Karl Schulmeisters Is mouthwash being used to treat a medical condition? Does it make claims of efficacy? does it have potential side effects?

Ibid toothpaste.

QED medical device. Most likely 510k

Gordon MacPherson Can it enter the body? Yes, via the oral cavity therefore it meets the classification. Does not seem fair but it's the rules we are governed by in the U.S.

Gordon Millar If the product description makes medicinal/therapeutic claims, then it may be deemed to be a medical device although the criteria may be vague. Contraindications are considered. The MDD is at times ridiculous. At the head of it all is the EU and if you approach the EU Medical Devices Directorate, you will be told "Ah yes, it's a broad church with many denominations". Translation: Germany will interpret the rule one way, France another, Italy will probably flap and ignore some of them, UK will adhere religiously etc etc. It's a pendant's paradise.

Chris Elliott That still doesn't explain why it is being regulated as a device and not as a medicine.

Alan Farthing Good to see other's thoughts on this. To clarify, I'm only looking at EU (more specifically UK). If in the US, the inclusion of fluoride makes them pharmaceuticals anyway.

...but ...but ...4 out of 5 dentists recommend toothpaste, isn't that good enough? ;-)

Bruce Toman It depends on the function. Collagen that is injected into skin to remove wrinkles is a medical device, not a drug; the collagen is not interacting chemically with the tissue - it is serving as a mechanical bulking agent. Since the toothpaste itself (not fluoride (which is a drug that prevents cavities) is interacting in only a mechanical way with teeth (e.g. abrading away dirt) it is a medical device. Ditto mouthwash itself (not any specific chemical in it) Here is an example, for mouthwash: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071642.htm. Here is an article on the history of the regulation of toothpaste. http://dash.harvard.edu/bitstream/handle/1/8846762/msandier.pdf?sequence=1

Aron D. Haber You may want to review the Electronic Code of Federal Regulations (e-CFR)
Title 21: Food and Drugs
PART 355—ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=139c3bb1fa5eff36bdbf64ec1f7a62ae&ty=HTML&h=L&n=21y5.0.1.1.26&r=PART#21:5.0.1.1.26.3.1.1

Bruce Toman yep, aron, the fluoride is that active drug ingredient in the toothpaste, as per the 'Anticaries active ingredients.' section of CFR 21:355. if the toothpaste had no fluoride, that regulation would not apply.

Gordon MacPherson NIce input and thread...

Robin C. Hart, Ph.D. And to add to the confusion, if the toothpaste has anti-plaque and prevention of gingivitis claims, it is additionally regulated as a drug, e.g., Colgate Total with fluoride and Triclosan. Whitening toothpastes may be regulated as cosmetics, as well. So, to sum, if the action is only mechanical (abrasion, flushing), it's a medical device; fluoride toothpastes have their own regulatory category (anti-caries); whitening toothpastes that contain peroxides may also be cosmetic; and antibacterial/antimicrobial are regulated as drugs. Do we have an easy to understand regulatory system in the US or what?

Easy enough Alan. Medical Device is, but not limited to, an instrument, apparatus, in vitro reagent or compositions that enables the improvement of medical conditions without influence and change metabolic pathway in vivo. Therefore surgical knife can be described as a “therapeutic modality” and toothpaste and mouthwash as device i.e. they are in vitro compositions that improves medical conditions (healthier gums) and do not influence on metabolic pathway.

The inclusion of fluoride in the US does not necessarily make a product a drug; the claims behind the fluoride do (i.e. prophy paste, varnish). In the EU the same approach applies, BUT the MHRA (UK) has classified any device with fluoride in it as a Class III device based on Rule 13 (ancillary medicinal product). A Class III device would still have the CE mark with the NB number. If the product is not claiming caries prevention (elevates to a drug) it could still be a device with sensitivity claims.

Michael A. Swit, Esq. In the U.S., "pure" toothpaste without any type of anti-caries agent (e.g., fluoride) and labeled only to clean teeth is a cosmetic and not a drug or a device. Add fluoride to prevent or treat caries, and toothpaste becomes a drug. In turn, some mouthwashes are devices if their mechanisms of action do not involve metabolic or chemical activity, such as to act as a mechanical barrier to adhesion of bacteria to teeth. Other mouthwashes, if labeled only for bad breath, arguably are cosmetics. Add an anti-plaque claim to a mouthwash that uses an anti-plaque agent that works in a "drug" fashion and you have a drug.

