A typical query I get is whether or not hydroxyapatite is FDA authorized. The brief reply? No, it’s not. However let’s delve deeper into why that’s and what it means for you.

Conventional fluoride varnishes, typically utilized in dental places of work, have garnered FDA approval as Class II Medical Gadgets.

Nonetheless, it’s essential to grasp that this approval pertains to their use as cavity liners and tooth desensitizers, not as caries preventive brokers.

In reality, fluoride varnishes are incessantly utilized “off-label” for caries prevention, a apply permitted by the FDA.

Why isn’t hydroxyapatite FDA authorized for dental use but?

Hydroxyapatite is FDA authorized for medical functions, however not but dental. In america, the Meals and Drug Administration (FDA) doesn’t enable cavity-fighting claims for toothpastes that don’t have fluoride.

The reality is, many oral care substances, together with fluoride (sure, fluoride!), lack FDA approval for sure makes use of, and we use them off-label. This doesn’t imply fluoride or hydroxyapatite don’t work—as an alternative, it highlights the evolving panorama of oral well being analysis and regulation.

The FDA’s stance on off-label use underscores the significance of knowledgeable decision-making and accountable utilization by healthcare professionals. Practitioners are inspired to depend on scientific rationale and medical proof when using merchandise for functions past their authorized labeling. FDA approval is just not required to make use of fluoride varnish off-label. (USFDA, 1998, USP DI, 2006) 

In abstract, the absence of FDA approval for hydroxyapatite doesn’t diminish its effectiveness or security. As a substitute, it underscores the necessity for a nuanced understanding of oral care substances and their functions.

Many medicines are at present prescribed and administered for off-label use, and lots of medication utilized in medical apply for youngsters have by no means been examined in youngsters. The FDA regulation states: “Good medical apply and the most effective pursuits of the affected person require that physicians use legally accessible medication, biologics and gadgets in accordance with their greatest data and judgment. If physicians use a product for a sign not within the authorized labeling, they’ve the duty to be well-informed concerning the product, to base its use on agency scientific rationale and on sound medical proof, and to take care of information of the product’s use and results.” (USFDA, 1998; AAP, 2002)

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So, within the absence of FDA-approval, what must you search for in a hydroxyapatite toothpaste?

The FDA at present regulates toothpaste as a beauty product, which I consider is inadequate for a product that immediately impacts the oral microbiome and whole-body systemic well being. To not point out, it’s used twice a day for all times. 

Within the absence of regulation, these are the standard requirements that I’ve give you to establish shopper efficacy, well being, and security, and I encourage you to share these broadly together with your sufferers, associates, or household. 

1. Does it work on tooth?

Peer reviewed research are the gold normal, as we all know. A number of peer-reviewed research have demonstrated the efficacy of hydroxyapatite for caries, sensitivity, and even whitening. 

The Environmental Working Group has given hydroxyapatite a 1/10, discovering that hydroxyapatite is just not suspected to be an environmental toxin, not anticipated to be doubtlessly poisonous or dangerous, and never suspected to be bioaccumulative (Supply).

2. Is it secure for the remainder of the physique?

In dentistry, we have now a foul behavior of specializing in simply the tooth and neglecting the impression of medicine and medicines on systemic well being. 

This is the reason I look to the SCCS ruling, because the SCCS is like an FDA however with stricter requirements, and so they have assessed hydroxyapatite’s impression on systemic well being. As of this writing, the one hydroxyapatite on the earth that meets the rigorous requirements supplied by the SCCS remaining opinion on March 2023 is Fluidinova, made in Portugal, and this is without doubt one of the causes we selected Fluidnova because the supply of hydroxyapatite for all of our toothpastes and varnishes at Fygg.

From the SCCS Remaining Opinion on nano-Hydroxyapatite, March 2023, web page 3:

The SCCS concludes the next:

1. In view of the above, and taking into consideration the scientific information supplied, does the SCCS think about hydroxyapatite (nano) secure when utilized in oral beauty merchandise in accordance with the utmost concentrations and specs as reported within the submission, taking into consideration fairly foreseeable publicity situations?

Based mostly on the info supplied, the SCCS considers hydroxyapatite (nano) secure when used at concentrations as much as 10% in toothpaste, and as much as 0.465% in mouthwash.

