FDA Upping Their Game for Cosmetics

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

Healing Claims for Ingredients

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

Claims and Intended Use

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

What’s in a Name?

Once again we’re discussing ingredient names, but this time in the name or identity of the product, not in the ingredient declaration. It can get a little tricky because there are different regulations for cosmetics and for soap that is exempt from the definition of a cosmetic.  See Intended Use – Know Before You Go and Melt & Pour Soap: Soap or … Read More

Intended Use – Know Before You Go

It is the intended use  of the product that determines what it is. Oddly enough, it can be the exact same product formulation, but it could be classed as different types of products depending on what you say is its intended use. What is it? If the intended use is… To cleanse and it is marketed only as “soap” It … Read More

Roaming the Back Roads

In order to not confuse our travel adventures with my posts on Labeling and Good Manufacturing Practices (and in order to give Jere a place to post about our travels), we have started a new blog just covering our travel adventures. Come join us at Roaming the Back Roads (www.roamingthebackroads.com). You can find maps, summaries of our trip, pictures of … Read More

Brexit and Cosmetics

If you are following international news, you probably heard that Brexit was approved and Great Britain will be leaving the European Union.  What does that have to do with cosmetics? Well, honestly, I don’t know all the ins-and-outs of how the process of their leaving the EU will work, but I was struck by a couple of lines in an article The Daily … Read More

Toxic Substance Control Act Reform 2016

If you’re following chemical news, you may have heard that reforms of the Toxic Substance Control Act of 1976 were just signed into law by President Obama.  A pretty concise summary of the changes in existing law is available here. In very, very brief summary, the revisions to the TSCA passed in 1976 include giving the EPA authority – and a … Read More