A standard query I get is whether or not hydroxyapatite is FDA accredited. 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, usually utilized in dental places of work, have garnered FDA approval as Class II Medical Units.

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

The truth is, fluoride varnishes are steadily utilized “off-label” for caries prevention, a follow permitted by the FDA.

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

Hydroxyapatite is FDA accredited 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 accredited labeling. FDA approval just 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 medicine utilized in medical follow for kids have by no means been examined in youngsters. The FDA regulation states: “Good medical follow and the very best pursuits of the affected person require that physicians use legally obtainable medicine, biologics and gadgets in response to their finest information and judgment. If physicians use a product for a sign not within the accredited 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 data 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 give you to determine shopper efficacy, well being, and security, and I encourage you to share these broadly together with your sufferers, buddies, or household. 

1. Does it work on tooth?

Peer reviewed research are the gold commonplace, 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 just isn’t suspected to be an environmental toxin, not anticipated to be probably poisonous or dangerous, and never suspected to be bioaccumulative: https://www.ewg.org/skindeep/components/703046-HYDROXYAPATITE/ 

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

In dentistry, we now have a nasty behavior of specializing in simply the tooth and neglecting the influence of medication and drugs on systemic well being. 

For this reason I look to the SCCS ruling, because the SCCS is like an FDA however with stricter requirements, they usually have assessed hydroxyapatite’s influence on systemic well being. As of this writing, the one hydroxyapatite on the planet that meets the rigorous requirements offered by the SCCS last opinion on March 2023 is Fluidinova, made in Portugal, and this is among the causes we selected Fluidnova because the supply of hydroxyapatite for all of our toothpastes and varnishes at Fygg.

From the SCCS Ultimate 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 offered, does the SCCS take into account hydroxyapatite (nano) secure when utilized in oral beauty merchandise in response to the utmost concentrations and specs as reported within the submission, taking into consideration moderately foreseeable publicity circumstances?

Primarily based on the info offered, 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 not 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 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 optimistic motion ahead:

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

D2991 Software of hydroxyapatite regeneration medicament – per tooth 

1. When coated, 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 similar 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 shall 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 keen about this matter, I encourage you to write down letters to insurance coverage corporations and the FDA. My colleague and companion 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 corporations and/or FDA approval of hydroxyapatite

Staci Whitman:

Topic: Request for Protection of Hydroxyapatite Varnish

Expensive {{NAME}},

I’m writing to you immediately to advocate for the inclusion of hydroxyapatite varnish as a coated profit in your dental insurance coverage. As a pediatric dentist with almost twenty years of medical expertise, I’ve witnessed firsthand the transformative influence of this materials on youngsters’s oral well being.

Hydroxyapatite varnish provides 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 sometimes sedation and normal anesthesia, varnish may 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 follow, using hydroxyapatite varnish has resulted in a big lower within the variety of fillings and crowns I place on youngsters. This interprets to fewer anesthesia visits, diminished therapy time, and in the end, a decrease general value for each sufferers and insurance coverage suppliers. Moreover, by arresting the development of cavities early, we will stop 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’t do. 

Right here’s a breakdown of the optimistic influence I’ve noticed:

• Lowered Variety of Fillings: Since incorporating hydroxyapatite varnish into my follow, 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 instances, 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 useful device for caries prevention. By together with protection for code D2991, Delta Dental can be demonstrating a dedication to proactive oral healthcare for kids, in the end resulting in a more healthy and more cost effective strategy to pediatric dentistry.

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

Thanks in your time and consideration. I’d be completely happy to offer any additional info, analysis, or reply any questions you’ll have.

Sincerely,

Anastacia M Whitman, DMD, IFMCP

Board-Licensed Pediatric Dentist