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Response from the International Fragrance Association to the claims made in "No More Dirty Looks"

TODAY reached out to the International Fragrance Association about the claims about the dangers of some beauty products made in the new book No More Dirty Looks. Here is the statement they issued in response:

Book claim: The perfume industry today is not strongly regulated.

Fact: The fragrance industry has a strong record of safety. The lack of regulatory enforcement actions by the Food and Drug Administration in the United States, and by its counterparts abroad, is the testament to that. The system we have in place is a model of scientific evaluation of product and ingredient safety. The protocols for safety evaluation of ingredients are comprehensive, the testing is rigorous, the reviewers are independent, and the results are implemented immediately in a format of all-industry directives. The industry track-record shows that the most cutting-edge science drives the decisions about ingredient use in fragrance formulas, sometimes directly limiting creative freedoms of our perfumers.

Book claim: Many chemicals used in fragrances have not been studied to analyze the long-term effects of even small doses. Some chemicals used have a tendency to build up in our bodies.

Fact: The Research Institute of Fragrance Materials (RIFM) has a database of over 100,000 studies on fragrance ingredients. RIFM has developed a methodology to evaluate fragrance ingredients in the context of their common use in a variety of products and varied levels of use. The scientific name for the approach is the "Exposure-Based Quantitative Risk Assessment" and it has been described in detail in a peer-reviewed scientific publications. The bottom line is, RIFM studies dermal, respiratory, systemic, and environmental effects of specific ingredients as well as cumulative exposure to fragrance materials.

Book claim: The fragrance industry does not have to disclose or list all of the ingredients used in their formulas making it difficult for consumers to make informed decisions about what they buy.

Fact: The palette of a perfumer is limited to the ingredients and usage levels that have been assessed and deemed safe. Earlier this year, the industry published the complete list of over 3,000 ingredients used to make fragrances to demonstrate our commitment to transparency.

The fragrance formulas, however, do remain protected as they are the unique and artistic creations of the perfumers who design them. These creations are the intellectual property of the company that created them and are protected by trade secret and intellectual property laws around the world. Once released, the door would be open to counterfeit and unscrupulous manufacturing of fake, unsafe, and untested products.

Fragrance makers also have a long-standing policy of cooperating with medical professionals in identifying specific ingredients in fragrance formulas that may be of concern to their patients.

Book claim: Why are there only 9 banned ingredients in the United States and over 1000 are banned in Europe. Why is a product ok in the United States but not safe in Europe?

Fact: This statistic has no relevance to fragrance ingredients. RIFM’s scientific findings are routinely made public and form the foundation for strict industry Standards for use of fragrance ingredients. These Standards and the global fragrance industry’s Code of Practice are universal and are applied worldwide.

Book claim: Phthalates are among the chemicals used in fragrances that have been linked to health problems. If there is any chance that these could be harmful as studies have shown, why aren't they removed?

Fact: The phthalate primarily used in fragrance formulas is DEP (diethyl phthalate). DEP has been deemed safe by legislators and regulators around the world. Specifically, the FDA, the US Congress, The European Commission’s Scientific Committee on Consumer Safety, The World Health Organization all looked into this phthalate, and unlike with other chemicals in the phthalate family, all saw no reason for concern about DEP use.

I hope this summary demonstrates how uninformed the book authors are and how wrong it would be to air their claims without careful investigation.

10 Truths: The Real Facts About Cosmetics

Consumers deserve to know the truth about the safety of the cosmetic and personal care products they trust and use every day. Unfortunately, a special interest campaign by certain activist groups has been muddying the waters with misinformation about these products. To set the record straight, the Personal Care Products Council is offering the following “10 Truths,” which are intended to provide credible information to assist consumers in educating themselves about the safety of their products and help them make sound purchasing decisions.

Truth 1

MYTH: Mystery Ingredients. Thousands of ingredients in cosmetics and personal care products have never been tested for safety.

FACT: An Open Book. Research and safety assessments are done for all ingredients actually used in personal care products – not the approximately 12,000 chemicals listed in the Cosmetic Ingredient Dictionary.

Truth 2

MYTH: No Oversight. There is no regulatory oversight of the industry.

FACT: Existing Regulations. Under federal law, the U.S. Food & Drug Administration (FDA) has abundant legal and regulatory authority over cosmetics. Cosmetic manufacturers have responsibility for ensuring their products’ safety. It is a federal crime to put an unsafe product on the market. Federal law also dictates FDA enforcement and oversight to ensure companies comply with the regulations governing pre-market approval, labeling, packaging and safety substantiation requirements.

Truth 3

MYTH: Self-Policing. The cosmetics industry polices itself for safety and therefore possesses a conflict-of- interest that harms consumers.

