All About CELLIANT’s FDA Determination
At CELLIANT®, we believe in science. It is the guiding force behind our innovation and development. We are continually working with our Science Advisory Board to affirm the benefits of both infrared technology and CELLIANT itself through their oversight of continued peer-reviewed, published studies. The culmination of this research led to a breakthrough in 2017 when, in response to our 513(g) Request for Information submission, the United States Food and Drug Administration (FDA) determined what it deemed appropriate health and wellness claims for CELLIANT products. Furthermore, the FDA determined that CELLIANT products are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act and general wellness products.
What is the 513(g) Submission Process?
Section 513(g) of the Federal Food, Drug and Cosmetic Act (FFDCA) is a process established for companies to engage with the FDA to solicit guidance on how the FDA would classify their device. Submitted in the form of a written request, the 513(g) application contains a description of the device, a description of what the device is to be used for, and any proposed labeling or promotional material for the device. The FDA then issues a response to the questions posed in the request. In some cases, either more information is required, or the product does not meet the threshold for classification of a medical device. However, in the case of CELLIANT, we received confirmation that the FDA had determined that CELLIANT products were, in fact, a medical device with general wellness claims. In addition, the FDA determined that the health and wellness claims proposed by Hologenix for CELLIANT products are appropriate.
Is CELLIANT FDA Approved?
No, CELLIANT is not FDA approved. FDA’s responses to 513(g) Requests for Information are not device classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the FD&C Act. In the FDA’s response to our 513(g) submission, we were informed that the FDA has determined that CELLIANT products are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act and are general wellness products. The FDA determined products containing CELLIANT are medical devices because they are intended to affect the structure or function of the body of man by temporarily promoting increased blood flow at the site of application in healthy individuals. The FDA has not approved or designated CELLIANT products for any purpose and has not made any determination about, or endorsement of, its stated use or benefits. Simply, the FDA has affirmed that CELLIANT does meet the definition of a medical device and a general wellness product.
What is Meant by a Medical Device and Why is CELLIANT a Medical Device?
By definition, the FDA regulates medical devices. Per section 201(h) of the Federal Food, Drug and Cosmetic Act, a medical device is defined broadly as “any instrument, machine, contrivance, implant, in vitro reagent that’s intended to treat, cure, prevent, mitigate, diagnose disease in man.” Under this definition, any product that is intended to alter the physiology of man is considered a medical device. As CELLIANT products are intended to temporarily increase blood flow and local circulation at the site of application in healthy individuals, they, by definition, are medical devices.
What is Meant by a General Wellness Product? Is CELLIANT Safe?
FDA, specifically the Center for Devices and Radiological Health (CDRH) defines general wellness products as products that meet the following two factors: (1) are intended for only general wellness use as defined in FDA’s guidance, and (2) present a low risk to the safety of users and other persons. A general wellness product, for purposes of FDA’s guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
General wellness products are defined by the FDA as being a low-risk product that promotes a healthy lifestyle. These products are designed to maintain and/or encourage healthy living unrelated to the diagnosis, cure, mitigation, prevention, or treatment of any disease or condition. Thus, it can be concluded that CELLIANT is a low-risk product. To further reduce risk with CELLIANT, biocompatibility testing was performed to evaluate the potential for an unacceptable adverse biological response resulting from contact of the device with the body. Such tests included: cytotoxicity, skin irritation, sensitization and leeching. CELLIANT passed all tests and thus is biocompatible.
Can I See Your Official Documentation From the FDA?
Oftentimes, the brand partners we work with do request to see the FDA response to our 513(g) submission as part of their diligence process. We encourage brand partners to do their due diligence in finding a transparent partner for their infrared ingredient brand of choice, and for this reason we are happy to share digital proof of our correspondence with the FDA. If you have worked with a CELLIANT business developer to sign a mutual non-disclosure agreement, simply get in touch with them asking for this information and they would be happy to share.
Does Your FDA Determination Apply to My Company’s Products? Do I Need to Submit My Company’s CELLIANT Products to the FDA?
CELLIANT’s FDA determination as a medical device and a general wellness product extends to any product containing CELLIANT, provided the underlying technology and claims are unchanged, follows CELLIANT’s usage guidelines, and has passed the tests that our IRB certified testing laboratory utilizes to ensure CELLIANT minerals are present in the correct amounts. When you have worked with our team to develop a product that is loaded with the proper amount of CELLIANT and has passed our certification process, and the medical device and general wellness claims remain intact, by extension, CELLIANT’s FDA determination applies to your products. Therefore, you do not need to submit your products to the FDA. You can learn more about how CELLIANT is tested on our blog.
How Can I Use the FDA Determination to Help Market My Products?
If you would like to use language related to the FDA in your marketing materials for your products, please be advised that you must recite the following sentence in its entirety: The FDA has determined that CELLIANT products are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act and are general wellness products. Under no circumstances may the FDA logo ever be used.
We understand that this is not the most marketing-friendly language, so what may be more beneficial is to consider that based on CELLIANT’s capability as a general wellness product, there are a variety of permissible claims that may be used for marketing purposes. These are dependent on the type of product you have created, therefore a combination of the following may be appropriate depending on the desired function:
- Temporarily increases blood flow (temporarily increases local circulation)
- Enhances/increases performance
- Increases/more energy
- Increases/more/better endurance
- Increases/enhances/more speed
- Improves/increases strength
- Increases/more stamina
- Faster/quicker recovery
- Promotes restful sleep
- Helps increase comfort
- Supports heat generation
- Increases/more thermal energy
- Recycles human energy
Our marketing team regularly works closely with our brand partners to develop language that contextualizes these benefits for your end consumer, helping them to visualize and understand why these benefits are an advantage to them. For example, if you create CELLIANT bedding products, you can explain to your customers that they increase local circulation, which helps improve thermoregulation whether you run hot or cold and promotes restful sleep.
For support on language related to CELLIANT’s benefits as they apply to your specific products, you can reach out to firstname.lastname@example.org. And, for further questions related to our FDA determination and compliance requirements, please reach out to our Regulatory Affairs department at email@example.com.