Signed on December 29, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) has provided the first revision to cosmetic laws since 1938. The new rules will affect all US cosmetic manufacturing, packing, and distribution facilities. These laws are set to take effect by December 2023.
The Act defines a cosmetic product as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a final product.” The MoCRA will expand the US Food and Drug Administration’s (FDA) authority over cosmetic products and related businesses.
So, what exactly does this new law require from manufacturers?
Provisions made by The Act
- Reporting of serious adverse events
- Participating in “Good Manufacturing Practices” for all cosmetic manufacturing facilities
- Listing products and ingredients used in every formula
- Keeping records that show the safety substantiation for products and ingredients
- Labelling of fragrance allergens and ingredients on all products
- Awarding the FDA power to recall adulterated or misbranded products
- Exempting small businesses from certain practices
- Stopping states preemptively from passing more stringent laws
- Requiring tests and assessments administered by the FDA for harmful chemicals
Serious adverse events
A “serious adverse event” can cause “serious and persistent rashes, second or third-degree burns, significant hair loss, or significant alteration of appearance, other than as intended, under conditions of use that are customary or usual.” Personnel responsible will be required to document and hold any complaints of adverse events, no matter how minuscule, for six years.
Good manufacturing practices
Good manufacturing practices (GMP) help keep processes, products, and formulas consistent throughout a manufacturing facility. The FDA will issue these practices within two years, and a final rule will be made no later than three years. These rulings will likely include keeping clean workspaces, documenting important information, and adequately labeling. If products are not manufactured under conditions that meet the FDA’s requirements, they will be considered adulterated and are subject to recall.
Product listings will include fragrances, flavors, colors, and the facility registration number of the manufacturing plant, along with other requirements. For products already on the market, a list will be required within one year of the enactment date, and responsible personnel will be required to update the product listing annually. Products with similar formulas will be included on the same list with differentiators, like color, flavor, or fragrances listed respectively.
This provision allows the FDA to request records related to a product’s safety substantiation and ingredients. Records are referred to as “tests or studies, research, analyses, or other evidence and information that is considered by qualified experts to evaluate the safety of cosmetic products and ingredients sufficient to support a ‘reasonable certainty of product safety.” While it is not explicit who is considered an expert or what is considered “reasonable certainty,” these guidelines are still better than the precedent.
Two years after the bill is enacted, all products will be required to update labeling based on these new requirements. Labels must include a domestic address, phone number, or electronic contact information of the person responsible for reports on adverse events, identification of any “fragrance allergens,” and clear indication if the product is to be used by licensed professionals only.
The FDA now has the approval to recall cosmetic products based on three criteria; the Agency has a “reasonable probability” that the product is misbranded or adulterated; the FDA determines that the use of or exposure to a product will cause “serious adverse health consequences or death”; the responsible person refuses to voluntarily recall the product upon request. Once the FDA announces the recall, the FDA will have ten days to provide evidence to the persons responsible for continuing with the recall.
Small business exemption
A small business will be defined as one whose gross annual sales for the past three years equates to less than $1 million; who does not manufacture or process cosmetics that will come in contact with the mucus membrane of the eye, are for injection, are intended for internal use, or alter appearances for more than 24 hours. These small businesses may hold adverse events records for only three years. They are also exempt from GMP requirements, facility registrations, and product listing expectations.
This clause relates to registrations, product listings, GMPs, records, recalls, and adverse events reporting. In plain terms, this clause prevents any state from creating laws stricter than those placed by the MoCRA. It does not, however, prevent states from banning certain ingredients, or specific amounts of an element, from being used within cosmetic products.
Within one year, the FDA will be required to provide standardized testing for talc and asbestos within products. Within three years, the FDA will assess the use of PFAS chemicals in cosmetics. Businesses will then be required to publish reports summarizing the results of these assessments. Congress also suggests within The Act that animal testing does not satisfy safety testing and should be phased out.
What does this change mean?
This act will bring better visibility into ingredients and safety on the consumer side. In the 30 years before this act was updated, cosmetic manufacturing brands were not required to report adverse effects, even if every user complained about it. The previous clauses provided a loophole for cosmetic brands to label products “for professional use only,” which allowed them to skip providing an ingredient list for the product. These upgraded regulations will provide cosmetic safety across the board on all types of products. While it will be an adjustment, it is crucial to equip your facility now with the tools needed to capture and keep all these new documents in place.