FACT: Independent Research & Consumer Protections. Individual cosmetic companies invest a great deal of internal resources to develop and market safe cosmetic products. The industry has also advocated for strong FDA oversight and participation in an independent body of scientists and physicians known as the Cosmetic Ingredient Review (CIR) Expert Panel. This approach works. It has kept consumers, industry and government regulators fully informed for the past 34 years.

Truth 4

MYTH: Health Risks. Many ingredients in cosmetics and personal care products cause cancer, autism, obesity and sterility.

FACT: Safe & Sound. Cosmetics and personal care products are among the safest FDA-regulated products. Suggestions to the contrary – especially any that suggest association with such serious health problems – are irresponsible and represent an attempt to scare consumers without any basis in fact, scientific research or medical reality.

Truth 5

MYTH: Body Burden. Because people use so many products, the chemicals accumulate in the body over time and therefore pose a danger that is never researched.

FACT Long-Term & Cumulative Impacts Are Considered in the Safety Assessment Process. In addition to research by companies themselves, both independent and government-sanctioned research considers the bioaccumulation of ingredients in the body. Exposures over long periods of time and the impacts to potentially sensitive populations including children, pregnant women and the elderly are also examined.

Truth 6

MYTH: Chemical Detection = Risk. The mere presence of a “toxic” chemical or ingredient in a product signals a concern and likely a public health risk.

FACT: Dose & Exposure = Risk. Mother Nature is made up of chemicals. The human body is made up of chemicals. The presence of chemicals themselves should not cause alarm. For example, arsenic and lead are found naturally in clean drinking water. The reason no one is concerned about these is because for the most part their levels are so low as to be inconsequential. The same is true for the so-called “toxic” chemicals in cosmetics and personal care products. Some of these materials are traces, meaning they are already in the water, mineral, plants or pigmentation used to make the product.

Another key point is exposure. The existing levels of lead found in lipstick and suggested to be “linked” to cancer are not relevant because the levels and absorption rates are extremely low. The public health risk from lipstick would be to a person eating two tubes a day for more than 70 years.

Truth 7

MYTH: The “Precautionary Principle” Makes People Safer. It is only common sense for society to err on the side of caution – that is, if any chemical could be a risk, it should be banned until proven safe.

FACT: The “Precautionary Principle” is Neither . . . Consumers Are Already Safe. Certain activist groups have redefined the “precautionary principle” using it as a political phrase – one that creates the illusion of scientific credibility necessary to advance advocacy goals. If applied in earnest, the precautionary principle would necessitate a ban on virtually everything in commerce – from aspirin and automobiles to wheat and water. Virtually everything possesses a risk at some level. A more commonsense approach to product safety is best achieved when the world’s most respected scientists conduct and review all available research according to proven, credible and widely accepted toxicological principles.

Truth 8

MYTH: Global Companies Have Already Re-Formulated Products for Europe and So Should the U.S. Europe has banned hundreds of ingredients and now has safer substitutes than products in the United States.

FACT: Consumers of Both U.S. and European Cosmetics are Protected. Europe uses the same regulatory approach as the U.S. – manufacturers are responsible for ensuring the safety of their products before marketing them to the public. It’s important to note that many of the ingredients listed on the European ban list are not even used in cosmetics or personal care products. That’s one reason why global companies do not have different products for these markets. Personal care products and cosmetics sold in Paris and London are often the same as what is sold in New York and Washington, D.C. and consumers can be assured of their safety. The same safety assessment processes are used globally.

Truth 9

MYTH: Fragrance Ingredients Are Not Regulated. Ingredients used in fragrances are especially dangerous because companies refuse to reveal what they are.

FACT: Fragrances Are Subject to the Same Regulations As Other Personal Care Products. While fragrances are made up of a very complex and proprietary mix of ingredients that would be difficult to list on a product label, they nonetheless are required to be tested to ensure their safety, and like all ingredients in personal care products, are regulated under current federal law. The European Union uses the same regulatory approach for fragrances as the United States.

Truth 10

MYTH: Congress Needs to Clamp Down on Industry. Manufacturers of cosmetics and personal care products are hiding their ingredients and trying to shirk regulation and government review that will protect consumers.

FACT: The Cosmetic Industry is Leading the Charge for Meaningful Improvements in Regulatory Policy. While the industry is proud of its track record on safety and health, it is always seeking to enhance consumer protections. In July 2010, the Personal Care Products Council announced a comprehensive federal policy initiative designed to modernize, bolster and expand the regulatory process in a way that continues to benefit consumers and provides a simple public process with timelines to evaluate the safety of any ingredient if FDA or any member of the public has a concern.

RESPONSE FROM FDA TO THE CLAIMS MADE IN THE BOOK:

The powers of the FDA are limited when it comes to the cosmetics industry.

