About the Author
RUTH WINTER, M.S., is an award-winning author of thirty-seven books. Visit her at BrainBody.com or IngredientBlog.blogspot.com.
Excerpt. © Reprinted by permission. All rights reserved.
Why You Need This Book
Are you afraid of aging?
Does a wrinkle on your face cause you to panic and make you fear you are becoming unattractive and unemployable?
Do you believe a fragrance can make you irresistible?
Are you willing to spend your hard-earned money to buy expensive cosmetics that promise you a cure for whatever flaw you think you may have?
If you answer yes to these questions, you have become a pawn of the manipulative cosmetic industry. These geniuses of marketing have convinced you and most of society of the following:
• Aging and wrinkles are to be greatly feared.
• Natural body odors are mortifying.
• Cosmetics can cure anything.
I really do admire the cleverness of cosmetic producers and sellers— even if they don’t like me because I reveal to you what is really in their products. But I believe they are still fabulous sociologists, psychologists, and marketers. They know before anyone else what we want or should want, and they immediately build upon those desires to sell us what we may or may not need. From the department store counter to the drugstore to the Internet, they have given us literally thousands of choices of cosmetics. As you will read in this dictionary, some of the potions and powders are excellent and fulfill their promises, many of the compounds do nothing and are actually fraudulent, and some may be damaging to our health because they contain toxins or cancer-causing agents.
You may be asking yourself at this point: “Well, doesn’t the FDA protect us?”
The answer is NO!
Cosmetics have always been a low priority at the U.S. Food and Drug Administration (FDA), but now its regulatory powers have been weakened to the point where they are almost nonexistent.
Why Are Cosmetic Regulations So Limited?
The agency’s regulations were determined more than seventy years ago when it was wrongly assumed that the skin is an impermeable barrier that prevents chemicals from penetrating into the body. Scientists now know that this is not true, yet most consumers and cosmetic companies are concerned only with allergic reactions and skin irritations. But what of systemic absorption, toxicity, and chronic effects? What degree of absorption is there when a cosmetic is left on the face (as a makeup base might be for twelve hours) or spread over the entire body (like suntan lotions)? What is the impact when these products are used for many years?
No one knows. Cosmetic companies do know that an increasingly popular way to deliver drugs is “transdermally.”
All we know is that cosmetics can affect us outwardly and inwardly, so the question becomes, What safeguards does the FDA have today?
THE FDA’S COSMETIC SAFETY REGULATIONS
The following quote is directly from the current FDA Handbook:1
Although the FD&C Act does not require that cosmetic manufacturers or marketers test their products for safety, the FDA strongly urges cosmetic manufacturers to conduct whatever toxicological or other tests are appropriate to substantiate the safety of their cosmetics. If the safety of a cosmetic is not adequately substantiated, the product may be considered misbranded and may be subject to regulatory action unless the label bears the following statement: “Warning—The safety of this product has not been determined.”2
Why Is the FDA So Powerless?
The Report of the Subcommittee on Science and Technology on the FDA Science and Mission at Risk presented answers.3 The committee said its major findings were as follows:
• The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
• The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
• The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
Inspections have declined while the work assigned to the FDA has skyrocketed. In 2008, the United States imported more than $2 trillion worth of products sent to the United States by an estimated 825 major importers, through more than 300 ports of entry. The FDA projects a total of 18.2 million import lines a year, 9 percent of which is cosmetic products. The FDA is also responsible for overseeing more than ninety thousand U.S. facilities where food, drugs, and other products are manufactured, processed, or stored. Twenty-one cents of every dollar spent by consumers goes toward products the FDA is supposed to regulate. The Office of Regulatory Affairs (ORA) is the lead office for all FDA field activities. The largest portion of ORA’s work involves postmarket inspections of foods, human drugs, biologics, animal drugs and feeds, and medical- device manufacturers (nothing is designated specifically for cosmetics). The FDA has about 3,472 full-time employees associated with field activities with a requested budget at $542,534,000. They are sometimes helped by state health inspectors.4
Why is the FDA so beleaguered and underfunded? No matter how skilled and well intentioned the staff may be, they are being smashed under an impossible workload. Unless consumers like you and savvy organizations such as those listed on pages 559–564 lobby effectively for changes, nothing will happen.
