Don’t make your cosmetic a drug

I have often wondered where the process of skin moisturization falls on the spectrum between cosmetic and drug claims. On first glance, it seems a simple cosmetic claim, since there are so many “moisturizing” lotions lining drugstore shelves. But when I dug deeper into the physiological process of moisturization, such as barrier repair, reduction of transepidermal water loss, restoration of lipids, etc — I could see someone making the case that an effective moisturizer affects the structure of the body and thus, could be considered more of a drug. Has there ever been a sign of FDA concern in this area?

Well, Paula’s Choice could get into some trouble.

@ElaineB Yeah, every humectant could technically be a drug under the FDA’s broad definition. I’d feel a lot better if the FDA actually goes into specifics and monographs more ingredients.

I’m not quite up-to-date with the technicalities, but I’m wondering if claiming that a certain ingredient (i.e, urea) “soothes dryness-induced irritation” would count as a drug claim.

I know you can avoid legal problems by claiming the product/formulation does it, as long as you don’t go into specifics such as “inhibits NFkB”.

I’m pretty sure that “soothes irritation” comes dangerously close to the OTC skin protectant category.

Consulting lawyers are inevitable, but another thing I’m wondering about: would you get into any more (or less) trouble if you had evidence an ingredient “soothes [dryness-induced] irritation”, such as a placebo-controlled study?

The FTC also investigates marketing claims, so would adequate evidence keep the FTC away from you, or would it incur FDA’s investigation as you haven’t submitted that evidence for FDA review?

Michelle, my opinion is that this all boils down to one’s opinion.  Including the opinion of the FDA agent / inspector who may (or may never) look at your product.  For me, the term “soothes dryness-induced irritation” is an acceptable cosmetic (non OTC) claim.  Claims such as:
“soothes irritation due to eczema”
“soothes itching due to poison oak etc…
would be drug claims.

Thanks, DavidW and Perry. I suppose it wouldn’t hurt to contact the FDA itself just to be sure.

Noooooo, my #1 rule is never contact the FDA.  Why get on their radar?  Others may not care but they are nothing but trouble.  Besides I have always found they say we can’t tell you yes and we can’t tell you no.

@DavidW

> Besides I have always found they say we can’t tell you yes and we can’t tell you no.

absolutely 100% correct.  Unless you are getting an agency ruling from the higher ups, FDA policy specifically prohibits lower echelon agents from “formulating policy” for the FDA.

Backed, by many court rulings to that effect (‘deference’ to the agency).

Or more plainly.  FDA inspectors can lie their ass off, with absolutely no repercussions because reliance on their statements, has no binding authority.

I couldn’t make this shit up, if I tried.

Right now its a crap shoot.I had to go to higher ups once for ruling but what happens when that person moves on?

@”DRBOB@VERDIENT.BIZ”

> Right now its a crap shoot.

says it all, don’t it. I just made the same point in PM to another member.

I have NEVER had an issue with the FDA and I have gone through quite a few audits.

1. The rules are widely set. Just be conservative. Honestly, I see more problems arise from lines looking to skirt the regulations using the “what if I do this” mentality.

2. The FDA is not one faceless entity and when you do an audit, don’t make it adversarial. They will tell you in advance why they are there. Cooperate. Ask questions. In the end, each of the 10 plus audits I have been through ended well. We assuaged the FDA’s concerns and by following their guidance, our processes were improved.

In summary, believing the FDA is an evil force or part of a bigger conspiracy is a waste of time. If anything, they are a much larger presence in the Prescription Drug Industry where I first started.

@Microformulation

> I have NEVER had an issue with the FDA

So whats your practical experience then?  In a conversation where the FDA is adversarial (or deliberately obtuse), what practical experience do you have?

> In summary, believing the FDA is an evil force or part of a bigger conspiracy is a waste of time. If anything, they are a much larger presence in the Prescription Drug Industry where I first started

Might be why you don’t really see “complying” as a problem.  You come from pharma regs.  Except, under the law (FD&C), and under their regs, not everything is pharma.  Thats the point.  Trying to convert everything into pharma, selectively and arbitrarily, is the problem.

>  following their guidance

guidance ain’t binding, EVEN under their regs.  you shouldn’t have to follow their guidance, simply because they think you should.  Shit, if anything, you are the expert, not them, no?  You don’t strike me as some neophyte chemist.

There comes a time, when the regulation, ceases to be productive (or lawful).  If you are entitled to produce and market a good, under the law, and under their regulations, shouldn’t this be enough?

So yeah, I like cooperative.  But that ain’t what they’re offering. 

Shit if anything its being run like a criminal extortion racket.  I wouldn’t seriously consider running any business regulated by the FDA, absent an excellent lawyer, on speed dial.

… and that is WITH nothing to hide.

My background is in Pharmaceutical, Personal Care, and Cosmetic Manufacturing. As such, my practical experience is being the appointed liaison to an FDA Inspector in excess of ten times, maybe even closer to 15.

The FDA Inspector will present his/her ID and they will tell you the primary reason they are there. Be polite and respectful. You are a Business and this is what Professional means. Answer their questions succinctly and ask follow-up questions. The Inspector will suggest corrective action. In fact, in many cases, you and the Inspector can turn it into a teachable moment. You will get a list of corrective actions. Complete them and move on.

