“Make fine lines and wrinkles disappear!” “Reduce the visibility of fine lines and wrinkles!” At first read, these claims sound one in the same. But for decades, a slight difference in phrasing of cosmetics claims—created as a function of current cosmetics regulations—has been responsible for allegedly confusing customers and complicating regulations. Lawmakers have tried and failed to reform federal cosmetics regulations in the past and are now gearing up for another attempt.
Current FDA Regulation of Cosmetics (or Lack Thereof)
The U.S. Food and Drug Administration (FDA) regulates both drugs and cosmetics under the Food, Drug, and Cosmetic Act (FDCA). The FDCA defines a “cosmetic,” in part, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.” 21 U.S.C. § 321(i). The FDCA’s definition of “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man . . . ,” and “articles (other than food) intended to affect the structure or any function of the body of man . . . .” 21 U.S.C. § 321(g)(1).
Certain products can meet the definitions of both cosmetics and drugs under the FDCA depending on their intended uses. The claims made about a certain product are determinative of whether the product is regulated as a cosmetic, drug, or both. For example, a shampoo is a cosmetic because its intended use is to cleanse hair. An anti-dandruff treatment is a drug because its intended use is to treat dandruff. An anti-dandruff shampoo is therefore both a cosmetic and a drug, and is regulated by the FDA as both. Unlike drugs or medical devices, however, cosmetic products and ingredients (with the exception of color additives) currently do not require FDA approval before they go to market. For this reason, a cosmetic product containing the same ingredients as a drug product can enter the market without premarket oversight as long as the product is not advertised as having therapeutic uses.
But drug claims and cosmetic claims can sound indistinguishable to a consumer. Take anti‑aging products for example. If a product is intended to make lines and wrinkles less noticeable by moisturizing the skin, it is a cosmetic because moisturizing is a cosmetic claim. On the other hand, products intended to affect the structure of the skin are drugs even if they affect the appearance. So a product that is intended to remove wrinkles or increase the skin’s production of collagen is a drug. And the slight difference in the way these two products are advertised can create large disparities in the level of premarket regulations such as mandatory good manufacturing practices.
Further, under present cosmetics regulations, cosmetics companies are not required to report postmarket adverse events. The lack of premarket oversight and mandatory adverse event reporting has contributed to consumer concerns over the safety of the products they use every day. For example, the FDA is currently investigating reports of hair loss and rashes linked to the use of WEN by Chaz Dean Cleansing Conditioner products. By November 15, 2016, the FDA received 1,386 adverse event reports from consumers about these products, the largest number of reports ever associated with any cosmetic hair cleansing product. However, the FDA also became aware of over 21,000 complaints reported directly to Chaz Dean, Inc. and the product distributor, Guthy Renker, LLC, during inspections of the companies’ facilities. Had these companies been required to submit these reports to the FDA—as drug companies are—it is almost certain that far fewer customers would have been affected.
Due to the fine line between the definitions of drugs and cosmetics, as well as the significant difference in FDA regulations for the two categories of products, stakeholders have been calling on lawmakers to reform cosmetics regulations for many years now. Some believe this long‑overdue legislation is right around the corner.
Two Senate Bills on Cosmetics Regulation Reform
In May 2017, Senator Dianne Feinstein (D-CA) reintroduced the Personal Care Products Safety Act, S. 1113, 115th Cong. § 1 (2017), which was originally introduced to the Senate in April 2015 with co‑sponsor Senator Susan Collins (R-ME). Later in October 2017, Senator Orrin Hatch (R-UT) introduced the FDA Cosmetic Safety and Modernization Act, S. 2003, 115th Cong. § 1 (2017), to the Senate. Both proposed bills include the following proposed regulations for cosmetics:
Mandatory reporting requirements. Both bills would require cosmetic manufacturers and distributors to report “serious adverse events” to the FDA within 15 business days of receipt of notice. As defined by both bills, this would include adverse events associated with the use of a cosmetic product, ranging from disfigurement to death. This is similar to the existing mandatory reporting requirement for drugs, see 21 C.F.R. § 314.80(c)(1), but adverse event reporting is currently voluntary for cosmetics. The Feinstein‑Collins bill also includes an annual report requirement, under which companies would have to submit to the FDA a yearly report summarizing all adverse events for each cosmetic product marketed during that year.
