MoCRA regulations: What Asia’s beauty firms need to know about US’s landmark law

The passing of MoCRA has left cosmetic companies in Asia wondering about the changes, some of which are set to be enforced by the end of 2023.

Mike Sohn, CEO of Reach24H, said MoCRA was likely to impede the US-bound ambitions of some Asian cosmetic companies.

“The beauty industry is very fast paced; it’s about fashion and trends. Once you have this regulatory hurdle, a new one that has never been implemented before, it’s definitely going to slow down market penetration and entry,” ​he told CosmeticsDesign-Asia.​

He highlighted the MoCRA’s mandatory facility registration, which would require US and foreign facilities that manufacture or process cosmetic products for US distribution must register with the Food and Drug Administration (FDA).

Under this requirement, facilities must declare the brands and products they manufacture.  Furthermore, this mandatory registration must be renewed once every two years.

Sohn highlighted that this is separate from Good Manufacturing Practices (GMP) guidelines, which have yet to be confirmed.

However, he anticipated it would add an additional layer of complexity to the proceedings.

While this may not be a problem for major manufacturers, smaller manufacturers could face challenges, said Sohn.

“In the past, the US regulations were very different from other countries. With VCRP, in meant that it was not mandatory to notify your products within the US. So, it’s a huge change especially coming from something that was voluntary.”​

The Voluntary Cosmetic Registration Program (VCRP) non-mandatory registration system for cosmetic products. The system was decommissioned early in March in preparation of MoCRA.

With MoCRA, each product will have to be registered separately. Sohn said this would be a bigger burden for brands with a wide range of product offerings.

Facilities and product registration are two of the provisions scheduled to come into effect by the end of the year.

In addition, the new regulations have stated that companies must appoint a responsible person who can be the manufacturer, packer, or distributor of a cosmetic product.

Landmark law: MoCRA background

Enacted in December 2022, MoCRA is a significant overhaul of the Food and Drug Administration’s regulatory framework for cosmetics.

The landmark regulation amends Chapter VI of the Federal Food, Drug, and Cosmetic Act (FDCA) and represents the first update to US cosmetics law since 1938.

This comes after years of industry lobbying for increased regulation at a national level.

Sohn highlighted that MoCRA seems to be following a trend of stricter regulations in the beauty and personal care industry.

“China, for instance, has built higher hurdles regulation-wise. With MoCRA, the US is aligning with this regulatory level.”​