Cosmetic Regulation-FDA-CIR-FDCA-State Legislation

There is a serious problem that consumers live with everyday. It is the use of unsafe, toxic (poison) cosmetic products.

This article will focus on the governing bodies, at the federal, state, and private level, that presumably govern cosmetic regulation. Other articles have looked at these individually, but can be confusing. What we will do here is provide you with a clear cut summary of each agency’s authority, or the lack thereof. In the end you will have the intelligence necessary to conclude that the Cosmetic Industry is self-regulated, thereby having the ability to produce whatever they want and say whatever they want in their advertising and on their packaging, leaving the consumer to figure out for herself what is safe and what is not, what has toxic ingredients (poisons), and how to determine which products do not have toxic ingredients.

Before getting started. Let’s review what we know to be facts.

  • Fact: there are over 10,500 chemicals used to manufacture cosmetic products;

  • Fact: many of these ingredients are toxic (poisonous);

  • Fact: the skin is the largest organ of the body;

  • Fact: over 70% of what is placed on the skin manages to seep into the body and our bloodstreams;

  • Fact: women, on average, apply over 5 pounds of lotions and creams to their skin annually;

  • Fact: like tobacco, before regulation, no one currently knows the cumulative effect these toxic ingredients have on a person when used for decades;

  • Fact: some of these toxic ingredients have been directly linked to cancer, birth defects, respiratory problems, liver and kidney disease, and much more;

  • Fact: recent clinical studies on pregnant women have shown the same toxins at the same levels are in the bloodstreams of the fetuses and enter through the umbilical cord;

  • Fact: the European Union (EU) has banned over 1,100 toxic ingredients in the manufacture of personal care products;

  • Fact: the US has banned 10.

Perhaps now one can begin to see the potential problem of the daily use of products that are not regulated. Perhaps now one can appreciate the reasons cosmetic regulation is needed in this country. Instead of being leaders, however, we are simply ignoring the potential problem. Reason? The Cosmetic Industry is a 50 billion annual business with a very high profit margin. Could the industry be more concerned about their revenues and their profits than they are for consumers and their health and well being?

Here now is a summary of these different organizations and the role they play in managing the safety of cosmetics in the US.

FDA Regulations: this agency virtually has no authority over the Cosmetic Industry. It does no pre-market testing of products. It does not review nor does it regulate what goes into personal care products. In fact, close to 90% of ingredients have not even been tested for safety and daily use by consumers.

To prove this point, here is a direct quote from the FDA website that explains its limitations:

“FDA’s legal authority over cosmetics is different from other products regulated by the agency …. Cosmetic products and ingredients are not subject to FDA pre-market approval authority, with the exception of color additives.”

The bottom line is that the Cosmetic Industry has been voluntarily self-regulated since 1976 through the Cosmetic Ingredient Review Panel.

CIR Regulations: the Cosmetic Ingredients Review is presumably the self-policing panel for the Cosmetic Industry. According to its Web site, the CIR “thoroughly reviews and assesses the safety of ingredients used in cosmetics in an open, unbiased, and expert manner, and publishes the results in the peer-reviewed scientific literature.” This is its claim. However, here are the facts:

  • in their 30 year history it has reviewed only 11% of the 10,500 ingredients used in the manufacture of personal care products;

  • through June of 2008 it has found only 9 products to be deemed unsafe to use as ingredients in cosmetic products.

    They work independently of the FDA and words like “organic”, “natural”, “safe”, since they have no definition in law, and do not apply necessarily to the ingredients, are used indiscriminately. They do not take into consideration, for example, the negative effects of multiple toxic ingredients, timing of use (infants vs. adults), cumulative use over time (decades of use). They do not even look at worker exposure, an aestitician at a spa or a worker in a manufacturing facility, both of which are exposed daily to these toxic chemicals.

Bottom line? This voluntary system of self-regulation simply is not working in the best interests of consumers, particularly when you consider what steps other countries have taken to control this situation. Consumers simply deserve better. They deserve a regulatory agency that controls cosmetic regulation and protects them from the daily use of unsafe, toxic chemicals in personal care products.

