Lobbyists(A lobbyist is an activist who seeks to persuade members of the government to enact legislation that would benefit their group),Scientists,Policy experts,Public relation folks and some guy who used to be the head of FDA's cosmetic department.

But according to the book 'No More Dirty Looks': "It's also the group that powers up the PR machine when someone says cosmetics might not be so good for you."

PCPC has a history of lobbying against proposed regulations on cosmetics! It brings up the CIR when questions arise about the lack of proper regulation.

Now let's see what the CIR ha done till now: It  is made up of nine voting members who give the PCPC recommendations on different ingredients.It does not itself test the ingredients or products, though.Instead,it's panel reviews scientific research on high priority ingredients and meets four times a year to discuss what it has found and then gives safety recommendations.Reps from big companies are also present during these meetings to take part in the discussions.(Isn't something smelling fishy?).

From 1976,the CIR assessed 1,468 ingredients for safety.That's 11% of the ingredients listed in the cosmetic ingredient dictionary that the PCPC uses! To this day only 9 ingredients have been deemed unsafe for use in cosmetics.

FYI: Europe has banned more than 1000 ingredients for use in personal care products!!!

Now,that should explain what game these regulatories are playing!

Let's jump to India now..,according to

"The cosmetic products  have  to  be  formulated  and manufactured in accordance with Schedule M-II of Drugs and Cosmetics Act 1940 and Rules 1945 and Indian Standards issued by BIS (Bureau of Indian Standards),New Delhi, GMP guidelines of USFDA as well as guidelines of CTFA (Cosmetic, Toiletries and Fragrance Association) which is now known as PCPC(Personal Care Product Council), IFRA (International  Fragrance Association) and similar bodies." 

So,what did you understand after reading the above paragraph? Yes,you are right..the Indian cosmetic regulations are dependant on PCPC and USFDA! 

Aren't there any rules in our "Drugs and Cosmetics act" that do not depend on other regulatories? Hmmm..Actually yes, there are! or better say, there 'is'! Let's have a look at what it is:
  • Pre-market approval of a product before it hits the market is mandatory in India.
But how far do you think is this useful? Not much,because if the product satisfies the the USFDA or the PCPC's criteria for safety then they get easily approved..and we saw how those criterias are a little loose.

Our rules for imported cosmetics are little loose too! Let's see what's in our Drugs and Cosmetics act:

"No cosmetic shalt be imported  unless  it complies  with the specifications  prescribed under schedule S and schedule Q or any other standards of quality and safety,applicable  to it,and other provisions under the rules.In case the cosmetic is not included under schedules,it shall meet with specificaffons  under  the rules and standards applicable to it in the country of origin."

So,the cosmetics which are not included under the mentioned schedules can easily make an entry in to the market without being questioned it's safety!

However,on a global scale, countries are reaching a consensus on the standards of quality of cosmetics by coming under a common umbrella of CHIC (Cosmetic Harmonization and International Cooperation) initiated in 19995 and revised from time to time." It is  not known as CHIC anymore.That process has now been superseded by ICCR (International Cooperation on Cosmetic Regulation).I tried so hard to find out what exactly this ICCR does but couldn't!

Anyways,my final word is: Our Indian regulations are no better than the USA's. :(

So,this is how game of cosmetic regulation is being played.In the next post we'll see how The 'Claim' Game is being played by the USA and Indian regulatories.

If you find this info useful,then please share it with as many friends and dear ones as you can to spread the awareness.




Please see the "References" section of THIS post.

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