As with much in the law and FDA, the devil is in the details of the intended uses and technological characteristics of the products involved. So, we can't generalize here.

Caveat: these views are mine and do not necessarily reflect those of my law firm or any of our clients.

David Lim, Ph.D. RAC, CQA Alan, since you are only looking for in EU/UK, let me tell you that a toothpaste in UK/EU is generally considered as a cosmetic. As for mouthwashes, it is generally considered as drugs. it is explained here at http://wp.me/P33LGu-12G What dictates is "intended use/indications for use" in combination with "primary mode of action." I would also refer to the MHRA's document explaining "borderlines between medical devices and medicinal products" at the link above.

Alan Farthing Some interesting insights here and a lot depends on the claims. Thanks for your input, people. Just to clarify the UK situation for those unfamiliar with it:-
Toothpaste and mouthwash are generally cosmetic products even if they contain fluoride and other additives and have anti-caries, anti-plaque or 'antibacterial' claims. However, A 0.2% chlorhexidene gluconate mouthwash with claims regarding gingivitis is (rightly) a pharmaceutical but a 0.06% CHxG mouthwash (same company and brand name) sold as a "Daily Mouthwash" is a cosmetic. A sensitive toothpaste containing potassium salts is generally a cosmetic but one with arginine (said to plug open dentine tubules) is a Class II device. There are examples of toothpastes being registered as pharmaceuticals (sensitive toothpastes) whilst identical products with fewer claims remain cosmetics. This could even be two products from the same company.
Could the 0.2% CHxG mouthwash and the arginine toothpaste be marketed as a cosmetic if the claims were reduced? In the first case, probably not, but in the second?
Borderline products are interesting!

Alan Barta FDA would certainly regulate mouthwash and toothpaste that enter humans bodies, so expect same in UK. They likewise regulate foods, either/or. I applaud any effort to regulate, since it is responsible for saving countless lives from unscrupulous manufacturers who would risk anything to make a buck, including health of consumers.

Ali Bora Bingöl Okay, first of all, let's look at the scope of MDD. MDD declares that;

“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

So, what is a toothpaste or a mouthwash?

Do those products covered by the scope of the directive?

Absolutely yes, according to the intended use and the mechanism of the device!

Before going any further, I want to raise a very good example which falls in the very same case; head lice treatment solutions. There are several types of these solutions;

(a) Solutions which kill the head lice by poisoning them. This is an insecticide.

(b) Solutions which uses natural oils to choke the head lice by pluging their trachea channels mechanically (mostly tea tree or coconut oil is used along with pine oil, anise and such essential oils for some side treatment effects). This is a medical device.

Why are those solutions are medical devices? Because, they mechanically choke the insect! There are no pharmacological, immunological or metabolic means in or on the human body, but it is a treatment!

It is the same case with the toothpaste and mouthwash. If the intended use is treatment, then it is a medical device.

For instance, toothpaste mechanically scratchs/wipes of the enviroment of the bacteria and this is a prevention of disease. There are no pharmacological, immunological or metabolic means for the mechanism of the device. And, be aware that, this is an invasive medical device!

On the other hand, if you have any active substance in the toothpaste which is pharmaceutical and if you claim the intended use as a treatment, then your toothpaste is a class III medical device as a medical device containing medicinal product.

I hope that helps.

Gordon Millar Ali: You mention head lice treatments. I was actually involved in the development of what became a No 1 market leader and one contentious issue which had to be resolved was an element of the EU Biocides Directive.

Fred Adler Read the FDA definition of a "medical device" directly from fda.gov. Don't you love "legal" terms?

Is The Product A Medical Device?
Introduction
Determine if your product meets the Definition of a device. If it does, there are FDA requirements that apply. First, see the definition below.

Medical Device Definition
Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products1 with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA)2 as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
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, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug. Human drugs are regulated by FDA's Center for Drug Evaluation and Research3 (CDER). Biological products which include blood and blood products, and blood banking equipment are regulated by FDA's Center for Biologics Evaluation and Research4 (CBER). FDA's Center for Veterinary Medicine5 (CVM) regulates products used with animals. If your product is not a medical device but regulated by another Center in the FDA, each component of the FDA has an office to assist with questions about the products they regulate. In cases where it is not clear whether a product is a medical device there are procedures in place to use DSMICA Staff Directory6 to assist you in making a determination.

