Safety decisions left to companies and consumers

“The [Food, Drug and Cosmetic Act] contains no provision that requires demonstration to FDA of the safety of ingredients of cosmetic products… prior to marketing the product.” — FDA response to EWG petition, September 29 2005

On September 29, 2005, the Food and Drug Administration issued a final written response to a cosmetic safety petition filed by the Environmental Working Group in June 2004. In this document the Agency revealed deep deficiencies in its power to protect the public health under the nation’s cosmetics law. Notably, FDA affirmed its inability to enforce a requirement that a warning label be posted on products that have not been substantiated for safety.

Many consumers believe the government ensures the safety of personal care products before they are sold. FDA confirmed in its response that it does not: the Agency cannot require premarket safety testing of personal care product ingredients, and, therefore, cannot prevent the introduction of dangerous products onto the market. “The [Food, Drug and Cosmetic Act] contains no provision that requires demonstration to FDA of the safety of ingredients of cosmetic products… prior to marketing the product,” wrote FDA.

In its response FDA reiterated that even if it believes a product is harmful, it generally must prove in court that the product is misbranded or adulterated before taking enforcement actions. The Agency noted that it cannot even require a recall of harmful products — recalls are voluntary company actions, and the mere act of FDA suggesting a recall requires that the Agency have firm evidence of potential human harm. “[T]he [Food, Drug and Cosmetic Act] does not authorize FDA to order a recall for a defective or possibly harmful cosmetic product,” writes FDA.

In the vaccum of authority summarized in FDA’s petition response, consumers can find some assurance in knowing that the law requires manufacturers to adequately substantiate their products for safety before they are sold. But even this requirement fails to provide clear protection: FDA has not defined what safe means or how to achieve it, and companies, who make safety findings independent of FDA, do not have to disclose the basis for their conclusions. The only thing that companies must do is list ingredients on their product labels.

In place of government authority to ensure safety, the cosmetics industry polices itself through an industry panel called the Cosmetic Ingredient Review. This industry-funded panel of scientists has reviewed just 11 percent of all ingredients in cosmetics; our 2004 petition to FDA was based on the safety assessments that have been completed by this panel. We challenged the claim that products were substantiated for safety in two cases: products containing ingredients that were contraindicated for the product use (for example, skin creams with ingredients for which the industry review panel concluded the ingredient should not contact the skin); and products containing ingredients that the industry panel concluded lacked the safety data needed to support a finding of safety in cosmetics. In our petition we also requested that all such products bear the required warning label: Warning — the safety of this product has not been determined.

But in their response to our petition, FDA replied that it could not take action against these products, arguing that the Agency could not find them misbranded or adulterated, and could not require the warning label because it lacked the information to determine whether or not the ingredients were adequately substantiated for safety, or were causing acute injury. The FDA argued that the industry panel recommendations were not sufficient evidence to determine if ingredients are, indeed, safe, although in practice this is the only authoritative body that reviews the safety of cosmetics ingredients.

In its petition response FDA delivers one final blow to public health protection: the Agency declines to develop guidance for industry on what must be done to substantiate safety, and what standard must be met to ensure a product is safe. The agency’s self-declared impotence — and, further, their refusal even to develop safety guidance — leaves companies to make their own choices about what is safe enough to be sold, and leaves consumers guessing about the possible risks.

Cosmetic safety – voluntary and discretionary. Over the past year the personal care product industry has combated a growing stream of scientific publications raising questions about the safety of chemicals in cosmetics. Industry representatives have fielded questions about research linking the fragrance ingredients called phthalates to low testosterone and stunted reproductive system development in baby boys. They have responded to concerns over the presence in human breast tumor tissue of the ubiquitous, estrogen-like cosmetic preservatives called parabens, and have rebutted a new study showing that the popular preservative called MIT, or methylisothiazolinone, kills neurons and impairs brain signaling in laboratory animals.

