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Is Your Product Label Up to Code?

Posted by Lisa Capote | May 01, 2017 | 0 Comments

The FDA strictly regulates what you put on your product label if you're manufacturing or selling dietary supplements. Recently, a popular essential oil and aromatherapy company came under FDA fire for claims of treating and curing diseases. 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 786.871.5680,

About the Author

Lisa Capote

Ms. Capote represents various domestic and international corporate clients from Fortune 500 companies to small businesses and entrepreneurs  with corporate matters and regulatory compliance issues. As outside general counsel, Ms. Capote assists clients with contract negotiation, dra...

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