Dave Darley I couldn't say without reading the 510K or whatever application they submitted with accompanying rationalle. It is a Drug and falls under FDA regulation anyway. A drug can be used topically (externally) ingested or injected (internally). If I might hazard a guess, I think Class I, II, and III with regard to classifications of medical devices (in general and grossly simplified) are external (like X-ray), internal (like a cathiter) and life sustaining (like a pace maker). This might be with reference to the fact that it is for internal use.

David Lim, Ph.D. RAC, CQA In EU (or even in the US), to be accurate, we have to interpret each and every word of the claims: For example, does a toothpaste contact with our human body (say, the teeth) or our mucous membranes of the oral cavity with our view exclusively or mainly to cleaning the teeth or changing appearance or protecting them or keeping them in good condition? If you agree with these terms, you can see what it is (http://wp.me/P33LGu-2IL)

I think Ali and Fred have provided very useful references from the regulations. My two cents based on the input I have received from very worthy working professionals would identify these as consumer goods or cosmetics within USA if they do not make any medical claims. This is the link from FDA website regarding these types of articles:
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm242716.htm
If any medical claim is made regarding fighting any type of known gum disease or tooth decay then you can enter into grey area and there may be some pharma regulations applicable to you.
The most unique aspect of regulation which still makes it confusing for me are the herbal and homeopathic products in this category. Based on my understanding such articles regardless of their claims are not regulated by FDA. There might be specific states like California which have identified some regulations in this category but consumer protection agencies and FDA have to catch up with other countries to properly regulate such types of articles to ensure protection of public.

Dear Alan, Muhammed, Dave and Dave, that is quite an interesting discussion! and it can be widened also from pharmaceutical towards M.D..
Other products - like products for scar treatment or wound healing that have no API's but a lot of clinical evidence on medical efficacy can also be reclassified as cosmetical or M.D.. In one country an ingredient like vitamin E is considered to be an API where in other countries it isn't. It becomes even more fascinating when the first country that considers vitamin E as an API reclassifies/re-evaluates it own definitions towards M.D. when vitamin E can be documented in a simple declaration as an aid in the composition of a formula.
in this case the pharmaceutical can be rapidly reclassified as MD or even as cosmetical. Are there any other similar experiences where products move from pharmaceutical towards MD?

Anil Mansukhani myself cath lab intervention technologist BS rcis (CCI) PGDHA. yes, absolutely, no doubt , for this one has to understand the definition of a medicine and a device.
medicine - taking care of an ailment, symptom or disease.
medical device - which facilitate as a tool to help achieve the target in medical field say an injector is medical device, an endoscopy is device.
dentistry knows that there are bacteria which can lead to many problems even to the extent of causing disease to the heart(cardiac) muscle, so the tool as toothpaste or mouth was acts as an device to help prevent reduce the bacterial growth or prevent to further entry into the life biological system.
thus.
Thank u for giving me the opportunity to express.

Anil Mansukhani i have one reservation that is only what impact we would have when we accept the above that they be classified as medical device, is in which direction we take into.

Luigi Torre Hi. I have a little experience both with MDD (EN 43/92) and with Cosmetic Regulation (EC1223/2009). I learnt that (for example) toothpastes can fall into the MDD or into the CR (or they can even be considered a drug) according to:
1. Concentration of active principles (there is a comprehensive list at the end of the Cosmetic Regulation which shows the limit to be considered a cosmetic)

1. Claim on the label

1. Real effect on the body (but this is less important because it also depends on the claim).

Pleas refer to
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
and to
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=IT

Hope this helps.

Anil Mansukhani dear luige T u r right but if this is done like claim on label real effect on the body to the end user end user will not able to digest it awareness yes but excees information or knowledge would lead to disorientation.

It's all about the claims.

Albert de Richemond, M.S., P.E. Read the FDA's definition of a medical device. If the device, which can be anything, is used to diagnose or treat disease, it is considered to be a regulatable medical device.

