Listing omega-3 fatty acids on new Supplement Facts labels

CRN Member query:

“Can you offer some guidance on a couple of questions we have about the new Supplement Facts labeling requirements? Is it necessary to list the form of the omega-3 fatty acid(s) present in fish oil products? Also, can we update our Supplement Facts labels before the 2020 compliance deadline?”

CRN's Andrea Wong, Ph.D., responds:

In accordance with FDA’s new requirements for Supplement Facts labels on dietary supplement products, companies do not have to identify the specific forms of omega-3 fatty acids present in fish oil products. Forms are often listed for marketing purposes, but are not required.

You are more than welcome to roll out updated Supplement Facts labels at your discretion prior to January 1, 2020, as long as all newly-manufactured products have updated labels by this compliance date. In fact, many companies have already started doing so. Note that manufacturers with $10 million or more in annual sales must comply by 2020, and manufacturers with smaller annual sales have until 2021.

I recommend contacting a third-party regulatory consultant to review new labels for compliance. CRN can connect you with regulatory consulting member companies if you would like—contact Rashidah Denton for more information.