Are personal care products safe? Although the government cannot require cosmetics manufacturers to conduct safety tests of their products before marketing, industry experts have reassured the public that the industry does, nevertheless, voluntarily and rigorously ensure the safety of products before they’re sold, and that the government has broad authority to “take immediate action to top the sale of any product that does not meet [the law's safety] standards” (CTFA 2005).

The core provision in the cosmetics law that protects public health is held in a single paragraph:

Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the principal display panel:

Warning — The safety of this product has not been determined.

When asked if any products are sold bearing this warning label, the answer from industry spokespeople is an emphatic no: “Why would a company put a product that requires a warning label on the market?” replied one expert (Solomon 2004). “The law is absolutely clear. Companies are not allowed to put on the market a product that’s not safe or has unsafe ingredients,” says the cosmetic trade association’s lead technical advisor, adding that enforcement actions can include “throwing [violators] in jail. . . I’m sure someone looking at that would not allow themselves to be placed in that position” (Huget 2004).

But in their September 29, 2005 response to EWG’s 2004 cosmetic safety petition, the Agency indicates that by its own interpretation of the law and implementing regulations, FDA has little to no authority to enforce provisions in the law that require manufacturers to substantiate the safety of their products before they are sold.

FDA’s position leaves safety testing optional and companies largely without fear of retribution. The safety panel established and funded by the industry’s main trade association to dampen enthusiasm for stronger regulation has, in its 30-year history, reviewed just 11 percent of the 10,500 ingredients that FDA has documented in personal care products.

Ninety-nine percent of all products contain one or more of these unassessed ingredients, and in our 2004 assessment we found that more than 300 products contain one of more of the 126 ingredients the panel has reviewed but found specifically lacked the data needed to substantiate safety. When EWG reviewed the labels of these 356 products, we found that none of them bore the warning required on a product with unknown safety: Warning — the safety of this product has not been determined. Perhaps each company independently assessed the safety of these ingredients, or perhaps not. Either way, FDA presents arguments showing that it largely lacks the power to enforce the law that mandates the warning.

FDA’s argument for its own impotence relies on two key prongs. First, the Agency notes that enforcement actions rely on findings that the product is misbranded or adulterated. Both findings are impossible to make when it comes to cosmetics containing ingredients that haven’t been assessed for safety.
Proving health harms for ingredients with unknown safety is impossible. FDA’s response to EWG on this point is ironic: the Agency writes that “your petition did not provide sufficient data and information for FDA to evaluate the safety of [ingredients not assessed by industry's panel] in connection with the petition’s assertion that the safety of the product [containing these ingredients] has not been adequately substantiated.” Even knowing whether or not the products have been substantiated for safety is impossible — safety studies are not required to be made public, and FDA has no means to know what studies have or have not been conducted.

FDA has one fallback enforcement option: the Agency can request a voluntary recall of products. But, as FDA notes in their response to EWG, even this meager action requires the Agency to determine that the product presents a risk of illness or injury or gross consumer deception. Since FDA has no way to know the full range of studies that have or have not been conducted — and thus the depth of consumer deception — or the potential health harms from ingredients with unknown safety, the Agency cannot even make this simple request.

Where does this leave consumers? Public health is in the hands of an impotent agency, safety testing is voluntary, safety decisions are at the discretion of individual companies, and the burden of choosing safe cosmetics falls squarely on the shoulders of each consumer.

FDA refuses to establish guidance for safety. Consumers’ expectations for safe personal care products are embodied in the single provision of the Food, Drug and Cosmetic Act that requires a prominent warning label on a product with unknown safey: Warning — The safety of this product has not been determined.

In EWG’s review of more than 20,000 product labels in 2004 and 2005, we have not identified a single product that bears this warning. Implicitly, companies are claiming without exception that they have sufficiently substantiated the safety of all their products. But FDA provides the industry with no substantive guidance whatsoever on what must be done to adequately substantiate safety, or even with a definition of “safe.” Companies’ blanket, implicit safety claims may be based on rigorous testing and assessment, or on nothing at all. Either approach is legal. And, as noted above, FDA argues that it has little or no authority to enforce the provision, anyway. EWG has requested that FDA at the very least provide industry with guidance on what must be done to substantiate safety.