In the meantime, I have written both A Consumer’s Dictionary of Cosmetic Ingredients and A Consumer’s Dictionary of Food Additives to give you the information you need to make wiser choices in the almost unregulated marketplace. For example, anyone can go into the cosmetics business without notifying the FDA. If you don’t believe it, the following is directly from the FDA Handbook:5
Although the FD&C Act does not require cosmetic firms to register manufacturing establishments or formulations with the FDA or make available safety data or other information before a product is marketed in the United States, manufacturers or distributors of cosmetics may submit this information to the agency voluntarily. Voluntary registration and assignment of a registration number by the agency does not denote approval of a firm or product by the FDA. Any use of a registration number in labeling must be accompanied by a conspicuous disclaimer phrase as prescribed by regulation.
Cosmetic companies that wish to participate in the voluntary registration forward data to the FDA. Only an estimated 35 to 40 percent of the companies are honorable enough to inform the FDA of the ingredients they are using. But since the last edition of A Consumer’s Dictionary of Cosmetic Ingredients, there is a new game being played. A significant number of the companies are “registering” their names with the FDA and then saying in their ads “Registered with the FDA” in an attempt to have us believe their product has been approved by the agency.
The truth is the FDA admits it cannot require companies to do safety testing of their cosmetic products before marketing. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by the FDA before they are sold to you. Recalls taken by the cosmetic industry to call back products that present a hazard, or that are somehow defective, are voluntary. The FDA is not permitted to require recalls of cosmetics but does monitor companies that conduct a product recall.
The FDA can only take action against a company if complaints are made by consumers or health providers and the complaints are registered. For this edition, I found out the FDA no longer has a database of reports of adverse effects from cosmetics. When I asked why, a very frustrated FDA staff member said, “Because our staff and our money have been cut!”
Although there are no full-time field agents assigned to cosmetics, investigators in district offices may be assigned “as the need arises.” The FDA is supposed to collect cosmetic product samples as part of its rate plant and import inspections.
The FDA reports that it has 1.75 professional staff persons per year to process submitted cosmetic forms and maintain computer files at a cost of $97,465 per year. (Don’t you wonder what a .75 professional looks like?) Since cosmetic companies are always worried about the competition stealing their formulas, the FDA assures the registrants that their information is locked in a safe and guarded by 1.75 professionals—presumably except when a guardian has to eat lunch or go to the restroom. Then the door is locked.6
While consumer and industry assistance has been significantly reduced or eliminated, the FDA has increased its Internet presence, and its website offers statements such as: “The FDA does not function as a private testing laboratory”; “The FDA is prohibited from recommending private laboratories to consumers for sample analysis”; and “Consumers may consult their local phone directory for testing laboratories.”
If the FDA does wish to remove a cosmetic from the market, it must first prove in a court of law that the product is injurious to users, improperly labeled, or otherwise violates the law. Such court cases in the past have cost the budget-strapped agency millions and the companies with their powerful lawyers and political clout almost always win.
Again, this is directly 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. The law requires that color additives used in food, drugs and cosmetics must be tested for safety and approved by the FDA for their intended uses. A cosmetic containing an unlisted color additive; i.e., a color additive which has not been approved by the FDA for its intended use, is considered adulterated and subject to regulatory action. The color additives approved for use in cosmetics are listed [see them in this dictionary]. The use of the following ingredients is either restricted or prohibited in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants, and hexachlorophene [see all in the dictionary]. The agency also considers as adulterated cosmetics nail products containing methyl methacrylate monomer or those containing more than 5% formaldehyde. 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, irritation, neurotoxicity, or phototoxicity or allergic reactions. (See all the restricted or prohibited chemicals in this dictionary.)7
Is there anyone at the FDA who deals with a consumer’s physical problems caused by cosmetics or ingredients not explicitly prohibited by the FDA?
