In today’s video, we discuss some key questions that clients bring to us when they have a new dietary supplement or cosmetic.

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate healthcare and FDA legal issues and either launch or successfully scale their health and wellness business.

Here is a fairly typical client consultation.  The client says for example: “I have four products – a facial cream, a hair product, a deodorant, and an herbal formula for weight loss. What do I do?”

The first thing you need to know here is that it’s important to understand how FDA will classify each of these products, from a regulatory perspective.  A product that claims to treat a skin condition will probably be considered a drug—possibly OTC or over-the-counter; whereas for example a product that only claims to beautify or moisturize your skin will be probably just be considered a cosmetic.

A lot depends on what you say the product can do.  So the claims that you make are very important to regulatory classification.

We’ve seen many companies in the FDA-regulated space invest tens, if not hundreds, of thousands of dollars into marketing, not realizing that they are pouring money into marketing a product that’s going to be regulated as a drug, and not as a dietary supplement or cosmetic.  So they get surprised when FDA issues a warning letter and then steps up enforcement, perhaps even seizing the product, say perhaps even seizing hundreds of thousands of dollars of inventory.

FDA has very technical rules about what must go on the label of the product.  For example, the name and place of business.  The rules are so dense here, that for example, there even a rule that says: “You must include the street address, city, state, and ZIP Code. You may omit the street address if it is listed in a current phone directory or city directory.” Very, very specific. This rule is in 21 CFR 701.12(a).

The rules about what goes on the label are very technical, and, they are not the same as the rules about claims.  If you make a drug claim, then your product is labeled as a drug.  And there are at least ten different ways that FDA says you can make a drug claim, inadvertently.  Most of these are “implied claims,” meaning, although the claim doesn’t say, “we expect this product to work like a drug,” FDA can basically imply a therapeutic promise, or drug claim, from the words, or images, or symbols used for the claim.   For example, if you have a picture showing wrinkles going away, that could be an implied claim to remove the wrinkles, as opposed to simply moisturizing the skin to make the wrinkles less noticeable.

Reviewing claims can take a fair amount of work, since dietary supplement and cosmetics manufacturers and distributors rarely stick to one or two, or even three claims.  Typically, they say many, many things about their product, and the more you say, the more that needs review.

Thanks for watching. If you still have questions, please contact us, click on the link, cohenhealthcarelaw.com/contact.  Here’s to the success of your healthcare venture, we look forward to speaking with you soon.