You’ve developed the perfect product and you want to keep the formulation secret. Can you hide some of the ingredients? Well, yes and no. Trade Secret Any formula, pattern, device or compilation of information which is used in one’s business and which gives him an opportunity to obtain an advantage of competitors who do not know or use it. The … Read More

When we talk about “drug claims” we are actually talking about the statements that tell the consumer that product is intended to be used to diagnose, mitigate, treat or prevent disease or to change the structure or function of the body. How does the FDA determine the intended use of a product? Where do they look? Recent Warning Letter Sometimes examples … Read More

In 1988, the FDA issued Import Alert 66-38 titled “Skin Care Products Labeled as Anti-Aging Creams” which clearly stated that exaggerated ‘anti aging’ claims could cause a product to be an unapproved new drug.  Import Alert 66-38 was the basis for understanding restrictions on cosmetic claims like anti-aging, rejuvenating and repairing. That Import Alert was withdrawn at the end of … Read More

The FDA regulates color additives and their use. For cosmetics, the FDA has a list of color additives permitted for use in cosmetics and each color additive has specifications on how it may be used: “Eye Area” means the area around the eyes. Which is the area from the brow to eyelids, lashes, eyeball and area just under the eye. Color additives … Read More

Even though the requirements for the street address on the label are pretty clear cut, it still seems to be an issue for those working out of their homes. The street address IS required on the product label, but may be omitted under certain circumstances (the city, state and zip code are always required).  The regulations that define those “certain … Read More

The FDA has finally stated, clearly and definitely, that “love” isn’t an ingredient … at least in granola. Recently the news and social media have been filled with articles about the FDA’s recent warning letter to a bakery in Concord, Massachusetts, in which they were cited for (amongst other things), including “love” which is “not a common or usual name … Read More

The EPA website has been updated since the last time I looked at it. It still wasn’t too easy to find the Minimum Risk Pesticides page, but once I found it, I discovered it was much clearer and easier to understand than before the updates. Of course, the information and regulations haven’t changed – but it is a little easier … Read More

The FTC has issued the final rule for updating some aspects of their labeling regulations, including the requirements for the business name and address. Note that these revised regulations will apply to non-cosmetic items, including to soap that is exempt from the definition of a cosmetic (see Soap, the Chameleon). The updated regulation concering the business name and address is updated … Read More

As you can probably imagine, I am on a lot of Facebook groups. I see many, many pictures of labeled soap and cosmetics. People send me soap labels to look at; they ask for my advice. I have a label review service. The net result is that I see a HUGE number of labels. Why do I mention that? Because … 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)?

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