Hyaluronic Acid Molecular Weight and FDA Documentation for Nano Claim

Asked by: okdivj01 On: April 01, 2021 Product Type: Cosmetics

Question

I would like to ask if [url=http://www.myskinrecipes.com/shop/%E0%B8%A1%E0%B8%AD%E0%B8%A2%E0%B8%8B%E0%B9%8C%E0%B9%80%E0%B8%88%E0%B8%AD%E0%B8%A3%E0%B9%8C/404-double-hyaluron-liquid.html:30neeh6o]Hyaluronic Acid[/url:30neeh6o] (Standard Molecule) with a molecular weight of 1,000,000 daltons can be considered nano-sized. I have submitted the analysis document received from MySkinRecipes to the FDA (อย.), and they have asked me to highlight which part of the document specifies that the molecule is small.

Answer

Based on the information you provided, Hyaluronic Acid with a molecular weight of 1,000,000 daltons is considered a high molecular weight hyaluronic acid. This size is not typically classified as nano-sized. Nano-sized or low molecular weight hyaluronic acid usually refers to molecules much smaller, often in the range of a few thousand to tens of thousands of daltons.

It's possible that the "double-hyaluron-liquid" product you purchased contains a mixture of different molecular weights of hyaluronic acid, including both the high molecular weight (1,000,000 daltons) and a lower molecular weight fraction.

When the FDA (อย.) asks you to highlight where the document specifies a "small molecule", they are likely referring to the documentation for the low molecular weight component of the product, if one is present.

You should look for sections in your analysis document that mention:

  • Low Molecular Weight Hyaluronic Acid: Look for terms like "Low Molecular Weight Hyaluronic Acid", "Hydrolyzed Hyaluronic Acid", or specific molecular weight ranges that are much lower than 1,000,000 daltons (e.g., < 10,000 Da, < 5,000 Da).
  • Molecular Weight Distribution: Some documents might show a distribution curve or list the percentages of different molecular weight fractions present in the product. Look for a peak or mention of a fraction in the low molecular weight range.

The documentation specifically for the "Hyaluronic Acid (Standard Molecule)" at 1,000,000 daltons will show that it is a large molecule, not a small or nano one. You need to find the part of the documentation that describes the other component of the "double-hyaluron-liquid" product, which is likely the low molecular weight part, and highlight the information related to its smaller size.