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”.