FDCA Regulation: the Food Drug & Cosmetic Act does protect consumers from the mis-branding of cosmetics in interstate commerce. Under this act, a product is considered adulterated or mis-branded if:

  • “it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” [hair dye is an exception];

  • “it consists in whole or in part of any filthy putrid, or decomposed substance”;

  • “it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”;

  • “its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”; or

  • except for hair dyes, “it is, or it bears or contains, color additives which are unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601)

Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. Under the FD&C Act, a cosmetic is considered misbranded if–

  • “its labeling is false or misleading in any particular”;

  • “its label does not include all required information”;

  • “the required information is not adequately prominent and conspicuous”;

  • “its container is so made, formed, or filled as to be misleading”;

  • “it is a color additive, other than a hair dye, that does not conform to applicable regulations issued under section 721 of the FD&C Act”; and

  • “its packaging or labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.” (FD&C Act, sec. 602)

In order for consumers to make informed decisions the FDA also requires an ingredient declaration and this falls under the authority of the Fair Packaging and Label Act (FPLA).Cosmetics that fail the standards of the FPLA become in violation of the FD&C Act.

The problem here is that if no one is testing ingredients prior to placing them on the market, how does any of this become enforceable? The answer is it does not and so the cycle continues. Cosmetic manufacturers are not even required to register themselves, file lists of ingredients, or even report cosmetic-related problems (injuries, rashes, health issues) with the FDA.

This truly is a perfect example of “ignorance is bliss”.

State Legislation: as a last resort states have taken steps to protect consumers. The problem here is each state would create its own set of standards and become very difficult to adhere to by the cosmetic companies. They would have to possibly use different formulas for different states and this would become very costly. Having said that, numerous states have introduced legislation providing for the safety of consumers over the last four years. There have been only two successes:

  • In 2008 Washington State banned the use of Pthalates (synthetic fragrances) in personal care products for children;

  • In 2005 California became the first state to require the safety and reporting of ingredients. The California State Cosmetic Act has a list of ingredients that are known to cause cancer and birth defects and bans these ingredients in the manufacture of cosmetic products sold in California.

So, imagine this is where we are. A list of ingredients exists known to cause cancer, birth defects, and who knows what else and there is but one state, California, that bans those ingredients be used in the manufacture of personal care products. That is it. Nothing more. Nada, zip, zero, nothing more to control the safety of personal care products through cosmetic regulation.

This should be a wake up call to all consumers that the only way to be sure of the safety of the cosmetic products used daily is to purchase only certified organic and/or natural beauty products. This is the subject of other articles, the mini-course, and the ebook “Organic Skin Care Answers”.


Certified Organic &/Or Natural Beauty Products

There are several agencies around the world whose purpose is to certify organic and/or natural beauty products. These institutions have varying standards that they apply in their certification process. Here are the six European organizations that assure consumers the personal care products they buy are certified to be toxic-free. A brief description of several of these organizations will be provided. Each subscribes to the European cosmetics standards working group that is in the process of establishing a not-for-profit COSMOS-standard International Association. This association is seeking to obtain legal status on pronouncement of the Belgian Royal Decree expected to be finalized in April of 2010.

The COSMOS-standard, the cosmetics organic and natural standard, has been developed in Europe by BDIH (Germany), BIOFORUM (Belgium), COSMEBIO & ECOCERT (France), ICEA (Italy), and SOIL ASSOCIATION (UK). Through these companies the association will define minimum requirements and definitions for certified organic and/or natural beauty products.

This article cannot get into the details of the standard for several reasons. One, because the information is copyrighted and is prohibited from use without express written consent of the founding organizations. Two, it is not a legal document and not expected to be before April, 2010, and therefore, would be premature at this time. However, what can be done is introduce the measures by which Europe and these companies are taking this serious public issue, the production of safe, toxic-free personal care products.

So, let’s begin. Why, you might ask is this necessary? The answer is quite simple. It has been scientifically proven that there are over 10,500 chemicals used in the manufacture of personal care products. Although no one knows for sure how many of these chemicals are toxic (poisons), what we do know is that the European Union (EU) has banned over 1100 of these chemicals for cosmetic beauty products sold throughout Europe, while the US has banned a mere 10. We also know, through new scientific studies, that many of these toxic ingredients are directly linked to cancer, birth defects, respiratory problems, liver and kidney diseases, etc. In an article printed on December 9, 2009 in the San Francisco Chronicle, it started with this statement: “Chemicals from cosmetics, perfumes, and other fragrances were detected along with dozens of other industrial compounds in the umbilical cords of African American, Asian, and Latino infants in the United States…” It went on to say “laboratory tests, paid for by the nonprofit Environmental Working Group (EWG) and Rachel’s Network, found 232 chemicals and pollutants in the umbilical cords of the 10 babies tested in five states between December 2007 and June of 2008.” This was the 11th time the EWG has conducted these laboratory tests and cumulatively has found over 414 chemicals and pollutants in 186 people of all races and ages, including Caucasians.

