In today’s video, we help you further understand some of the important FDA rules around labeling your cosmetics product.

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you every day, navigate the very complex terrain of healthcare and FDA legal issues so that they can launch, or continue to scale, their health and wellness product.

So what information is required on cosmetic labels?

There are two main places where the information is stored: the Principal Display Panel (or PDP), and the Information Panel.

On the PDP, you must have the following information.

1. An identity statement, indicating the nature and use of the product, by means of either the common or usual name, a descriptive name, a fanciful name understood by the public, or an illustration.
2. An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure. Very specific, as you can see.

On the Information Panel you must have the following information:

1. Name and place of business. This may be the manufacturer, could be the packer, the distributor. The information must include the street address, city, state, ZIP Code. The rules says you may omit the street address if it is listed in current city directory or phone directory.
2. Distributor statement. If the name and address are not those of the manufacturer, which is often the case, the label must say “Manufactured for…” or “Distributed by…,” or similar wording expressing the facts. This has come up a lot with distributors.
3. Material facts. Failure to reveal material facts is one form of misleading labeling and therefore makes a product misbranded. An example is directions for safe use, if a product could be unsafe if used incorrectly.
4. Warning and caution statements. These must be prominent and conspicuous. The caution statements, there are some that are very specific that are in the regs. Cosmetics also that are hazardous to consumers have to bear appropriate label warnings. So for example, flammable cosmetics – you got to flag that.
5. Ingredients. If the product is sold on a retail basis to consumers, even if it is labeled “For professional use only” or words to that effect, the ingredients must appear on the information panel, in descending order of predominance. Remember, if the product is also a drug, like you could have a shampoo that’s also for dandruff, it must comply with the regulations for both OTC and cosmetic ingredient labeling.

Now, these are hodge-podge of general rules, and know that there are also specialized rules for particular types of claims that require special handling. So for example, FDA has special rules for anti-aging and wrinkle claims, since, these claims can often cross the line into drug claims, especially wrinkle claims.

Products intended to help people be more attractive generally are cosmetics. Skin moisturizing cream, moisturizing claims are among the most common types of cosmetics claims and you’ll find them all over the shelves.

If a product is intended to make wrinkles less noticeable, simply by plumping your skin, made by moisturizing it, it’s a cosmetic. Similarly, makeup or “primers” intended to make the signs of aging less noticeable just by hiding them are also cosmetics.

But, products intended to affect the structure or function of the skin, or the body, are drugs, or sometimes they could be medical devices, even if they affect the appearance because you could have a combination device which is both a drug and medical device.

Again, these are distinctive legal definitions and cosmetics is legally defined so as drug, so the consequences of breaking this risk could be very serious, that’s why I encourage you to have an FDA review every single claim because there are fine lines and wrinkles on this claim and they bear legal review.

Thanks for watching. Please contact us with your questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. Here is to the success of your healthcare venture, keep a lot of people looking youthful and we really love the cosmetics industry, we look forward as always to connecting with you soon.