| There are two federal laws pertaining to cosmetic | | | | with no one really watching, it leaves discretion as to |
| safety, including safe skin care, in the United States: | | | | what is safe cosmetics, or safe skin care, totally up |
| the Federal Food, Drug, and Cosmetic Act and the | | | | to the cosmetic company. Even recalls of products |
| Fair Packaging and Labeling Act. | | | | are voluntary actions and up to the manufacturer and |
| In this article, we will look at both acts and discover | | | | or distributor. |
| what they control, how they control, and why the | | | | Couple the above with the following statistic: of the |
| consumer should be concerned. The conclusion will | | | | 10,500 chemicals used in the manufacture of |
| leave you surprised to learn that the burden of | | | | cosmetic products, only 11% have been screened |
| cosmetic safety, in the end, will rest on you, the | | | | safety tested. |
| consumer, to decide what is and what is not safe for | | | | Now let's look at the Fair Packaging and Labeling Act. |
| you and your children to use daily. | | | | Although it reads "improperly labeled or deceptively |
| First up is the FD&C Act. This law prohibits the | | | | packaged products are considered mis-branded and |
| marketing of mis-branded cosmetics in interstate | | | | subject to regulatory action", the process is |
| commerce. Violations due to product ingredients | | | | cumbersome, at best, and the FDA takes regulatory |
| cause cosmetics to be subject to regulatory action. | | | | action based on agency priorities, and these must be |
| To enforce the law, Congress authorizes an agency, | | | | consistent with health concerns and available |
| in this case the FDA, to police the regulations, but | | | | resources. The agency must use the federal court |
| only as authorized under the law. The problem is this. | | | | system and pursue action through the Department |
| Under the law the FDA's legal authority over | | | | of Justice. Once again, it appears the Cosmetic |
| cosmetics is different than its legal authority over | | | | Industry, generally speaking, can police itself as to |
| drugs and medical devices that are subject to | | | | what it places on its packaging and labels. |
| pre-market approval. Cosmetics are not subject to | | | | Does the FDA test cosmetic products before |
| pre-market approval, with one exception, color | | | | distribution. The answer is no. The agency does not |
| additives. If cosmetic products are not subject to | | | | function as a private testing lab, and to avoid conflict |
| pre-market approval, one must ask how effective | | | | of interest, does not even recommend private labs |
| the FD&C Act really is in protecting the consumer? It | | | | where product and ingredient analysis can be |
| would appear the proverbial cow can leave the barn | | | | performed to address safety concerns. |
| before the door is closed, that is, the products can | | | | Lastly, do cosmetic manufacturers register with the |
| reach the market and be consumed without the | | | | FDA? The answer again is no. Cosmetic |
| consumer being aware of whether these presumably | | | | manufacturers are not required to register their |
| safe cosmetics products are, in fact, safe. | | | | companies with the FDA. However, what is most |
| One might ask then, who is responsible for the | | | | disturbing, is that cosmetic establishments are not |
| safety of cosmetic products? The answer, believe it | | | | even required to register the ingredients used in the |
| or not, is the cosmetic companies themselves are | | | | manufacture of their products, nor are they |
| held responsible for the safety of their own | | | | expected to file consumer complaints with the FDA. |
| products, including the ingredients. And, unless this | | | | The registration process is completely voluntary. |
| warning statement appears prominently on the label, | | | | The bottom line is simply that the law is really not |
| "Warning-- The safety of this product has not been | | | | going to protect the consumer against using products |
| determined." (21 CFR 740.10), the product can be | | | | with ingredients that have proven to be dangerous |
| distributed and will not be considered to be | | | | to one's health. Safe cosmetics and safe skin care, in |
| mis-branded, leaving the decision to buy or not to | | | | the end, is the consumer's responsibility, and to do |
| buy solely up to the consumer. Therefore, generally | | | | that, the consumer must make themselves aware of |
| speaking, other than color additives, a cosmetic | | | | those products that have been determined to be |
| manufacturer can use any ingredient it so desires | | | | toxic, and, if used daily, can have a cumulative |
| provided it determines the product to be safe. Again, | | | | negative effect on one's health. |