MoCRA is not a crisis for personal care companies

Don’t Panic!

Update May 23rd, 2024: The FDA is fast now. If you send your info to get an FEI number to feiportal@fda.hhs.gov it is down to a day or two (don’t ask me about last year). And about when I wrote this in March the agency released official FDA instructions for the process online and it seems to be working pretty well as of late April. So the rest of this blog article may be gently obsolete. The snark isn’t obsolete. YMMV.

This post is an attempt to dispel FUD and is not legal or compliance advice, and glosses over a lot of fine points. Given some of the overheated discussions we are seeing online, we want to share some advice (and some snark). And seriously, some of the big name consultancies are cleaning up by feeding MoCRA panic, it's shameful. We hope we can help.

The FDA rules for Cosmetics (and Personal Care Products) are really, no we actually mean it this time, kicking in at the end of June this year (2024). Call it MoCRA, take two aspirin with a big glass of water, and let us dive in. The aspirin should kick in when it is needed (in about a page if you are doing the homework assignments as you go).

Step one: Don't Panic! This is an overdue regulatory step (our unpopular opinion) that will help companies get harmonized with global norms AND clarify for consumers that the products you sell them are safe. We believe that the MoCRA regs are a Good Thing for honest companies.

Seriously, have you seen some of the stuff being sold on Amazon these days? Can your company really compete with mystery materials with bogus claims undercutting your pricing for your quality product at fair prices? Have you looked at TikTok Market? So here we are, let’s leverage the shiny new rules for good purposes.

Advice: The FDA has very helpfully set up a portal so you can do all of your work with them online using "structured product labeling" which we strongly advise against. You can still file using the old fashioned method of ink on thin slices of dead tree delivered by a real human to the FDA in an envelope, and have the comfort of a copy in your file (along with proof of delivery). In a couple of years we are sure the portal will be friendlier and less likely to time out or dump out, but for now, keep your life simple.

Step two: Here are the Big Questions:

1.     Do you own a brand or a branded product?

2.     Whose contact information is on the label? There is contact info on the label, yes/no?

3.     Do you formulate or fill product(s) on contract?

4.     Is your annual revenue (total sales) in the last three years LESS than a million USD each year? If so, please have a delightfully simple life until you cross that hurdle, you are excused from class.

Step three: So, you need to register your facility (FDA Establishment Number application) which is Form 5066… unless the only thing you do is R&D, or third party logistics, or just sales. Here's a link if you think you might not need to file but it isn't completely spot on for brand owners who have outsourced their production or for some common edge cases with licensing and sub-licensing.

Contractors & formulators: When you look at form 5066 you'll see that you have to list the brand names of products you produce, and provide the name of the Responsible Person - look at those labels, you are almost certainly not the Responsible Person, that's the brand on the printed label. You'll also notice that they only provide three lines to provide info, and we are still waiting to learn if we can simply attach a complete list or if the FDA is forcing us to use the portal or buy expensive software. Isn't 2024 wonderful so far?

YMMV.

Okay, so you own a brand OR your contact information is on a label, congratulations you are a Responsible Person and to be responsible you need to prep the next steps while you are waiting for your FEI Number. You did complete Step three, yes/no?

Step four: The Product List (Form 5067). This can also be done using the aforementioned portal. This process is a delight (not), but let's break it into simple unpalatable bite-sized pieces while we sing along to "A spoon full of sugar." Remember, we are doing this old school, on paper, not the online portal.

How many products are you responsible for as a Responsible Person? One of the brands we advise has just under 30 SKUs made by several different contractors, so that is their product count. The form holds not more than space for THREE. Again, they want you to use that portal, but as old heads we're going to look at our SKUs and look for patterns. Do you have a bunch of hair conditioners that have common ingredients, for instance? Or a family of lotions?

Did the aspirin kick in? It will be really important about now.

Group your full list of SKUs in threes based on ingredients. This is for your sanity. Also, if that collection has more than 21 ingredients, please revise. You can only list 21 ingredients per form.

Now Section III wants to know where those SKUs are made. You did get the FEI for each of your contractors, yes/no? Oh, they haven't read this advice either and are still holding fire. Again, Don't Panic! Send them this info and then lean hard so they get their number(s) to you before the end of May. Meanwhile you can keep going, and thank us for the advice about aspirin because we have reached:

Section IV. You do have your product specs neatly organized and know all your product vernacular names, INCI aka proper scientific names, and CAS numbers. The FDA does not let you use the CAS numbers to specify your ingredients. That's why you needed those aspirin.

Snark on: The FDA has their very own shiny super special incomplete ingredient code system called "Unique Ingredient Identifier" which they TLA'd to UNII. Tequila may have been involved, but we weren't at that party either, though we did submit feedback on the draft guidance. We asked for CAS. We didn't get it. We got UNII.

Okay, end of snark.

The UNII system is pretty well harmonized and used internationally for certain important tasks in ISO compliance and you will be just as impressed as we are (see the wiki). Having served on ISO standards committees, we recognize the impulse to improve systems that aren't quite broken, so here we are, you can not use CAS. Get used to UNII because it's globally harmonized under treaty and you'll need the info for EU and Asia registrations soon enough. Now your product composition specifications have another column. At least you only have to do it once.

The UNII search tool at the FDA is a pain. Here you go, one search at a time: https://precision.fda.gov/uniisearch. Really, you can only search one ingredient at a time.

So complete Section IV for each of your groups of products. Filing and registration info are on the FDA website. Notice that the FDA isn't asking for percentages or tolerances. And also, notice that we can’t just link our data from UL Werks, that would have been Too Easy (one last quick snark, given that Target is demanding a lot more info about your products).

We hope this short exegesis in regulatory hermeneutics has de-mystified MoCRA just a little, and that our key advice stays with you: Don't Panic! And let us know if this is helpful or you want some hand-holding at info@cdm.expert.