What To Expect from MoCRA

Tariffs, trade wars and international tensions make headlines. But what to make of MoCRA? The Modernization of Cosmetics Regulation Act was in the news for years. Now, it appears to be on the backburner in Washington, DC. But, out of sight doesn’t equate to out of mind, at least not at the Personal Care Products Council. During a Cosmo Talk at Cosmoprof North America, PCPC’s Jonathan Hicks provided a MoCRA update.

As senior director, international trade and regulatory affairs, Hicks monitors, evaluates and acts on a range of issues, including MoCRA. Prior to joining PCPC, he spent 10 years at FDA in policy analysis. That experience makes him uniquely aware of what MoCRA means for the Agency and the industry.

Background on MoCRA

The Food Drug & Cosmetic Act of 1938 gave the US Food and Drug Administration oversight of the cosmetics industry. The FD&C Act went into effect due to a public health crisis in 1937 involving the drug Elixir Sulfanilamide, which contained a toxic solvent and caused over 100 deaths, many of them children. Around the same time, Lash Lure, an eyelash and eyebrow dye, caused blindness in several cases and even death in some instances.

The FD&C Act set standards for the safety and effectiveness of products including food, drugs, medical devices and cosmetics. The law did not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market.

PCPC and allied trade organizations worked for more than a decade to enhance the US Food and Drug Administration’s oversight of cosmetics. Nearly three years ago, President Joe Biden signed into law the Consolidated Appropriations Act 2023, which includes the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. The legislation gave FDA additional tools to ensure the safety of cosmetics and to protect public health. MoCRA brought the FDA’s oversight of the beauty and personal care sector more in line with other categories the Agency regulates and contributes to global regulatory alignment.

But a new Administration in Washington, DC paused some elements of MoCRA implementation. In 2025, President Donald J. Trump issued a regulatory freeze pending review. That freeze impacts several aspects of MoCRA.

“FDA is late for proposing rules on fragrance allergens and good manufacturing practices,” explained Hicks.

The freeze impacts new or pending rules until they undergo further review by new agency leadership. As a result, several important MoCRA regulations are delayed, including:
• Fragrance Allergen Labeling – A rule that would require disclosure of certain fragrance allergens in cosmetic products.
• Talc-Containing Cosmetic Testing – The FDA’s new standardized testing methods for detecting asbestos contamination in talc-based products.
• Good Manufacturing Practices (GMP) for Cosmetics – The FDA was developing formal GMP regulations to ensure the safety and consistency of cosmetic production.

Besides the regulatory freeze, President Trump implemented a hiring freeze for federal civilian employees. As a result:

• Open positions at the FDA cannot be filled.
• No new positions can be created unless an exemption is granted.
• The Office of Management and Budget (OMB) must develop a workforce reduction plan.

This hiring freeze is particularly concerning for the cosmetic industry, as the FDA has already cited limited manpower as a reason for past delays in MoCRA implementation. A smaller workforce could further slow regulatory reviews and enforcement actions, according to industry observers.

While portions of MoCRA may be in limbo, others are already in force. For example, FDA recently clarified that some samples can be distributed at trade shows.

Cosmetic or Drug?

When it comes to enforcement, FDA historically has reviewed product claims.

“What catches a lot of companies is borderline claims that are actually drug claims,” said Hicks. “It all starts with a Warning Letter to the to the company being scrutinized.”

According to the FDA, cosmetics are articles (other than soap) intended for cleansing, beautifying, promoting attractiveness and altering appearance. In contrast, drugs are articles intended to diagnose, cure, mitigate, treat or prevent disease. Articles that have elements of both include sunscreen, antimicrobial cleanser, antidandruff shampoo, anticaries and antiperspirants. Drug requirements are applicable in these cases, noted Hicks.

Color Additives

“Color additives are in the news,” Hicks told attendees. “You can’t use colors in the eye area unless they have been approved.”

Under the Delaney Law, FDA has the power to delist colors, too. But Hicks noted there hasn’t been any effort to do so.

Unlike other cosmetic ingredients, color additives must be pre-approved by FDA for each intended use. In addition, certain color additives must be batch “certified” by FDA. Only certified colors may be labeled with (optional) prefix “FD&C” or “D&C.” Exemption for coal tar-derived colors in hair days with directions for preliminary testing; e.g., patch tests and a caution statement. The Delaney clause prohibits any color that “is found by the Secretary to induce cancer in man or animal.”

MoCRA Definitions

Hicks provided insights on several MoCRA definitions. For example, a Responsible Person is a “manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with” FD&C or FPLA. It includes international brand owners, but it cannot be a consultant. It could be an individual, partnership, corporation or association.

Cosmetic Product. “Preparation of cosmetic ingredients with a quantitatively and quantitively set composition for use in a finished product.” It includes final formulation of cosmetic ingredients, with a single ingredient, not yet packaged.

As of July 2, 2025, the number of unique, active facility registrations registered under MoCRA was 12,049. The number of unique, active product listings was 784,270.