While MoCRA provides a small company exemption from FDA Product Registration, all companies regardless of size, must maintain on file a Safety Substantiation Dossier documenting that their products are safe for human use. This is the most significant new requirement in MoCRA affecting Indie Beauty Brands.

Here’s the language from the FDA MoCRA Draft Guidance For Industry

“Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.”

“A Responsible Person (ie: the Brand) is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers (Brands) can use relevant safety data that is already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product. It’s important, however, that all data used to support the safety are derived from scientifically robust methods.”

The FDA is somewhat vague in its requirements to establish Safety Substantiation, but clearly states that neither MoCRA nor the FDA require specific tests to establish Safety Substantiation.

So, what exactly is Safety Substantiation?

Here’s some guidance for Indie Beauty Brands:

(1). Preservative Challenge Testing: Conduct either static Preservative Challenge Tests or In-Use PCT on all of your products

(2). Conduct 48 Hour Patch Testing or HRIPT (Human Repeat Insult Patch Test) on all of your products. If you want to distribute through third-party online channels such as Amazon, you will need to conduct HRIPT

(3). Commission an Ingredient Toxicology Safety Assessment Report on the ingredients in each product. If you plan on selling in the EU you will need to commission an EU Safety Assessment compiled by a qualified EU Safety Assessor.

With these records in hand, you will be able to provide a Safety Substantiation Dossier should the FDA request to see your records.

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.

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.