Elexes has created numerous supplement fact sheets for dietary supplements, the nutritional label for foods, and has also reviewed labels of cosmetic products to make sure that there are no drug claims.

Few months ago, two companies reached out to us. One was a cosmetic company and the other, a food product company. The cosmetic company client got a warning from the FDA about making drug-related claims, so they wanted to make all their product labels FDA, TGA, MHRA compliant. Whereas, the food company needed several FDA-compliant fact sheets. We took on both the projects and can proudly claim that we successfully completed them.

We made 20 supplement fact sheets for the food company. The only information that we needed from the client was their supplement material specification and formulation sheet. For creating the supplement fact sheets, we took into account FDA’s daily recommended values, leveraged our experience with similar data and decided what special regulations need to be taken into account for pregnant women and children. Our turnaround time for all the 20 fact sheets was 5 days.

Now let’s talk about our second client. For the cosmetic company, we reviewed all the labels, manuals, content on the website, and advertising and promotional material to make sure that they are complying with applicable regulations. We retracted and reworded many claims which implied that the cosmetic product was affecting the structure or function of the body, or that it had a therapeutic or pharmacological action. Some redacted or restructured claims were “The ABC oil is used for massaging, it provides instant pain relief by acting on sore muscles”, “The XY anti-wrinkle cream rejuvenates your skin and makes you look 20 years younger”, “The hair shampoo makes your hair stronger” and “The mouth wash reduces plaque or tartar”. These were replaced by acceptable cosmetic claims such as – “The XY cream moisturizes skin, covers up age spots and makes you look younger”, “The hair shampoo adds body to hair and makes them fuller and thicker”, and “The mouth fresh reduces bad breath or mouth odour”

Elexes takes great pride and pleasure in helping food and cosmetics companies to prevent FDA or global regulatory warning letters or notices by providing proactive solutions for complying with regulations.

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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