On October 25th, 2017 during the 115th US Congress Meeting, Senator Orrin Hatch (Representative of Utah) introduced to the US Senate the “FDA Cosmetic Safety and Modernization Act”. The declared intention of the bill is to modernize the regulations of cosmetics in the United States and would amend the US Federal Food, Drug and Cosmetics Act (“FD&C Act”) of 1938.

The “FDA Cosmetic Safety and Modernization Act” (henceforth referred to as the “Hatch Bill” based on the originating senator) [S.2003] introduces many processes to ensure regulation of cosmetic ingredients, monitoring of adverse events related to cosmetics and establishment of Good Manufacturing Practices (GMPs) in relation to cosmetics. To expand further, the FDA would be required to identify cosmetic ingredients to be reviewed for safety in consultation with industry and consumer groups (Section 605) and accredit third-party organizations to review their safety (Section 607). In the case of “serious adverse events” associated with cosmetics, the cosmetic manufacturers/distributors would have to report the occurrence to the FDA within 15 days of receipt (Section 764). With this bill, the FDA intends to establish GMP regulations for cosmetics (Section 605) and require all domestic and foreign facilities of the manufacturer/distributor seen on the US-marketed label to register with FDA every two years.

The Hatch Bill is not the only bill relating to cosmetics that has been brought before Congress in recent years. The “Personal Care Products Safety Act” was introduced on April 20th, 2015 and last discussed by the US Senate on September 22nd, 2016 by Senator Dianne Feinstein of California and Senator Susan Collins of Maine during the 114th US Congress Meeting. Like the Hatch Bill, the “Personal Care Products Safety Act” (henceforth referred to as the “Feinstein-Collins Bill” based on the two originating senators) [S.1014] expands the jurisdiction of the FDA to oversee cosmetics and personal care products including facility registrations, ability to suspend registration and requirements to report serious adverse events. The differences lay in the funding model (the Hatch Bill relies on funding from the US government while the Feinstein-Collins Bill would collect fees from the Cosmetic/Personal Care products industry) and the responsible acting party enforcing the bill and their timelines (the Hatch Bill permits third party organizations to determine chemical safety, while the Feinstein-Collins Bill requires the FDA to review the chemical safety of ingredients with a minimum of five per year).

Currently, both the Hatch Bill and Feinstein-Collins Bill have been read at Congress and referred to the Committee on Health, Education, Labor, and Pensions by the Senate. Before either bill can become US law, they must pass the Senate, then through the House of Representatives, and then be approved by the President. Time will tell which of these bills will be the one chosen to amend the FD&C Act in relations to cosmetics.

dicentra is well-versed in the provisions of the current FD&C Act, and the Fair Packaging and Labeling Act (FP&L Act) that cosmetics in the US must be in compliance with. dicentra can determine if your product is appropriate as a cosmetic in the US and can advise on product claims, warning declarations, advertising strategies, and compliant labeling. Concerning cosmetic ingredients, dicentra can review evidence to establish the ingredient safety and can prepare the FDA Cosmetic Product Ingredient Statements (CPIS) Form 2512 Filing. At present, there is a Cosmetic Registration Program (currently voluntary) that dicentra can assist in registering your product. We can be reached at 1-866-647-3279 or at info@dicentra.com.