FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims for Omega-3 Fatty AcidsApril 28, 2014
By Ricardo Carvajal –
FDA issued a final rule that prohibits nutrient content claims for the omega-3 fatty acids DHA and EPA, as well as certain nutrient content claims for ALA. The final rule carries through on the proposed rule issued in November 2007 with no substantive changes (see our prior posting on the proposed rule here).
With respect to the notified claims for EPA and DHA, FDA determined that the notifications submitted to the agency did not meet the statutory requirement of referencing an authoritative statement that identifies the nutrient level to which the claims refer. The notifications referenced certain statements included in an Institute of Medicine ("IOM") report on dietary reference intakes, but FDA found that those statements “do not reflect a recommended or defined intake level of DHA and/or EPA that could serve as a basis for setting a DV that could be used to characterize a given level of DHA and/or EPA.” As partial support for that conclusion, FDA noted that the three notifications “reflect different readings” of the statements in the IOM report.
With respect to ALA, the IOM report identified several adequate intake levels (AIs) specific to subgroups in the population. One notification submitted to FDA proposed nutrient content claims based on a population-weighted AI (essentially an average of the AIs identified by the IOM). Another notification proposed nutrient content claims based on a population-coverage AI (essentially the highest AI identified by IOM). FDA deemed the nutrient content claims based on a population-weighted AI to be impermissible, but is “taking no regulatory action at this time” with respect to nutrient content claims based on a population-coverage AI – the same approach used by FDA to derive reference values for other nutrients. The final rule provides a helpful table of the nutrient content claims for ALA that “will be allowed to remain on the market at this time,” copied below.
Nutrient Content Claim for ALA
Conditions For Making the Claim
≥ 320 mg of ALA per RACC (≥ 20% of 1.6 g/day)
≥ 160 mg of ALA per RACC (≥ 10% of 1.6 g/day)
≥ 160 mg of ALA more per RACC than an appropriate reference food (≥ 10% of 1.6 g/day)
A footnote to the table reminds industry that “nutrient content claims must comply with all applicable FDA regulations regarding the making of such claims.”
In response to the proposed rule, FDA received comments contending that the agency’s prohibition of certain nutrient content claims for omega-3 fatty acids would violate the First Amendment. The final rule includes an extensive rebuttal of that contention. FDA’s position is that the use of defined terms such as “good source” in a manner that does not comply with their regulatory definitions is inherently misleading – if not false – and thus not entitled to First Amendment protection (FDA nonetheless includes a Central Hudson analysis for good measure). FDA also concludes that there is no disclaimer that can cure the “fundamental” flaws or contradictions of the proposed claims.
To facilitate a transition period for currently marketed products, the rule will not take effect until January 1, 2016.