Europe is taking a lead position on this subject starting with the EU. It is evidently determined to provide consumers certified organic and/or natural beauty products and is now moving to a non-government, not-for-profit Cosmos-standard International Association. Briefly, let’s look at several of these organizations’ standards, BDIH, ECOCERT, and the UK SOIL ASSOCIATION.

BDIH: any product that carries the BDIH “Certified Natural Cosmetic Seal” must use natural raw material, namely oils from plants, fats, waxes, extracts from herbs, and aromatic oils, collected from “controlled biological cultivation or controlled biological wild cultivation”. Further, there must be no animal testing, performed or commissioned, in end products. (Cleverly, in the US, a cosmetic company can claim their product was produced with no animal testing, without having to disclose if some of the ingredients were animal tested by the companies from which they purchased the said ingredients.) BDIH will reject any deliberate use of synthetic dyes or fragrances. To ensure biologically safe products, BDIH will use natural preservatives. They do allow some synthetic preservatives, but these are very limited and when used, BDIH requires the label states “preserved with…[name of preservative]. As a final precaution BDIH uses a third party neutral source to check that the above criteria is complied with.

BDIH has extended goals, probably the most important being ecological factors such as “environmentally-friendly manufacturing processes”; “optimal biodegradability of raw materials and finished products”; and “environmentally-friendly and recyclable packaging”.

ECOCERT: this standard is 38 pages long and reproduction is strictly prohibited. Therefore, I must emphasize that the following, although taken from their published site is this authors interpretation of their principles.

This is a voluntary partnership between ECOCERT and certain cosmetic companies and is conducted for the following reasons:

  • there are no standards for the manufacture, packaging and labeling of certified organic and/or natural beauty products;

  • it is impossible, or at best, difficult, for the consumer to recognize what is purported to be products manufactured from organic and/or natural substances with environmentally-friendly procedures.

There objectives are:

  • link organic and/or natural agricultural products to cosmetic products;

  • in doing so, to respect consumers and the environment.

In the certification process ECOCERT addresses the consumer, based on product labeling and usage; the manufacturer, based on ingredients; formulas to produce the final product; manufacturing rules; final inspection of products; and environmentally-friendly plant and processes.

UK SOIL ASSOCIATION: Certification is defined on their website as: “we offer an unrivaled service, value for money and robust organic standards through our not-for-profit, market leading certification body.” The following comes directly from their website.

“Our standards for organic beauty products are based on our food standards. This means if an ingredient is available organically, it must be used. The remaining ingredients must meet strict criteria to ensure that they are not damaging to our health or the environment.

To achieve organic certification, a company must:

  • Have their manufacturing facility inspected annually by the Soil Association. This includes an audit of organic ingredients use and demonstration of ecologically sound production methods

  • Submit all product formulae and labels to the Soil Association for approval

  • Provide clear labeling so that the consumer can make an informed choice about the product they are purchasing

  • For any non-organic ingredient, submit a declaration from the supplier that it is non-GM, plus declarations from 3 suppliers that the ingredient is not available in organic quality

  • Use the maximum possible amount of organic ingredients; a product that carries the Soil Association symbol and is labeled organic, must contain at least 95% organic ingredients. In cases where the product contains more than 70% organic ingredients, it can still be certified by the Soil Association but the company must state on the packaging exactly what proportion of ingredients are organic

  • Use minimal non-organic additives and only those from a restricted list. These must be non-GM and can only be used if the organic version of that ingredient is not yet available.

  • Use ingredients that if processed, are processed by ecologically sound means.

Therefore, there can be a large difference between a beauty product that is certified organic and one that is merely described as ‘organic’ on the label. To ensure a product is guaranteed organic, look for a certification  logo, such as the Soil Association symbol.”

This should provide some idea of the lengths that Europe is taking this major issue. One must comprehend that the skin is the largest organ of the body and what you put on it, regardless of the amount, will be absorbed into our bodies. We are just now beginning to understand the long term effects of these toxic materials absorbed over decades and the benefits of the daily use of certified organic and/or natural beauty products.

The eBook covers this subject in much greater depth with documentation provided for each assertion.