Who is responsible for cosmetic safety? - and the answer may shock you!

Who is responsible for cosmetic safety? - and 

the answer may shock you!

There are two federal laws regarding the safety of cosmetics, including skin care safety, in the United States: the Federal Food, Drug, and Cosmetic Act and, consequently, the Fair Packaging and Labelling Act.

In this article, we will look at these two laws and find out what they control, how they do it and why the buyer should be concerned. The conclusion will leave you surprised to discover that the burden of cosmetic safety, ultimately, will rest with you, the buyer, to make a decision about what is and is not safe for you and your children to use on a daily basis.

First of all, there is the FD&C Act. This law prohibits the marketing of mislabeled cosmetics in interstate commerce. Violations through product ingredients cause cosmetics to be subject to regulatory action. To enforce the law, Congress authorises the workplace, in this case the FDA, to enforce the regulations, but only to the extent authorised by law. By law, the FDA's legal authority over cosmetics is different from its legal authority over drugs and medical devices, which are subject to premarket approval. Cosmetics are not subject to pre-market approval, with one exception, colour additives. If cosmetics are not subject to pre-market approval, it is questionable to what extent the FD&C Act actually protects the consumer. It seems that the proverbial cow can leave the barn before the door is closed, i.e. products can arrive on the market and be consumed without the buyer knowing whether these allegedly safe cosmetic products are really safe.

This raises the question of who is responsible for the safety of cosmetic products. The answer, believe it or not, is that cosmetic companies themselves are held responsible for the safety of their own products, including the ingredients. And, unless this warning statement appears prominently on the label, "Warning - the safety of this product has not been determined." (21 CFR 740.10), goods are often distributed and cannot be considered misbranded, leaving the choice to buy or not to buy solely to the buyer. Therefore, generally speaking, with the exception of colour additives, a cosmetics manufacturer may use any ingredient it wishes, provided it determines that the goods are safe. Again, since no one is really monitoring, it is up to the cosmetic company to decide what constitutes safe cosmetics or skin care. Even product recalls are voluntary actions and the responsibility of the manufacturer and/or distributor.

Add to this the following statistic: of the 10,500 chemicals used in the manufacture of cosmetics, only 11% are tested for safety.

Now let's look at the Fair Packaging and Labelling Act. Although it states that "mislabelled or deceptively packaged products are considered misbranded products and are subject to regulatory action", the method is cumbersome at best, and so the FDA takes regulatory action according to the agency's priorities, which must be consistent with health concerns and available resources. The agency must use the court system and prosecute through the Department of Justice. Once again, it seems that the cosmetics industry, in general, can control itself what it puts on its packaging and labels.

Does the FDA test cosmetic products before distribution? The answer is no. The agency does not operate as a personal testing laboratory and, to avoid any conflict of interest, does not even recommend private laboratories where product and ingredient analysis is often conducted to address safety concerns.

Finally, do cosmetics manufacturers have to register with the FDA? Again, the answer is no. Cosmetic manufacturers are not required to register their company with the FDA. However, the most annoying thing is that cosmetic companies are not even required to register the ingredients used in the manufacture of their products, nor are they required to file consumer complaints with the FDA. The registration process is completely voluntary.

Ultimately, the law does not protect the buyer from using products containing ingredients that have been found to be hazardous to health. Ultimately, the safety of cosmetics and skin care products is the responsibility of the consumer. To achieve this, the buyer must be aware of the toxicity of these products which, if used daily, can have a cumulative negative effect on health.