I would add some clarification, plus my own opinion here:
When Victor says, "My thought is that the claim determines the classification more than the mechanism of action." I agree. When Laura says, "I tend to think like you in that I consider the overall claims,
and all other aspects of the product to help determine where best it falls," I think she is expanding beyond what Victor said, and dragging the technological characteristics back into it. I don't think the technology is a consideration
at all. I don't think Victor thinks this, either, but I will leave it to him to clarify this point.
Laura, given your background in dental implants, I think you may be trying to apply SE thinking (same intended use
and same or similar technology) to this situation. But this is not a determination of SE; it is a determination of cosmetic versus medical device, and I think the latter determination is based
entirely on the claims. The only way i can think of that the nature of the technology might creep into it is if a company made a cosmetic device identical to a medical device for the express purpose of encouraging/misleading consumers into thinking the device could be used for the same purpose as the identical medical device. Then I think FDA would look to see whether the company was engaging in any behavior that indicated this intent (e.g., advertising it as a cosmetic directly to the patient population that would normally buy the identical medical device).
If I had RA responsibility for this device, I would write a good memo to file that explains why the company considers it to be a cosmetic, rather than a medical device, with reference to the definitions in the FD&C Act. The worst that happens is that some day FDA disagrees, and then the company either withdraws the product from the US market or begins marketing it as a medical device, a bridge yet to appear on the horizon, much less to be crossed.
But I don't have RA responsibility for this device, so it is not my call. It is your call, so if you want to call it from the gut, that's your decision to make.
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 01-Feb-2019 09:11
From: LAURA HOSHUE
Subject: FDA Registered
Victor,
I am deeply appreciative of your feedback. I came from a very different world (dental implants), and so navigating the cosmetics area, while not have as complicated as implants, has been challenging. While some of the things that my company proposes are quite obvious to be medical devices, I find myself in limbo sometimes because some of the products by the way they are intended to be used are cosmetic, but have technological features that one would question whether or not they would fall under the medical device realm.
That said, I tend to think like you in that I consider the overall claims, and all other aspects of the product to help determine where best it falls. I am delighted that you have recommended that resource Victor, and I will look into being a part of that group. A great portion of my learning has been on my own along with webinars etc., and of course from great resources like you guys. I thank you again and will propose that to management.
Thanks again everyone for a great discussion from seasoned professionals like yourselves!!
Cheers,
Laura
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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
Original Message:
Sent: 01-Feb-2019 08:41
From: Victor Mencarelli
Subject: FDA Registered
OK ladies, I am going to jump back in here.
Tones and "reduces the appearance of" type claims have always to my knowledge (been doing this 25 years in this specific space) been seen as a cosmetic benefit claim. Jean is correct that "lifting" or "reducing wrinkles" would then be considered a structural claim that would fall out of cosmetic and definitely into either drug, device or combination product.
The thing I have found the most interesting is that there are some very major players in this space that in my opinion have essentially created a combination drug-device product out of simple creams and applicators because of the way the benefits of the product have been described. Some of them have been called to task in ways like Warning Letters and Untitled Letters as Jean pointed out. However, many of them have not.
My thought is that the claim determines the classification more than the mechanism of action. However, FDA has repeatedly said (I have been on panels with FDA senior cosmetics office leadership for each of the last 4 years at conferences where it is has been consistently brought up!) that they review the entirety of the presentation and the benefit information in making any determination as to classification. To Jean's earlier point about the definition of cosmetics, while I would generally agree with you that the definition would appear to be geared specifically towards creams, ointments, lotions, powders, etc., the fact is that you can "apply" a device to the face if you parse the definition of "apply" at all. Essentially rolling a roller on your skin is an "application" of the roller.
Laura, I would highly recommend that if you and your company are not currently part of the Independent Cosmetics Manufacturers and Distributors (ICMAD) trade group it might be well-worth your company's time and money. They host 2 separate regulatory conferences each year (1 is in a 2-day conference in the LA area the week of 2/18 this year and the other is in NYC in mid-May) where FDA has been featured speakers. In fact, the one in NY where I have presented for the past few years is actually co-sponsored by FDA and regularly we get Dr. Linda Katz (Director of the Office of Cosmetics and Colors) and usually 1 or 2 other speakers from FDA (2 years ago we had 2 of the compliance officers from the Northeast Division, last year we were actually lucky enough to get one of the inspectors from the Albany region, etc.) as well as speakers from both National Advertising Division of the Better Business Bureaus and Federal Trade Commission so it is truly a full day!)β). End of commercial!
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Victor Mencarelli
Director Regulatory Affairs
United States
Original Message:
Sent: 31-Jan-2019 17:16
From: Jean Bigoney
Subject: FDA Registered
"Tones the face?"
That almost sounds like a physical fitness claim. Fitness devices and medical devices also have gray area between them.
Even though this is a scintillating discussion, I think I may have to bow out. Statements like "lift" or "reduce wrinkles" are unambiguous. Saying "reduces the appearance of wrinkles" or "tones" takes it to a place where I am not sure how the Agency would see it.
Sorry I can't be of more help!
