Federal program may suspend exports of fish oil supplements, GOED warns

By Hank Schultz

- Last updated on GMT

©Getty Images - batuhan toker
©Getty Images - batuhan toker

Related tags Fish oil supplements EPA and DHA Fish oil Omega-3 fatty acid Omega-3s regulations

A fast developing regulatory issue has the potential to throw a wrench into the works of the fish oil supplement trade, a trade group has revealed.

In a notice last week the Global Organization for EPA and DHA Omega-3s (GOED) made members aware of a developing hitch in the supply chain for finished fish oil supplements. The notice said the Seafood Inspection Program (SIP), a division of the National Atmospheric and Oceanographic Administration (NOAA), is planning to suspend export licenses for encapsulated fish oils effective May 1, 2022.

Issue with complexity of supply chain

Steven Wilson, the division chief of SIP’s Office of International Affairs, Trade, and Commerce, sent a memo​ to GOED and other registered stakeholders stating that certifications would no longer be available for encapsulated fish oil products.  The SIP certification is intended to verify that the fish species stated on export labels truly represent what’s in the packages.  In other words, if customers are paying for grouper, the SIP approval assures that’s what they’re getting and that the products are safe and were processed in accord with federal regulations.  The SIP certification also extends to shellfish and ‘fishery products.’

Wilson said  because SIP is not party to all parts of the encapsulation process, in which bulk oils may be shipped to an encapsulation facility and then on to another location for bottling and labeling, it cannot verify that the species mentioned on the labels (in most cases these would be anchovy, sardine, mackerel or tuna oils) are what are actually in the bottles. 

In the memo Wilson said SIP is being “requested to certify the product after it has already been encapsulated and packaged without any first-hand knowledge of the process involved in the production and formulation of the shipment.”

Wilson noted that bulk fish oil shipments, which represent a simpler chain of custody equation, would not be affected.

Encapsulated oils have been an issue in the past

This is not the first time the issue has come up.  In 2014 exports of flavored fish oils were briefly suspended​ because NOAA had construed the addition of a plant-based flavoring agent to make the result into a ‘combination product’ and not a fishery product.

Harry Rice, PhD, GOED’s vice president of scientific and regulatory affairs, said the current issue remains to be resolved.  Wilson set a hard deadline for the action in the apparent hope to drive a quick resolution of the issue and to not leave the industry hanging.  “He set the date for the imminent suspension in order to get some attention around the issue and to resolve it quickly,” ​Rice said.   

Rice said the relevant official at FDA had been on vacation until earlier this week.  Rice said he had been in contact with the Agency yesterday but did not get as much clarity on what the near term future holds as he had hoped, but he said GOED will be involved in the process on a continuing basis going forward.  GOED did say in its notice to members that Wilson seemed open to extending the deadline.

“Members are looking to us to resolve this issue.  Nobody saw this coming,” ​Rice said.

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