Is Hydroxyapatite FDA Accredited? – Ask the Dentist


A standard query I get is whether or not hydroxyapatite is FDA authorised. 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 truth, fluoride varnishes are often utilized “off-label” for caries prevention, a observe permitted by the FDA.

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

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

The reality is, many oral care components, 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 a substitute, 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 authorised labeling. FDA approval isn’t 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 components and their functions.

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

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So, within the absence of FDA-approval, what do you have to 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 instantly 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 provide you with to establish client efficacy, well being, and security, and I encourage you to share these extensively together with your sufferers, buddies, 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 isn’t suspected to be an environmental toxin, not anticipated to be doubtlessly poisonous or dangerous, and never suspected to be bioaccumulative: 

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

In dentistry, we now have a foul behavior of specializing in simply the tooth and neglecting the impression of medicine and drugs 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, they usually have assessed hydroxyapatite’s impression on systemic well being. As of this writing, the one hydroxyapatite on the planet that meets the rigorous requirements supplied by the SCCS last 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 Last Opinion on nano-Hydroxyapatite, March 2023, web page 3:

The SCCS concludes the next:

1. In view of the above, and bearing in mind the scientific knowledge supplied, does the SCCS take into account hydroxyapatite (nano) protected when utilized in oral beauty merchandise in accordance with the utmost concentrations and specs as reported within the submission, bearing in mind fairly foreseeable publicity circumstances?

Primarily based on the information supplied, the SCCS considers hydroxyapatite (nano) protected 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 facet ratio lower than 3, and the remaining 4.2% have a facet ratio not exceeding 4.9; 

– the particles aren’t coated or floor modified.

Will the FDA approve hydroxyapatite in the future?

Despite the fact that hydroxyapatite toothpaste and polish aren’t FDA-approved, there’s optimistic motion ahead:

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

D2991 Software of hydroxyapatite regeneration medicament – per tooth 

1. When coated, process D2991 is a profit twice per tooth per profit 12 months. Advantages for greater than twice per tooth per profit 12 months 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, aren’t 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 can 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 jot down letters to insurance coverage corporations and the FDA. My colleague and associate at Fygg, Dr. Staci Whitman, shared with me a letter she’s written to the FDA, and I’ve included it beneath with permission as a template so that you can copy/paste and use your self when you select:

Instance letter urging insurance coverage corporations 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 coated profit on your dental insurance policy. As a pediatric dentist with practically twenty years of medical expertise, I’ve witnessed firsthand the transformative impression of this materials on kids’s oral well being.

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

In my observe, the usage of hydroxyapatite varnish has resulted in a major lower within the variety of fillings and crowns I place on kids. This interprets to fewer anesthesia visits, decreased remedy time, and in the end, a decrease total value for each sufferers and insurance coverage suppliers. Moreover, by arresting the development of cavities early, we are able to forestall the necessity for extra in depth 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 optimistic impression I’ve noticed:

  • Diminished Variety of Fillings: Since incorporating hydroxyapatite varnish into my observe, I’ve seen a [Percentage] lower within the variety of fillings positioned on kids.
  • Fewer Anesthesia Visits: The painless utility of varnish eliminates the necessity for anesthesia in lots of circumstances, decreasing anxiousness and making a extra optimistic 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 invaluable software for caries prevention. By together with protection for code D2991, Delta Dental could be demonstrating a dedication to proactive oral healthcare for kids, in the end resulting in a more healthy and cheaper strategy to pediatric dentistry.

I urge you to strongly take into account including hydroxyapatite varnish to your listing of coated advantages. I’m assured that this choice would have a major optimistic impression on the oral well being of your pediatric sufferers.

Thanks on your time and consideration. I’d be joyful to offer any additional data, analysis, or reply any questions you could have.


Anastacia M Whitman, DMD, IFMCP

Board-Licensed Pediatric Dentist


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