One of the most recent questions that we had was regarding the FDA approval of Manuka Honey. Unfortunately, when we did our comprehensive search, we noted that some of the websites were addressing Manuka Honey as FDA approved, which was not the fact actually.
Is it FDA Approved?
I really don’t remember how many times I saw these words somewhere on a company’s website. Once you start searching, you’ll also figure out that some websites and promoters say that their Manuka Honey is FDA approved, but is that the truth?
First of all, FDA has explained their responsibility as “FDA is responsible for protecting the public health by regulating human and animal drugs, biologics (e.g. vaccines and cellular and gene therapies), medical devices, food and animal feed, cosmetics, and products that emit radiation.” on the FDA’s official website here.
Secondly, FDA does not approve companies, health care facilities, or manufacturers. What is clearly mentioned on FDA’s website is that FDA inspects product manufacturers to verify that they comply with good manufacturing practices.
To have a better understanding of what FDA does and does not approve, I listed a brief summary for you before touching base to the Manuka Honey FDA approval:
- FDA approves new drugs and biologics
- FDA uses a risk-based, tiered approach for regulating medical devices
- FDA approves additives in food for people
- FDA approves drugs and additives in food for animals
- FDA approves color additives used in FDA-regulated products
- FDA does not approve compounded drugs
- FDA does not approve cosmetics
- FDA does not approve medical foods
- FDA does not approve infant formula
- FDA does not approve dietary supplements
- FDA does not approve the food label, including Nutrition Facts
- FDA does not approve structure-function claims on dietary supplements and other foods
As per the above facts, it looks like that Manuka Honey is not FDA approved! One of the results that I’ve reached after making a search on FDA website regarding Manuka Honey is a 510(k) file dated 23 April 2008 for Derma Sciences Medi Honey Dressings with Active Manuka Honey. There are couple more 510(k) files that are showing as a result for Manuka and can also be found on http://www.fda.gov/ website.
What is FDA 510(k)?
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to Premarket Approval (PMA). More details regarding 510(k) can be found here.
What is clearly written within the FDA letter for is as follows (extract a copy from the FDA letter):
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, a listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to the market.
As I have underlined the quoted parts of the FDA letter, it can be seen that this is not a product approval letter, and just clears the fact that the device, which is Derma Sciences Medi Honey Dressings with Active Manuka Honey can be marketed. That’s it!
Note: The above quoted FDA letter is not a full copy of it and it can be reached from here.