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Zooman009

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Jul 29, 2020
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I have an idea for an ointment to help people with a problem that nearly everyone has. Problem is that it’s got essential oils in it, and I’m not exactly sure how to navigate the maze that is the law. I looked at the FDA website and it sounds like (with the claims I want to make) it’s a drug. So I don’t know if I need to get FDA approved before hitting the market. I think it may not need it, because the oils I need to use are already out and in the market.

not sure why I’m putting this on here when I should be studying it on my own, but I figure that I might as well.
 
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Zooman009

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Perhaps label it as a balm or a salve then it's not an ointment.
Plus you don't make claims, you infer.
Hmmmm. I like the balm idea a lot. Now I just need to write up a good description which helps the customer to infer the use of the product.
 

Flint

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Look at other products that use the ingredients you want to use, see how their copy gets around making claims whilst inferring it's beneficial.

Agree, pay attention to claims and intended use statements. Not just in the copy but also in instructions for use and all forms of labelling.

“Essential Oils” and “Aromatherapy”

There is no regulatory definition for “essential oils,” although people commonly use the term to refer to certain oils extracted from plants. The law treats Ingredients from plants the same as those from any other source.

For example, “essential oils” are commonly used in so-called “aromatherapy” products. If an “aromatherapy” product is intended to treat or prevent disease, or to affect the structure or function of the body, it’s a drug. To learn more, see “Aromatherapy.”

Similarly, a massage oil intended to lubricate the skin is a cosmetic. But if claims are made that a massage oil relieves aches or relaxes muscles, apart from the action of the massage itself, it’s a drug, or possibly both a cosmetic and a drug.
Source: Fragrances in Cosmetics
 

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