FDA Compliance In The Natural Product Business
Many of us who lead a natural and organic lifestyle know the benefits of natural products, and how effective natural choices can be. With the rate of growth in the natural product sector, the FDA is paying closer attention than ever to claims made by natural product companies, including Essential Wholesale & Labs. Essential Wholesale & Labs dedicates a significant amount of time every month to researching FDA regulations and to understanding how they apply to our business.
We have recently completed an audit of all our library articles and product descriptions for compliance. You may notice some information just doesn’t have the substance it used to have. This is due to our efforts to be in compliance with FDA regulations as a cosmetic manufacturer. You may find it helpful for your own compliance efforts to know the reasons you are seeing these changes.
Essential is a cosmetic authorized manufacturing facility, which means we cannot make any claims that would lead the general public to believe that Essential’s products would cure, prevent, treat, or otherwise mitigate any condition or disease. These are considered “drug claims” and are prohibited by FDA regulations. We have worked to remove any content that could be considered a claim on products and ingredients. We have also revised the Essential Educational Library and Blog pages removing any content that is considered to be a claim by the FDA. This resulted in the removal of more than 300 blog postings and a great portion of the Library. We’ll be adding back content in the coming months to keep this valuable resource relevant to you.
You may have noticed that products or ingredients we offered in the past are no longer available, or they might be renamed. For instance, Sunbutter Crème. The name alone is considered a drug claim only because a consumer might assume from the name that the crème is a suncare product, and one of the ingredients is considered a drug as it is used as an active ingredient in sunscreen formulations. Our very popular Bug Off Essential Oil Blend was renamed to Don’t Bug Me Essential Oil Blend and the photo of a mosquito correlating to it was removed.
What this means for you:
Labeling – The FDA Cosmetic Labeling Guide is an excellent resource and states “The cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations published by the Food and Drug Administration under the Authority of these two laws.” The guide also defines a cosmetic – “A cosmetic is a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance”. If you work with an Account Executive in our custom formulation area, you already know that Steven, our Compliance Coordinator is now reviewing your custom product labels to make sure they are in compliance with FDA regulations.
Essential Wholesale & Labs has deep and vast knowledge and experience with natural ingredients. FDA regulations prohibits companies like ours from sharing that expertise. Essential is even prohibited from providing you with any resources such as links and articles to aid you in your research.
The good news is that with our expertise on compliance, we are more confident than ever that we can help you avoid those FDA prohibited claims. While we cannot provide information on ingredients and their time proven efficacy, we enthusiastically encourage you to research ingredients and their well known effects. With a wealth of information so readily available at our fingertips, finding facts about natural products and ingredients is easier than ever.