For an overview of FDA's regulation of cosmetics, see “FDA Authority over Cosmetics” at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074162.htm

It’s important for consumers to realize that, under the FD&C Act, FDA does not evaluate cosmetic products before they go on the market and that manufacturers are responsible for marketing a safe product. The FDA can take action if it has evidence of safety issues, and encourages consumers to file a report with the Agency if they experience an adverse event.

The manufacturer is responsible for marketing a safe product and for conducting appropriate assessments to satisfy that requirement.

Unlike other cosmetic ingredients, color additives, with the exception of coal tar hair dyes, are subject to FDA premarket approval. A color additive is defined as any dye, pigment or substance that is capable of imparting color to a food, drug, or cosmetic (21 CFR 70.3(f)). This definition also applies to black, white, and intermediate grays. However, if an color additive is used solely for a purpose other than coloring, and if “the material is used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned,” it would not be considered a color additive (21 CFR 70.3(g)).

Product recalls of cosmetics, as with almost all FDA-regulated products, are voluntary on the part of the manufacturer. With the exception of infant formula and certain medical devices, FDA does not have the authority to recall products.

The FDA can only regulate products once they have been released to the public.

The FDA does regulate cosmetics, as addressed in the previous answer. While the agency does not evaluate products prior to marketing, it does set standards for safety and labeling that manufacturers must abide by. It also requires the approval of color additives before they can be used in products.

The FDA has only banned less than a dozen ingredients for use in products.

Some ingredients are prohibited or restricted from use in cosmetics by regulation http://www.fda.gov/Cosmetics/ProductandIngredientSafety/SelectedCosmeticIngredients/ucm127406.htm

Manufacturers may essentially use any ingredient not on the list above (except color additives, discussed above) in the formulation of a cosmetic product provided that the ingredients and the finished products are safe, the product is properly labeled, and the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded.

For the majority of products the FDA relies on outside testing as a source.

The FDA does utilize the Cosmetic Ingredient Review (CIR) Expert Panel in determining its priorities for ingredient safety review. The CIR is an independent, industry-funded panel of scientific experts that regularly assesses the safety of numerous cosmetic ingredients and publishes its findings. FDA representatives attend CIR meetings in a non-voting capacity.

Manufacturers are not required to disclose all of the ingredients and byproducts that are in products.

Cosmetic products marketed on a retail basis to consumers in the U.S., whether manufactured domestically or imported, must bear an ingredient declaration on their product package label, in which all ingredients down to 1% concentration are listed in descending order of predominance. Fragrance ingredients may be listed simply as "fragrance," rather than listing fragrance components individually. FDA requires the ingredient declaration under the authority of the Fair Packaging and Labeling Act (FPLA). Because the FPLA applies only to products marketed on a retail basis to consumers, the requirement for an ingredient declaration does not apply in other cases, such as to cosmetics marketed only to professionals, or only for institutional or workplace use, or distributed as free samples.

Regulations in Europe are a lot stricter than in the US.

It is not appropriate for the FDA to comment on European regulations and whether they are more or less stringent than the U.S.

By law the FDA has no authority to force a recall of a cosmetic even after public safety issues are raised.

Product recalls of cosmetics, as with almost all FDA-regulated products, are voluntary on the part of the manufacturer. With the exception of infant formula and certain medical devices, FDA does not have the authority to recall products.

Cosmetics companies are not required to register with the FDA, report the ingredients they use or send the FDA safety-testing data.

FDA has a Voluntary Cosmetic Registration Program (see http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/default.htm). The information received by FDA from the VCRP is entered into a computer database. If it is determined that a cosmetic ingredient presently being used is harmful and should be removed from product use, FDA can notify the manufacturers and distributors of affected products by using a mailing list (or email list if you participate via Internet) generated from the VCRP database.

With regard to safety data, cosmetic manufacturers must be able to substantiate the basis for the safety profile of their products.

Cosmetic companies are only required to list intended ingredients, not byproducts and contaminants.

Cosmetic products marketed on a retail basis to consumers in the U.S., whether manufactured domestically or imported, must bear an ingredient declaration on their product package label, in which all ingredients down to 1% concentration are listed in descending order of predominance.

The fragrance industry is not required to list the ingredients in their formulas.

Perfumes and other similar products such as colognes, toilet waters, eau de parfum or eau de cologne, among others, are required like other cosmetics to bear an ingredient declaration on their product package labeling. “Fragrance” may be declared as such, without listing each individual component. Substances added to the formulated fragrance for their technical function in the final product (such as fixatives, vehicles, solvents, light stabilizers, or color additives) must be listed in the ingredient declaration. Under the law and FDA regulations, a manufacturer may elect to declare additional ingredient information but is not required to do so.

Website you can visit to see what’s in your products: http://www.cosmeticsdatabase.com/