RUŌOD Lab

Level 10 · Safety, IFRA, Regulatory Compliance and Quality

United States, MoCRA: Study Guide

Read our MoCRA guide, then decide which duties apply to a small US fragrance brand and which exemptions truly fit, using FDA's own page as your source.

Professional 15 min study By the RUŌOD Lab team Updated

In short

The US Modernization of Cosmetics Regulation Act of 2022 (MoCRA) gives FDA new powers and sets duties for facility registration, product listing, safety substantiation, adverse event reporting and record keeping, with limited exemptions for small businesses. At the time of our last check, FDA's rules on fragrance allergen labeling and GMP had not been finalized, so follow FDA's page. The guide lays out the duties. This exercise has you apply them to one brand.

What you will learn

  • List the main MoCRA duties for a fragrance brand
  • Test whether a small-business exemption applies

Before this lesson: Perfume Regulations by Market: Study Guide

What to look for as you read

  • Who the "responsible person" is, and what that person has to do.
  • What the 15-business-day report covers, and what counts as serious.
  • Which exemptions exist, and which products fall outside them.

Practical exercise: MoCRA duties for one brand

About 30 minutes · You will have: a duties table for one brand, with sources and open questions

  1. Describe an imagined small US fragrance brand: who makes it, who sells it, how much it sells.
  2. List each MoCRA duty, marking who holds it and whether an exemption applies, citing FDA's wording.
  3. Draft what you would keep on file as safety substantiation, with what you do not know flagged.
  4. Write a three-step plan for receiving an adverse event complaint.

You have done this well if each exemption you claim quotes its source, and you have stated what you would ask a US regulatory advisor. This is an exercise, not legal advice.

Knowledge check

1. Within what period must a serious adverse event be reported under MoCRA?
Show the answer

15 business days. FDA's MoCRA page states 15 business days. Check it for current details.

2. What must a responsible person have under MoCRA?
Show the answer

Adequate safety substantiation for the product. Safety substantiation is a central duty.

3. Does the small-business exemption remove every duty?
Show the answer

No, it is limited and has exceptions. Read FDA's wording on exemptions and their exceptions.

Sources

Further reading and materials

Written and reviewed by the RUŌOD Lab team. This is general education, not legal, regulatory, medical or safety advice. Example dilutions and exercises are for learning, are not validated products, and have not been safety-assessed. Completing a lesson confers no qualification. How we check these lessons.