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When Does Your Colloidal Oatmeal Product Fall Under FDA Regulations?

When Does Your Colloidal Oatmeal Product Fall Under FDA Regulations?

In 2003, the FDA-approved colloidal oatmeal as a “skin protectant,” meaning the FDA considers colloidal oatmeal to be an effective ingredient for alleviating dryness, itching, and discomfort caused by certain skin conditions. Since colloidal oatmeal formulations are effective in treating conditions like eczema, psoriasis, and dermatitis, colloidal oatmeal can be found in a wide range of cosmetics and over-the-counter topical drugs.

While colloidal oatmeal is considered safe and effective for use in over-the-counter creams, lotions, and shampoos, manufacturers are required to adhere to guidelines laid out by the FDA and the United States Pharmacopeia (USP).

FDA Requirements for Colloidal Oatmeal Products

The FDA guidelines for colloidal oatmeal products are laid out in the Over-the-Counter Final Monograph for Skin Protectant Drug Products (released in 2003). In this document, the FDA states that chemical information about colloidal oatmeal must be made publicly available.

Based on a proposal from a manufacturer, the FDA worked with the USP to develop a standard process for the formulation of colloidal oatmeal. The standard process includes limits on:

  • Total aerobic microbial count
  • Weight loss on drying
  • Particle size
  • Nitrogen content
  • Fat content
  • Residual solvents

The FDA also set minimums for the amount of colloidal oatmeal used as an active pharmaceutical ingredient (API). Skin protectant drugs must contain at least 0.007 percent colloidal oatmeal when it is the single API, or a minimum of 0.003 percent colloidal oatmeal when it is combined with mineral oil.

Mineral oil is the only active ingredient that can be combined with colloidal oatmeal. Other common skin protectant active ingredients, such as cod liver oil, cocoa butter, and zinc oxide, are described and listed in separate active ingredient lists and cannot be used in formulations containing colloidal oatmeal.

What Do the FDA Requirements Mean for Your Colloidal Oatmeal Products?

The FDA requirements for colloidal oatmeal are not meant to create obstacles – they are meant to ensure safety, efficacy, and transparency. Most cosmetic and pharmaceutical manufacturers should have no issues adhering to the established FDA and USP standards for the use of colloidal oatmeal. However, if you are formulating a new colloidal oatmeal formulation or switching a raw material supplier for this active ingredient, it is worth having an independent chemical testing lab perform a qualification of the raw material and/or the finished product. This type of analysis could provide the following information:

  • Determination of the average particle size
  • Identify and quantify the vitamin content
  • Evaluate the quality of the ingredient from your raw material supplier
  • Identify potential sources of contamination
  • Determine why your finished product is not performing as expected (e. failure analysis)

In addition to helping you adhere to FDA guidelines, a colloidal oatmeal analysis can help you release a better product so that you can gain a competitive advantage over other OTC topical drug manufacturers. Contact us to get a colloidal oatmeal analysis completed.