In EWG’s 2004 petition to FDA, we requested that FDA clarify the requirements of “adequate substantiation of safety,” suggesting the following language, and argued that anything less would be a disservice to the millions of Americans who rely upon the FDA to ensure the safety of cosmetic products available on the marketplace:

Substantiation, through peer-reviewed scientific publications or publicly available industry studies, of a reasonable certainty of no harm from aggregate exposures to the product and its component ingredients including impurities, taking into account chemicals that may increase penetration of the product or its component chemicals through the skin, and including all anticipated cosmetic exposures and all other exposures for which there is reliable information, taking into consideration vulnerable populations such as infants and pregnant women.

Any finding of safety for a cosmetic product must explicitly account for risks posed by impurities until such time as impurities are removed from the component ingredients or the product is reformulated in such a way as to preclude the formation of impurities by the component ingredients in the product.

In its response to EWG’s petition, FDA declined to fill this notable vacuum of guidance. Instead of choosing to actively develop safety criteria for the personal care product industry, FDA instead notes that it is “looking into the possibility of issuing guidance on [the substantiation of safety] in the future.”

Looking into possibilities for guidance in the future is far less than American consumers need. In a product use survey we conducted in 2004 with partner organizations in the Campaign for Safe Cosmetics, we found that the average adult uses 9 products daily, with 126 unique ingredients that contact. With companies’ free rein to interpret “safe,” the ingredients in these products include everything from oatmeal to known human carcinogens. FDA’s refusal to develop guidance not only leaves companies on unequal footing, but also leaves consumers guessing about the safety of their everyday brands.

In its response to EWG’s request for clarification on “safety,” FDA notes that the Agency did, in fact, “discuss” the phrase “adequately substantiated for safety” in a 30-year-old preamble to the cosmetic labeling rule (21 CFR 740.10; 40 FR 8912 at 8916, March 3, 1975). The totality of the discussion directed cosmetic manufacturers to first rely on “already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic,” and, secondly, to perform “any additional toxicological and other tests that are appropriate in the light of such existing data and information,” or, in short, to review existing studies and conduct more as needed.

These guidelines are reasonable and supported by common sense. But they fail to cover the two crucial areas of safety assessments: what tests should be conducted and evaluated, and what standard of safety should be met for products that industry claims as “adequately substantiated for safety”? On these two counts, FDA is silent. Even Superfund sites must satisfy guidance on health-based standards of safety — no more than 1 in 10,000 excess lifetime cancer risk in surrounding communities, for example. Companies must subject pesticides proposed for use on food to a battery of up to 120 tests prior to approval. But for cosmetics, testing is voluntary, and any level of risk is legal.

Thirty years ago industry’s trade association (Cosmetic Toiletry and Fragrance Association, or CTFA) established, and continues to fund and run, an outside safety panel called the Cosmetic Ingredient Review that serves to systematically review the safety of cosmetic ingredients, a function that FDA in its vacuum of authority does not perform. According to FDA’s former Director of the Office of Cosmetics, “The cosmetic industry is sensitive to the image of an uncontrolled market where anything goes… They counter this image with well-established self-regulation programs. Part of the incentive for such industry policy is to avoid increased regulatory authority.” He notes that “in the absence of the CIR program, there would be no systematic examination of the safety of individual cosmetic ingredients” (FDA 1995). This panel is our public health backstop for safety, but it operates in a vaccum of guidance from FDA when it comes to the safety of personal care products. Acceptable levels of risk are entirely at this panel’s discretion.

