Regulatory + Quality Assurance | Michelle Lott | lean RAQA

Cosmetics

Claims. Claims. Claims.

Cosmetic regulations are tricky. Really tricky.

If you’re casually visiting this page, you may not know….. Cosmetic regulations are voluntary.

Yup. You heard me right. (risk to saying “you don’t have to” because in some cases you do. Better to stay silent.)

Okay. Question. What’s the catch, you astutely ask?

The line between “cosmetic” and “drug” or “medical device” is really thin.

FDA.gov (of all places!) has a wonderfully illustrative page called, “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)”

If you don’t have time to read it, that’s cool.

But remember, as soon as you say “helps promote [some attribute],” you are making a claim.

You may have unwittingly wade into Pandora’s regulatory, mandatory clearance, and other mythical boxes.

Wade carefully.

Or just contact us.

Check Out All These Flavors:

21 CFR 1271.265(f)

Return to inventory – procedures

21 CFR 1271.47(a)

Donor eligibility procedures

21 CFR 1271.47(a)

Procedures for all steps

21 CFR 1271.320(a)

Procedures re complaints

21 CFR 1271.265(e)

Procedures and release criteria

21 CFR 1271.75(e)

Abbreviated procedure

21 CFR 1271.230(a)

Process validation procedures

21 CFR 1271.190(d)(1)

Procedures for cleaning, sanitation

21 CFR 1271.200(c)

Calibration procedures and schedules (general)

21 CFR 1271.230(a)

Validation & approval – established procedures

Shall I Continue?

No, you get the idea. I hate to see bad things happen to companies doing good, important work.In my storied (indulge me) career, I’ve seen one too many “If only so-and-so followed the procedure, we could have avoided this” messes that cratered otherwise-promising technologies.

Call me so you can avoid the same fate. Please?

call me

How many can you confidently answer?

My friend was pretty sure he knew the first answer. He was wrong.

Now you try:

  • 1. Does FDA recognize the term cosmeceutical?
  • 2. How do my claims need to change if FDA considers my product a drug instead of a cosmetic?
  • 3. If my product is considered a cosmetic in other countries, how likely will it be considered a cosmetic here?
  • 4. What are the requirements for color additives?
  • 5. FDA cleared my claims. Am I set from an FTC standpoint? If not, what else do I have to do?
  • 6. What is FDA’s position on the use the terms “cruelty free” and “not tested on animals?”
  • 7. If I label my product “all natural” or “organic,” does it have to also be hypoallergenic?
  • 8. Who is responsible for cosmetics safety?
  • 9. Under what circumstances is additional testing required?
  • 10. Which good manufacturing practices apply to cosmetics?

How’d you do?

🌟 I got a 10, Michelle! I get a star!

💪 I’m pretty sure I got 9 right, Michelle. I’d say that’s worth a solid pat on the back!

😬 I don’t know, an 8, maybe fewer and:

(a) That’s okay. I was just playing. We don’t make cosmetics.

(b) Maybe I should give you a call. Where’s your calendar thingy?

Help Has Arrived!

Pick an open half hour on my calendar. Maybe I can lighten your workload and I would LOVE to help!

let’s connect!