FDA Info

Our products are meant to be used strictly for cosmetic or cleansing purposes and have not been evaluated by the FDA for safety or efficacy. Our products are made from some materials that are not solely regulated by federal agencies and many are considered supplements. As such, any statements made regarding our products have not been evaluated by the Food and Drug Administration and are therefore not intended to diagnose, treat or prevent any disease or medical condition. Please refer to your doctor or other health care provider for assistance with medical concerns or for the treatment of medical conditions.

Our products are intended to help you feel beautiful and clean while supporting a healthy lifestyle and the planet. We hand make all of our products using guidelines set forth by the FDA known as Good Manufacturing Practices, or GMP’s. These guidelines spell out quality control standards and procedures as well as certain methods that ensure you get a clean, quality product every time.

The GMP standards come easily to our company, as our founder worked in biomedical/pharmaceutical research for many years and was subject to a much stricter set of FDA standards known as Good Laboratory Practices (GLP’s). The FDA regulates several different constituents within cosmetic products. They don’t regulate products specifically for the purpose of cleansing the body, so soap products are not included in their regulatory activities and are not considered cosmetics. All other products intended to promote beauty or enhance the appearance of the body such as moisturizers, serums, face oils, etc are included in the FD&C Act. If there are ingredients in a product that also provide physiological actions and therefore act as a drug, ie, sunscreens, topical antifungal treatments they must be clearly and uniformly labeled and the active ingredient(s) must first be approved by the FDA prior to inclusion in said product. They are also particular about colorants. They maintain a list of approved ingredients that are allowed to be used for the purpose of coloring cosmetic products. This gets a little hairy because many skin safe and other products that are taken as oral supplements are not on the approved list and cannot be considered the colorant of the formula.

We carefully follow all of the guidelines and laws that the federal statute includes, GMP’s, labeling requirements and others, even for our soap and cleansing products. Because of this, you may notice warnings or other generic information on our products, these are likely due to the FDA’s labeling requirements although some may simply be important information from us. We want you to be an educated and informed consumer. There is an ocean full of skincare products out there and it can be a bit overwhelming when it comes time to choose. We are trying to pull the curtain back so that you are aware of how the industry works, the ingredients, as well as the products themselves before you purchase.

If you ever have any questions or concerns about anything on our website please feel free to contact us.

• help@plumeraessentials.com
• 9 N. Loudoun St.
• Suite 300A
• Winchester, VA 22601
• (540) 692-9470