There are regulatory enforcers and criminal investigators under CFSAN, the FDA’s Center for Food Safety and Applied Nutrition. The personnel are responsible for a wide variety of products, including foods, seafood, wine beverages less than 7 percent alcohol (including wine coolers), bottled water, food additives, infant formulas, dietary supplements, and cosmetics. Each of these products is used differently and regulated under a different part of the FDA Act and thus has slightly different investigational requirements. Do you think it is important that the FDA conducts appropriate investigations and follow-up on adverse events attributed to cosmetic products?8
How many expert regulators are there on CFSAN’s staff to enforce the above? Five, at this writing. How many do they have on staff for all the products potentially involved in criminal activity? Three!9
This does not mean no one is watching the cosmetic stew. The trade organization Personal Care Products Council (PCPC; formerly the Cosmetic, Toiletries and Fragrance Association) is doing an admirable job and has established its own safety assessment system, the Cosmetic Ingredient Review (CIR). It has a six-member Steering Committee chaired by the president and CEO of the council (from the industry); a dermatologist representing the American Academy of Dermatology; a toxicologist representing the Society of Toxicology; a consumer representative from the Consumer Federation of America, and the council’s executive vice president for assessing the safety data. Since its establishment in 1976 CIR panels have reviewed 1,298 ingredients as of August 2006. (You can read about them in the dictionary.) Of that number,
• 781 ingredients were found safe as used.
• 408 ingredients were determined safe with qualifications.
• 119 ingredients could not be evaluated because of insufficient data.
• 9 ingredients were cited unsafe.
The basic purpose of the review is to gather information from the scientific literature and from company files on the safety of cosmetic ingredients. It alerts the FDA and makes that information publicly available without any private review or comment. Thus far, members have questioned the safety of ingredients—such as
6-methyl coumarin and musk ambrette (see both)—and these substances have been voluntarily removed by PCPC member companies. However, proponents of increased cosmetic regulation argue that participation in this voluntary compliance system is low. In addition, critics contend the CIR is an industry-funded expert panel established to conduct safety assessments of cosmetic products, yet has only reviewed 11 percent of cosmetic ingredients since 1976.10
In 2007, the trade organization the Cosmetic Toiletries and Fragrance Association’s (CTFA) board of directors changed its name, as mentioned, to the Personal Care Products Council (PCPC) because “the change represented a new, broader and more contemporary name to better represent the association’s growing and diverse membership.” In addition, the board chose a new motto for the association: Committed to safety, quality and innovation. The PCPC states that its members produce the majority of the cosmetics on the market. We should be grateful that there are scientists testing ingredients for us. The cosmetic companies, however, are politically astute. Such self-testing and efforts at self-regulation fend off potential outside regulation by government agencies. And the cosmetic manufacturers contribute heavily to political campaigns, including the presidential race. It is in their own interest, of course, to avoid using an ingredient that might be found at some later date to be potentially harmful. Adverse publicity can instantly kill a product into which millions of dollars have been invested.
THE STATE OF STATE COSMETIC REGULATIONS
Due largely to consumer pressure, some states have been formulating stricter regulations concerning cosmetics.
MAKING UP INTERNATIONALLY
Since the commerce in cosmetics is global today, there has been an effort to “harmonize” labeling and regulations. In 2011, the global makeup market is forecast to have a value of $32.1 billion, an increase of 27.8 percent since 2006.11
The European Union (EU) has worked toward agreement on ingredient terms to ease marketing across the borders in countries representing nine different languages. The U.S. Office of Cosmetics and Colors (OCAC) has considered these harmonizing requests on a case-by-case basis, in line with its legal responsibilities under the Fair Packaging and Labeling Act (FPLA) to promulgate regulations “necessary to prevent the deception of consumers or to facilitate value comparisons.”