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Where the FDA fails consumers

BB and CC Creams: Where the FDA fails consumers

October 3, 2013

Most people use cosmetics and other personal care items without a second thought, believing the government oversees their safety. Not so. No health studies or pre-market testing are required for these products.

Americans’ frequent exposures to cosmetics and personal care products raise questions about the potential health risks from the myriad of ingredients that have not been comprehensively assessed for safety. These ingredients migrate into the bodies of nearly every American.

For instance, in August 2005, scientists from the University of Rochester reported that prenatal exposure to phthalates — chemicals found in personal care products and other consumer products — could cause the reproductive organs of male infants to develop abnormally (Swan 2005). Studies have shown again and again that hormone systems of wildlife are thrown in disarray by chemicals from personal care products that rinse down drains and into rivers (NIEHS 2010).

The FDA has failed to issue a comprehensive set of rules for over-the-counter sunscreens. Thought it has tackled certain misleading claims about these products, it has yet to establish a definitive list of active ingredients it considers to be safe and effective. It does not limit SPF values, even though its scientists know that SPFs greater than 50 offer little consumer benefit. It has not banned sprays, even though they may not provide adequate protection and they can be inhaled.  It has not barred retinyl palmitate, even though its own scientists found significant associations between this chemical and skin tumors and lesions

EWG has researched and advocated personal care product safety for more than a decade.  We believe that the nation’s laws and regulations governing cosmetics and personal care products are desperate need of overhaul.

Here’s why:

Myth – If it’s for sale at a supermarket, drugstore, or department store cosmetics counter, it must be safe.
Fact – The FDA has no authority to require companies to test products for safety.  The agency does not review or approve the vast majority of products or ingredients before they go on the market. The agency conducts pre-market reviews only for certain color additives and active ingredients in cosmetics classified as over-the-counter drugs (FDA 2005, 2010).

Myth – The government prohibits dangerous chemicals in personal care products, and companies wouldn’t risk using them.
Fact – According to the FDA’s Office of Cosmetics and Colors, “a cosmetic manufacturer may use almost any raw material as a cosmetic ingredient and market the product without an approval from FDA.” (FDA 2012) Personal care products are manufactured with 10,500 unique chemical ingredients, some of which are known or suspected carcinogens, toxic to the reproductive system or known to disrupt the endocrine system. Though some companies make products that are safe to eat, others choose to use dangerous ingredients like coal tar and formaldehyde, both human carcinogens, and lead acetate, a developmental toxin.

Myth – Cosmetic ingredients are applied to the skin and rarely get into the body. When they do, levels are too low to matter.
Fact – People are exposed by breathing sprays and powders, swallowing chemicals on the lips or hands or absorbing them through the skin. Studies find evidence of health risks. Biomonitoring studies have found cosmetics ingredients – like phthalate plasticizers, paraben preservatives, the pesticide triclosan, synthetic musks, and sunscreens – as common pollutants in men, women and children. Many of these chemicals are potential hormone disruptors (Gray 1986, Schreurs 2004, Gomez 2005, Veldhoen 2006). Products commonly contain penetration enhancers to drive ingredients deeper into the skin. Studies find health problems in people exposed to common fragrance and sunscreen ingredients, including elevated risk for sperm damage, feminization of the male reproductive system, and low birth weight in girls (Duty 2003, Hauser 2007, Swan 2005, Wolff 2008).

Myth – The FDA would promptly recall any product that injures people.
Fact – The FDA has no authority to require recalls of harmful cosmetics. Manufacturers are not required to report cosmetics-related injuries to the agency. The FDA relies on companies to report injuries voluntarily (FDA 2005).

Myth – Consumers can read ingredient labels and avoid products with hazardous chemicals.
Fact – Federal law allows companies to leave many chemicals off labels, including nanomaterials, ingredients considered trade secrets and components of fragrance (EWG 2008). Fragrance may include any of 3,163 different chemicals (IFRA 2010), none of which are required to be listed on labels. Fragrance tests reveal an average of 14 hidden compounds per formulation, including potential hormone disruptors and diethyl phthalate, a compound linked to sperm damage (EWG and CSC 2010).

When risky chemicals are used in cosmetics, the stakes are high. These are not trace contaminants that may be measured in parts-per-million or even parts-per-billion in food or water. They are substantial components of the product, just as flour is a primary ingredient in bread.

The FDA’s spotty record on sun safety

The FDA issued several new rules for sunscreens in 2011 but left unresolved a number of critical questions (FDA 2011). Addressing them is vital to ensuring the safety and efficacy of sunscreen products.

The FDA has been working on sunscreen rules for more than three decades — and yet consumers still can’t be sure that their sunscreen offers adequate protection. Among the shortcomings of the FDA rules:

  1. FDA does not yet prohibit SPF values above 50, even though the FDA acknowledges that they don’t work better and give sunscreen users a false sense of security;
  2. FDA has not yet approved petitions to allow newer sunscreen filters to be added U.S. sunscreens;
  3. FDA has not restricted problem ingredients like oxybenzone, associated with endocrine disruption, and the vitamin A-derivative retinyl palmitate (EWG 2013); and
  4. FDA is studying but has not yet restricted spray sunscreens, even though it acknowledges they can be inhaled and may not provide a thick enough coating of sunscreen on skin.

Meanwhile, every year more people are diagnosed with skin cancer than any other form of cancer (ACS 2013).

Sunscreen regulations should be a top priority for the FDA, especially since some studies suggest that people use sunscreen to extend their time in the sun, unaware that these products won’t thoroughly protect them (EWG 2013).

These critiques of the current regulatory system are important for consumers to keep in mind when choosing a BB or CC cream.   You simply can’t trust the FDA to ensure that those products are truly safe and effective.