From Bathroom Shelf to FDA Oversight: What MoCRA Means for Cosmetics Companies

Take a look at a typical bathroom counter. The products are familiar: cleanser, moisturizer, shampoo, deodorant, makeup, and fragrance. Most consumers use several cosmetic products every day, often without giving much thought to how those products are regulated.

For decades, there was relatively little change to the federal framework governing cosmetics. While the cosmetics industry evolved into a global marketplace with increasingly complex products and supply chains, FDA's oversight tools remained largely unchanged. The Modernization of Cosmetics Regulation Act of 2022 (PDF p. 1389; 136 Stat. 5847) commonly known as MoCRA, changed that. The law represents the most significant expansion of FDA's authority over cosmetics since 1938 and gives the agency greater visibility into products sold in the United States and more tools to respond when safety concerns arise. FDA’s update to its MoCRA webpage provides a timely opportunity to revisit what the law means for cosmetics companies as they operate under its core requirements and prepare for additional requirements that FDA is still developing, including good manufacturing practice regulations. 

Why MoCRA Was Needed

Cosmetic companies have long been responsible for ensuring the safety of their products. Historically, however, FDA had limited visibility into the cosmetics marketplace. Companies generally were not required to register manufacturing facilities, list cosmetic products, or report serious adverse events in the same manner expected of many other FDA-regulated industries.

MoCRA addresses those information gaps. Its requirements help FDA identify who is making cosmetic products, what products are being marketed, and whether consumers are experiencing serious health problems associated with their use.

FDA Now Sees More of the Marketplace

Facilities that manufacture or process cosmetics generally must register with FDA and renew their registrations every two years. Companies must also submit product listings identifying marketed cosmetic products and their ingredients. Together, these requirements provide FDA with a clearer picture of where products are manufactured, what products are being sold, and what ingredients are being used in those products.

These requirements make accurate product and supply-chain records more important. Product inventories, ingredient information, manufacturing locations, contract manufacturers, and product listings should reflect current operations.

FDA has issued guidance and established systems for facility registration and product listing, and companies are now submitting product and ingredient information through those systems.

Companies Must Be Able to Support Product Safety

Knowing what products are on the market is only part of the picture. MoCRA also requires companies whose names appear on cosmetic product labels to maintain evidence supporting the safety of their products. Depending on the product, that evidence may include testing, safety assessments, scientific literature, toxicological information, and other relevant data.

MoCRA also reaches the information consumers see on product labels. Companies must provide domestic contact information through which consumers can report adverse events. This helps ensure that safety information reaches the company after a product enters the market and can be evaluated when concerns arise.

A company should be able to explain why the available evidence supports the safety of each finished product under its intended conditions of use. Safety documentation should be revisited when a formula, supplier, manufacturing process, or intended use changes.

MoCRA also directs FDA to establish good manufacturing practice requirements for cosmetic facilities. These practices are the controls companies use to help ensure products are produced consistently and are not contaminated, mislabeled, or otherwise compromised during manufacturing. FDA has not yet finalized these regulations, but companies should begin reviewing their quality systems and clarifying responsibilities among brand owners, manufacturers, and suppliers.

FDA Has New Tools to Respond to Safety Concerns

MoCRA requires companies to report serious adverse events associated with cosmetic products to FDA within 15 business days. These may include hospitalization, a life-threatening experience, significant disability, infection, or significant disfigurement, such as serious and persistent rashes, significant hair loss, or lasting changes in appearance.

Consumer complaints therefore cannot be treated only as customer-service matters. Reports received through call centers, websites, retailers, social media, or healthcare providers may need regulatory review and prompt escalation.

MoCRA also authorizes FDA to access certain product and safety records when the agency has a reasonable belief that a cosmetic product, or an ingredient in it, presents a threat of serious adverse health consequences or death. If FDA requests records, the company must make them available within the time specified by the agency, which may require production within 24 hours. FDA may also order a recall when a cosmetic is likely to cause serious adverse health consequences or death and the company does not voluntarily remove it from the market. The agency may suspend a facility's registration when a product made there presents that level of risk and the underlying problem may affect other products from the facility.

Three Questions Every Cosmetics Company Should Be Asking

MoCRA's requirements extend across product development, manufacturing, and post-market monitoring. As companies assess their readiness, three practical questions are worth asking.

Do we have a complete picture of the products we are marketing?

Confirm that product inventories, ingredient information, manufacturing locations, contract manufacturing arrangements, and product listing information accurately reflect current operations.

Could we explain the basis for our safety conclusions if FDA asked tomorrow?

Identify the testing, scientific literature, safety assessments, and other evidence supporting each finished product. Keep those records organized so they can be located and produced within FDA's specified timeframe, which may be as short as 24 hours.

Are we prepared to identify and respond to a safety issue quickly?

Make sure complaints are routed for appropriate review, employees know when escalation is required, investigation responsibilities are clear, and affected products can be traced through the supply chain.

Companies that begin strengthening their product information, safety documentation, and response systems now will be better positioned as FDA continues implementing MoCRA and refining its oversight of the cosmetics marketplace.