Knowingly or unknowingly, cosmetic products have become an indispensable part of our daily lives. Majority of women wear some kind of cosmetic product like eye and facial makeup, skin moisturizers, nail polishes, perfumes, hair colours, and so on, on a regular basis. Though these products are not directly governed by the US Food and Drug Administration (FDA), the cosmetic products need to be in compliance with US Federal Food, Drug, and Cosmetic Act (FD&C) and US Fair Packaging and Labelling Act (FP&L), both of which are a part of the US FDA.
These two agencies, apart from regulating the cosmetic colour additives, express concern in the following areas:
- Cosmetic products not meeting the definition of the FDA
For a product to be termed cosmetic, it should fall under the definition given by the FDA, i.e. “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.”
“Cosmetic substances are appearance or odour enhancers, and have no role to play in anatomical remodelling.”
- False claims
Though FDA has been hard at work, trying to make cosmetic companies liable to their customers, these companies however, inadvertently or intentionally, have been flouting these instructions.
An example of false claims are claims made on the anti-ageing creams, that claim to offer “wrinkle-free skin”. But in reality, the temporary hydrating effect of the cream on the skin gives a reduced “appearance” of wrinkles, as opposed to the claim which announces that the user could magically get rid of wrinkles. Some other claims concerning the FDA are “The products will “rejuvenate,” “repair,” or “restructure” the skin”, such claims are considered to be Drug Claims.
“Any product claiming to change/affect the body’s structure or function, or claiming to diagnose, treat, mitigate, cure, or prevent any disease is not a Cosmetic.”
- Use of regulated elements
The manufactures need to ensure that the ingredients that go into the cosmetic do not bring about any “structural or functional” changes to the body of the user.
“None of the ingredients of a cosmetic product, must be regulated as a Drug or Biologics in the US.”
Whenever cosmetic products do not comply with the above mentioned requirements, the FDA steps in, and companies involved face repercussions, few listed below:
- Mistrust amongst the users – A product black marked by the FD&C is most definitely shunned by the general society.
- Warning letters from the FDA – In recent years, the agency has sent a number of warning letters to cosmetic companies for not adhering to the set mandates.
The pie-chart below shows what kind of products have received warning letters from the FDA in the past ten years. The major reason for getting these warning letters was “false claims”.
- Lawsuits and fine – A company apart from gearing up to respond to the warning letters issued, must also prepare itself for possible lawsuits filed against it. Not just will the company cough up huge fine amount to the petitioner, the company might also be ordered to recall all of its products or even worse might see also see itself shutting down.
To avoid a face-off with the FDA and the commercial market, cosmetic companies need to review their ingredients and labels thoroughly for compliance. Elexes specializes in helping companies comply with quality and regulatory requirements. Feel free to write to us with any questions or comments.
Photo Credit : Joshua Geiger
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.