As far as Guidance goes, yes I am not a neophyte Chemist and I submit that if you got some of the more experienced Chemists in a room and formulated a plan to comply in almost any situation, I would wager that we would all likely be almost 100% in agreement. The regs are not so murky that you can’t navigate them. And if you have any doubt or disagree, consult a Regulatory Professional. Get their input on letterhead and POLITELY disagree via writing. They have a review process.

In the end, no offense but I believe that you damn the torpedoes, full speed ahead, us versus them attitude will become an obstruction to your Regulatory compliance.

Most cases where I see someone rail against the FDA they are so far out of spec that they are fearing correction. Small start-ups that foolishly choose to manufacture themselves without formally trained staff will get dinged, as they should.

So, what is my experience? Likely as much as any Chemist can get outside of someone working in Regulatory can get.

My attitude on compliance? 100% compliance. Do it right.

My attitude towards the FDA? They are not the enemy.

@Microformulation 

> As such, my practical experience is being the appointed liaison to an FDA Inspector 

You’re missing the point; I ain’t questioning your credentials on running a tight ship; I’m questioning your experience, under fire.  By your own admission, “you’ve never had a problem”, right?  Give’m whatever they want (in essence), right?

> The FDA Inspector will present his/her ID and they will tell you the primary reason they are there.

Nope.

> In the end, no offense but I believe that you damn the torpedoes, full speed ahead, us versus them attitude will become an obstruction to your Regulatory compliance.

F*&k’em.  Mafia rolls up to my door, mafia gets treated like the mafia.  Regulatory “compliance” (cough) I leave to you.  I stick by what the law actually says, and what the regs actually say.  Not a single, iota, more.

> My attitude on compliance? 100% compliance. Do it right. 

S&*t I love it.  Provided its what the law actually calls for.  And the actual promulgated regulations in effect.  Not, guidances.  Not “suggestions” (out of their extensive “inspection” experience at other places).   Not upcoming regs not yet in effect.  Not the wrong regs.  Cite the fucking reg. and be prepared, to have an informed professional ‘discussion’; with legal involved if necessary.

> My attitude towards the FDA? They are not the enemy.

My attitude is their incompetent, corrupt, petty, highly-political, and powerful.  NOT, a good combination.  Particularly when you compare their enforcement on small and mid-size manufacturers, vs large manufacturers.

I’m not a big fan of rollover, take it up the ass without vaseline(1), as a sign of “cooperative” attitude.

> In the end, no offense but I believe that you damn the torpedoes, full speed ahead, us versus them attitude will become an obstruction to your Regulatory compliance.

Regulatory compliance? Thats the easy part.  Getting them to comply with their regulations?  Thats the dark arts, right there.   One, you don’t learn, if your ass is constantly end-up in the wind.

Now there is at least three different posters, with somewhat similar concerns, regarding regularity uncertainty, with respect to promulgated regulations, regulatory compliance inspections and the so-called “cooperative” attitude of the FDA.  Wildly different background I’m sure, but generally, in agreement on the main points.

Thats what we were discussing.   The dark arts.  Apparently, you don’t need’em.  More power to you, knock on wood, hope you never need them.

But your situation, is not the same as everyones situation, yes?

> Most cases where I see someone rail against the FDA they are so far out of spec that they are fearing correction. Small start-ups that foolishly choose to manufacture themselves without formally trained staff will get dinged, as they should

Thats your mistake.  Don’t let your presumption, get in the way, of reading the actual point being made.

I posted simply to confirm DavidW’s point (and expand on the reason why); and to concur with DrBob who commented on that expansion.  None of which, I think, you actually disagreed with, right?

This isn’t a regulatory board; this is a chemists board.  To the extent that chemists of small firms, have to deal with this, and they make an accurate point, I will probably post a concurrence, or expand on a point. Here it is the bare minimum, to get the point across, and possibly, inform the reader.  If people want to carry on an extended conversation, thats what PM is for.

Lastly:

> In fact, in many cases, you and the Inspector can turn it into a teachable moment.

I’m not looking for a “teachable” moments.  When I want to learn something, I consult professional grade resources and study the matters in depth. 

…and I sure as s&*t, am not on the payroll for the FDA, to train their inspectors.

—
(1) sorry, petrolatum!

We will have to agree to disagree. Looking at my to-do list, you have already exceeded the time which promotes this dialogue. Learn, experience and deal with the FDA. They are not the enemy.

> We will have to agree to disagree.

Not really.  You simply don’t have any experience.  You want to claim your avoiding it through “skill”, but your really just giving them whatever they want. 

This, is not skill, this is the absence, of skill.

> Looking at my to-do list, you have already exceeded the time which promotes this dialogue.

Very good.  First sensible thing you’ve said.

> They are not the enemy.

No they really aren’t.  They’re just obstacles.  Hazardous, obstacles.  To be worked around, despite their best efforts to be something other.

Its like when I cross the street, and theirs a big pile of steaming s&*t, I don’t go out of my way, to step in it. 

… I walk around.  Shortest path, notwithstanding.

Different strokes, for different folks.   On that, we can agree to disagree.

Good Lord. SMH