FDA or U.S. Food and Drug Administration examines many products that are stored on your shelf at home before you can buy them. How they do it, and most importantly, why they do it, are the topics of this article.
First of all, what are the products that FDA regulates?
The FDA regulations embrace all different sorts of products which also have to be classified properly in the first place. One has to know if the article they are dealing with is a cosmetic, a drug or maybe a mixture of both. Hereunder are the official definitions:
- A cosmetic is a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering one’s outer appearance. Among the cosmetics group skin moisturizers, cleansers, toners, shampoos, make – up, hair dyes, toothpastes and deodorants can be found.
- A drug is a product intended to treat or prevent disease or affect the structure and/or function of the body. These include acne treatments, sunscreens (since they intervene with the skin’s function), antiperspirants (since they intervene with the skin of the armpit area), ointments and anti – fungi treatments.
- A cosmetic and a drug is a product which combines the functions of a cosmetic and a drug together, like anti-dundruff shampoos or SPF moisturizers.
As it is pretty self-explanatory, a cosmetic is associated more with the outer, superficial part of the body while a drug affects the internal body and its function.
What exactly is regulated in the products by FDA?
When it comes to the active ingredients of the products, it is the very responsibility of the cosmetic/drug company to prove that they are effective and safe to use – with the exception of pigments and a few of definitively prohibited ingredients, a manufacturer is allowed to use basically any raw material as a cosmetic component. FDA focuses more on the color additives (more exactly if they are on the list of the verified ingredients) – a color additive can be either subject to certification or not subject to certification, there is nothing in between. Furthermore, the product labeling is reviewed to ensure it complies with labeling requirements and that everything is clear to the customer.
What ingredients are strictly prohibited to use in cosmetics?
The definitive list includes: bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene.
Based on the whole ingredient list, can FDA ban a product before it goes on the market?
FDA – regulated does not mean FDA – approved – FDA does not have any legal authority to approve cosmetics before they go on the market, although it approves color additives used in them (except coal tar hair dyes), as mentioned earlier. Therefore, no, simply put, FDA cannot officially ban a product before it is free to buy by customers. The only thing that the organization can do is taking the case of a detrimental/toxic cosmetic/drug to the higher level within their legal authority if it is provided with reliable information showing that the article is adulterated, toxic or misbranded.
What exact product regulations do take place?
When a product gets in the hands of FDA, the following actions take place:
- the organization determines if the manufacturer/product is subject to detention without physical exam (DWPE) – e.g. if a specific alert comes up, the item contains illegal colors and is automatically moved to the DWPE category
- FDA checks the CIN (Color Identification Number) at the time of importation if the colors used are officially certified
- FDA monitors the Affirmation of Compliance (A of C) codes, also at the importation time. The codes are not mandatory everywhere, however they do shorten the time of the FDA’s screening
- the organization uses Voluntary Cosmetic Registration Program (VCRP) to check the information provided by the manufacturers/packers and distributors about the product and its ingredients as well as its frequency of use
- FDA ensures that the cosmetic labeling is correct according to FDA laws and regulations, e.g. the labeling has to be truthful and written in English (or additionally in Spanish in Puerto Rico).
Does FDA ban animal testing?
FDA strongly supports the development and use of alternatives to animal testing as well as adherence to the most humane methods available within the manufacturer’s capacity to test the new products. Nevertheless, the organization does not specifically require the cosmetics or drugs not to be animal tested as long as the test have proven that the article is safe to use by humans – the testing part relies 100% on the particular manufacturer.
Why does the FDA Regulate Cosmetics?
By continuously collecting samples and carrying out various examinations, FDA ensures that the substances used as cosmetics ingredients are safe for the body of the customer and that they are not anyhow toxic or detrimental to one’s health. For instance, once a toxic substance is used in a product, the organization starts an investigation and discussions with medical experts about the topic to eliminate the compound from the article. It has been successfully done before numerous times.
What should one do if they have a reaction from a cosmetic or a drug?
As said earlier, FDA will not ban the product from being introduced to the market, however one can always submit a complaint to them so a further investigation may take place. Moreover, one should instantly go to their doctor and they can report the problem to the cosmetic/drug manufacturer as well.
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