Update: The Safe Cosmetics and Personal Care Products Act of 2019 was reintroduced on September 12, 2019.
The multi-billion dollar U.S. cosmetics industry is booming. The U.S. Food and Drug Administration (FDA), which regulates cosmetics in the United States, reports through its data dashboard that over 2.7 million cosmetic line-items entered U.S. ports in Fiscal Year (FY) 2018. However, this immense volume of cosmetic imports poses certain challenges as current regulations and resources limit what the Agency can do to effectively prevent potentially harmful cosmetics from entering U.S. distribution.
FDA was only able to examine 5,403 (less than 1%) cosmetic line-items in FY 2018. 784 (14.5%) of the examined lines were refused entry into the U.S. because they were found to violate regulations. It is probable that, in the unexamined shipments, many non-compliant and potentially harmful products evaded enforcement and made their way to shelves.
Meanwhile, domestically-produced goods, which are not subject to any screening before entering the market, present a different issue. In April 2018, fraudsters in Los Angeles were discovered marketing feces-laced makeup kits using the brand name of celebrity Kylie Jenner’s cosmetics line. The incident caused Jenner’s sister Kourtney Kardashian to lobby with U.S. legislators for stricter cosmetics regulations.
Solutions For Proactive Regulations
Current FDA regulations for cosmetics are reactive, often addressing compliance issues after a product has already entered U.S. distribution. FDA can issue Warning Letters for non-compliance and refuse cosmetics in port, but the Federal Food, Drug, and Cosmetics (FD&C) Act does not give the Agency authority to order a mandatory recall of a cosmetic.
Other products under FDA’s authority such as food, medical devices, and drugs are more proactively regulated. These products are subject to pre-market submissions and facility requirements that not only help the Agency prevent significantly more non-compliant products from entering the U.S., but also better enforce action against them when they do.
In order to provide comparable regulations for cosmetics, the U.S. Congress has introduced three bills in the past two years: the Personal Care Products Safety Act (S.1113), the FDA Cosmetic Safety and Modernization Act (S.2003), and the recent Safe Cosmetics and Personal Care Products Act of 2018 (H.R.6903). While these bills have been referred to committees and have not yet been voted on, they share some commonalties that illustrate the direction U.S. cosmetics regulations may take in the next decade. This article will discuss major changes industry should expect if any of these bills becomes law.
Mandatory Registration of Cosmetic Facilities
FDA requires businesses in most industries under its authority to register or report to the Agency prior to marketing their products in the United States. Under current regulations, FDA does not require cosmetic establishments to register, but allows them to do so voluntarily.
The proposed bills would require facilities that manufacture, process, or (in some cases) distribute cosmetics for use in the United States to register with FDA. S.1113 and H.R.6903 would require annual registration renewal, while S.2003 would require renewal every two years. All bills would require facilities located outside of the United States to designate an agent physically located in the United States to communicate with FDA on a facility’s behalf.
Mandatory registration of cosmetics facilities provides FDA a paper trail of who is marketing cosmetics in the United States and grants the Agency authority to detain or refuse products from unregistered establishments. If any of these bills were to pass, FDA could suspend the registrations of facilities that violate regulations, effectively prohibiting them from marketing their products in the United States.
Additionally, S.1113 and H.R.6903 propose to require annual fees from cosmetics businesses averaging over $2 Million and $10 Million respectively in annual gross sales as part of the registration process. Fee amounts would be calculated based on a business’s annual gross sales.
Cosmetic Ingredient Statements
S.1113 and H.R.6903 would both require cosmetic facilities to submit a statement to FDA for each cosmetic intended to be marketed in the United States. The statement would contain, among other requirements, information on the facility manufacturing a cosmetic as well as the cosmetic’s ingredients and applicable warnings. FDA would require these statements to either be submitted annually under S.1113 or submitted when changes occur in information under H.R.6903.
Similar to registration, cosmetic ingredient statements would notify FDA which products a particular facility processes and would allow the Agency to prohibit a cosmetic from being marketed without a valid statement. S.1113 even includes specific provisions for suspending a cosmetic ingredient statement if the product has “a reasonable probability of causing serious adverse health consequences.”
Serious Adverse Event Reporting
The proposed bills would require cosmetics businesses to submit serious adverse event reports to FDA. The bills’ definitions for “serious adverse events” vary, but they are generally health-related events associated with the use of a cosmetic that result in or require medical intervention to prevent death or other serious injury.
Additionally, both S.1113 and S.2003 would require the label of a cosmetic product to bear contact information for an entity located in the U.S. to receive notification of adverse events from consumers. A product not containing this information would be considered misbranded, subjecting it to detention or refusal at the U.S. border.
Good Manufacturing Practices
The proposed bills would give FDA the authority to establish good manufacturing practices (GMPs) for cosmetics based on “current industry standards.” In other FDA-regulated industries, GMPs regulate production aspects such as sanitary conditions, hazard controls, and record-keeping. For cosmetics, GMPs would provide enforceable standards for FDA to reference during inspections. Violation of GMPs could result in regulatory actions such as Warning Letters, Import Alerts, and Import Refusals.
GMPs for cosmetics would be determined through FDA rulemaking. During rulemaking, FDA proposes a rule and allows industry and consumers to provide comment. Depending on the comments FDA receives, the Agency may issue an additional proposed rule for further comments, cease rulemaking, or issue a final rule.
A final rule contains compliance deadlines for industry, which are often determined by the size of businesses covered under the rule. It may take years for industry to see a rule’s full implementation as FDA prepares guidance and provides businesses time to process and comply with requirements.
The proposed bills would establish an annual review of cosmetic ingredients by FDA. FDA would analyze safety data surrounding certain cosmetic ingredients to determine whether they are safe for use without restriction, safe under certain conditions or uses, or not safe for use at all. FDA would then use these determinations to establish regulations that either permit or prohibit the use of certain ingredients in cosmetics.
H.R.6903 would even immediately prohibit 12 ingredients from being used in cosmetics, including coal tar dyes (commonly used in hair dyes), Styrene or Styrene acrylates (a film-forming agent), and cocamide diethanolamine (an emulsifying agent).
As more resources would be allocated to evaluating cosmetics’ safety, FDA may forbid or restrict the use of certain ingredients currently used in cosmetics. Businesses using these ingredients would need to reformulate their product to remain compliant.
As stated previously, none of these bills are near enactment, but the push for the above requirements is supported by congressional Democrats and Republicans, and the proposed regulations bear significant resemblance to existing requirements in other FDA-regulated industries.
Even if none of these bills become law, it is likely another that proposes similar measures may be enacted within the next several years. If this change is realized, industry will need to adapt and adjust to continue business in the United States.
Companies that need assistance with FDA requirements can contact Registrar Corp, a leading FDA compliance consultant. Registrar Corp’s Regulatory Specialists can review your labeling for compliance, register your cosmetics establishment with FDA, assist with reporting under the California Safe Cosmetics Act, and more.
This post was originally published in Personal Care Magazine.