FDA OTC Monographed Products

No Prescription Needed

Young Living introduced the over-the-counter (OTC) line of products at the 2016 Convention. These products are formulated with powerful active ingredients to give you natural results—no prescription needed!

The new line is Young Living’s first step into the world of OTC medicine formulated with natural ingredients. Because these new products meet strict FDA regulations, they give Young Living and our members the ability to share specific yet significant claims about OTC products. It’s one more way Young Living strives to bring the world natural wellness solutions that are backed by science.

So what sets OCT products apart? It starts with FDA regulations. The FDA has written OTC monographs, which are detailed documents that list the specific conditions required for a product to become on OTC medicine. A product is essentially pre-approved as a certain OTC medicine when it adheres to its monograph.

While the monographs outline the necessary active ingredients, amounts of active ingredients, and format, companies still determine a number of variables, allowing them to create proprietary medicines. That’s what enables Young Living to produce OTC medicines with powerful claims, while using natural active ingredients and adhering to the Young Living standard.

For example, while other companies or brands might use synthetic active ingredients, our current OTC products source active ingredients from pure essential oils. Take a look at Cool Azul Pain Relief Cream: The required methyl salicylate is a naturally occurring compound in Wintergreen, while the menthol comes from Peppermint. This way Young Living meets FDA requirements through plant-based ingredients, and Young Living and our members can make specific claims that otherwise couldn’t be made.

Thanks to our skilled Research and Development team, we’re able to pair our knowledge of plant-based, naturally derived products with the FDA’s regulations for safe and effective medicine. This exciting chapter reasserts Young Living’s commitment to research-based products—and from here we’re poised to reach new heights!

The Essential Edge, August 2016

More details from the FDA website on the difference between FDA approved and FDA registered.

Current FDA OTC Monographed Products

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