An interesting discussion. As a student seeking to start a medical device engineering career next year, it's valuable to read out about grey areas such as this. My first assumption was that was that toothpaste can't possibly be medical devices. However, challenging this, I can see how small nuances in the definition can swing it either way. I agree mostly with Robert Teague - it's all about the claims. If you claim to treat or prevent tooth decay, then it could be a medical device. If you claim to alleviate symptoms or 'may prevent' tooth decay and gum disease, then you're probably OK. Certainly some of those herbal toothpastes won't be medical devices.

Anil Mansukhani no comments

Yeah Nathan, there are a lot of 'grey areas'!

An intersting document I suggest the reading of is the EC BORDERLINE MANUAL, which gives non binding indications for the classification of bordelines products in the EU and provides very nice examples.
You can find the latest release (june 2013) at:
http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf

As many of you correctly suggested, the classification mainly depends on the claim/intended use of the product. In the EU the same lidocaine gel can be:
* classified as a drug product if the intended use is to provide local anhestesia;

* classified as a medical device if the intended use is to provide lubrification (e.g. for catheterization).

This even if lidocaine is clearly an API.

However the new Medical Device Regulation, which will substitute soon (2015? 2016? Who knows...) the actual Med Dev Directive, is expected to clarify the situation and to reduce the 'grey areas'... You can find a draft of the regulation at the following address:

http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf

Giacomo.

Ali Bora Bingöl @Giacomo; I have just finished the documentation of literature search and clinical evaluation report of a catheter gel containing lidocaine and CHG. It is a class III medical device. And, when the scope of the directive (MDD) and classification rules are considered, I can tell that the product is clearly a medical device leaving no grey area.

@Gordon; First of all, I appreciate your success. I think you had a hard time registering the product. However, the scope, intended use and the ingredients do shape the direction of the registration (or certification, whatever). So, if the product contains a chemical which effects the insect by any biological means -e.g. Permethrin-, then the product shall fall within the scope of Biocidal Products Directive. But, if the active(!) substance(s) only have a mechanical effect on the insect like I have mentioned before (new products have silicon based ingredients for the same purpose), and if you claim that this is a treatment, then it is a class I medical device (except Turkey, Turkish MoH has announced that those products will be classified as class IIa; not joking, true story). On the other hand, you can claim that the product is -for instance- a shampoo and it "helps" the treatment, but does not act as a treatment, then you may look for the cosmetics directive. This is also the case for most toothpastes and mouthwashs.

@Muhammad; thanks for your comments.

@All; I don't feel competent to comment on FDA issues; but all CE issues are welcomed.

Gordon Millar Ali: You have touched on the area which was amended but as it's not my patent, I won't make any further comment. I think the regs which you understand now post date what was done to get the product into the market.

Ali Bora Bingöl @Gordon; probably you are right. I have consulted a manufacturer last year and had CE certification as class IIa from TSE (NB 1783) in Turkey according to the story I have told above. On the other hand, I would like to stress that the NB's approach is really helpful or painful :) time to time.

Michael A. Swit, Esq. @Nathan and Robert Teague -- I agree the claims are very important. However, in the U.S., it also is the technological nature of the product that also can impact if it is a medical device. A product that is not metabolized or dependent on chemical action that, nonetheless, "looks like" a drug (e.g, a liquid bandage), still can be a medical device.

Doesn't anybody remember that the tooth paste trouble a few years ago with tainted tooth past and the international recall, It made may people all over the world sick.

In the US, toothpastes with claims for mechanical occlusion of tubules for desensitization are generally medical devices (adding fluoride would make them a combo product) (see the cavity varnish product code for more products regulated this way for this indication). In the EU, there is a GMDN code for "Dental material, dentine-desensitizing", which is likely how they are calling it a medical device similar to those in the US, rather than a drug or cosmetic.

Karl Schulmeisters Nathan - frankly these gray areas are why we have started ClearRoadmap.com - what my CEO discovered as an Entrepreneur In Residence at the FDA was that for things like say a Balloon Catheter, adding one "indication of use" took it from a Class II to a Class III medical device. similarly there is an app out there called Kindara, which currently advises women on their fertility. Now the way it works is that it actually provides a "medical diagnosis" and suggests a "treatment" (a course of action).

The builders of this solution (its a mHealth app) don't seem to realize they are a Software as a Medical Device.

