Michael H. Cohen: Dietary Supplements and Natural Products

Hello, my name is Michael H. Cohen. I’m principal of the Cohen Healthcare Law Group in Beverly Hills, California. My law firm represents dietary supplement manufacturers and distributors. There are at least three things you need to be concerned about if you are a dietary supplement manufacturer or distributor.

Number one, claims.

Number two, labeling.

Number three, substantiation.

Claims are a very critical area, under the Dietary Supplement Health Education Act or the DSHEA, you can make structure function claims, you cannot make disease claims. Sometimes it’s difficult to distinguish between the two. For that reason, you need expert legal counsel to review your claims to be sure that they’re not prohibited under the DSHEA.

Labeling is highly complex, specific and nuanced. You want to be sure that those labels that go on the back of the bottle or on the package are 100% compliant with what the FDA and the FTC require. Three, you’ll want to have a backup file substantiating all of the claims that you make on your website, in your marketing materials and on the product. Remember that your marketing materials can be considered part of the labeling. So you’ll want to be compliant with FDA, FTC and other legal rules in all respects.