Cosmetic Regulation Update

On May 17, 2022, the Senate HELP (Health, Education, Labor, and Pensions) Committee introduced a draft bill which includes the Modernization of Cosmetic Regulation Act of 2022. The draft bill mainly addresses FDA user fees which must be renewed this year. However, it also has additional FDA reforms for cosmetics, dietary supplements, in-vitro clinical tests, and some other areas of FDA responsibility.

[Update June 16, 2022] On May 26th Senate Bill 4348, the Food and Drug Administration Safety and Landmark Advancements Act of 2022. It appears to be nearly identical to the draft bill. It includes the Modernization of Cosmetic Regulation Act of 2022 AND the exemption provisions for small business noted below.

In the House, H.R. 7667, the “Food and Drug Amendments of 2022” was introduced in early May. It also addresses FDA user fees but does not contain any amendments to the current cosmetic laws.

[Update June 16, 2022] Meanwhile, on June 8th, H.R. 7667 passed the house and was received in the Senate the next day.

What happens next?

The FDA user fees must be renewed this year – by September, I think. Since they are the source of funding for much of the FDA activities, one way or another, there will be legislation passed which covers that.

The Senate bill hasn’t yet been introduced–it’s still in draft mode. Several groups have voiced opposition to some aspects of it (not cosmetics, as far as I have found). I expect there is plenty of discusssion going on to finalize the official bill and get it introduced.

Once both the House and Senate bills are passed (with any revisions), they are “reconciled” into a final bill that must be passed by the both the House and Senate. When that’s done, the bill goes to the President to be signed.

Changes to Cosmetic Laws & Regulations

As noted, some version of the bill will be passed because the FDA user fees must be passed. Whether the sections affecting cosmetics actually make it all the way through remains to be seen–but there’s a pretty good chance they will.

The good news is that small businesses making less than $1 million per year are exempt from the most difficult requirements.

The Senate HELP Committee draft proposes the following changes to cosmetic laws:

1. Adverse Event Reporting

The responsible person (that is, the person or business listed on the label) would be required (that’s new) to submit a report to the FDA for any serious adverse event concering a cosmetic product.

2. Good Manufacturing Practices

The FDA is directed to create Good Manufacturing Practices regulations (that’s new) for making cosmetics. They would have two years to get the regulations finalized. The bill specifically mandates making sure there are provisions for small manufacturers in the GMP regulations. Small businesses would be exempt..

3. Facility Registration

All cosmetic manufacturers would be required to register (that’s new) with the FDA. Small businesses would be exempt.

4. Product Registration

All cosmetic products would be required to be registered (that’s new) with the FDA. Where a line of products only differs because of fragrance, color, or quantity of ingredients it would only need to be registered once. Small businesses would be exempt.

5. Product/Ingredient Safety Substantiation

The safety of a cosmetic product would need adequate substantiation in the form of tests, studies, research, or other evidence. “Safe” is defined as meaning the cosmetic product, including the ingredients thereof, is not injurious to the user under customary and normal use. “Adequate substantiation” is not defined specifically, but it’s likely that documentation of ingredient safety would be sufficient.

6. Labeling

Labels would need a domestic address, phone number, or electronic contact information (that’s new) through which the responsible person could receive an adverse event report. It apparently means that if the street address is omitted, a phone number or email address would need to be included–but we’ll have to wait and see what the regulations say when they are issued (if this is included in the final bill).

7. Fragrance Allergens

Fragrance allergens would need to be identified on the label (probably in the ingredient declaration). The FDA would have one year to identify what fragrance allergens must be listed and issue proposed regulations. They are supposed to consider international, state, local, and European Union requirements for fragrance allergens when they make their proposed rule.

8. Records Inspections

The FDA would have the authority to access and copy certain records related to cosmetic products during an inspection or on request. Currently the FDA can ASK to see records, but can’t REQUIRE them to be made available.

9. Mandatory Recall

The FDA would have the authority to order (that’s new) a recall of cosmetic products if FDA determines there is a reasonable probability that the product could cause serious adverse health consequences. Currently the FDA can REQUEST that a company voluntarily recall a product, but they can’t REQUIRE a recall.

10. Preemption (Good news!)

The draft bill calls for preemption, which means that the final law would take precedence over any state laws. In fact, it says that no state may establish or continue in effect any law, regulation, or other requirement for cosmetics that is different from or in addition to, or otherwise not identical to these provisions. It looks like that would mean that states that require facility or product registration, or GMP, would have to change their laws. We’ll see if that makes it way forward–it would be great for people in states like Florida where there are existing regulations in place!

Moving Forward

Over the next several weeks the Senate bill will likely be introduced. In the coming months, there will likely be revisions, updates, concessions, and modifications as the House and Senate bills come together. I expect that the Handcrafted Soap and Cosmetic Guild’s legislative team will be watching closely and working with their contacts on the hill to make sure small business is protected.

I’ll keep you posted!

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6 responses to “Cosmetic Regulation Update”

  1. If there is any room to negotiate through HSCG, consider increasing the definition of “small business” from $ 1 Million to $2 Million. If we are exporting to various countries and selling in the USA, $ 1 Million revenue is too small. After excluding expenses (8% inflation and cost in transportation and materials), not much profit is left for people with revenue under $2 Million. In such situation, having to bear the cost of added regulations is neck breaking

    • You’d have to contact the HSCG for sure, but I think that the $1 million was an acceptable compromise (the HSCG wanted more; others wanted less). It was a huge success to get the exemption in at $1 million.

  2. I purchased your book ‘soap and cosmetic labeling’. I am an active student to become a certified aromatherapist though Aromahead. Your book was suggested, so I purchased it. I have a question the aromatherapy blends that I will be making for sale in the future are they considered ‘cosmetic? Thank you.

    • Aromatherapy products which are sold retail are generally cosmetics since they are applied to the human body. As such, they can improve or alter appearance, beautif,y or cleanse. If they are intended to alter the function or structure of the body or to treat, cure, mitigate or prevent disease, they would be unapproved new drugs.

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