This is a clear violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Here’s what you need to know about what you should — and shouldn’t — be putting on your product labels.
What Needs to Be on Your Product Label
The product label, in addition to your logo and marketing content, should have a Primary Display Panel. The Primary Display Panel should have:
- Statement of Identity — this is simply a statement of what the item is. It generally uses the most commonly recognized names for an item.
- Statement of Net Quantity — your PDP should state the net quantity of your product contained within the packaging. Depending on what your supplement is, you can display net quantity in weight, measure, or both.
- Ingredients List — this is perhaps the most crucial component of your Primary Display Panel. Your ingredients should be listed prominently on the package. Arrange them in order of greatest amount used within the product to least amount used.
- Nutrition Information — your label should contain any nutrition information that is applicable to your product. This labeling requirement is very similar to food labeling requirements, since dietary supplements are typically ingested.
- Contact Information — the FDA requires that the product manufacturer or distributor’s name, address, and other contact information is displayed prominently on the label.
What Not to Include on Your Product Label
While there are some things that you absolutely want to be sure is on your product label, there are a few things that you want to leave out. Namely, any claims or guarantees that the product will do a certain thing. For example, if you are manufacturing a weight loss supplement, you do not want to guarantee weight loss on your packaging. Also, if you are selling an essential oil, you don’t want to make any claims that the oils treat or cure diseases or illnesses.
When to Contact an Attorney
It’s always in your best interest as the manufacturer of a product that is regulated by the FDA in some way to have the label examined by an experienced attorney. At FDAlaw.net, we can help you ensure that your label meets FDA requirements and leaves out anything that could potentially cause you to be sent a warning letter. Contact us today for a consultation by calling.
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“Cosmeceutical” is a marketing term, not an FDA category. Your claims decide whether your product is a cosmetic or an unapproved drug. Capote Law Firm reviews skincare claims before they become warning letters.
“Cosmeceutical” is a marketing term, not an FDA category. Your claims decide whether your product is a cosmetic or an unapproved drug. Capote Law Firm reviews skincare claims before they become warning letters.
“Cosmeceutical” isn’t a legal category — and using it can turn your cosmetic into an unapproved drug. FDA recognizes only two categories: cosmetics and drugs. Your claims decide which one you’re in.