Is Hydroxyapatite FDA Approved? – Ask the Dentist

A common question I get is whether hydroxyapatite is FDA approved. The short answer? No, it’s not. But let’s delve deeper into why that is and what it means for you.

Traditional fluoride varnishes, often used in dental offices, have garnered FDA approval as Class II Medical Devices.

However, it’s crucial to understand that this approval pertains to their use as cavity liners and tooth desensitizers, not as caries preventive agents.

In fact, fluoride varnishes are frequently utilized “off-label” for caries prevention, a practice permitted by the FDA.

Why isn’t hydroxyapatite FDA approved for dental use yet?

Hydroxyapatite is FDA approved for medical applications, but not yet dental. In the United States, the Food and Drug Administration (FDA) doesn’t allow cavity-fighting claims for toothpastes that don’t have fluoride.

The truth is, many oral care ingredients, including fluoride (yes, fluoride!), lack FDA approval for certain uses, and we use them off-label. This doesn’t mean fluoride or hydroxyapatite don’t work—instead, it highlights the evolving landscape of oral health research and regulation.

The FDA’s stance on off-label use underscores the importance of informed decision-making and responsible usage by healthcare professionals. Practitioners are encouraged to rely on scientific rationale and medical evidence when utilizing products for purposes beyond their approved labeling. FDA approval is not required to use fluoride varnish off-label. (USFDA, 1998, USP DI, 2006) 

In summary, the absence of FDA approval for hydroxyapatite doesn’t diminish its effectiveness or safety. Instead, it underscores the need for a nuanced understanding of oral care ingredients and their applications.

Many medications are currently prescribed and administered for off-label use, and many drugs used in medical practice for children have never been tested in children. The FDA regulation states: “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well-informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.” (USFDA, 1998; AAP, 2002)

So, in the absence of FDA-approval, what should you look for in a hydroxyapatite toothpaste?

The FDA currently regulates toothpaste as a cosmetic product, which I believe is insufficient for a product that directly impacts the oral microbiome and whole-body systemic health. Not to mention, it’s used twice a day for life. 

In the absence of regulation, these are the quality standards that I’ve come up with to ascertain consumer efficacy, health, and safety, and I encourage you to share these widely with your patients, friends, or family. 

1. Does it work on teeth?

Peer reviewed studies are the gold standard, as we know. Multiple peer-reviewed studies have demonstrated the efficacy of hydroxyapatite for caries, sensitivity, and even whitening. 

The Environmental Working Group has given hydroxyapatite a 1/10, finding that hydroxyapatite is not suspected to be an environmental toxin, not expected to be potentially toxic or harmful, and not suspected to be bioaccumulative: https://www.ewg.org/skindeep/ingredients/703046-HYDROXYAPATITE/ 

2. Is it safe for the rest of the body?

In dentistry, we have a bad habit of focusing on just the teeth and neglecting the impact of drugs and medications on systemic health. 

This is why I look to the SCCS ruling, as the SCCS is like an FDA but with stricter standards, and they have assessed hydroxyapatite’s impact on systemic health. As of this writing, the only hydroxyapatite in the world that meets the rigorous standards provided by the SCCS final opinion on March 2023 is Fluidinova, made in Portugal, and this is one of the reasons we chose Fluidnova as the source of hydroxyapatite for all of our toothpastes and varnishes at Fygg.

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

The SCCS concludes the following:

1. In view of the above, and taking into account the scientific data provided, does the SCCS consider hydroxyapatite (nano) safe when used in oral cosmetic products according to the maximum concentrations and specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions?

Based on the data provided, the SCCS considers hydroxyapatite (nano) safe when used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash.

This safety evaluation only applies to the hydroxyapatite (nano) with the following characteristics: 

– composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9; 

– the particles are not coated or surface modified.

Will the FDA approve hydroxyapatite one day?

Even though hydroxyapatite toothpaste and varnish are not FDA-approved, there is positive movement forward:

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

D2991 Application of hydroxyapatite regeneration medicament – per tooth 

1. When covered, procedure D2991 is a benefit twice per tooth per benefit year. Benefits for more than twice per tooth per benefit year are denied and are the patient’s responsibility. 

2. The fees for D2991, on the same tooth and on the same date of service as a restoration, are not billable to the patient at the same dentist/dental office.

Movements into new materials and procedures take time. We saw this with the movement away from alloy fillings and with the implementation of SDF, and we are confident hydroxyapatite will be recognized soon.

In the meantime, what can you do?

Whether you’re a patient or a practitioner, if you are passionate about this topic, I encourage you to write letters to insurance companies and the FDA. My colleague and partner at Fygg, Dr. Staci Whitman, shared with me a letter she’s written to the FDA, and I’ve included it below with permission as a template for you to copy/paste and use yourself if you choose:

Example letter urging insurance companies and/or FDA approval of hydroxyapatite

Staci Whitman:

Subject: Request for Coverage of Hydroxyapatite Varnish

Dear {{NAME}},

I am writing to you today to advocate for the inclusion of hydroxyapatite varnish as a covered benefit for your dental insurance plans. As a pediatric dentist with nearly twenty years of clinical experience, I have witnessed firsthand the transformative impact of this material on children’s oral health.

Hydroxyapatite varnish offers a safe and effective, minimally invasive approach to arresting and remineralizing early cavitations. Unlike traditional fillings, which require local anesthetic and drilling, and often sedation and general anesthesia, varnish can be applied topically during follow-up and routine checkups to manage disease just like fluoride vanishes. This not only reduces the need for more invasive procedures but also creates a positive dental experience for young patients, fostering a lifelong commitment to oral health.

In my practice, the use of hydroxyapatite varnish has resulted in a significant decrease in the number of fillings and crowns I place on children. This translates to fewer anesthesia visits, reduced treatment time, and ultimately, a lower overall cost for both patients and insurance providers. Additionally, by arresting the progression of cavities early, we can prevent the need for more extensive and expensive restorative procedures down the line.  Hydroxyapatite has also been shown to help modulate and optimize the oral microbiome, something fluoride cannot do. 

Here’s a breakdown of the positive impact I’ve observed:

• Reduced Number of Fillings: Since incorporating hydroxyapatite varnish into my practice, I have seen a [Percentage] decrease in the number of fillings placed on children.
• Fewer Anesthesia Visits: The painless application of varnish eliminates the need for anesthesia in many cases, reducing anxiety and creating a more positive dental experience for young patients.
• Early Intervention: Varnish allows for early intervention, stopping the progression of cavities before they require more invasive procedures.

The American Academy of Pediatric Dentistry (AAPD) recognizes hydroxyapatite varnish as a valuable tool for caries prevention. By including coverage for code D2991, Delta Dental would be demonstrating a commitment to proactive oral healthcare for children, ultimately leading to a healthier and more cost-effective approach to pediatric dentistry.

I urge you to strongly consider adding hydroxyapatite varnish to your list of covered benefits. I am confident that this decision would have a significant positive impact on the oral health of your pediatric patients.

Thank you for your time and consideration. I would be happy to provide any further information, research, or answer any questions you may have.

Sincerely,

Anastacia M Whitman, DMD, IFMCP

Board-Certified Pediatric Dentist