Labeling of ingredients – optional. Although the safety of products is discretionary, ingredient labeling is not. The law requires that ingredients appear on a label “likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” Even if the vast majority of ingredients in cosmetics have not been assessed for safety by FDA, the industry safety panel, or any other publicly accountable institution, consumers can still fall back on reading ingredient labels to make safe choices for their families. The Food, Drug and Cosmetics Act requires that “each package of a cosmetic… bear a declaration of the name of each ingredient in descending order of predominance,” and that “[t]he declaration of ingredients … appear with such prominence and conspicuousness as to render it likely to be read and understood by ordinary individuals under normal conditions of purchase.” (21 CFR 701.3)

Unfortunately, though, labels are not always so easy to read. The names can be inscrutable for those without a strong chemistry background, and the cosmetics industry makes it even more difficult when it fails to follow FDA’s ingredient name convention guidelines. In EWG’s assessments of product labels, we found more than 13,900 unique ingredient names on the labels of 14,200 products, but upon rigorous analysis of misspellings and synonyms, these ingredients collapsed into just over 9,800 unique chemicals; approximately half of all ingredients were mislabeled. Just one example — we found 22 unique spellings of the botanical ingredient “witch hazel.” The industry’s spelling challenges complicate a consumer’s ability to interpret labels.

FDA’s new interpretation of the labeling law, embedded in their response to EWG’s petition, further weakens consumer’s ability to make use of ingredient labels. EWG identified 41 online retailers of cosmetics that fail to post ingredient labels likely to be read under normal conditions of purchase (in this case, an online purchase), as required by law. We requested that FDA require that ingredients be posted as required by law. FDA has declined to do this, stating that “[t]here is no requirement that a manufacturer put an ingredient list on a website.” There is specific language requiring ingredients to be posted on bottles, boxes, brochures, and catalogs, but not online. Thus, consumers can’t know what is in products until after their purchase.

Drugs and cosmetics and the FDA. The now notorious health risks uncovered for the millions of people who relied on VIOXX and Celebrex to relieve arthritis pain spurred deep and widespread doubt about FDA’s ability — or willingness — to screen drugs for safety before they are sold. In the wake of these debacles, FDA found itself both headed by a new Commissioner and facing a public skeptical of the Agency’s ability to ensure that drugs are safe.

But while some government leaders might have used such a revelatory low point to inspire broad and sweeping reform, FDA’s recent response to EWG’s safety petition is one more lift of concrete over the feet of an Agency accused repeatedly of prioritizing corporate profit over public health.

Every day the average consumer uses nine personal care products with 126 unique ingredients – shampoo, lotion, sunscreen, lip balm, deodorant, and other products that nearly all of us rub, spray or pour onto hair, skin or lips daily throughout our lives. Companies that manufacture these products do not face the same burden as drug manufacturers for premarket testing — and even with premarket testing, people can face risks.

Cosmetics and drugs find broad common ground. Many cosmetic ingredients are designed to penetrate the skin, just like drugs delivered through skin patches. Many use ingredients that are also active ingredients in over-the-counter drugs — cosmetics that contain ingredients linked to cancer or reproductive harm, like progesterone, hydroquinone and selenium sulfide, are just three examples. Many ingredients in cosmetics are biologically active, just like drugs, and many cosmetics cross over into the gray area FDA calls “cosmeceuticals” — products that are half drug, half cosmetic.

Are cosmetics safe? As one national media outlet reports: “[The] director of the FDA’s office of cosmetics and colors, said the agency’s lack of authority to require pre-market safety testing makes it difficult to enforce the law.” (Huget, 2004). Product safety is any company’s choice and any consumer’s guess.

References

CTFA (Cosmetic Toiletry and Fragrance Association). 2005. How cosmetics are regulated. Accessed online October 5 2005 at http://www.ctfa.org/Content/NavigationMenu/Consumer_Information/

Cosmetic_Regulation/Cosmetic_Regulation.htm.

Huget, Jennifer. 2004. Purely cosmetic? A new report gives risk ratings to thousands of personal care products. It reveals how little is known about them 151; but not whether there’s really much to fear. The Washington Post. June 22, 2004.

Solomon, Goody. 2004. Wash those fears right out. The Washington Times. August 14, 2004.