Registration of cosmetics facilities. Both bills would require cosmetics manufacturing facilities to register with the FDA and would also give the FDA the authority to suspend a facility’s registration if its products have a reasonable probability of causing serious adverse health consequences or death. The Feinstein‑Collins bill includes a registration fee based on a company’s annual gross sales of cosmetics. By contrast, registration under the current regulatory scheme is voluntary, through a program that the FDA administers to collect information on product ingredient listings and registration of manufacturers, packers, and distributors on a voluntary basis.
Submitting ingredients to the FDA. The Feinstein‑Collins bill would also require companies to submit cosmetic ingredient statements for each cosmetic product to the FDA. The Hatch bill does not contain an analogous provision. Under the authority of the Fair Packaging and Labeling Act (FPLA), 15 U.S.C. § 1451 et seq., the FDA already requires a list of ingredients for cosmetics marketed on a retail basis to consumers. 21 C.F.R. § 701.3. Cosmetics that fail to comply with the FPLA are considered misbranded under the FDCA. 15 U.S.C. § 1456.
Ingredient review. Both bills would require the FDA to review the safety of certain cosmetic ingredients and non-functional constituents (incidental components of the ingredients) through a notice and comment process. The Feinstein‑Collins bill would require the FDA to review at least five ingredients a year and goes as far as to set out the first five ingredients for review: (1) Diazolidinyl urea; (2) Lead acetate; (3) Methylene glycol/methanediol/formaldehyde, propyl paraben; and (5) Quaternium-15. The Hatch bill, on the other hand, would have the FDA, in conjunction with industry and consumer groups, identify ingredients for safety review based on public health concerns. The Hatch bill also provides for accredited third‑party review of these selected ingredients.
Good manufacturing standards. Under both bills, the FDA would be required to establish mandatory good manufacturing practices, and, under the Hatch bill, a cosmetics manufacturers’ noncompliance would constitute the cosmetics being adulterated. The FDA’s good manufacturing practices for cosmetics manufacturers are currently voluntary. Both bills would provide small businesses with additional time to comply with the good manufacturing practices—one year under the Feinstein‑Collins bill and two years under the Hatch bill.
Mandatory recall authority. The Feinstein‑Collins bill would give the FDA the authority to order mandatory recalls, while the Hatch bill does not. The FDA only has the authority to oversee voluntary recalls at this time.
Past Failures on Cosmetics Regulation Reform
While some are encouraged by the bipartisan support for cosmetics regulation reform, the fact that similar bills have previously died in Congress casts doubt on whether either of the Senate bills have any hope of becoming law.
Just earlier this year, Representative Pete Sessions (R‑TX) reintroduced his bill, the Cosmetic Modernization Amendments of 2017, as H.R. 575. This bill was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015, H.R. 4075. Before this, similar legislation included the Cosmetic Safety Amendments Act of 2012, introduced by Representative Leonard Lance (R‑NJ), H.R. 4395; the Cosmetics Safety Enhancement Act of 2012, introduced by Representative Frank Pallone (D‑NJ), H.R. 4262; and the Safe Cosmetics Act of 2011, introduced by Representative Jan Schakowsky (D‑IL), H.R. 2359.
Not one of these bills has passed.
Cosmetics companies should consider proactively adopting some of the proposed practices described above regardless of whether either of the currently pending bills becomes law in the near future. As the two proposed bills indicate, any future FDA regulation of cosmetics would build upon the existing voluntary programs for cosmetics and mandatory reporting schemes for drugs, including the Voluntary Cosmetic Registration Program, existing adverse event reporting system, and Good Manufacturing Practices guidelines. Efforts to employ these programs therefore would not be in vain. Early adopters can also develop compliance programs at a predictable pace as opposed to an accelerated or unknown schedule set by future legislation. Lastly, there is little doubt that consumers are demanding self‑regulation in this space in the absence of government action. Premarket considerations can effectively minimize costly litigation down the road.