FDA Regulations About Cosmetic and Makeup Products and How It Allows Manufacturers Include Harmful Ingredients?
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FDA Regulations About Cosmetic and Makeup Products and How It Allows Manufacturers Include Harmful Ingredients?

After reading my recent article Are You Aware of Hidden and Harmful Ingredients Used in Your Favourite Lipstick? one of factoidz writer wrote a comment: \\\\\\\"I wonder if the FDA regulates these? If only I didn\\\\\\\'t throw out the boxes of my lipsticks\\\\\\\" Comments section is a limited space to answer this question, If FDA regulates it and in other words how manufactures of cosmetics and personal use products are allowed to use harmful ingredients in their products? Truth is that FDA regulations about cosmetic or personal care products have many loopholes which helps manufacturers take advantages or it and add as many ingredients which may cause health hazards. I hope that you may find the answer of many related questions and after knowing the hard and bitter facts, I assume that many of us would be throwing away boxes of not only lipsticks but other cosmetic products as well. The Food and Drug Administration (FDA), a federal safety agency within the Department of Health and Human Services, has created guidelines for cosmetic manufacturers to ensure that consumers are aware of the risks associated with certain products and that product labels contain accurate information

After reading my recent article Are You Aware of Hidden and Harmful Ingredients Used in Your Favourite Lipstick? one of factoidz writer wrote a comment:  "I wonder if the FDA regulates these? If only I didn't throw out the boxes of my lipsticks"

Comments section is a limited space to answer this question, If FDA regulates it and in other words how manufactures of cosmetics and personal use products are allowed to use harmful ingredients in their products? Truth is that  FDA regulations about cosmetic or personal care products have many loopholes which helps manufacturers take advantages or it and add as many ingredients which may cause health hazards.

I hope that you may find the answer of many related questions and after knowing the hard and bitter facts, I assume that many of us would be throwing away boxes of not only lipsticks but other cosmetic products as well.

The Food and Drug Administration (FDA), a federal safety agency within the Department of Health and Human Services, has created guidelines for cosmetic manufacturers to ensure that consumers are aware of the risks associated with certain products and that product labels contain accurate information.

Ingredient Warnings

According to the FDA's regulations, any cosmetic product that contains harmful ingredients which may injure consumers if used for their intended purpose is considered contaminated. This applies to products made from decayed or decomposed ingredients or those that are manufactured or packaged in unsanitary conditions which may taint the items. As a result, these products must be marked with a proper warning label that alerts consumers to the fact that its ingredients may irritate the skin and should be tested prior to use to ensure that it will not cause an adverse reaction.

The reality and FDA regulation loopholes:

The FDA Handbook is the standard for regulations in the US regarding the manufacture of food and drugs, including cosmetic and skin care products. It is interesting to learn that this handbook actually allows the use of known harmful ingredients in the creation of cosmetic and skin care products.

In fact, almost any ingredient is permissible in cosmetics and body care products, as evidenced by these quotes from the FDA Handbook:

"With the exception of color additives and a few prohibited ingredients, a cosmetic manufacturer may, on his own responsibility, use essentially any raw material as a cosmetic ingredient and market the product without approval."

"Although not prohibited by law or regulation, in addition, the manufacturers of cosmetic fragrance products have voluntarily agreed to not use or to limit maximum use levels of certain selected ingredients which have been found to cause depigmentation, irritant, neurotoxic, or phototoxic or other allergic reactions."

Mercury is permissible in cosmetics and other products, even though mercury is easily absorbed through the skin and will accumulate in the body. Mercury in any form is extremely toxic. Mercury poisoning can result from inhalation, ingestion, injection, or absorption through the skin.

"The use of mercury compounds as cosmetic ingredients is limited to eye area cosmetics at concentrations not exceeding 65 parts per million of mercury calculated as the metal (about 100 ppm or 0.01% phenylmercuric acetate or nitrate) and provided no other effective and safe preservative is available for use."

Nitrosamines are known carcinogens. Nevertheless, the FDA permits their use. Amines and their derivatives are typically present in creams, lotions, shampoos and hair conditioners. The nitrosation may occur during manufacture or during product storage.

"Cosmetics containing as ingredients amines or amino derivatives, particularly di- or triethanolamine, may form nitrosamines if they also contain an ingredient which acts as a nitrosating agent as, for example, 2-bromo-2-nitropropane-1,3-diol (Bronopol, Onyxide 500), 5-bromo-5-nitro-1,3-dioxane (Bronidox C) or tris(hydroxymethyl)nitromethane (Tris Nitro), or if they are contaminated with anitrosating agent, e.g., sodium nitrite."

Dioxane is also permissible in products by the FDA. Dioxane irritates the eyes and mucous membranes. Prolonged exposure is considered toxic to the liver and kidneys.

"Cosmetics containing as ingredients ethoxylated surface active agents, i.e., detergents, foaming agents, emulsifiers and certain solvents identifiable by the prefix, word or syllable 'PEG', 'Polyethylene', 'Polyethylene glycol', 'Polyoxyethylene', '- eth-', or '-oxynol-', may be contaminated with 1,4-dioxane. It may be removed from ethoxylated compounds by means of vacuum stripping at the end of the polymerization process without an unreasonable increase in raw material cost. In rodent feeding studies conducted for the National Cancer Institute, 1,4-dioxane was found to produce cancer of the liver and the nasal turbinates. It also caused systemic cancer in a skin painting study. Skin absorption studies demonstrated that dioxane readily penetrates animal and human skin from various types of vehicles."

Of note is the fact that it has been determined that when products containing dioxane are applied to the skin, most of the dioxane evaporates into the air and may not be actually absorbed into the skin. Many products analyzed have been found to contain dioxane. Some products contain as much as 100 ppm.

Source: FDA Safety Regulations for Cosmetics at eHow

FDA Regulations Permit Toxins in Cosmetics

Useful links:

* FDA Authority Over Cosmetics

* 11 Toxic Cosmetic Ingredients To Avoid

* Ingredients Prohibited & Restricted by FDA Regulations

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Comments (1)

Great info, but the FDA is a joke, in my opinion.

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