The FDA just published a warning letter to a cosmetic manufacturer in St. Louis. Once again, the FDA reviewed the website and cited drug claims: “…the claims on your website establish that the products are drugs under the … Food Drug and Cosmetic Act … because they are intended for use in the cure, mitigation, treatment, or prevention of disease … Read More
I have a wonderful Facebook feed and see an amazing number of soaps. All sorts of soaps … cold process, hot process, melt & pour, swirled, layered, piped, molded, embossed, stamped – you name it! I also see packaged soaps galore. While the traditional cigar band label is most common, soapmakers have also put together some different kinds of very creative … Read More
Some stunning hybrid soap can be made by combining two different types of soaps into one artistic bar. The problem is, how do you figure out the ingredient declaration when you have a CP soap with MP soap embeds (or vice versa)?
Soap is a chameleon – it can be many things depending on what you claim it can do. It is the CLAIM that determines what the product is, and that, in turn, determines what REGULATIONS/LAWS apply. Soap can be a drug: if you make claims that it (or any of the ingredients in it) is intended to treat physical issues (eczema, … Read More
Babyganics is now the last in a long line of cosmetic companies sued for false advertising over organic-type claims. Last month there were two suits filed against Babyganics, one for falsely advertising and implying their products are organic and one by a mom who alleged that her toddler sustained chemical burns from Babyganics tear-free shampoo. I wrote a couple of years … Read More
The FDA just updated their Warning Letters Address Drug Claims Made for Products Marketing as Cosmetics Claims page with yet more warning letters. That makes twenty-five warning letters issued so far in 2016 (and of those 18 were issued in just the last 3 months!). Compare that to nine warning letters in 2015 and only two issued in 2014 and it’s easy … Read More
When you say that an product ingredient can heal, you are making the same claim for the product itself, so it becomes an unapproved new drug. As a perfect example, the FDA issued a warning letter to Sevani Botanica in mid-July in which most of the cited issues had to do with statements made about the essential oils in the products. … Read More
When describing your product, keep in mind that the whole point of “claims” is that they are providing information to the consumer about the intended use. Technically it’s not the claim, but what the consumer perceives to be the intended use of the product that determines whether it is a drug or cosmetic. If your product description, customer testimonials or … Read More