Cell-based or cell-cultured seafood products (seafood products grown in a bioreactor from tissue specimens from fish / seafood) are not yet commercially available, but the FDA is working to decide how they will be labeled.  Last October the FDA announced that it was seeking comments from the public to determine what regulatory action it should take to ensure that cell-based seafood products are properly labeled when they become available.  The FDA comment period ended on March 8, 2021, after 35 comments had been submitted.  What the FDA does with these comments and any regulatory action it takes with regard to cell-based seafood products will be notable, because, undoubtedly, it will offer guidance for rules which may later be adopted for the labeling of cell-based meat, poultry, etc.

The FDA’s Questions

The FDA posed a number of specific questions for comment, but the general gist was:

• Do we need to explain to consumers how these products are produced?

• What should we call cell-based seafood products?

• How do we distinguish cell-based products from conventional seafood products?

• Do we need to create new categories for describing the cell-based seafood products?

• What characteristics (such as taste, nutritional profile, texture, aroma) are material to consumers when comparing conventional seafood to cell-based products?

The Comments

There were several comments from individuals, but most were from either companies that hope to produce and sell cell-based seafood or meat products, industry groups that represent conventional seafood or meat producers, or consumer groups.  Predictably, the nature of the group making the comment was instructive in the recommendations made by the group.  However, a couple of areas of agreement were evident:

• Because some consumers have allergies to certain types of seafood, the species of the seafood used to make the cell-based product needs to be identified.

• There should be uniformity between the FDA and USDA¹ in labeling practices for cell-based products (including meat, poultry, etc.) because inconsistent labeling requirements between the FDA and USDA would confuse consumers.

Most commenters, but not all, agreed that consumers should be informed as to how the cell-based products are created.  A consensus of commentators thought the term “cell-cultured” or “cell-based” should be used to describe the products.  However, the National Milk Producers Federation disagreed with the use of the word “cultured” to describe seafood or meat created in laboratories because it could create confusion with the term “cultured” as used in certain dairy products, such as yogurt.

There was disagreement over whether cell-based products should be permitted to be labeled as “fillets” or “steaks” as flesh harvested from fish are labeled or whether some other term should be used.  Most commenters suggested using the common name of the seafood in conjunction with an identifier, such as “cell-based” or “cell-cultured” to distinguish the laboratory created seafood products from conventional seafood.

One area that was acknowledged by various commenters (particularly those involved in the production of conventional seafood, meat, and poultry) as an unknown is whether the cell-based seafood, meat, and poultry will have the same taste, texture, nutritional profile, etc., as traditional seafood, meat, and poultry.  The possibility of genetic modifications to cells used to create cell-based products and how genetically modified cell-based products, if created, would be labeled is another consideration.  

A couple of commenters recommended that the FDA issue a Compliance Policy Guide (a document that explains the FDA’s strategies and policies to be followed in evaluating compliance with the FDA’s regulations) for cell-based seafood.  Another commenter urged the FDA to create a pre-market label approval process for cell-based seafood products.

The Future

What the FDA decides to do with labeling of cell-based seafood products remains to be seen.  While no cell-based seafood or meat products are yet approved for sale in the United States, it seems inevitable that they are coming.  We just have to decide how they are going to be labeled.

¹ The FDA regulates the labeling of seafood, including most fish, except catfish.  The USDA regulates the labeling of meat, poultry and eggs, as well as catfish.