An Almond Doesn’t Lactate

Last month, pointing out that “almonds don’t lactate,” FDA Commissioner Scott Gottlieb announced that the FDA will soon issue a new guidance on the use of the term “milk.” Currently milk is defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows” or goats.1 Let’s put that all together. Since … Read More

Are Your Color Additives Legal?

As I’ve discussed in previous posts (here,  here and here) color additives are a major concern for the FDA. Certain color additives are subject to certification by the FDA before they can be used. Using one of those colors that is NOT certified causes your product to become “adulterated” (and therefore illegal to sell). So how do you know if … Read More

If One, Then All?

“If you put one ingredient on your soap label, you have to list them all” is an idea is being bandied around a lot lately.  But is it true? As with most questions about legal stuff and regulations … yes … and no. Cosmetics If the product is a cosmetic, then the answer is a resounding YES. Not only do … Read More

Natural Colorants, More

Since my last post about natural colorants I’ve gotten some questions about using ingredients that change the color of the soap or cosmetic but that really wasn’t the point of the ingredient. Lets review the definitions.  I’m just including the important bits, and bolding the really important bits. Color Additive Any material that is capable of imparting a color to … Read More

Trade Secrets

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

Looking for Product Drug Claims

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

Anti-Aging, Rejuvenating, and Repairing Claims

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

Color Additives for In-Bath Products

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