------------------------------
Jean Bigoney PhD, RAC, CQE
Regulatory Affairs Specialist
Morrisville
United States
Original Message:
Sent: 31-Jan-2019 15:41
From: LAURA HOSHUE
Subject: FDA Registered
So that said Jean, I think what really needs to be defined in my case would be what is considered "affecting structure" as opposed to altering appearance. In the case of wrinkles, where today even when the claim is changing the appearance of the wrinkles it is deemed as medical in nature. My interpretation of that would be altering appearance.
So, what terms in terms of cosmetics would we say affects structure other than lifting? If I were to claim that the product tones the face. Would that be affecting structure or altering appearance?
What are your thoughts? Canada is great in that it has a resource where one can reference things they deem as cosmetic claims and therapeutic claims. It is a bit more difficult navigating the US's.
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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
Original Message:
Sent: 31-Jan-2019 14:37
From: Jean Bigoney
Subject: FDA Registered
If that were the case, then lightbulbs, stoves, and thousands of other products would be regulated by FDA, but they are not. And again, as far as I know, FDA does not regulate "devices."
I'm not aware that anyone is claiming that lightbulbs do anything other than provide illumunation and stoves do anything other than cook food.
If they are being marketed with the claim of being "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals," then they become devices. It's the "affect the structure" part that triggers the regulatory requirement. Even if the manufacturer says "it's only cosmetic," the Agency will see it differently.
Here is an example of lightbulbs being considered a device and getting a warning letter :
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm381666.htm
The irony is that there are LED devices cleared for acne treatment, so the technology concept is accepted by FDA.
------------------------------
Jean Bigoney PhD, RAC, CQE
Regulatory Affairs Specialist
Morrisville
United States
Original Message:
Sent: 31-Jan-2019 13:15
From: Julie Omohundro
Subject: FDA Registered
"If it imparts heat, and has other energy etc., it will be considered a device, irrespective of the claims attached to it"
βIf that were the case, then lightbulbs, stoves, and thousands of other products would be regulated by FDA, but they are not. And again, as far as I know, FDA does not regulate "devices."
I'm going to have to let this one go now. Hope my comments have been more enlightening than confusing, but it's a very murky area, IMO.
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
Original Message:
Sent: 31-Jan-2019 12:59
From: LAURA HOSHUE
Subject: FDA Registered
Jean,
This is the question I have been wanting answered for the longest time. If it imparts heat, and has other energy etc., it will be considered a device, irrespective of the claims attached to it. I have been in limbo about this because there are several devices out there with LED, micro current etc., that have cosmetic claims, etc., and are not regulated as devices and hence the reason I was confused.
Thank you for providing me with this very clear and succinct and very enlightening information.
Regards,
Laura
------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
Original Message:
Sent: 31-Jan-2019 12:38
From: Jean Bigoney
Subject: FDA Registered
Unless something drastic has changed at the Agency, a product which claims to alter the structure of the human body and which relies on a physical or mechanical means as opposed to a chemical or metabolic means is considered a device. You cannot escape playing by CDRH rules by stating it is for "cosmetic purposes."
I had the experience a few years ago of getting a panic call from someone carrying a suitcase of plastic masks from Canada to the US. These masks had apertures to hold magnets which were located at accupuncture points. The manufacturer claimed that by putting magnets into the mask and wearing the mask, a "lifting" result could be achieved.
Needless to say, he was stopped at customs. It didn't help that the website had testimonials from customers claiming that these masks had helped relieved symptoms of toothache etc.
The customs location was near my office, so he called me. Like Julie, I thought about the rows of cosmetics that made all kinds of claims to "lift" "rejuvenate" "reduce the appearance of wrinkles" etc. and that this was surely a cosmetic. Weeks later after conferring with people at various divisions of FDA, I learned that this is considered a device, period. FDA/VCRP wanted no part of this and CDRH said that if he wanted to make those claims, he would need a 510(k).
The FD&C Act defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance". They don't say it explicitly, but the intent is that this refers to ointments, lotions, creams and similar. If the product emits electromagnetic fields, imparts heat, energy, radiation, kinetic energy or similar, they will consider it a device, regardless of claims that make it clear that it is not intended for use relating to a medical ailment or condition.
------------------------------
Jean Bigoney PhD, RAC, CQE
Regulatory Affairs Specialist
Morrisville
United States
Original Message:
Sent: 31-Jan-2019 11:55
From: LAURA HOSHUE
Subject: FDA Registered
So Julie, I am correct to assume that though microcurrent is used for medical purposes or "cosmetic-medical" purposes that are known to affect structure i.e. removal of or erasing of wrinkles, then if we are to use it for beautifying purposes with zero medical claims, then it is a non-medical device, regardless of the fact that it is known to have some effect on the body?
I ask only because I see so many cleared and un-cleared devices that use microcurrent technology and make the similar claims, some of which (are on Amazon of course), that aren't cleared.
I hope my point is clear as it can get confusing.
Thanks,
Laura
Original Message------
FDA's regulatory definitions do a fair amount of βmixing of apples and oranges, so it gets confusing.
The mechanism distinguishes a device (mechanical) from a drug (chemical). It does not, as far as I know, distinguish either one from a cosmetic. Instead, the claim distinguishes a cosmetic (cleansing, beautifying, promoting attractiveness, or altering the appearance) from a drug or a medical device (long-winded definition -> "a medical purpose.")
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------