OTOH if all they did was to say something like "90% of women at this point are ovulating within the next 3 days" and "70% of women are unlikely to conceive during the next 3 weeks" - they would suddenly not be a SaaMD.

Same app, simply by changing what the text of their guidance says

Check out our web site in 4-6 weeks when we launch our initial Med Device guides

Alan,

Toothpastes contain fluoride, and sometimes trichlosan, and/or other active ingredients, all with an inherent purpose that has to be demonstrated and supported by documentation and that is where the Class comes in. Any non-active paste could also be claimed to be a Class 1 device if formulated and manufactured to specific good manufacturing practices

Karl Schulmeisters Michael,, what makes the liquid bandage a "device" is that it

a) has explicit indications of use
b) makes explicit claims of medical efficacy

These are both "claims". A somewhat infamous example is Pfizer being involved in various lawsuits with the food supplements industry on mevastatin and lovastatin. Pfizer's atovarstatin (Lipitor) makes explicit medical claims and indications of use.

Whereas the dietary supplements of Red Yeast Rice and Oyster Mushroom Extracts make general statements about what the research indicates http://www.sciencedirect.com/science/article/pii/S1567568804000728 And thus does not qualify as a drug.

which is why the 1998 ban on Red Yeast Rice supplements was lifted under court order a year later http://www.nytimes.com/1999/02/18/us/cholesterol-treatment-upheld.html

So it very much IS ...All about the claims

The goverment safety regulations has put the toothpaste ingredients as a medical device.

Sean Hägen Karl's two rules (a & b) are consistent with my experience with the FDA.

Star Simkins, RAC (US, EU) Classification is dependent upon the intended use of the device. If the claim for the toothpaste is to prevent cavities, for whitening, etc. it must be proven to be safe as well as effective. It's limited contact in the oral cavity leads to it's classification at a lower level than say a dental implant. FDA defines a drug as a substance recognized by an official pharmacopoeia or formulary; a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease;
a substance (other than food) intended to affect the structure or any function of the body; a substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.

Michael A. Swit, Esq. @ Karl: I agree that claims are tremendously important. But, the claims -- indications for use and medical efficacy -- you talk about easily could also apply to a drug. However, we can not overlook technological characteristics in assessing whether a product is or is not a medical device. Look at the liquid bandage. It looks like a topical drug; is applied like a topical drug. However, it does not depend on metabolic or chemical activity. Thus, it is a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act. So, it is the claims AND the product's characteristics that drive how a product is regulated.

BTW, if I recall correctly, the 1998 decision on Red Yeast Rice was overturned on appeal and the products banned. What a dietary supplement can say has to be carefully assessed to ensure it does not become a drug through its claims. But, not all products that are marketed as dietary supplements, even with proper claims, are in fact dietary supplements if they don't meet the definition of a dietary supplement as to (a) how administered and (b) containing a dietary ingredient. Thus, you will not see a transdermal dietary supplement (even if contains an acceptable dietary ingredient) because the technological requirement under the law for a dietary supplement requires that the product be ingested via the alimentary tract (thus, mouthwashes also cannot be a dietary supplement if not intended to be swallowed).

Caveat: these comments are my views and do not necessarily reflect the views of my firm or any of our clients. Nothing in this post is intended to provide any form of legal advice.

The toothpaste and mouthwash can be Medical Devices if you use it with a tooth brush which has to be newly invented . If the tooth brush can dispose & detect the condition of the paste or mouthwash that has been disposed by using sensors those measure conductivity , pH , bacteria count , gum bleeding , etc.
The functional toothpaste & mouthwash can have various chemicals which monitor & measure the level of cleanliness that has been achieved ( evidence based mouth cleaning???). The toothbrush can generate a daily report and monthly trend report for this evidence based mouth cleaning)

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To help understand MDD, consider that in the USA, FDA regulates products, such as fluoride toothpaste and mouthwashes, via the Anticaries Drug Products for Over-the-Counter Human Use Monograph (go to: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm080389.pdf

Basically, if your product ingredients and labeling comply with this monograph, then the product can be legally marketed in the U.S. even though it is technically a drug. However, Your firm would still need to register the product with FDA by getting an NDC number.