This security analysis solely applies to the hydroxyapatite (nano) with the next traits: 

– composed of rod-shaped particles of which no less than 95.8% (in particle quantity) have a side ratio lower than 3, and the remaining 4.2% have a side ratio not exceeding 4.9; 

– the particles should not coated or floor modified.

Will the FDA approve hydroxyapatite at some point?

Though hydroxyapatite toothpaste and polish should not FDA-approved, there may be constructive motion ahead:

In 2024, the CDT adopted new codes for using hydroxyapatite varnishes:

D2991 Utility of hydroxyapatite regeneration medicament – per tooth 

1. When lined, process D2991 is a profit twice per tooth per profit yr. Advantages for greater than twice per tooth per profit yr are denied and are the affected person’s duty. 

2. The charges for D2991, on the identical tooth and on the identical date of service as a restoration, should not billable to the affected person on the identical dentist/dental workplace.

Actions into new supplies and procedures take time. We noticed this with the motion away from alloy fillings and with the implementation of SDF, and we’re assured hydroxyapatite will probably be acknowledged quickly.

Within the meantime, what are you able to do?

Whether or not you’re a affected person or a practitioner, in case you are enthusiastic about this matter, I encourage you to write down letters to insurance coverage firms and the FDA. My colleague and accomplice at Fygg, Dr. Staci Whitman, shared with me a letter she’s written to the FDA, and I’ve included it under with permission as a template so that you can copy/paste and use your self if you happen to select:

Instance letter urging insurance coverage firms and/or FDA approval of hydroxyapatite

Staci Whitman:

Topic: Request for Protection of Hydroxyapatite Varnish

Expensive NAME,

I’m writing to you at the moment to advocate for the inclusion of hydroxyapatite varnish as a lined profit in your dental insurance policy. As a pediatric dentist with practically twenty years of scientific expertise, I’ve witnessed firsthand the transformative impression of this materials on youngsters’s oral well being.

Hydroxyapatite varnish gives a secure and efficient, minimally invasive strategy to arresting and remineralizing early cavitations. In contrast to conventional fillings, which require native anesthetic and drilling, and infrequently sedation and common anesthesia, varnish might be utilized topically throughout follow-up and routine checkups to handle illness similar to fluoride vanishes. This not solely reduces the necessity for extra invasive procedures but additionally creates a constructive dental expertise for younger sufferers, fostering a lifelong dedication to oral well being.

In my apply, using hydroxyapatite varnish has resulted in a major lower within the variety of fillings and crowns I place on youngsters. This interprets to fewer anesthesia visits, lowered remedy time, and finally, a decrease total price for each sufferers and insurance coverage suppliers. Moreover, by arresting the development of cavities early, we are able to stop the necessity for extra intensive and costly restorative procedures down the road.  Hydroxyapatite has additionally been proven to assist modulate and optimize the oral microbiome, one thing fluoride can not do. 

Right here’s a breakdown of the constructive impression I’ve noticed:

• Decreased Variety of Fillings: Since incorporating hydroxyapatite varnish into my apply, I’ve seen a [Percentage] lower within the variety of fillings positioned on youngsters.
• Fewer Anesthesia Visits: The painless software of varnish eliminates the necessity for anesthesia in lots of circumstances, decreasing nervousness and making a extra constructive dental expertise for younger sufferers.
• Early Intervention: Varnish permits for early intervention, stopping the development of cavities earlier than they require extra invasive procedures.

The American Academy of Pediatric Dentistry (AAPD) acknowledges hydroxyapatite varnish as a priceless instrument for caries prevention. By together with protection for code D2991, Delta Dental can be demonstrating a dedication to proactive oral healthcare for youngsters, finally resulting in a more healthy and cheaper strategy to pediatric dentistry.

I urge you to strongly think about including hydroxyapatite varnish to your listing of lined advantages. I’m assured that this choice would have a major constructive impression on the oral well being of your pediatric sufferers.

Thanks in your time and consideration. I might be completely happy to supply any additional data, analysis, or reply any questions you could have.

Sincerely,

Anastacia M Whitman, DMD, IFMCP

Board-Licensed Pediatric Dentist