B. Why Are Nutrient Content Claims for ALA Based on a Population-
Weighted Approach Prohibited By the Rule?
We are prohibiting the nutrient claims for ALA set forth in the seafood processors notification
because the claims were based on a reference value that was determined by a different approach
than reference values already established for other nutrients (i.e., DVs). The FD&C Act requires
that a claim based on an authoritative statement have a nutrient level identified in the statement
and be stated in a manner that enables the public to comprehend the information provided and to
understand the relative significance of such information in the context of the daily diet (section
403(r)(2)(G)(iv) of the FD&C Act). There were two different approaches to set a reference value
in the notifications for ALA (i.e., the population-weighted approach
2
used in the seafood
processors notification and the population-coverage approach
3
used in the Martek notification).
We determined that using two different approaches to set a reference value for ALA would result
in inconsistent and conflicting nutrient content claims on food labels. Such inconsistencies make
meaningful product-to-product comparisons impossible. To enable the public to comprehend the
information provided in nutrient content claims and to understand the relative significance of that
information in the context of the daily diet, as required by section 403(4)(2)(G)(iv) of the FD&C
Act, qualifying ALA levels for nutrient content claims in food labeling must be based on a single
nutrient value determined using the same approach for reference values for other nutrients, which
is currently the population-coverage approach established in the 1993 final rule for determining
DVs (58 FR 2206, January 6, 1993). Therefore, to prevent inconsistent and conflicting claims on
food labels, we are not taking regulatory action with respect to ALA claims based on the
population-coverage approach, but are prohibiting claims based on the population-weighted
approach.
C. Which Nutrient Content Claims for ALA Are Allowed to Remain on
the Market?
The rule explained that FDA is taking no regulatory action with respect to the nutrient content
claims for ALA based on the population-coverage approach set forth in the Martek notification.
4
2
This approach looked at the various adequate intake levels (AIs) that the IOM identified for different age and
gender groups (excluding children under 4 years of age and pregnant and lactating women) and averaged out all of
those numbers taking into account the predominance of the various groups within the population, to arrive at their
label reference value (79 FR 23262 at 23263).
3
This approach used the highest Recommended Daily Allowance (RDA) or AI for adults and children 4 or more
years of age (excluding values for pregnant and lactating women) to serve as the label reference value (79 FR 23262
at 23263).
4
The Martek notification proposed ‘‘high,’’ ‘‘good source,’’ and ‘‘more’’ claims for ALA. The notification
proposed the following exact words for these claims:
‘‘ ‘Excellent source of ALA.’ (‘High in ALA,’ ‘Rich in ALA’) Contains l mg of ALA per serving, which is
l % of the 1.6 g Daily Value for ALA.’’ [Products would need to contain at least 320 mg of ALA per
RACC to qualify for the claim.]
‘‘ ‘Good source of ALA.’ (‘Contains ALA,’‘Provides ALA’) Contains l mg of ALA per serving,
which is l % of the 1.6 g Daily Value for ALA’’ [Products would need to contain at least 160 mg of
ALA per RACC to qualify for the claim.]