On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has provided screenshots of the draft electronic system, draft Form FDA 5066 — Registration of Cosmetic Product Facility, and draft Form FDA 5067 — Cosmetic Product Listing — for review and comment. Comments on FDA’s proposed collection of information are due October 18, 2023. 88 Fed. Reg. 63960.

Background

As reported in our August 11, 2023, memorandum on the draft guidance for industry on the registration and listing of cosmetic product facilities and products under MoCRA, MoCRA is the first major amendment to FDA’s cosmetics authorities since President Franklin Delano Roosevelt signed the Federal Food, Drug, and Cosmetic Act (FFDCA) into law in 1938. Enacted on December 29, 2022, MoCRA seeks to ensure that cosmetic products are safe for their intended uses and provides FDA more enforcement authority. This authority includes mandatory recall if it determines there is a reasonable probability that a cosmetic is adulterated or misbranded, as this would result in a serious adverse event. MoCRA also introduces mandatory facility and product registration, a process that has, until now, been entirely voluntary.

Cosmetics Direct

Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. According to FDA, this will help respondents organize their registrations and listing submissions to include the information needed for FDA and will give respondents access to their previous Cosmetic Direct registrations and listing submissions.

FDA states that it “strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.” Respondents that prefer to submit paper registrations and listings will still have the option to do so, however.

Forms 5066 and 5067

Forms 5066 and 5067 include the following definitions:

• Manufacturing or processing of a cosmetic product — Means engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.

• Operator — Means a person, as defined in FFDCA Section 201(e), who has management authority over an establishment.

• Owner — Means a person, as defined in FFDCA Section 201(e), who has an ownership interest in an establishment.

• Responsible person — As defined in FFDCA Section 604(4), means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with FFDCA Section 609(a) or Section 4(a) of the Fair Packaging and Labeling Act.

• Small businesses — As defined in FFDCA Section 612, means responsible persons, and owners and operators of facilities, whose average gross annual sales in the United States of cosmetic products for the previous three-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of certain cosmetic products described in FFDCA Section 612(b). A small business is exempt from the registration and listing requirements.

Commentary

MoCRA mandates that the facility registration and cosmetic product listing occur no later than one year after enactment, or by December 29, 2023. The deadline for the submission of comments on the draft guidance and content of each form proposed is October 18, 2023. If FDA is to meet these ambitious deadlines, FDA will need to act quickly after the close of the comment period for these draft documents. Procedurally, it is difficult to envision how FDA will accomplish these tasks timely and how this rush to judgment ensures cosmetic stewardship, a key driver of MoCRA. Once facilities complete the Form 5066 for registration, the biennial renewal is triggered and the submitter tacitly agrees to report changes. This means the impact of this submission does not end with the original registration. Rather, it initiates ongoing commitments the submitter must satisfy.

Beyond facility registration, the requirements to complete the cosmetic product listing (Form 5067) are also included in the request for comments. The cosmetic product listing requires a substantial amount of detail on the finished cosmetic product. As the form notes, the submitter, by signing, agrees to report changes that include ingredient modifications and label changes. Both forms also include definitions that cosmetic product and ingredient manufacturers may wish to review carefully and on which to comment to ensure the final documents get it right.