On December 29, 2022, the President signed into law the “Modernization of Cosmetic Regulation Act of 2022″ that requires increased Food and Drug Administration (FDA) oversight of cosmetics and the ingredients in them. MoCRA, the new cosmetic regulation law, establishes a process that ensures the cosmetic manufacturers provide assurances that the cosmetic products are safe. The US regulations governing cosmetic products was last updated in 1938.
The law establishes obligations on the “responsible person” that is, the manufacturer, packer, or distributor of a cosmetic product and those whose name appears on the product’s label. Responsible persons include the brand distributing the product and their contract manufacturers.
MoCRA will establish new requirements for brands in the areas of Good Manufacturing Practices (GMP), Product Safety, Adverse Event Reporting, and product Labeling.
Good Manufacturing Practices: Protocols will be established by Health & Human Services (through the FDA) that all companies must follow by December 29, 2025. The purpose is to ensure that products are manufactured safely, are not adulterated and it allows the FDA to inspect manufacturing batch records to ensure compliance. Most contract manufacturers already follow some form of GMP.
Product Safety Substantiation: This is perhaps the most significant change for beauty brands. MoCRA requires that brands must maintain records that demonstrates adequate substantiation of the safety of their cosmetic products. Adequate substantiation means tests, studies, or other evidence to support a reasonable certainty that the product is safe. Further, the safety profiles of each individual ingredient are not sufficient to establish the safety of the product.
It is unclear if “tests, studies or other evidence” are going to be similar to the Product Safety Assessments conducted by professional, independent Safety Assessors as is required in the European Union. Or, it may require Human Repeat Insult Patch Tests (HRIPT) which are clinical studies on human volunteers in which the product is applied to the back of individuals under occlusion and assessed for irritation, allergy or other adverse reactions. Regardless, brands need to be prepared to conduct safety testing prior to the launch of new products.
Adverse Event Reporting: An Adverse Event is when a consumer using the brand’s products experiences a health-related event such as an allergic reaction or inflammation when using a cosmetic product. Serious Adverse Events are those that require medical intervention to address health issues that arise from use of the products. Brands will be required to report Adverse and Serious Adverse Events to the FDA within 15 days of notification by a consumer who was adversely affected by use of the product. Adverse event records must be maintained for a period of 6 years.
FDA Registration and Product Listing: This is similar to the EU model in which manufacturers must be registered with the FDA and must provide a listing of all cosmetic products it manufactures or processes including product category (or categories), list of ingredients (fragrances, flavors, or colors), and product listing number. At present, product registration with the FDA is on a voluntary basis. MoCRA now makes product registration mandatory. Unlike the EU, pre-market approval is not required by the FDA to actually market the product, but each product must be registered.
Product Labeling: The FDA enters the internet age! Each product shall have a label that includes the manufacturer or distributor’s domestic address and domestic phone number (currently a land line is required). Or, electronic contact information such as an e-mail address or website. So, instead of having to maintain a land line phone, your electronic contact information can instead be listed on your product label.
Fragrance Allergens: Individual allergens found in fragrances will be required to be disclosed on the product’s List Of Ingredients as is currently required in the EU.
Mandatory Recall & Records Review: The FDA has the authority to request to review the records and examine the product if there is reason to believe that a cosmetic product is adulterated or an ingredient could cause harm to consumers. This is primarily a review of the product’s ingredients and safety substantiation records for the subject product.
If the FDA determines there is a reasonable probability that a cosmetic product is adulterated or misbranded and the use or exposure will cause serious adverse health consequences, the FDA shall provide the cosmetic manufacturer an opportunity to voluntarily cease distribution and recall the product. If the company refuses or does not recall the cosmetic within the time and manner prescribed, the FDA may then order that the product not be distributed.
Small Business Exemption: Responsible Persons, Brand Owners and Operators of facilities whose gross annual sales in the United States of cosmetic products for the previous three-year period is less than $1,000,000 shall be considered small business and not subject to Good Manufacturing Practices, Registration, and Listing Requirements. But, no company is exempt from the Safety Substantiation.
All-in-all, these are good regulations and the US regulations on the manufacture and sale of cosmetic products are now more similar to the EU regulations, but still not as stringent as the EU.
Transparency In Product Labeling: The 1% Rule – The Missed Opportunity: The FDA Labeling Rule for cosmetic products is unchanged under MoCRA with the exception that Fragrance Allergens are now required to be included in the product’s List Of Ingredients.
The FDA requires that all ingredients included in a cosmetic product be listed in descending order of inclusion on a percent basis. However, all ingredients included at 1% or less may be listed in any order. From a consumer transparency perspective (and this is my personal opinion) consumers would be better informed if all ingredients were required to be listed in descending order of inclusion, period. Let me show you how the 1% Rule can be used to present alternate versions of the List Of Ingredients of a cosmetic product:
Let’s take a look at a List Of Ingredients for a Hyaluronic Acid Brightening Serum with the ingredients listed in descending order in the percentages actually incorporated in the formula.
Water (79.68%), Niacinamide (10%), Pentylene Glycol (3%), Glycine Betaine (Beta Vulgaris) Beet Sugar Extract (2%), Saccharide Isomerate (2%), Zinc PCA (1%), Gluconolactone (0.7%), Phenoxyethanol (0.6%), Sodium Hyaluronate (0.5%), Sodium Benzoate (0.3%), Ethylhexylglycerin (0.1%), Glycyrrhiza Glabra (Licorice) Root Extract (0.1%), Centella Asiatica (Gotu Kola) Extract (0.01%), Camellia Sinensis (Green Tea) Extract (0.01%)
Using the 1% Rule, all ingredients that follow Zinc PCA (and Including Zinc PCA), can be listed in any order. So, it is perfectly legal to present the List Of Ingredients as follows by listing the Sodium Hyaluronate (Hyaluronic Acid) and Plant Extracts immediately after Zinc PCA and moving the preservative ingredients to the end of the List Of Ingredients as follows:
Water, Niacinamide, Pentylene Glycol, Glycine Betaine (Beta Vulgaris) Beet Sugar Extract, Saccharide Isomerate, Zinc PCA, Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Root Extract, Centella Asiatica (Gotu Kola) Extract, Camellia Sinensis (Green Tea) Extract, Gluconolactone, Phenoxyethanol, Sodium Benzoate, Ethylhexylglycerin
This is a much more attractive List Of Ingredients from a consumer’s perspective and the marketing for the product can highlight the skin brightening and antioxidant benefits of the plant extracts when the product actually contains miniscule amounts of these ingredients.
Obviously, the use of the 1% Rule in the presentation of the List Of Ingredients is at the discretion of the product manufacturer and is a reflection of how transparent the brand is to its consumers. And, there are many companies that list all ingredients in descending order of inclusion regardless of the 1% Rule. But, I hope you can appreciate my opinion on why the 1% Rule should have been eliminated in MoCRA.