Other dental paste and oral wash products that contain higher amount of fluoride are drugs that have never been registered with FDA. For those, FDA just looks the other way as long as your product ingredients are pretty similar to those already on the market and for which your labeling is similar. These were grandfathered products that are low priority for FDA. However, theoretically, they could ask for NDAs for all of these products at any minute. However, since doing a clinical study that proves caries were reduced because of the fluoride toothpaste or gels would be very difficult so unless or until there is a public outcry, FDA won't take any action.

A similar situation exists in Europe. Standard toothpastes are regulated as cosmetics. I have achieved CE marking for high fluoride products by showing that my firm complied with the monographs and by referencing the ingredients and labeling of predicate products. The requirements for that, of course, varies from one Notified Body to another so I would not undertake this without consulting with my NB first.

Arthur Brandwood A lot of discussion here - but two separate consideratoins apply:

1. IS IT A DEVICE? Yes in most jurisdictions toothpaste meets the definition of a medical device - it treats dental caries by a PHYSICAL action of cleaning off all the gunk and bacteria. If it has fluoride then there's a medicinal action as well.

2. HOW IS IT REGULATED? The way the devices are regulated can vary tremendously. Low risk devices such as toothpastes may be considered Class I (i.e. require no premarket review). In Australia, toothpastes are "exempt devices". That means there is no requirement for TGA review or for device registration. However they are still subject to safety and performance requirements as set out in the Essential Principles. The only exception is if the Fluoride content is above a certain threshold - in which case they would be regulated as medicines.

Ester Freitas You're right, to me, doesnt make any sense, as long as is not accoplated with a medical device. A toothpaste in my understanding ,could be classified as a medicine if it has any therapeutic action, but nothing else. But I know that the RA approve cosmetics and even medicines, sometimes as cosmetics and medicines and in other situations, the same substance/set of substances, are approved as medical devices. My feeling is that it's a consequence of the legislation being made by lawers without clear feedback from the Pharmaceutical area. We can create a new name to cosmetics medicalised like cosmeceuticals and withdraw them from the medicines law, but we should'nt have call it medical devices, unless they are part of a medical device. A medical device is a sphingomanometer, a urinary catheter, a pacemaker...
This is what makes sense and the law should always be clear and logical! But it the way it is and we should follow it the best we can.

Anil Mansukhani toothpaste acts as lubricant also has particles which by abrasion clears deposit on the tooth. mouthwash enters the and is more effective then plain rinsing. simple, but a strong concep, i suppose so fda's classification.

Champa Patel Sensodyne rapid relief is an example of tooth paste which is a medical device. This is because it provides a barrier i.e. mineral like seal over the dentine and within microscopic channels. In doing so it relieves the pain of sensitive teeth. It does not provide pharmaceutical action, just physical barrier.

Ester Freitas There's a lot of medicines that act as physical barrier, ex. Sucralfate for dispeptic complaints. To act as a physical barrier should not ibe, n my understanding, a reason to classify a product as a medical device. A medical device is what the name says, is a device ( a physical object, not a cosmetic) that is to be used in medical settings. Catheters, strips to measure glicemia, etc.

Champa Patel Toothpastes can be medical device, cosmetic or medicine. The classification is dependent on the property of the toothpaste. When the toothpaste claims to whiten teeth: it is clearly a cosmetic. When an active is indicated to treat an illness i.e. gingivitis it is clearly a medicine as the active is providing a treatment for a particular illness. If however, it is not providing a cosmetic effect nor a medicinal treatment but just acting as a barrier as in sensodyne rapid relief where the manufacturers claim it provides a barrier by mineral like seal over the dentine and within microscopic channels, no active is cited here and it is not providing cosmetic effect, but relieves pain of sensitive teeth hence it is a device. The classification is essentially based on the specific claims of the tooth paste.

Karl Schulmeisters not sure that whitening teeth would be considered a cosmetic. Its a cosmetic treatment but because its a chemical interaction between the toothpaste and the body, that would make it a drug and hence a pharmacological not consmetic

Michael A. Swit, Esq. Dr. Freitas: In the U.S., a device usually is a physical object, but does not have to be as the definition of a device focuses on whether the "article" works by metabolic or chemical activity. If it does, it is a drug if intended to prevent, treat or diagnose disease or affect the body. If it does not -- such as some mouthwashes that act as barriers -- it is a device if intended to prevent, treat or diagnose disease or affect the body. Thus, hyaluronic acid, when used to fill up a wrinkle or to treat osteoarthritis looks like a drug (it is not an object, but is in liquid form), but is a device because it does not depend on its effectiveness by being metabolized or via chemical action in or on the body.

