FDA Guidelines vs. Organic Natural Skin Care
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Organic Natural Skin Care

Being a Cosmetologist (someone who is not just a hair expert, but skin care expert as well), I hear all kinds of comments about the products we use and their health safety. People ask me for skin care advice to keep them safe as well as healthy. I take that very seriously. I care for my clients, and I feel it is important for us all to stay up to date on what ingredients are placed in our products and how they may harm us. Most people will comment on FDA Guidelines, “if the FDA approves it, then it has to be safe.” This statement couldn’t be further from the truth. Let me share with you what the FDA does concerning the cosmetics and skin care products we use, how cosmetics are defined as in FDA terms and what is currently being done to change this. The answer to the question is important to organic natural skin care products people are demanding more and more each day.[FDA logo, organic natural skin Care, fda guidelines

The FD&C Act defines cosmetics and skin care by their intended use, as “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” (FD&C Act, sec. 201(i)). FDA.gov, Federal Food, Drug, and Cosmetic Act (FD&C Act ), 2/16/2016 )

The FD&C Act means that everything you put in your hair, on your face or your body falls into this category. “Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, skin care products, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.  FDA Guidance Regulation

http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm

The FDA Does Not Approve Cosmetics or Skin Care Products The only thing they approve is color additives used in cosmetics. The responsibility has been placed solely on the cosmetic manufacturers to ensure, before marketing their product, which products are safe when used as directed.

Since the industry is motivated by product, in the past it has no interest in formulating organic natural skin care or any product which fall under these FDA guidelines. Under the law, cosmetic ingredients and products do not need FDA approval. Which means that the manufacturer can put anything into their cosmetic that they want, as long as it is not a direct poison.

The only thing the FDA ask the cosmetic manufacturers to do is 1. To accurately label their ingredients 2. That the ingredients listed are safe under labeled conditions 3. That the ingredients do not cause the cosmetic to be adulterated or misbranded. The very broad interpretation leaves lots of freedom for cosmetic and skin care companies to use ingredients as they please to create a product they want.

It does not necessarily mean that all ingredients used are safe or don’t have harmful effects. Neither the law nor FDA requires tests to demonstrate the safety of products or their components. The FDA has suggested to manufacturers that testing would be a good idea to ensure the safety of all their products and their ingredients, but it is only a suggestion. “FDA has stated that “the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information.” (Federal Register, March 3, 1975, page 8916).”

Older Testing Methods vs the Speed of New Ingredients

With the advances in technology and the new things we learn about ingredients, old testing methods may not give us a good foundation for the ingredients in our cosmetics. So we may not have the big picture. It is important to understand that any ingredients used which may have a harmful effect must be labeled on the cosmetic with a warning. They have permission to continue using it but have to place a warning on the bottle. Of course, the safety of products would be less expensive to test if natural organic, ingredients were used and skin care products, but the manufacturers do not have to worry much about safety because of the loose FDA Guidelines.

Voluntary Recalls – Not Recalls From the FDA

Recalls on cosmetics do not come from the FDA. The manufacturer all voluntarily does them. What this means for you is that even if a cosmetic or ingredient in a cosmetic threatens to be harmful, the FDA will not recall that product. If the manufacturer wants to recall it they can, but it is not mandatory. If a company does recall, then the FDA will monitor that company and may ask for a product to be recalled if the firm does not remove the dangerous product from the market. If the manufacturer does not decide to do a recall on their product, the FDA does not get involved.

The FDA only gets involved if they have reliable information that a cosmetic is adulterated or misbranded. Cosmetics not in compliance with the law may be subject to “seizure”. Seizure means that the government takes over possession of the property of someone who has is suspected of or has violated the law.

The FDA can inspect cosmetic manufacturers facilities to determine if cosmetics are adulterated or misbranded. Under section 801(a) of the FD&C Act, imported cosmetics are subject to review by FDA at the time of entry through U.S. Customs. Products that do not comply with FDA laws and regulations are subject to refusal of admission into the United States. They must be brought into compliance (if possible), destroyed, or re-exported.

FDA does not inspect every shipment of cosmetics that come into this country, but imported cosmetics are still subject to the laws we enforce, even if they are not inspected upon entry.  FDA.gov, Laws Regulations, Manufacturers are not required to register their facilities or file their products formulations with the FDA, and no registration number is required for products imported into the United States. This makes monitoring any cosmetic manufacturer very difficult to not impossible.

Manufacturers are encouraged (but not required) to participate in the FDA’S Voluntary Cosmetic Registration Program (VCRP).In April of 2015, a new bill was introduced by Dianne Feinstein (Democrat- California) and Susan Collins (Republican- Maine) to help the FDA ensure that cosmetics and their ingredients are safer for the consumer. The proposal is titled the Personal Care Product Safety Act and requires the FDA to investigate five potentially dangerous ingredients every year. If an ingredient is found to be dangerous, it must be banned or restricted.

Heather White (EWG executive director) said, “The fact is that companies can put potentially dangerous ingredients into the products they sell without ever having to prove they are safe. We are grateful for the leadership of Senators Feinstein and Collins on trying to improve the safety of the products that families use every day.” EWG.org, Feinstein-Collins Bill Would Improve Cosmetics Safety, 02/16/2016 According to the EWG or Environmental Working Group, women use approximately 12 personal care products a day exposing themselves to 168 chemical ingredients while men use about half the number of products but still expose themselves to 85 chemicals daily.

Under the Feinstein-Collins bill, the FDA would have the power to stop cosmetic companies from selling products that are unsafe and recall products that are dangerous. EWG.org, Feinstein-Collins Bill Would Improve Cosmetics Safety, 02/16/2016

The cosmetic industry is a 62 Billion dollar industry used to help us to look and feel our best. With so many different ingredients and chemicals used to do that, we must be mindful about what we are putting on our hair, skin and nails. Although the FDA has few rules to protect us, the real power is in our hands. Learning about the ingredients that we are using in our products and being proactive in making good choices will empower us to look and feel our best.  The beauty industry is not the enemy, but with our help, we can partner with them to let them know what we do want and protect our overall health as well.


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