Why the Stars May Be Aligning for Cosmetics Regulatory Reform
In March of this year, the U.S. Food and Drug issued an alert warning consumers to avoid three cosmetics products that agency inspectors had found to contain asbestos, a known carcinogen. In a statement, the FDA cited its responsibility as federal regulator of the cosmetics and personal care product industry to "share these findings with American consumers and warn them about [the] potential public health threat" posed by the products — Eye Shadows, Compact Powder, and Contour Pallette, all produced by the teen- and tween-focused brand Claire’s.
What the agency did not do is direct Claire’s to suspend production of the offending products or recall them from stores, the kind of FDA action the American public has grown accustomed to hearing about when tainted meat or a defective drug is identified. In fact, the FDA lacks the authority to require a mandatory recall of a cosmetics product. (While disputing FDA’s findings, the company withdrew the products voluntarily.)
Food, prescription drug, over-the-counter drug, and medical device manufacturers are subject to a host of basic consumer protection rules that are enforced by the FDA. However, many of these rules do not apply to cosmetics. The FDA cannot require cosmetic manufacturers to: disclose the ingredients in their products; obtain agency approval for ingredients, other than color additives, before they go on the market; undergo pre-market safety testing; or be produced according to "good manufacturing practices”; or even report “adverse effects” caused by their products, among other safeguards that apply to the other products that FDA regulates
For the most part, the FDA monitors cosmetics safety by responding to product complaints, reviewing scientific literature or evaluating safety testing after the fact. In other words, as a Congressional Research Service report puts it, “cosmetics are arguably more self-regulated than other FDA-regulated products.
This may be about to change. Momentum has been building behind an effort to put teeth into FDA's regulatory authority over the cosmetics industry. A bill recently introduced in the U.S. Senate by Sens. Susan Collins (R-Maine) and Diane Feinstein (D-California), would toughen standards for cosmetics, bringing personal-care products under the same regulatory regime as food and drugs. (A similar bill was introduced in the House of Representatives.)
According to its sponsors, the bill “updates 80-year-old federal safety rules.” Those antiquated rules are contained in two laws from which the FDA draws its regulatory authority over cosmetics – the 1938 Federal Food, Drug, and Cosmetic Act and the 1957 Fair Packaging and Labeling Act. Under these laws the agency has the authority to take enforcement actions – such as seizures, injunctions, and criminal penalties – in cases where cosmetics products are “adulterated” (that is, contain any “poisonous or deleterious” substance) or “misbranded” or “mislabeled” (that is, make unfounded claims). It can request that a company voluntarily recall cosmetics products
The Feinstein-Collins bill would significantly beef up the agency’s authority. Among other provisions, it would: require the FDA to study at least five chemicals or ingredients included in personal care products per year to determine their safety; create regulations on Good Manufacturing Practices (GMP), as it does with pharmaceuticals; require companies to share “serious adverse event” reports; give the FDA mandatory recall authority; compel companies to tell the FDA what’s in their products and put full ingredient lists, with any warnings, online. The objective is to "help increase safety for consumers, protect small businesses, and provide regulatory certainty for manufacturers."
This is not the first time the two senators have introduced a cosmetics reform bill, and similar bills have been introduced multiple times over the past decade. But past reform efforts have fallen short, in part because the legislation did not enjoy universal support from the cosmetics industry. This time around, prospects for reform look much brighter. The Senate bill has been endorsed by the American Academy of Pediatrics and “a diverse and growing coalition of companies, from small manufacturers of handmade personal care products to large companies in the industry,” including Johnson & Johnson, Estee Lauder, Revlon, and Elsevier.
Meanwhile, the Personal Care Products Council, the leading trade association for the cosmetics industry, has called for reforms to “ensure that FDA has the appropriate authority and resources to regulate cosmetic products in the 21st Century."
Why the shift? In part because in the age of social media, companies run the risk of far greater reputational damage in the event of an incident like the one that befell Claire’s. At the same time, consumers have become more discerning about the ingredients in cosmetics and an indie beauty industry has emerged to cater to a savvier, more health and eco-conscious customer base. Moreover, in the absence of strong federal framework, states fill the regulatory vacuum, subjecting the industry to a patchwork of laws – a compliance challenge, to say the least. Hence, the industry seeks clear regulations and any new FDA power to supersede state-level requirements.
PCPC has put out a set of reform principles to guide bipartisan legislative action. They include:
- Preempt state and local laws that would duplicate new authorities in FDA regulation of cosmetics
- Require mandatory reporting by manufacturers to FDA of serious and unexpected adverse health events experienced by a consumer from a cosmetic product marketed and used in the United States.
- Authorize FDA to issue Good Manufacturing Practices for cosmetic products.
- Provide FDA authority to order a mandatory recall of a product if a manufacturer refuses to comply with an FDA request for a voluntary recall
- Create an FDA program authorized to review the safety of individual cosmetic ingredients and nonfunctional constituents found in cosmetics, in a timely manner and utilizing widely accepted scientific principles
- Require manufacturers to substantiate the safety of cosmetic products and ingredient
- Allow flexibility for small businesses to comply with certain requirements, and exempt very small cosmetic manufacturers (those making less than $2 million a year gross)
- Encourage FDA approval of alternatives to animal testing
According to Bloomberg, the PCPC has expanded its lobbying team, while at least 17 groups and companies—Unilever, Johnson & Johnson, the Fragrance Creators Association and the Independent Cosmetics Manufacturers and Distributors (ICMAD)—have listed lobbying on the bill since it was introduced.
There’s no guarantee, of course, that cosmetics reform will pass in this Congressional session. The departure of supportive FDA Commissioner Scott Gottlieb may stall momentum if his replacement is less interesting in pushing the issue. But the fact is that reform is in the interests of both companies and consumers and is likely to come sooner or later.
And so, as one legal expert puts it on the website Chemical Watch, “Manufacturers and retailers may want to consider staking out their positions now on proposed actions that may affect their products, before their products become the center of unplanned attention as a result of an emergent event.”
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