Thus, in the U.S., the devil is in the details and it is not possible to generalize by focusing on "objects."

Caveat: these comments are my views and do not necessarily reflect the views of my firm or any of our clients. Nothing in this post is intended to provide any form of legal advice.

Ester Freitas Dr. Michael, I know that toothpastes sometimes are considered cosmetics, other medical devices, other medicines, but for me continues to not make sense, because the differences between them dont justify it. As I said theres pharmaceutical products that act as a barrier and that are not considered medical devices. Are considered medicines, as sucralfate, by instance. How can we agree that a brand of carvon to treat aerocolia can be classified as a medical device and other times the same substance being considered a medicine? Or is one thing or another. In my understanding the classification should'nt be the result of arguments or claims. Besides being a pharmaceutical physician and used to work in the pharmaceutical industry and have to face this regulatory discrepancies in a daily practice, I'm by chance, specialized in dentistry so I clearly know what we are talking about when we speak about toothpastes and mouthwashes and their differences. To me as a physician, the split between the categories should be clear, logical and not prone to any terminologic confusion, arbitrariety from the regulatory authorities or marketing convenience. Rocket science!
But life is the way it it. Unfortunatelly we need to follow the legislation and to be adapted the best we can, to this mess.

In general, the breakdown is: mechanical action (physical removal of plaque)=device. Chemical action (fluoride repair of enamel)=drug. No alteration of health (whitening)=cosmetic.

Karl Schulmeisters Dr Freitas...
>> In my understanding the classification should'nt be the result of arguments or claims<<

That is a mistaken understanding. For example, Lithium as a component of batteries to power a pacemaker is something very different than Lithium in ingestible form.

and the primary difference - besides the form of the Lithium, are the claims being put forth for its indications and efficacy.

So absolutely what characterizes something as a Device, a Medicine or an unregulated product is completely about the Claims and the Effects and will differ from offering to offering as those vary

Ali Bora Bingöl Okay... I have found an interesting example. In fact, it's kinda funny though, I have been using this paste for a week now.

You can see the CE mark (CE 0120) at 1. You can also see it has flouride at 2. For the 3rd, there says, clinically proved relaxing(?) and daily protection for sensitive teeth. And for the last (4), it says daily protection, again.

You can see here :

http://tinypic.com/r/hs8308/8

Or, here :

http://i57.tinypic.com/hs8308.jpg

Sorry, for bad paint skills :)

Michael A., you make a great point here: "... in the U.S., the devil is in the details and it is not possible to generalize by focusing on "objects.""

Even if a device has a chemical effect, if you can prove that the primary mechanism of action is physical in nature (in this case a barrier), you can get a device classification, as shown by this de novo approval: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K041482 .

That approval resulted in the Class II Special Controls Guidance Document referenced by Bruce T above: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071642.htm

Robert Poyser Apples are sold as good for your teeth and helps prevent cavities...

Hmm another medical device this time from the tree?

Karl Schulmeisters Ah and therein lies the rub Robert. for example if peanut butter were to be sold as a food additive, it would likely not get approval.

Robert Poyser and a tea spoon is commonly used for administering medicine...............
also a contact lens is a medical device, but cosmetic in eye lenses are not!

crazzzzy old world.

Luigi Torre Mouthwashes and toothpastes are normally considered cosmetic products. However, the Cosmetic Regulation 1223/2009 establishes some limits to the concentration/quantity of active ingredients (like fluoride, chlorhexidine, etc.). Under these limits, the product is a cosmetic, above them, it is something else (e.g. a drug or a MD).

I know I'm a little late to the party, but I used to work for CDRH and there was an adverse event report that an ultrasonic toothbrush head loosened, the top came off and shot into the person's throat. I don't know the complete details, but when something like that is reported to the FDA, they have to look into it, even if they hadn't originally considered toothbrushes to be potentially dangerous. As far as toothpaste goes, I believe only toothpaste with fluoride has to be approved. Fluoride tablets that children take are also by prescription only.