The FDA recently issued a small entity compliance guide (SECG) for its final rule on nutrient content claims for omega-3 fatty acids. The SECG reiterates that, after several seafood processors and ingredient suppliers filed notifications of omega-3 fatty acid claims, FDA reviewed the underlying evidence and decided to allow several claims for ALA, but prohibit many other claims.  The following are the allowed ALA claims. 

  • “High” for ALA (must provide at least 320 mg/serving)
  • “Good Source” for ALA (must provide at least 160 mg/serving)
  • “More” for ALA (must provide at least 160 mg/serving more than reference food) 

FDA rejected “high” claims for EPA, DHA, and a combination of EPA and DHA.  It also rejected ALA claims that were based on a different daily value calculation than the allowed claims.

In the past year, the FDA has issued four warning letters alleging that companies used unauthorized nutrient content claims for omega-3 fatty acids. Two letters were to sellers of fish products. One was to a company selling chia waffle and pancake mix. The fourth letter was to a company selling macaroons.